Q3 2020 Five Prime Therapeutics Inc Earnings Call
Hi, Therapeutics third quarter 2020 earnings call.
As a reminder, this conference call is being recorded.
And then there's a host for today's conference call Martin for Vice President Investor Relations and corporate Communications you may begin.
Thank you Sarah good afternoon, everyone and thank you for joining us the press release with the Companys third quarter 2020 financial results was issued earlier today and can be found on the company website. Joining me today are Tom Civic, our President and Chief Executive Officer, Dr. Cohen Collins, Chief Medical Officer, and David Smith, Our Chief Financial Officer, Andy Rakesh.
Our VP of research will join us for Q and a portion of the call. Today. Today's conference call will include forward looking statements under the private Securities Litigation Reform Act would like to 95, including statements regarding our research and development programs and financial outlook actually results may differ from those indicated by these forward looking statements due to numerous factors.
Including those discussed in the risk factor section of our FCC farm.
Our expectations and assumptions could change while we may elect to update these forward looking statements in the future.
Specifically disclaim any obligation to do so even if our views change well now turn the call over to Tom.
Thanks, Martin Good afternoon, everyone and thanks for joining us today for our third quarter 2020 conference call.
Its pipeline, we're working to develop new treatment options with large and lasting benefits for people with cancer. Our focus remains on discovering new biological pathways that have the potential to deliver truly novel breakthrough treatments for cancer is the required a new treatment option.
Our but important work that we pursue with optimism incurred.
I'm proud to say that the five prime team has responded well so many challenges this year with an unwavering focus on advancing our pipeline.
I'm also proud to report that because of the teams hard work or programs remain on track.
In my remarks today, I will provide an update on the timing of the topline data for the fight trial a brief update on the progress we're making on the 155 program and an introduction to our newest preclinical program one size doesn't.
How long will provide updates on our clinical and preclinical programs, David will discuss the quarterly financial results and the Navy ranking or head of research will join us during Q1 <unk>.
Starting with people.
I'm pleased to report that we will announce topline data for the fight trial before the end of the year.
As a reminder, fight of the global trial 15 countries represented the Devaluating Bima in combination with modified FOLFOX and.
Gastric cancer patients, whose tumors are actually apart to be positive and her two negative.
This is the first randomized frontline study evaluating a few apart to be positive hertwo negative gastric too.
We are hopeful that the result of the fight trial will reveal a clear path forward for this important potential therapy.
Gastric cancer is the third leading cause of cancer death globally, and retrospective analyses show that patients with gastric cancer, whose tumors overexpressed FGF or to be have an even worse prognosis.
Unfortunately, the 200000 global gastric cancer patients, whose tumors overexpressed FGF are to be.
Only had chemotherapy to fight their disease.
The boys girls successful, we believe that we will have a clear path forward to developing a new targeted therapy for front line. After you apart to be positive hertwo negative gastric cancer.
We are inspired by this type of challenging work.
Help me therapies for patients, who desperately need new treatment options that leverage our scientific and clinical expertise and allow us to collaborate globally. We.
We look forward to sharing the topline results for the fight trial with you before the end of the year.
Moving on to 155, RCD 80 FC fusion protein.
The 1.5 program remains on track we.
We've been enrolling patients with warm and hot tumors that the 560 milligram monotherapy dose over the past few months.
And we expect to have enough data by year end to inform next steps for this program.
This novel first in class C. D 80 fusion protein was developed at five prime.
And as a result of its two complementary mechanisms of action direct stimulation of T cells and you feel like for checkpoint inhibition. We believe that the one to 155 might have significant potential across many tumor types and lines of therapy.
Here's where we are today with the 155 program.
For monotherapy, we've completed 11 safety dose cohorts and are at the 560 milligram flat don't we.
We are now enrolling additional patients with warm and hot tumors in an exploratory cohort at 560 milligrams, where we would expect to see clinical activity.
Early in the third quarter, we began rolling non small cell lung cancer patients in the dose escalation of 155 in combination with Pembrolizumab.
We are the first dose escalation court and are now enrolling patients in the second.
