Q4 2019 Earnings Call
[music] welcome to the five Prime therapeutics fourth quarter and full year 2019 earnings call.
As a reminder, this conference call is being recorded I'd now like turn to use your host for today's conference call Martin Forest, Vice President Investor Relations and corporate Communications you may begin.
Thank you Sonia good afternoon, everyone and thank you for joining US here today, a press release for the company's fourth quarter and full year 2019 financial results was issued earlier today. It can be found on the company website. Joining me today are building go or chairman and interim Chief Executive Officer.
Helen Collins, Chief Medical Officer, and David Smith, Our Chief Financial Officer. Today's conference call will include forward looking statements under the private Securities Litigation Reform Act of 1995, including statements regarding our research and development programs and financial outlook actual results may differ from those indicated by these forward looking statements due to numerous factors.
Including those discussed in the risk risk factor section of our FCC filings, our expectations and assumptions could change while we may elect to update these forward looking statements in the future we specifically disclaim.
Any obligation to do so even if our views changed I'd now like turn the call over to Bill.
Thank you Martin and good afternoon to all and thanks for joining us today to review our achievements over the past year with a focus on the fourth quarter.
Had a pretty view of our goals for 2020.
Last year, we made the difficult, but correct decision to restructure our company.
We did this to preserve cash resources, so we could take our clinical and late stage research programs.
And beyond near term milestones.
I'm pleased to say that we have largely implemented the restructuring program and we are in a position where our cash runway extends into 2022.
Turning to this year, we're focused on generating clinical data from our proprietary programs and growing our pipeline internally and through asset acquisition.
We're on track to achieve the data milestones this year from three programs starting with Bema, we expect a sufficient number of events will occur to trigger of utility analysis.
And the fight trial in mid 2020.
We remain on track to generate data by mid this year from the phase one combination of M. P. A 150, plus good trued up in a cohort of patients would be seven AIDS for overexpressing ovarian cancer.
We also expect to generate early monotherapy efficacy data in late 2020 from the M. P. T 155 program.
How long will provide additional details about these milestones later on the call.
Growing our pipeline is also a key focus for this year. In addition to our programs in clinical development. We are advancing three novel late stage research programs and we're on track to bring one new program into preclinical development later this year.
Two weeks ago, we announced a new licensing agreement with Seattle genetics to develop and commercialize novel antibody drug conjugates using monoclonal antibodies developed by five prime that are directed to a single target.
We're also working to supplement near term internal pipeline growth by acquiring programs that will leverage or agile clinical development interest translational expertise.
This will allow us to conduct early stage trials and generate actionable data.
We believe this multi prong approach to pipeline growth is the right strategy to pursue.
It will result in prudent advancement and prioritization of our corner current clinical programs, while we pursue other ways to grow our pipeline.
As part of the process I'm engaged deeply with many leaders in the organization, who are passionate about our goals and energized by the progress, we're making to position the company for future pipeline growth and success.
I will now turn the call over to Helen who will provide an update on our clinical programs.
Thank you Bill.
Let's begin with an update on them or to the man or FGF are to be monoclonal antibody, which is under evaluation in the fight trial, a phase three frontline gastric cancer trial.
As communicated previously we paused enrollment at approximately 150 patients pending the occurrence of a sufficient number of events.
Which will trigger a futility analysis.
Based on the current event rate, we expect the necessary number of utility events to occur in mid 2020.
Moving forward, we expect to resume enrollment in the fight trial only if the trial passes a futility analysis and five point enters into a collaboration or licensing agreement with a partner that can fund all of the remaining development and commercialization costs.
We remain optimistic that bema has the potential the benefit patients with gastric gastroesophageal cancer and at the study will pass utility.
However, in the context prudent planning, we're considering alternatives for the Bema program in the event that we passed futility, but are unable to secure a partner.
For example, one possibility might be converting the fight trial to a randomized phase two which would generate data that can be shared publicly and thereby informed discussions with potential partners in order to catalyze business development transaction.
