Q2 2020 Five Prime Therapeutics Inc Earnings Call
[music].
Welcome to the five time therapeutic second quarter, 20th 20th her name is call as a reminder, at this conference call is being recorded.
And I'd like to introduce your house for today's conference call Martin Forest, Vice President Investor Relations and Pepper communication you need again.
Thank you Julie and good afternoon, everyone and thank you for joining yesterday press release with the company's second quarter 2020 financial results was issued earlier today and can be found on our company website. Joining me today from different locations or Tom civic or President and Chief Executive Officer Doctor Helen Collins cheap.
Medical Officer, and David Smith, Our Chief Financial Officer. Today's conference call will include forward looking statements under the private Securities Litigation perform act with 1995, including statements regarding a research and development programs and financial outlook actual results may differ from those indicated buddies forward looking statements junior numerous factors.
<unk> knows discussed in the risk factors section a R. S V C 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 if our views change all now turn the call over to Utah.
Like Martin Good afternoon, everyone and thanks for joining us today to discuss a second quarter resolved to provide an update on two important near term data milestone for our Bima and 155 program.
I've been in my new role for nearly four months now so I'd like to begin with some comments on my initial experienced a side of fries.
What originally attracted me to five five has been confirmed in my short time at the company.
Amazing science talented and skilled people put three oh commitment passenger rewrite the cancer story for patient could be better treatment options.
Over the last few months, we had five fries I've adapted to a new work environment and the many challenges of the global pandemic.
I'm proud to stay that during these unique times a team continues to make substantial progress on key program.
When we have not experienced any delays and timeline or had any significant business <unk>.
Our team remain focused on there wasn't too important near term data readouts for the plate and 155 trials and advancing preclinical programs.
And my remarks today I would provide an update on quarterly progress a beagle 155 preclinical programs and our financial.
And then how long did David will provide additional updates on a critical programs and financial.
Starting with female.
And you will recall, we announce last quarter decision to turn the fight trial into a place to study P. S. S. As the primary and point.
After getting input from potential partners scientific advisors and our five crime team. We made this change for three reasons to generate data sooner to engage potential partners sooner.
And to quickly reallocate resources the other programs in the event the data are not positive.
We're studying bima frontline gastric cancer or.
There's a significant need here a gastric cancer is the fifth bleeding causes cancer deaths global and the last few therapy approved and frontline gastric cancer, that's more than a decade ago.
You wanted a lot about gastric cancer through this study's when we initiated the study over two years ago and saw rapid enrollment globally, which clearly signifies the need for new therapy for this population.
We also are able to determine that insignificant number of patients who gastric cancer on the phone line setting a tumor that over express F. T F R to be.
We know us tomato proximately 30 per cent.
This is the type of work that drives us patients, who desperately need new therapies, well, we can leverage our scientific expertise and collaborate globally to evaluate novel treatment approaches.
I look forward to sharing the results of the flytrap with you soon.
Moving onto 155 or <unk>, let's see [noise] excuse me protein.
<unk> novel, you know oncology molecule was developed five crime. It has a dual mechanism of action that is both an immune agonist send the checkpoint in heaven.
[noise] potential here quite significant there's 155 may I have brought applicability across many tumor tan lines of therapy.
I'm happy to report that this program remains on track to generate clinical activity results in monotherapy by the end of 2020.
We will use this information to determine the next steps for this Olga.
Here's where we are today for monotherapy, we have completed 11 safety bills cool with no D. L. P.
And we are now enrolling patient that adults, who we expect to see clinical activity.
While we were excited to see the monotherapy data. We're also interested in evaluating a combination of 155 and a P. D. One inhibitor.
Preclinical data reveal but when we combined these agents the results showed synergistic benefits.
As a result of this information and from what we have learned in the model therapy study, where now value I didn't a combination of 155 and probabilism.
I'm pleased to report that we don't start first patient and this cool Golan.
Hello, I'm will share more about this in a few minutes.
These two important program bima on 155 or approaching very important milestone I'm. So proud of the work we've done too advanced.
[noise] too advanced beamed program.