We continue to make progress with this important program and I'm proud to report that the program remains on track.
I remain hopeful that this unique science lead to meaningful patient outcomes.
Now to our preclinical program.
157 has a novel antibody directed to PCR rate.
This is a promising immuno oncology targets that is expressed by a highly immunosuppressive population of T regulatory cells.
But typically within two months.
The 157 antibody is engineered to eliminate these cells and lift the restraint they impose on anti tumor immunity.
So wind development is underway 157 is advancing through I end, the enabling studies and we expect to submit a 90 for this program in the first half of 2022.
And yesterday, we announced that we will be presenting a poster on one side seven lets see next week.
We also continue to advance to other novel research programs and I expect to do disclose details about one of these programs in early 2021.
Well in my remarks, with an update on Qashqai, we again raised our yearend cash guidance from the $80 million to $85 million range to the $100 million to $105 million range.
The increase in our cash position will allow us to continue investing in our pipeline.
Before turning over the call to Helena, David I'd like to thank the five priorities for the significant progress this year.
I joined the team six months ago, and I'm very proud to work with is capable and committed team and a very important time for the company and it gives me great pleasure to share their work and accomplishments with you today.
I'll now turn it over to Ellen to provide more detail on our clinical and preclinical programs.
Hello.
Thank you Tom.
Let's begin with an update on them or to the man or being as you call. It our F Q4 to be monoclonal antibody that's under evaluation.
She appeared to be positive hertwo negative gastric cancer.
As Tom mentioned, we expect to report topline efficacy and safety results from the flight trial before the end of this year.
The fight trial is a randomized phase two double blind study evaluating the benefits of adding bema standard modified so you know in front line. After you have heard to be positive hertwo negative advanced.
Advanced age gastric and gastroesophageal cancer.
Gastric cancer the poor prognosis the median survival in the U.S. only 10 to 12 months.
Frontline chemo hasn't changed in over 10 years.
And only provide the progression free survival of approximately five to seven months.
Yes, yes.
Fibroblast growth factor simulate multiple pathways that are important for cancer cell survival and growth beam.
<unk> is a first in class antibody that blocks the varied the FGF receptor. Two S. You are to be in.
In gastric cancer Overexpressed severity of heart you'd be on cancer cells was associated with a worse your life.
In conducting the phase two flights well over 900 patients were screened in 15 countries and we found approximately 30% of advanced stage Hertwo negative gastric cancer.
In the frontline setting over expresses that's yet to be this.
This frequency hi, Barbara expression was similar across Asia, the U.S. and Europe.
My Prime is the only company with an antibody directed against its year for TV patients with gastric cancer Bemis mechanism of action is different than that of the FGF <unk> oral tyrosine kinase inhibitor.
Target mutations in genes.
It's exciting that the results of this novel approach to treating gastric cancer will be available before the end of the year and I would like to take a minute to thank the patients their families. The investigator.
Slide 19 design lab, and all our clinical trial partners, whose contributions have brought us to this milestone to be in the program.
I would now like to turn to BT 155, our first in class C. D FC fusion protein.
If P.T. 155 stimulates the immune system to destroy cancer cells.
It does this in two ways.
My binding directly to see 28 directly stimulating effector T cells.
And secondly by binding to see Chile for walking its inhibitory signal and thereby also acting as a checkpoint inhibitor.
During the past quarter, we continue to enroll patients with warm and hot tumors at the 560 milligram monotherapy dose.
We also completed enrollment of the first cohort in the dose escalation of the combination of FP 155, and 10, but less than that.
In patients with non small cell lung cancer.
The trial remains on track and we expect to have enough preliminary data by the end of the year to guide our decision regarding the next steps in this program.
Turning to our preclinical program. It's Tom now we continue to make progress on our three wholly owned preclinical candidates and we are excited to announce that one of those programs.
Pay once my seven is an anti <unk> antibody.
Okay. One fiveseven originated from in house bio informatics screen, that's hard to identify extra.
Extra cellular targets preferentially express my T.D. for positive regulatory T cells that reside within the tumor.
Our in vivo murine studies conversion that selective depletion of TCR read expressing intra tumoral T. Reg cells elicited strong anti tumor response.