Moving on to SD 850, which is our monoclonal antibody targeting tumors that over express b seven each for.
The trial remains on track to generate data by mid Twentytwenty from the phase one combination of Epay 150, and Pembrolizumab in a cohort of patients would be seven eight for upper expressing ovarian cancer.
Last year at ASCO and at ESMO, He presented safety and preliminary efficacy data from the phase one a one be clinical trial of S.P.A. 150, showing that it is well tolerated in both monotherapy and in combination with Pembro.
We reported to confirmed monotherapy responses in ovarian cancer, but this is that response rate that is not sufficient for five prime to move forward and developing the compound as a single agent.
We continue to evaluate F. pay 150, pembro combination in patients with ovarian cancer that over express b seven each for but given our resources and priorities. We do not plan to advanced the development of the combination independently in the near term.
As a reminder, beast of an H. fourth homogeneous sleep over expressed in approximately half of ovarian endometrial and both hormone receptor positive in triple negative breast cancer.
This information combined with the lack of off target toxicity suggest that be 74, maybe a good target for antibody drug conjugates by specific antibodies or car T therapy.
Turning now to S.P.T. 155. This is our first in class C. D 80 FC fusion protein that directly engages CD 28, without super agonism, and buys to see telling for promoting T cell activation in the tumor micro environment.
We have completed nine dose escalation cohorts and the travel remains on track to generate early monotherapy efficacy data in the second half of 2020.
As we had predicted based on our preclinical data and the pharmacokinetics of the drug we are beginning to observe expected pharmaco dynamic changes.
Specifically were observing an increase of central memory T cells and the peripheral blood.
We are encouraged by this finding essence supports the predicted mechanism of action.
Based on this data we're now identifying patients with tumors that are more likely to have preexisting T cell infiltration. As these are the types of tumors that are more likely to respond to single agent SPP 155.
These tumors, which are known as warm or hot tumors include lung cancer melanoma, and Weve opened enrollment in South Korea, where there's a large lung cancer patient population.
I also want to add that while we anticipate single agent activity of S.P.T. 155, we've decided to amend the trial to add a parallel dose escalation of S.P.T. 155 in combination with Pembrolizumab.
We're doing this for two reasons.
First preclinical data suggests combining an anti PD, one with S.P.T. 155 will be synergistic.
And second as PD, one inhibitors continue to move to earlier in earlier lines of therapy in warm and hot tumors. It's important looking to the future development that we demonstrate the safety and tolerability of the combination.
Moving to our partner programs Dms recently informed us that their randomized phase two trials, there looking man plus nivolumab with or without chemotherapy in second line pancreatic cancer did not meet its primary endpoint.
BMS also informed us that they have no near term plans for additional sponsored development of Cabelas Mad, but we'll continue to support the evaluation of Kabira in select ongoing investigator sponsored trials.
And finally, BMS 986 to five eight.
And antibody targeting Tim three which is an immune checkpoint receptor continues to enroll in the phase one portion of the phase one two trial in combination with double now.
I'll now turn the call over to David Thanks Ellen.
Tails regarding our financial results can be found in the press release that we issued this afternoon.
Turning to our cash position, we finished 2019 with a strong balance sheet cash cash equivalents and marketable securities totaled 157.9 million as of December 30, Onest 29 team compared to 271.7 million as of December 30, Onest 2018, the decrease was it.
Tribute all to cash used in operating activities throughout the year.
Collaboration and license revenue for the fourth quarter of 2019 decreased by $800000 or 20% to 3.2 million from 4 million in the for the fourth quarter of 2018.
Decrease was primarily due to the completion of the research term of our immuno oncology research collaboration with BMS in March of 2019.
Collaboration and license revenue for the year ended December 31st 2019 decreased by 35 million or 70.1% to 14.9 million from 49.9 million for the year ended December 30, Onest 2018, lower revenue was the result with the decrease in revenue recognized under several partner collapse.