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With that let me turn it over to Hell.
Thank you Tom.
Let's begin with an update on them or excuse me ma'am R. S. T F R to be monoclonal antibody, which we're evaluating.
After cancer in the fight trial.
Advanced gastric cancer and gastroesophageal cancer is it difficult to treat cancer with a medium survival of only 10 to 12 months.
The standard frontline systemic therapy.
Kind of platinum in Florida, pyrimidine chemotherapy hasn't changed over 10 years and only provides a progression free survivor on the five to seven months range.
They'll just stink molecular profiles about and identified in subsets gastric cancer, we still don't have targeted therapies to benefit many frontline patients.
The fibroblast gross factor pathway isn't important one for several cancers in Denver choose a map or bima for short is the first thing class antibody, which is specific for the fibroblast gross factor receptor two b R. A F T a hard to be ice a form.
And gastric cancer overexpression a F T F. R to be has been associated with an even worse prognosis menu usual 10 to 12 months.
The fight trial is a double blind study in frontline gastric cancer. We're all patients receive standard modified full Fox six chemotherapy and a randomized to also received bima or placebo.
And this trial, we screened over 900 patient and found approximately 30 per cent of gastric cancer over Express F. T F R to be.
This trial was the first child to prospectively and systematically evaluate frontline gastric cancer four S. T F R to be Upregulation, and we found the frequency of over expression, a similar across Asia and Europe.
It's Tom highlighted in May we converted the fight child to faith to study and after and Rolling 155 patients. We are on track to a final day to read out at the end of this year or early next year.
The design of the fight child remains double blind and placebo controlled however, the primary endpoint has been changed from overall survival to progression free survival.
Assistant with a typical face to tile and to support generating meaningful data as soon as possible.
When the data are available we can determine the next steps for bima and how it might be used to best benefit patients.
Theme of represents the kind of drive five pine wants to work on a novel drugs that is effective will make a big difference to patients.
Five times, the only company with an antibody directed against the S. T F R to be receptor in development and gastric cancer and it's exciting to know that we will have the state of read out by the end of this year or early next year.
I'll know turned to F. P. T 155, her first and class C. D. A D S T P S and protein.
P. T 155 that drug that stimulates immune system to kill can't yourself.
It does this in two ways.
Binding C. D 28 on the T cell to directly stimulate T cells and secondly, my binding to see chili for I'm working as a checkpoint inhibitor.
Our focus in the first half of this year was continuing to dose escalation.
With the trial being conducted in Australia, and South Korea, we've been fortunate that enrollment has been minimally affected my Dakota 19 pandemic.
Now that we've reached the 560 milligram dose based on that predicted receptor occupancy and the clinical P. K. We think we are now and bowling patients had a dose with the potential to see clinical activity.
With that in mind, bernau, focusing on them rolling patients with hot and warm tumors.
These are patients with tumors, which usually have T cells infiltrating their tumors, which gives them the best chance benefiting from a therapy like 155.
This trial is on track to a clinical activity by the end of the year, which will guy that's in determining next steps in this program.
Is Tom mentioned in July we started treating the first patience with a combination of F. P. T 155, and Pamper Elizabeth.
[noise] preclinical data show synergy between anti P. D. One antibodies N F. P. T 155, so the combination may allow for more patients to potentially benefit from treatment.
There's been strong interest in this combination arm by the investigators and we are initially focusing on non small cell lung cancer, it's more efficiently evaluate the safety and preliminary clinical activity.
Finally, we continued to make progress on our three wholly owned preclinical candidates. The three programs are consistent with our focus on novel Anticancer biological therapies, we expect to advance at least one of these programs into I N D. Enabling studies by the end of the year.
And clothing, where excited to be on the cusp of meaningful and actionable data for our two leading novel cancer therapies demos and S. P. T 155.
And we are grateful to the patients their families. The investigators in the five time team for the hard work and sacrifices to keep these programs on track and he's trying times.
We look forward to sharing these results with patients investigators in the community soon.
Now turn the call over to David.
It makes Helen.
Details regarding our financial results can be found in the press release that we issued this afternoon.