157 offers unique approach to eliminate a key cellular mediator, but in your question tumors.
Our plan is to move through R&D, enabling studies into the clinic in the first half of 2022.
We will be presenting more details about this program in a poster presentation next week.
As Tom mentioned earlier, there have been no shortage of challenges this year and I'm proud than five time teams has done an exceptional work to keep our preclinical and clinical programs on track right.
On the cost of having meaningful and actionable data for to potentially novel cancer therapy be my nephew Q1, five five and we look forward to sharing these results with patients.
Instigators and you very soon I will now turn the call over to David.
Thanks Ellen de.
Details regarding our financial results can be found in the press release that we issued this afternoon.
Turning to our cash position, we finished the quarter with a strong balance sheet cash cash equivalents and marketable securities totaled 112.9 million as of September Thirtyth 2020, compared to 157.9 million as of December 30, Onest 2019. This decrease was primarily attributed.
Quarterly operating expenses that exceeded quarterly revenues.
Collaboration and license revenue for the third quarter of 2020 decreased 5.9 million or 31% to 2 million from 2.9 million for the third quarter of 2019. The decrease was essentially due to a reduction in revenue pursuant to the company's performance obligation under the November 2014 could be or lose a man cold.
Separation with BMS that was partially offset by an increase in collaboration revenue with design lab that resulted from our decision to amend the fight trial from a phase three to a phase two design.
Research and development expenses for the third quarter of 2020 decreased by 5.5 million or 20%.
The 21.4 million from 26.9 million for the third quarter of 2019. The decrease was primarily due to lower compensation costs, resulting from the October 2019 restructuring lower clinical trial expenses manufacturing costs, along with lower out allocated costs bio analytics and central lab costs.
And a decrease in costs related to preclinical programs. These reductions were partially offset by impairment charges related to the sublease of a portion of our facility as well as an increase in companion diagnostic cost related to be about.
General and administrative expenses for the third quarter of 2020 increased 5.5 million or 4% to $13.7 million from 13.2 million for the third quarter of 2019. The decrease was primarily due to impairment charges related to the sub lease of a portion of our facility and allocated costs are offset by lower costs.
Compensation.
Depreciation and other miscellaneous and general administrative costs.
Loss from the third quarter of 2020 was $26.4 million or 74 cents per basic and diluted share compared to a net loss of 36.1 million to one dollar and three cents per basic and diluted share for the third quarter of 2019.
Looking ahead, we expect full year 2020, net cash used in operating activities to be between 70, and 75 million and estimate ending 2020 with cash cash equivalents and marketable securities between 100, and 105 million. This represents an increase in our yearend cash guidance reflects sorry.
Continued financial discipline, a tax refund under the cares act and the use of our ATM the increase in our cash position will allow us to continue investing in our pipeline and extends our cash runway into 2022.
I'd now like to turn the call back over to the operator for the Q and a portion of the call.
Thank you.
Ask the question you need to press Star then one on your telephone to withdraw your question. Please press the pound key.
Please stand by while we compile the two and I lost her.
Our first question comes on the line up for the route with Guggenheim Securities. Your line is now open.
Great. Thanks for taking the question just wanted to know if there is anything we can infer from the timing of the data as far as the pace of PFS events.
The drugs versus control or maybe outside of the control arm performed relative to historical data.
On a.
PFS outcome generally that's one and then I have a follow up.
Sure.
It's Tom here I wondered I get started and then Helen can can fill in some gaps so just to walk back to sort of what we've what we've shared over the last couple of quarters. We paused. The program back in November of last year with about a 150 or exactly 155 patients at the program I think as you heard and Helen comments.
Aggressive free survival for this patient population.
Not very good at that average is somewhere between six and seven months.
The the overall survival is on average a little bit less than a year for the same patient population.
Some some retrospective analyses all point to the fact that it's it's probably less than a year for patients whose tumors overexpressed FGF are to be.
So we the data that we that.
That is available on the fight trial right now is all completely blinded. So we don't have any analysis, it's incomplete on.
Any of the information yet on the fight trial.