In addition agreements, including our October 2015, Kabira collaboration agreement or November 2014 collaboration agreement in our immuno oncology research collaboration agreement with BMS as well as lower collaboration revenues from our partnerships with ISI lab and you see b.
Research and development expenses for the fourth quarter of 2019 decreased by 8.8 million or 25.4% to 25.9 million from 34.7 million versus the fourth quarter of 2018, primarily due to lower compensation costs, resulting from corporate restructuring has undertaken in 2019.
<unk> decreased clinical trial expenses related to the Kabira study lower preclinical costs reduce use of temporary resources clinical services specialty laboratory services and lower manufacturing costs for Bema NFI. A 150. These decreases were partially offset by impairment charges for lab equipment.
And higher companion diagnostic expenses related to bema.
Research and development expenses for the year ended December 30, Onest 2019 decreased by 42.3 million were 27% 214.1 million from 156.4 million for the year ended December 30, Onest 2018.
Decrease was attributable principally to lower compensation costs, resulting from corporate restructurings undertaken in 2019, a milestone payment made to a partner in 2018, along with lower preclinical program clinical service expenses decreased companion diagnostic clinical trial expense.
The use of fewer temporary resources and lower allocated cost resulting from the restructuring.
These savings were partially offset by higher bio analytic and specialty laboratory and clinical trial expenses that were required to advance the bema and Lpa 150 programs as well as an impairment charge for lab equipment.
General and administrative expenses for the fourth quarter of 2019 decreased by 200000 were 2.2% to 9.4 million from 9.6 million in the fourth quarter of 28 team.
General and administrative expenses for the year ended December 31st 2019 increased by 3.1 million or 7.8% to 42.7 million from 39.7 million. The increase was primarily the result of higher allocated costs related to the corporate restructurings higher compensation costs and professional services fees.
There were partially offset by a reduction in the use of temporary resources.
Net loss for the fourth quarter of 2019 was 31.4 million or 89 cents per basic and diluted share compared to a net loss of 38.8 million or one dollar and 12 cents per basic and diluted share for the fourth quarter of 28 team.
Net loss for the full year, 2019 was 137.2 million or $3, a 92 cents per basic and diluted share compared to a net loss of 140.4 million or $404 in 13 cents per basic and diluted share for the full year of 2018.
Looking ahead, we expect full year net cash used in operating activities to be G. B between 77, and 82 million and asked and we estimate ending 2020 cash cash equivalents, a marketable series securities to be between 77 and 82 million.
At this time I'd like to turn the call back to the operator for Q1 day.
Thank you.
Hi, Andrew asked the question the first one on your telephone which all your question first Apociii.
First question comes from Christian Cowen and company. Your line is open.
Yes, hi, Thank you very much listed on the pipeline.
He compound.
Leave you have now plan to move into small cell lung cancer and B.
No not also involve work.
I don't Howard.
Yeah.
I believe that.
Go into first line setting night vision. So can you help frame for us what's your expectation are well learn from that.
Hi, Chris This is Alan I'll start with answering that so thank you for the question. So give me a chance to clarify I think you know how we designed this trial is that and you heard US say this many times before we had to start at it exquisitely low dose because of the history of people attempting to targets cdtwenty eight be foreign cars.
Super Agonism, and so initially what we do and as you know and a lot of these trials as we take all commerce and and then do our dose escalation and that is still continuing on the dose escalation as I said, we've cleared nine cohort I think the question then comes about in parallel to as were dose escalating with all commerce when do we start.
If you will use the term backfill or use the term exploratory cohort start enrolling some patients, which maybe or a little trickier to find that that we can that we've been really actually expect to have a higher chance of seeing a response based on the mechanism of action and to the comment about non small cell was just an example of obviously.
Patient population that would fit that criteria of having a warm hot tumor.