Turning to our cash position, we finish the corner with a strong balance sheet cash cash equivalent some marketable securities totaled 128.6 million as of June 30th 2020, compared to 157 $9 million as of December 31st 2019.
This decrease was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.
Collaboration and license revenue for the second quarter of 2020th was 3.4 million, which was essentially on par with second quarter, 20th 19 revenue a $3.3 million.
Research and development expenses for the second quarter of 2020 decreased by 16.9 million or 57 per cent.
212, 6 million from 29.4 million for the second quarter of 2019.
<unk> was primarily due to lower compensation cost, resulting from the October 2019 corporate restructuring.
<unk> clinical and research cost and again on sale of laboratory equipment.
General an administrative expenses for the second quarter of 2020 decreased by 1.7.
Or 17% to 8 million from nine 7 million for the second quarter of 2019.
The decrease was primarily due to lower compensation Cos depreciation expense and other miscellaneous general an administrative costs that were partially offset by an increase in allocated costs.
That loss for the second quarter of 2020 was 16.9 million or 48 cents for basic and diluted sure can bear do a net loss of 34 4 million 499 cents for basic and diluted sure for the second quarter of 2019.
Looking ahead, we expect for your 2020, net cashews and operating activities to be between 70 $479 million, an estimate ending 2020 with cash cash equivalents and marketable securities between 80, and 85 million. This represents an increase in our ear and cash guidance that as a result of our lower.
[noise] gear to date cash bone and more importantly, our ability to manage our resources, while investing in our highest priority Eclinical preclinical program.
We also announced in our press release today that the company is entered into a sales agreement with count and company pursuant to which the company may from time to time cell through at the market offerings with Cowan acting just sales agent.
Common shares with an accurate offering price I'm up to 75 million. The company is split this facility in place as part of good financial planning and practice when they utilize the facility to increase investment at our portfolio.
I'd like to turn to call back over to the operator for the Q&A portion of the call.
Thank you if you'd like to ask a question. Please press star followed by the number one on your telephone.
What type of your question. Please press the pound tea.
My first question comes from Donaldson came from S. T D. Leerink your line is open.
Hey, guys. Good afternoon. This is David Rude, Sean for Jonathan Congrats on there is some progress and thanks for taking our questions really appreciate all the color in the prepared remarks, but it was just wondering if you could help set expectations for the 155 read out later this year in terms of how many new patients who you expect to have versus the update last.
Let's see and whether we can expect these data at a medical conference or is it possible you just provide this update the a webcast conference call.
Hey, David It's it's down here why don't I'll I'll start with Atlanta question, and and I'll I'll do my best can manage the questions that they come in I also just got a text for my team that it looks like I've cut out there for a second is I would clothing of my prepared comment so I'll I'll, maybe closed on that when we get done with the call.
David Your question about 155 is a really important one where we've got a team working really hard to advance. This program in 2020 and right. Now. We're we've finished 11th does court and without any D. L. P number starting to expand into tumors, where we believe we should see some clinical out.
I can see and those are in warm and hot too much.
We haven't we haven't said, how many patient will be in the cohort, but we do know that this will inform our next steps with the program.
We also haven't revealed when or where will share the data clearly one more thing today as well have you expect to have this information and how to inform our next step let me let me kick it over to Ellen maybe she can add some additional colored to where we are on the 155 program.
Yeah, David I I don't know that I have that much more <unk> two to add I mean, I I I think cause we said based on our predicted receptor occupancy in the pharmacokinetics that were saying again, we think now <unk> <unk>, where we have the potential to see something so we're in bowling has many patients as you can as quickly as pop.
<unk> because you said, we're fortunate that this trial as in South Korea in Australia and.
And again, but in terms of the the external.
<unk> announcement of the data we have we haven't committed to anything yet.
Got it thanks, and then just if you could clarify a few things on the teach you to a combination study was there any root beer from monotherapy portion that allows you to start at a higher dose of 155 and combination add just could you clarify for me are there any modifications to the.
Oh does here or is it just as administered in a label.
Well I wanted to take that one.