Helen I don't know, if there's anything else you'd like to add to that.
No no I mean, I think that.
You've heard us say, we've been guiding to saying with the end of this year beginning of next year and I think we're sort of falling bright lights into the middle of that so I think things have gone along as we had predicted.
And the teams have done a great job.
Tobey, that's making sure the data coming along the way and so yeah, it's going to be.
It's an exciting.
[laughter].
Great. Thanks for that and then just one quick follow up I guess with one five side is if you can give us any sense of sort of the number of patients on the different tumor types that we may see and sort of the the next update here on for it for the onetime type program. Thanks.
Sure. So we as we announced we have been enrolling patients with warm and hot tumors at the 560 milligram monotherapy dose and those warm and hot tumors are the types of tumors that you would expect lung melanoma head and neck.
And so we're we're selecting those patients right now at the dose that we think we should be seeing clinical efficacy.
We also announced that we just completed our first dose cohort of the combination trial that is.
Is 155, plus pembrolizumab and that's exclusively lung cancer patients. So we we expect that we should have enough patients in hand.
How's it before the end of the year to inform the next steps on the program.
Great. Thank you for the update.
You're welcome.
Thank you. Our next question comes from I know, Jonathan Chang with SVB learning, Yeah, Let's now open.
Hi, guys. Thanks for taking my questions first question at a high level or how should we be thinking about positioning a P.T. one high five and the treatment landscape relative to our yervoy as he is.
Mm.
Alan you want to you want to get started on this one.
Yeah, I mean, I think you're right and one of the mechanisms back units inhibit T. Chile, four so I think that people, sometimes sneak that in comparison to a t. yervoy right I mean, obviously because Ms. Drug also directly stimulate the T cell it doesn't require the T cells. We activated so it's going to work on naive as well as.
You know already activated T cells <unk>. So we think you know the rationale should be that this will work essentially.
He talked about any tumor that's got T cells, there warmer hot tumor and and the idea would be that we would expect it to be better than Yervoy and I think that's what makes in terms of a thing that we think by the end of year, we'll have data that by going into the patient population. This range of non small cell, yes, yes, the melanoma renal cell block.
What are your head neck et cetera.
All the patients have been seeing a PD one prior and except the melanoma you really would not expect any response to Europe, where loan. So I think that that's what's going to allow us to see are we seeing something different or at least do we have a signal that potentially different.
That help you've got I think maybe just to add to that I I think that that's why we're so excited about the potential program is that it really does have broad applicability against many many different tumors and multiple different lines of therapy and as.
As we continue to interrogate the data that will have an out before the end of the year I think the the next steps for the program well we'll be clear.
Yeah.
Got it. Thank you a second question.
Also in 155 can you provide more granular guidance on when and where investors should expect to see clinical data from the program.
Should investors expect to see data by year end.
Yeah, I think we've been very intentional in our communication on this topic and just to reiterate it what we've been saying is that we will have enough information in house before the end of the year to inform the next steps on on 155 program, we have not yet made a decision on where or what.
When and how we'll share that information.
But we do believe we'll have enough patients in house before the end of the year to inform next stuff.
Got it and just one last question from me.
You've indicated before that you believe 155 is dosing therapeutically active levels can you remind me what the reasons are for that deal. Thank you.
Sure Colin you want to you want to take that.
Yeah. So it is based on no material correlation.
Correlation between our preclinical data.
Where.
You know using the expected receptor occupancy the pharmacokinetics and then when we went into the clinic, where we started to see a dose dependent increase and the proliferation of T cells at the dose that we would have predicted based on that modeling and so that's that's the evidence that weve been saying, okay no but this this.
Should be in a dose range now where we think that that's.
He is there to be had.
So I would say, it's a combination of telecom pharmacokinetics and pharmacodynamics based on modeling from preclinical to the clinical.
Mm.
Got it thank you very much.
Thank you.
Thank you. Our next question comes on the island.
Boris Peaker with Cowen Your line is now open.
Right and my first question is just in the cobot environment I'm. Just curious if you could comment on the data completeness and the fight trial, specifically do you have data on if and how many follow up scan patients may have skipped or delayed due to cold bid.