One of our reasons go to South Korea is because there are a lot of lung cancer patients there, but for this exploratory cohort it wouldn't be just limited to non small cell we would be willing to take you know non small cell melanoma renal cell you know anything where were clearly PD one sequelae for drugs have been approved we do have an exclusion criteria patients.
Not to have received a C Chile for.
Agent, but they can have received PD one so for these exploratory these will not be necessarily naive patients.
And again, our reason to start adding these cohorts now really has to do with at lower yes, we starting to see the PD changes the changes in the blood that you'd expect to see so you know it's taken a while to get to a dose where we think that we we might be at that dose level does that make sense, how we design and what were what we're doing.
Yes, and how that's very helpful. Then if I can just ask another question on theme began to describe some of the different options you will have.
As we get turned the futility analysis, including I believe potential to convert this overachieve piece too tight randomized where would you need to have that any.
Such that potential partner might continue that they have to restart again I'm just trying to understand the images that mechanics, when a potential partner.
Yes. So I think you know, it's it's important to point out that we know we don't have any new information again, we haven't DMC. They look at this is a double blind trial. They look at the data their recommendations have been to continue without without change from a safety point of view and again, because it's double blind we don't look at the at the efficacy, but at the same time.
Again with a world that we live in and you've heard the news about Kabira.
And there are other priorities and to be honest Maher early maybe excitements too stronger word but interest in what we're seeing in 155, we're trying to think of the how best to spend our resources. So we're trying to be as you know we've been looking for a partner with beam up for awhile, and we've said that and and I think what we're trying to do with acknowledge that there is the potential.
So we might not find one even if we passed futility and what are things that we might do.
In answer to your question.
First step is to pass utility and and see if that where that puts us, but if we do not have a partner unless something changes otherwise we would likely at that point amend the trial and then that would make it to a phase two now when we would actually make that data public about that phase two again depends on when events arm.
What we would get the most most information, but only if we make that that change to the phase two we'd be able to talk about the data right because a futility. It just kind of thumbs up comes down as far as the public disclosure.
Got it Okay, we'll continue.
Progress. Thank you yes.
Thank you and then next question comes from Jonathan Chang of Sep Leerink. Your line is that.
Hi, guys. Good afternoon. This is David grew shop for Jonathan Thanks for taking our question I guess just to go back to the last question.
To clarify your you mentioned the DMC Unblinding fights study.
Not wanting to Unblind the fight study.
So I guess im assuming you passed utility will there be any data you're available to share.
Publicly or with a potential partner or will we kind of be going just based on the passing of futility.
Yes, so for futility.
Again, the only people look at the unblinded data are the DMC and then what happens is we say.
Our borrowers that acts and we haven't made that public what that would be and and the DMC will come back to us and say, yes, you passed or no you did not path and so that's all that happens with the futility.
If we have a partner that's going to support the trial going forward. That's all we need right. We just need to show that this trial is powered appropriately to show the endpoints the partner agrees with that and we would resume enrollment.
At that point, but what we're trying to make it clear now is if we do not have a partner five prime has made a decision we would not move forward on our own.
With the phase three as design right now so nothing else changes.
Does that.
Clear and I wouldn't even in that.
Yes.
And again, if we just think it's prudent coming in it's nothing and I just want to make sure. It's not based on us thinking that anything negative about the data again, because that's blinded. It just has to do with what else, we haven't our portfolio our resources and.
And you have to pick and choose right how best to spend our spend our resources.
And a large phase three trial in a d. that ended disease that has historically been difficult to treat I think.
We have other things our pipeline may not be the best way to choose to spend as resources.
Got it thanks.
And then for the CD 80 program could you elaborate a little bit on the rationale behind the PD, one combo cohort and particularly with.
Patient through a previously received PD, one, but I believe you mentioned with the on the study.
When we might see initial data from the combination.
Yes, so I think we want to make it again clear that this is a drug that we think we'll have single agent activity.