Sure. So so it's filled out pemble is mad and we are starting at 70 milligram dose. So he did dose down from you know as as you heard where.
Alright, and rolling patients at 560, and the monotherapy. So, but then safety profile it'd be seen certainly allowed it's not to have to start at that exquisitely low I'm going to therapy dog seven had to start with initially.
So you want the 10th grade again, and and you probably seen by your questions are preclinical data that had been presented ACR. So I'm thinking of based on that time, we are potentially starting at a dos that we may see something with that combination.
Let's see right right. Okay Awesome and then just you mentioned you mentioned in the remarks, but I didn't see in the press releases potential I N D filing by the end of the year I was just wondering if you could clarify that and.
And just your thoughts on anything anything else you can sure about that program and <unk>.
Yep, Yeah, I think David let me take this one so we're making really good progress with with our preclinical assets and we haven't announced the timeline for one more what should I be information, except for that well well, we'll make someone else might that are reset your childhood pet with Ya.
Yeah, So yeah, and I'll, just <unk> clarify what what I meant to say and hopefully said was that it's I N D. Enabling studies by the end of this year.
Got it okay. Thank you so much for for clarifying and congrats again on all the progress.
Alright, Thanks, David.
Your next question comes from <unk>, calling and calling and calling your company. The line is open.
Great. Thank you. So much this is CJS off on for Chris Tonight.
Thanks for taking the question just wanted to.
Ask you a couple questions on the financials.
To see that the cash burn is coming down guidance has gone up for the end of the year when I look at our projections and consensus.
Both considerably higher than it looks like where do you guys are planning on being can you give us a sense of.
Sort of the shape of what's gonna be going on with.
A N D N S G N as it should be expected orange.
I'm coming down mostly.
Yeah, Let me excuse me I'll I'll get started with blonde hair done and then I'll kick it over the David but I I think this is oh really important story, we we.
I think that's playing a really strong instead of financial disappointed here to ensure that we're investing in the most important now so it's that we've got at five fries. We went through a major reorganisation to ensure that we had the resources too advanced are are most attractive assets.
And get them to the milestones that are most important so I I'm I'm glad that you're picking up.
Improve financial disappointed that word, which maybe David can can jump into some of the specific to your question.
Yeah C J.
Are diagnosed did we did bring I've got into.
One of the wage we were able to do that when we providing that is at the beginning of the year. We didn't include the benefit of the license payment from C. Jen and we only had half of what we ended up realizing from the equipment sale for a lab related equipment. So that's something that doesn't reoccur.
The second half of the year, but that provided some uplift and it's also I think reasonable to assume that as we have would be my you know be misspend has been <unk> would it be strawberry and a first off of the year than in the second half of the year.
N G N. A is it's the function of just got to where the yeah allocated Costco, we're allocating a restaurant research because of the restructuring.
So that number, but but that's relatively consistent on a year over year basis as well.
Sweet thing could you just give us a sense of.
Weird partnering discussions might be obviously.
Come into the partner are interested in seeing the final data.
That's right triangle before anything.
Agreed upon.
Have discussions basically come through scenario analysis with as soon as the date is available you'll be able to extra food Wanna deal or do you expect to process and take a little longer than that.
Yeah, basically just kind of get I'll I'll I'll I'll I'll take this one so we're we're we're really excited about the opportunity to see the the fight trial later on Pier early next year.
As you can imagine we've had quite a bit of inbound interest in the program. It's.
As I mentioned in my comments Doctor cancers, especially then cause.
Globally, so there's a whole lotta patient that need new therapy, Helen's mentioned, it many times and I'll I'll, just I'll reiterate it doesn't really well done say to trial with 155 pages isn't it. So it it likely will give us information that won't be able to dig into and.
And form what the next steps are for the beam a program. So no no news to to announce at this point about partnerships, except for consistent with what we said in the past that we believe this is a program that could benefit from a global partner has got to cancel the disease, but it's like people.
Especially outside the United States.
Great. Thanks, so much.
Does that.
Your next question comes from Robert girlfriend.