Yeah, maybe let me start with this one and then I'll, let Tom Polen add and Helen mentioned this in her comments, but I want to reiterate that this was just extraordinary work that our team did with all the challenges that are going on across the globe. As we mentioned this is you know that the team different.
Entries were in the fight trial, and all of them being impacted by co but in a different way.
So the reason we were guiding to a range of Q4 to Q1 was we wanted to make sure that we we could really tighten up and ensure that the data was going to be clean.
Clean and measurable so that we could we could.
Pivot off the information with confidence once once we turned over the cards.
Oh and I don't know if there's much you can share about the specificity of anything that we've we've learned about the impact on coal that to the question of that.
No I mean, I think we mentioned before back in the spring when I think of course, maybe cobots worse now, but at least back then people weren't sure as much how to handle it that we did have some patients who couldn't get into their particular clinic to get a scan but were able to go elsewhere to get scan. So.
And again that was very small number of patients you know we've said we stopped enrolling last November is a global trial and a you know and most of the world is not their medical care has not been impacted as much as maybe once heard in U.S. and also for cancer patients.
First line gastric cancer, and so patients that are getting treated they still got in to get their treatment and got their scans and so we did not have much impact that I shouldn't say zero, but very little and certainly nothing that in any way makes us think will affect profitability at the date <unk>, we feel very confident about how quantitative.
And that concludes monitoring.
And my second question is just curious turns about borrowing you're setting for it for the fight trial, what kind of hazard ratio do you think we need to see in this study to justify going into a phase three trial ultimately.
Yeah, we haven't updated exact.
I'm sorry.
You know you go and this is the the the challenges of all of us being across the country.
[laughter] I'm supposed to wait for Tom.
But I mean in patient person and I'm impatient for the state so but so.
I mean, I think you know what I'm looking to as you know many things have failed in front line gastric cancer and and usually when they failed the hazard ratio you'll see in the PFS with someone the 0.8 range. You know the few that's been successful have been closer to <unk> 0.7. So you know that that's that's the area.
Right, but we will be looking at response rate in the west and so we would expect with this drug is doing what we think that we will see no benefits across the board all three endpoints, although PFS in Brooklyn.
Great. Thanks, maybe just that maybe just to add to that I I think it's important to note that this is the first time anyone Sun a frontline study.
In gastric cancer patients that Overexpress FGF are to be in the patient population with a really significant need and the the prognosis for these patients is quite bad so well.
Without a new drug being approved targeted drug in the last 10 years, we feel like.
It's the fight trials positive Thursday.
Forward for us.
We have some really important conversations as we advance the program.
Great. Thanks, very much for taking my questions.
Thank you.
Thank you our next question.
Tony Butler with Roth Capital Your line is now.
Hi, good morning, or good afternoon, thanks, very much Helen on 155.
Could you maybe characterize.
Your view of the pace of enrollment, it's kind of a qualified cobi question.
And has that pace increased or stayed roughly the same that's 0.1, if I may and number two when you provide.
Provide that update later this year.
On the.
The monotherapy would also include the first dose cohort with the combination.
And then I have one follow up.
Hello.
Well I'll answer your second one first because I I just want to reiterate as well we have not no. We tried to be clear that we will may not necessarily be saying something publicly at the end of the year about the one fly Fi data. So what we're saying is that we will have internally enough data that we believe we can say what our next steps off.
So so I can't promise that there'll be some public announcement in terms of enrollment we've been really quite steady I mean, the trial as you may recall is being conducted in Australia and South Korea.
So you know and in general again, they've done they've been able to manage.
Taking care on cancer patients and managing cobot relatively well.
So no. We're on track I mean, we get anxious to know if suddenly there will be a week, where maybe nobody will whole or something and but but month by month. When you look at our average of Coopers.
Thank you and the last question is on one system for the entire Cc already.
So there are others I'm not necessarily marketplace, certainly that have demonstrated preclinical data one can push towards you know and then.
And then one from Chelsea, which recently licensed to kill yet.
I'm just curious if.
Ah I mean these.