And but at the same time as you know one of the mechanisms of action is through Cts before so so see Chile for alone drugs have seen a moderate activity and I think the world continues to move on right. So they don't see a lot of patients out there just getting Yervoy. For example people are getting PD, one plus yervoy, they're getting PD ones plus chemo so.
I think what we're trying to do is really look to the future of where therapies are going to be so so obviously for us. The number one thing is to show the single agent activity and nothing's changed about that trial design and that's what we're concentrating on in terms of enrolling patients from South Korea et cetera, who will have tumors that we think we'll be able to show that but again, we're really.
And also planned for the future and so we think it makes sense the way this drug works that we at least in those.
That we showed that you can add this for PD, one that we think would increase the value of the drug.
And then of course, we a preclinical data, which we've actually include presented at a CR and also within our our background of our poster I believe it sits even I know we presented at a CR that shows really significant synergy with the too. So so there is also obviously and that's the best reason is that the too.
The two drugs together.
Well.
We'll be more efficacious and P.T. 1.5 alone.
Got it thanks, and then just a Walmart.
Could you provide any additional color you can provide on the agenda deal and which targets the doors might make sense.
Thank you.
We are.
Not disclosing that target as further contract. We're obviously excited about the opportunity to work with Seattle genetics. There later in the space and we feel really really good about about the progress to date the transaction and the interactions between companies.
Great. Thank you.
Well thank you.
Thank you enter next question comes from Steve It House of Raymond James Your line is open.
Hi, this is somewhere about of on for Steve seed House and our first question just wanted to clarify on the EMA I think in the past if we remember correctly in the past you mentioned that some of the people that five prime could see more data from the from DMC not just the past fail is that still the case or or is it.
You know Baxter, just seeing whether it has failed.
So so yes, I guess from the previous question I was trying to make the distinction between what one might say publicly first is not so so certainly.
There can be.
Yes.
Let people who are not directly involved with the conduct of the trial, who can know the details of of the.
Yes sums up some down passing futility.
But in terms of and be able to say anything publicly it will just be yes no.
Okay. Thanks, Thanks for clarifying that and then I guess another follow up question on the 50 155 program I think you mentioned South Korea.
And you didn't really say what the timeline is but obviously it is.
Corona virus issue there now so so what do you think about in terms of the duration of this trial now the combination study.
Versus what it would have been normally.
Right now we don't have any indication that that the krona virus outbreak in South Korea is going to affect any of our timelines. We have patients that have that are no.
May go imminently I mean, so so that's all I can say right now.
Okay. Thank you, yes, and we're also in Australia. Thank you somebody somebody has reminded me that the trial continues in Australia and of course patients can also enroll from there so.
No.
Okay. Okay, great. Thank you and I guess the final question. So a follow up on Kabira. So I think you mentioned BMS doesn't really have.
Near term plans for sponsoring additional trial.
But I mean this this asset I mean, it could be used another indication.
And could you remind us whether you could potentially give your rights do another company around two to run out of the study or somehow restructured the deal because otherwise this asset will be sitting idle.
That's a great. That's a great question, maybe one we'll have to come back to your.
I don't believe we have the rights to do that but if you give us little bit at a time, we'll go back and check and make sure and then come back to answer your questions specifically.
Okay. Thanks for taking your question.
You're welcome.
Thank you and then next question comes from Eric Joseph of Jpmorgan. Your line is open.
Hey, good afternoon, and this is turnaround on for Eric and so on the these three flight futility analysis I'm curious what type of Ben a is it based on is it PFS or away and then in the situation that you do you have to convert to a phase two study to what extent utility analysis on the 150 existing patients.
We just serve as the phase two.
I have a couple of follow ups.
All right to make sure I understand so your first question has to do with our we're using awareness or PFS and.
And again, so to be to be clear with the futility or giving guidance right. It's not something that's included directly in the protocol it's not.