Bush Securities Your line is open.
Alright. This is a stripper bar on for robbed congrats over the progress and thanks for taking my question.
I just I was wonder if you could turning further details on the the I P. T 155 combo study in terms of what type of.
Long patients you were looking to enroll are you looking at.
P wants to add as et cetera, and maybe how refractory artist patients.
And any other any other details would be would be super helpful. Thanks.
Sure I think I think Helen probably about one day after that clubs.
Yeah. So you know again this is a favorite one trial. So safety is it's primary and point because the investigators are so interested in I really have had talked to the team that's running minutes and they're close relationship with the investigators delta over time.
The inclusion cry T R. A fairly broad so it's not small cell lung cancer.
But ah, but certainly you know we are collecting all of the details that I think are going to be extremely important to understand any efficacy data that we get out of this and certainly in this day and age even in Australia in South Korea. The patients are expected to seem prior P. D. One therapy.
So.
Okay, I guess, if I had a quick follow up are there are.
Are there other influence number types of makes sense of what the same regimen that you're you're thinking it might be able to follow up quickly with.
Certainly and envy right or protocol to your flexible way so that we could do that but again I think what we're trying to deal with.
If possible.
Patients, where we can fairly.
Quickly determine whether or not we're seeing some African see an addition of course to the safety, but certainly this could be expanded.
Okay. Okay. Thank you very much so yeah. Okay. No problem here I think obviously this is this is a program that work.
Quite interested in investing in we think that it has the potential that have brought applicability, let's hook off many tumors in multiple wives and that's all I mentioned, we're gonna start where we think it's most likely for us to see clinical activity and depending on what we table I'm, calling for the next steps with a program.
Okay makes him like a very much.
[noise]. Your next question comes from I'm, sorry, the route so I'm just going home security of your line is open.
Good afternoon. This is Paul on Fred Sir Thanks for taking our questions I wanted to add on a question on 155.
Can you provide a little context on you know the bar for dancing and a P. D. One refractory setting for non small cell understand isn't you know pretty early stage still kind of what you see 155 fitting into the treatment landscape.
Yeah, Hey, Paul Tom again, I I I think this is this is this is exactly what I was just saying we're really excited about the the broad applicability because of this program.
As it relates to sort of the future plan for 155, I I think what you've seen from from five crime, we'll we'll take a discipline sequential approach to making decisions about where to try to advance the science and so as we as we continue the dog escalate and the combination stuff.
Well, we'll use that information to determine what else to go.
It it is a phase 130, and I think I Wanna make sure that we set the right expectations here. We're we're trying to get the do fries right now as we learn information from this study they will inform next steps with a program.
Great. So I guess one more can you can you comment on any combination thought you kind of explore beyond T. Do you want and where do you see an opportunity for 155.
Right now right now Paul we've got our focus on our too near term events, which is bima fight trial 155, and bottle therapy both of those before the end of the early next year.
And we're quite excited to be able to kick off cause combination trial with combo isn't up so right now our focus Paul.
Those areas to make sure that we we execute them flawlessly, we get to a place where the data reveal sorta next step for us and we can we can we can plant a flag on the ground and pivot quickly and with precision what those make it that's my opinion.
Got it thanks a lot.
You bet.
Your next question comes <unk>, what else have the security of your line is open.
Who can help you pick up the gym and thanks, thanks for taking our questions.
Just so I was going back to 155 pulling up on it.
Early a question. So if we if we wanted to have you know two scans available for patients give you a chance to confirm a response how many of these we'll just add a grilled cheese with patients do you think you could report on at year and the 2021.
Time for responsive to scans.
Yeah, maybe why don't I get started Helen and then you can fill in Mcgath day.
Nick I think I think it's probably important to know that what we haven't set as the exact number of patients, but what we have so does that we believe will have enough patient.
To be able to determine the clinical ask if you have 155 and monotherapy by the end of the or to determine next duck.
And so we believe the the number of patients that we are planning to enroll in so far enrollment has gone quite well. Thanks to clinical team are investigators, we're fortunate to be enrolling exclusively in Australia in South Korea at this point.