May have obviously, some utility and those I have refractory patients.
In combination with other agents, but I'm curious if.
If there's anything unique that you could say about your program persons any numbers to the extent that you.
So I'm sure you do have some intelligence on what's going on with the other programs. Thank you.
Sure why don't I get started and then I'd love to introduce you to Andy ranking of heads up our research team.
We're really excited to be announcing one fiveseven.
Program targeting cc already we've been working on this for quite some time and the team that works with Andy here. This done some exceptional work it it's a.
It's a tricky target and we had to leverage all of our technical expertise to bring forward. This this program and so we were quite excited about the science behind that but also the complexity of what we were able to build and excited to move it forward very quickly as far as next steps so.
Andy maybe maybe you can fill in some gaps here.
Yeah definitely thanks, Tom.
Yeah Tony.
No. There are other programs that are out there targeting CCR rates and I think that speaks volumes to.
The interest in the excitement around this targets. We're aware that there are other programs out there there are.
Similar early stage like ours, and so the kind of information that's available is fairly limited right now.
What I can say is that you know we're we're moving full steam ahead, we're really excited about the program and we have a poster that we're going to be presenting at cincy next week.
And you know there will be additional information about the program there and we're looking forward to sharing more after that a poster presentation as well.
Thanks very much.
Thank you our next.
Question comes from a line of Jim Birchenough with Wells Fargo Securities. Your line is now open.
Good afternoon, it's Nick on Jim This afternoon.
The first question is on Bema and maybe.
You can let us know what you've been doing in the background as we've been waiting for the beam and data mature to mature over the last quarter and then if there isn't us statistically and clinically significant increase in PSS and what should we expect in terms of detail and timing of next steps and future plans.
Hmm.
Oh and Wonder why don't you take the first one and then I'll follow up with the second one.
Well I mean, I think I mean, yeah. That's the nice thing about how we designed this study is being double blind placebo controlled selected patient population as you know we've done all the work with Ventana and Pgx test really to have CBS is ready to go that should this trial readout positive.
Finally, we will be able to move very quickly you know and we've got our trial design down [laughter]. So yes, so I think.
That kind of answer your question Nick.
I mean, I think one of one of the points you made is.
But you know in.
In all likelihood you move ahead with a partner themselves.
Yes, you know manufactured product it would be ready to go into the clinic you need to extend the shelf life of the product to be just the sort of nuts and bolts of old right ticking the boxes to make this as attractive as possible into upon that yes.
Yes, yes.
Good Tom it's Tom here I.
I think as you've heard me say multiple times, we'll we'll be ready to pivot quickly once we see the data and we feel really well prepared to advance the program quickly.
Oh and started dimension it and I'll reinforce that I'm. The fight trial was designed and executed up until November of last year as a phase three trial and we.
Very confident in the design, obviously, we've learned a lot about the investigators and sites across the globe as well and so we'd be leveraging that information quickly.
I mean, as we think about next steps for the program do Youve heard US mentioned many times, there's about 200000 patients globally that overexpress FGF are to be in the front line gastric cancer.
And a lot of them are outside the United States. When we when we get to commercialization of this product to for fortunate enough to be their clearly we'll need a partner for that program.
In the short term after we see the results of the phase two and if it's positive I think we we will have options in front of us and we're fully prepared to explore multiple different options.
Once we see the data.
Okay.
Thanks, and then.
Moving to one Faisel Haven.
Certainly not lost on me you have 155 patients and femur and a program.
That's also a cold hundred 50, so too confusing [laughter].
So to give.
Get you know be something on I said, I'm little puzzle, but getting a mechanistic cross over with Yervoy and yet orders of magnitude higher dosing can you remind us why we should not expect to see access to their own time you'd events with 155.
Yeah Helen.
Yeah. So so some of it in terms of has to has to onto sort of mechanistic. One that we we believe that has to do with the pharmacokinetics of this has a shorter half life and yervoy and in general when thinks of.
Inventory molecule is requiring a.
A certain trough level has to be kept okay, and whereas score.