A regulatory issues. So right now we will be having the DMC.
Provide information on both of those but it is based on overall survival and that's because.
At least that is the primary endpoint of the phase three trial.
And then in answer to your question.
Should we switched to a phase II. So again should we passed futility, we do not have a partner and again that's that the comment about the phase two just one of many possibilities you were giving as an example that could be done.
I think I guess my short answer would be yes, I think 150 patients for a randomized phase two trial for the difference that we would like to see when you add bema to a back one of chemo that would be enough patients now when would be the best time to read out that phase two I do not want to imply that that would be right. After the futility, we may choose to wait longer.
Get more events.
Okay, and then you know to follow up on that how long are you, giving yourself to arrive at a strategic or partnering decision.
Post the close the futility analysis or.
And I haven't made that decision yet.
Okay. Then one last quick one for me you provided guidance, our Opex guidance, what does that assume in terms of fight trial resumption as both advancing.
Thank you.
Yes, so we we provided cash burn which is little bit different than.
Op ex.
But the you know this assumes that we are funding the fight trial.
Through futility.
And following patients and all the requirements that we have with that and funding P.A. 150 through the combination read out in any any other costs a follow on from that so as Helen laid out earlier we.
Do not have plans to take fight the bema program forward without a partner. So there are no phase three costs beyond the utility.
That we have considered in our in our guidance, but it will just clarify that the example of where we switched to a phase two we have included that.
But it's not just to whenever a futility happens, but falling as you said all of those hundred 50 patients out for survival. So.
That is included.
Great. Thank you.
Thank you and then next question comes from a circular out of Guggenheim Securities. Your line is open.
Hi, This is Paul Jang on for at there. Thanks for taking the question.
Just a quick one looking forward to that each utility analysis for fight.
You previously spoken about the her to overexpression population in gastric cancer, possibly reading due to ask you had far too.
How should we be thinking about parallel to the told the trial or other related clinical or preclinical data sets as we look ahead towards the analysis. Thanks.
I'm not sure that I understand the question.
But do you mean in terms of how the toga trial was designed for sure is there anything from the that read out what it is on the trial that could help us and looking forward towards your analysis.
No I mean, I know I'm not that and again, having not you know we only know about the told the trial what's in the public domain. So.
You know and certainly.
So I'm.
Not that I can think of right now again part of its I'm not sure. If I understand what made you can give me. An example of what kind of thing that you're.
No. That's all right. Thank you I have another question that.
Okay. So switching gears to FDA 150, so for the combination with Keytruda for patients with ovarian cancer do you have any projection on.
When or what circumstances, you might revisit advancing this combination and development.
So I am as we said what we expect to do is guests efficacy data from this about mid year.
And in terms of what else you know it next I guess, you're right. We made a comment specifically about near term I think there what we need to do is and we've said. This previously it's not just look at the data that comes out of that as well, particularly for the PD. One combination Wanda look and see what was the expression of PD L. One on the tumors.
We do have patients that continue on monotherapy in are having longer than one would expect durable stable disease. So there's some data digging that we would want to go into I think our point today is we again wanted to highlight that as we determining what programs, we want to prioritize and what ones were not prioritizing that if we were to continue with a combination.
Again, and again, we don't have the data yet from the combination, but a combination with 150 and and a PD. One we would want a partner because those trials are expensive to run.
Got it thanks very much.
Thank you and our next question comes from Tony Butler of Roth Capital Your line open.
Yes.
Thank you very much Howard two questions first to support to Stoop works Laurie.
When we think about 155.
I noticed in controls that all the participating sites 12 accounted were all or U.S. is that correct and maybe why.
Not to.
Enrolled patients from U.S.. That's number one number two is is it fair to simply.
155, perhaps says.
Substantially superior Gerben.
Okay. That's question one and then number two is on one city.
Glenn Please correct me if I'm wrong.
Seem to remember that at least removing some of the study there were also breast cancer patients.