So we've got confidence a lot of enough patient in house.
Before the end of the or to determine where it seemed like one o'clock because either we hope to see that's a 560 milligram dose.
Alright. Thank you can you just calling cut back to bima.
I'll be zero holding pattern, but is there anything you'd you can be doing raw doing it could make gas at more attractive.
Biomarker for example.
The ability to to initiate a phase three rapidly is there sufficient product manufactured for example, do you have to make them a product.
Yeah. Nick I. This is this is an area that we've been spending a lotta time on which is you probably heard it and my last comment about 155, the the T M. As in best thing a lot of time to ensure that when we see the results we can put it with the speed and precision.
The questions, you're asking about product what the protocol would look like are all things that the team is working hard to ensure that we are well positioned to do should we see great results from the fight trial.
We're in a a really unique situation, where the flight trial as design what'd. They say three trial that we enrolled globally and enrolled extraordinarily quickly.
So we we've got that as a roadmap to to use as we think about what could be the next phase three trial clearly we're gonna wait to see the data from what pieces to trial and that will help inform could we do it more efficiently could we do it more specifically, obviously, we're gonna we're gonna love with that information.
And then as it relates to a biomarker, we've actually made great progress here alright. So we've we've been working really closely with Montana and Roche on an ice tea as a a screened over 900 patient also include recruited P. P. D N a.
Cause we have we have quite a bit of information on a population that hasn't been studied prospectively before and we <unk>. We we plan to interrogate that thoroughly as we as we move into the next day for beam or should we be in a place where the fight traveled positive so lots of information and and I'm really happy.
To report neck that we're we're doing the work right now before we see the data. So that we can we can move quickly until the next steps with this program for the results be positive.
Terrific.
Thank you very much and look forward to the next update.
Does that sound correct.
Hi, There reminder, if you'd like to ask a question. Please pet star followed by the number one. Your next question comes on the 20th Doctor. Some Das Kapital. Your line is open.
Yes.
Perfect sounds good.
Okay.
Okay.
<unk>.
Oh.
Julianne or or we're having we're having a little bit of a connection issue. It seems like maybe you've got the same what I had earlier.
I don't know if you if you Wanna start again, maybe.
Oh, Virginia Yep.
Mmm.
Nope.
Alright.
Operator, maybe maybe we can go to the next question they wouldn't come back to this one.
We have no further question do you at this time.
Well, let's try one more time.
Once again to care for a question. Please pet star followed by the number one I need to authenticate that.
He told me about that from a capital your line is open.
Tom.
There you go.
Yeah.
Oh.
Hello.
No I I I I heard a hello.
Can you hear me now.
Yep.
Yes.
Yes, yes, I can hear Ya.
Okay.
So my apologies.
Literally screaming.
But.
Alright.
Alright.
Okay, I'll check them all.
Oh.
I'm sorry, Mr. Bhatt through your line is breaking up.
Let's.
Schedule of 155.
Hey, Tony I'm, sorry, it's a it's it's Martin here, you're you're you're really just breaking up so what I think we'll do is we'll call you afterwards and and see if we can respond to your question that way I do apologize it's been a great call I mean, they've been calling in from all across the state and and calm in Boston.
But we we have had a couple of technical difficulties. So Tony you'll be first on our list of calls for after the call operator, I think we'll move too closing comments in Tom.
[noise] good I think Martin, Thank you and Yep and and thanks for all the questions today and for joining us I I'd, maybe just like to make a couple kind of so I'd like to thank for five trying to.
For their commitment and focus during these challenging times extraordinarily proud to be representing their work for you today.
I'd you've heard today.
To report that for Bima, we're on track to have iced tea to resolve places here early next year.
But 155, monotherapy, where now enrolling patient with warm and hot tumor that 560 bellyband.
I expect to have monotherapy day to in N out by ear and.
Cause obviously, a very important time for five time, we remain focused on delivering that's important data very soon and being prepared to execute on strategy too advanced almost problem hang out but.
With that I, just want to say, thanks for joining us today and I hope that you're all set that.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may know disconnect.
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