Agonism activation, it's going to be more the cmax or the peak level and so we think that there may be a potential advantage with our drugs certainly in the preclinical there is that how this drug doses given every three weeks, but that you get this the higher dose you can get this high peak to stimulate you see 28.
And then have you 560 milligrams, which you might assume somewhere around eight makes for kids.
Or to make sure that.
Our typically trial constant throughout the whole <unk>.
And then your second question, let me looking money then the second question.
It was really just about how you know how you avoiding the excess water meter cookies. So discount. So yeah. So we would expect still to get to some extent I mean, I think anytime you're stimulating T cells, when you're doing a by inhibiting particularly for stimulating 15, 20, I would expect to get some.
No toxicity.
Right. So so I think the question can be whether how big a therapeutic window is going to be super.
Superior because of this if you will sort of intermittent stimulation.
The T cells.
I think you've heard some analogy before it's a little bit like kicking the ball right. So if you have but that's how we think of the agonism is that you just give it a quick and then the Balkans, while rolling and can you by using that additional mechanism.
The margin that therapeutic window.
Okay. Thanks, and then for the combo can you say, how many patients were dosed to 70 milligrams and how many you intend to dose 140 milligrams.
So right now the standard three by three Nick.
Okay.
Thanks, a lot.
You're welcome.
Thank you our next.
Question comes from an honest, Eric Joseph with JP Morgan. Your line is now open.
Thanks for taking the question just a couple.
One clarification on the uptick with site.
Does advancing the program hinge on seeing.
Hey, stat Sig benefit on either PFS or less and if not can you talk a bit about what type of trend do you think would be telling us to warrant advancing the program for further.
In a larger study and then I've a follow up on.
Thank you guys.
Yes. Thanks for the question I think this is let's get right back to again, the main driver behind us converting to a phase two trial.
Well well be able to see the results much sooner than we would have before that's water under the bridge at this point, but.
The benefit of really being able to interrogate the data before the end of the year will allow us to determine next steps and you know I think we're all really hopeful that it's.
Very clear and for a large patient population, but.
But the benefits here converting it to a phase two trial is we'll be able to to look for all sorts of different subgroups that they do exist that might inform next stuff.
Important to note that one of the big changes that we made was converting the primary endpoint of PFS.
Oh asked is still there, we obviously are still tracking that as well as response rate.
And so that's that will inform where we go.
Uh huh.
Okay, and then 155.
Just a follow up on an earlier question about how Fivesixty was selected as the exploratory dose was there anything in the way of adverse events.
Sort of predicted or.
Anticipated to correspond.
With biologic activity, perhaps g. I symptoms.
Based on what we know about the Tolerability profile Tolerability profile of Uruguay, and do you see any headroom to in terms of safety in order to further dose escalate beyond five C 560, if need be.
Yes.
When you want to you want to go.
Yeah as you said before that the dose of Fivesixty has more to do with the with the PD markers that we've seen in the circulating T cells have we seen in patient and I may have not commented on adverse events.
We certainly may still consider going higher doses and that's.
I mean, I'm just trying to air just trying to stay within what we said before [laughter].
Okay fair enough okay, great. Thanks for taking the questions.
Thank you.
Thank you there are.
No further questions at this time I would now like to turn the call back to Tom Civic for closing comments.
All right well. Thank you thanks for all the questions and for joining us today.
I'll close today by thanking the five prime team for their unwavering focus on our clinical and preclinical programs. Despite the serious challenges.
As you heard today, we are on track to report topline data from the five trial before the end of the year.
155 program remains on track and Weve been enrolling patients with warm and hot tumors at the 560 milligram monotherapy dose over the last few months, we expect that we will have enough data to inform next steps for this program by the end of the year.
We introduced 157, a novel antibody directed at TCR. Eight this is our newest preclinical program. When we expect to provide details on another preclinical asset very soon.
And finally, we raised our yearend cash guidance to 100 $205 million range. This reflects our continued focus on financial discipline and extends our cash runway into 2022 I'm proud of the work we've done to advance our pipeline and I'm hopeful that our novel science translates into meaningful patient outcomes in the very near.
Our future so with that I, just want to say thanks for joining us today and I Hope you all think that bigger.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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