That would eliminate the ovarian you enroll in Brooklyn proposal.
That's.
One of that question the number clearances.
I think the trial is just under 300 total patients. The question earlier is how many.
Possible that we.
You're at that at that.
Hi, I'm point, when you will provide data in combination pembro.
Sure. Thanks.
All right.
Yes, great. So so so in terms of 155 being done X U.S.. So you're right that originally we started the trial in Australia.
We did that because they were quick to get going we had investigators that new a lot of about.
Imminent developing immunologic Io drugs, if you will and also at that time, there was less ubiquitous use if you will a PD. One so we were hoping that during our dose escalation. We would have fewer patients that had been exposed to a PD, one which might make it easier to see efficacy as we dose escalated now of course, you know the times.
Page and there's more and more use of PD one globally. So I can't necessarily say, that's that's borne out but I can't say that the Australian investigators have been great to work with and really helped us enroll quickly.
In terms of adding in South Korea, rather than the U.S. that really have to do quite frankly, with our CRM BPO and again, where patients are so we are in a situation now where we could.
Soon enrolling the U.S., if we wanted to but but right now we're sticking with X U.S.. So there's not a.
Just on any other specific reason other than we thought it was speed and to enroll the right kind of patients that we wanted them the trial.
In terms of could this be substantially superior Yervoy, I guess I'd be happy with a substantially superior yervoy. So as long as you know that substantial is substantial.
So.
I don't know if if the if there was sort of a third part of that of what.
What you were trying to get out there.
Yes.
Yes, there wasn't really a third.
Yeah.
Yes.
The notion that it's it's I mean, because it's you you've had a real well.
She silly for skin or patients who have seem to see filter work in the passenger obviously can you give you want to combo, it's kind of why.
Do you feel like for PD, one combinations as you alluded to but yet again those have been not terribly great.
Right and that's why I just created a better you know your yeah, Yeah, I mean, I mean, I think you're right I mean, if you sit and you take some tumor type and they have a 15% chance to Yervoy alone and then you combined with the PD one and there is now 45% chance I think that you're sort of speaking to why we want to have combination data because let's just say and again I'm not.
The tumor types I suppose we had a 35% response that what's best way better than Yervoy alone, but that's not necessarily better than a yervoy plus a PD. One. So so again, we just sort of want that is that as a way to to mitigate if our if our efficacy is as you said significantly better than yervoy, but not as good as a PD one plus.
Yervoy that we want to make sure we have that data as well right.
Yes, ma'am I agree absolute thanks.
So now that you're 150 and question. So at ASCO last year. We did present, we you are right. Your memories cracked we had three expansion cohorts breast cancer, where we allowed patients who were either hormone receptor positive or triple negative.
Barry in cancer and endometrial cancer.
We.
Stopped enrollment Atsina, we did a variation I'm a simon two stage. So we stopped enrollment unless we saw a certain number of I've responses and we only saw responses in ovarian cancer.
So that's what made us choose only ovarian cancer for the combination and we did not continue to enroll and the breast cancer cohort.
Then terms at the end equals 300, the clinical trial was written that way because that would have been if we had gone to full enrollment for every single.
Cohorts, including the combination so so that's worth so we have not enrolled 300 patients total and I.
So.
And then in terms of and then we have not said exactly how many have been in our combination.
Cohort, but I can't tell you that are same approaches is Simon two stage that will enroll a certain amount will look and see make sure that we're getting a response so we'd want to see before would continue enrolling.
Hello, and thanks very much appreciate it.
Thank you.
Thank you and again, ladies and gentlemen, if he would like to ask a question at this time. Please press Star then one I touched on television.
Next question comes from CIMB richness of Wells Fargo Securities. Your line is open.
Yes.
First question can you make some comments about where you aren't partnership discussions the theme.
Yes.
And specifically a breakeven.
If you don't have Oh.
Mind.
Once.
Hosted decision.
Hey.
It takes you six months together partners could that be an issue is poised to reach any oil.
And.
We'll be passed the median second meeting on both the Bible imbalance.
Yes.
Right, it's not a great connection but.
Really had a hard to hear your question could you repeat it again.
I heard I actually Nick I didn't hear but I'm going to repeat it for ever been room, so you're saying that would be math if.
Weve, where are we in terms of finding a partner and presuming you don't find a partner until you passed futility, what if that meant been six months to negotiated deal what would that mean from the trial itself.
Well I guess, the first question, whether it whether it affects nickel alloys.
Im assuming that you will pass the median I expect a median overall survival Senate balance may become clearer on them.
Sure.
So maybe first about the partner me about the partner.
I think it's fair to assume that we're we're not waiting until for utility to start any kind of discussions from a partner standpoint. So some of those discussions are ongoing may not get a decision on a partnership to turn the card over on to utility, but the process will be a pretty far along with the Tom we get there.
Okay.
And the same would go for.
One 155, how many won 50 I'm sorry.
Tens of partnership.
So yes.
And then moving to 155 so.
That's that's collation American completed.
No. It has not so we're continuing to dose escalate in parallel yeah.
And then you said immense you've got this pharmacodynamic marker of central memory T cells.
From a translational perspective have you looked out what are these T cells, recognizing audio recognizing potentially tumor antigens.
So so that is included in our you know PD analysis, but.
That work is ongoing I guess, that's the best way to say that okay.
Don't happen there.
And then front and one on 155 minute Hello, Hello find one of them 50 guidance.
You got to combined with the PD one inhibitor mean obvious thing to do is just combined.
You know.
The label dose the PD one inhibitor with.
Okay.
Hi, it's going as you've tested 155.
From a summary.
Preclinical.
Stuart 'cause perspective is that the optimal strategy do you think.
Oh, Yeah does it make sense central line.
Look at optimizing the dosing of these two agents.
When you move to combination therapy.
Well since the PD one is approved the most did they tumors that we would be looking at kind of a situation have to start off by them getting the full dose and we do think there is significant synergy based on our preclinical data that we will not be able to start with full dose of 155. So we are truly doing a dose escalation first which is a little different than what 150 now so.
But I think based on the mechanism of action on our preclinical data, we think that we should dose escalate.
Or dose reduce this 155 by a couple of cohort.
Okay.
And then just finally on the new new preclinical assets when when Mike we hear on what those assets.
Repeat the question again, please I'm sorry, it was small city. They yeah I'm sorry, you see I think you said in your prepared comments that you have.
Sorry three.
Page research programs, one of which might come into preclinical development later on this year when when might we find out more detail on.
On the three programs and I guess.
Specifically on on the candidate to moves to preclinical development.
Well when we make a determination in terms of the development of that compound the timing around that will grow release that we haven't really released any of that targets. At this point in time are made them public.
So I suspect before the ended the year, you'll know more about that but we're not ready to talk about it yet.
Okay fair enough. Thank you very much.
Thank you very much.
Thank you and ladies and gentlemen, this does conclude or question answer session I would now like to turn the call back over to go for any closing remarks.
Thank you very much and as I said at the beginning of the call. The restructuring that we undertook in 29 team has successfully been implemented.
We're in a position where cash runway is as David mentioned earlier extends into 2022.
Really our focus for 2020 is on generating clinical data from our proprietary programs, we see the pipeline growth potentially coming from future development of our clinical assets from internally developed late stage research programs and from the possibility of acquiring an asset externally.
We believe this multi prong approach will result in a prudent advancement and prioritization of our pipeline.
With that I'd like to thank all of you for joining us today for your interest in five Prime I'd also like to thank the patience and investigators participating in our clinical trials and our five time employees and our strategic collaborators who all contribute to the continued advancement of our programs. Thanks.
Good for your attendance today.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating may now disconnect.
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