Q1 2020 Earnings Call
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Ladies and gentlemen, thank you for your patience something you could choose them buying your conference call. It begins I'd like to minute. Thank you for your patience and see what do you standby.
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Hi, and welcome to the five from therapeutic webcast and conference call.
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Now I'd like to introduce your host for today's conference call Martin for Vice President Investor Relations and corporate Communications you may begin.
Thank you Michelle and good afternoon, everyone. Thank you for joining up a press release of the company's first quarter 2020 financial results was issued earlier today and can be found on our company website joining.
Joining me today, or Tom Symbicort, President and Chief Executive Officer, Dr., Alan Cohen, Chief Medical Officer, David Smith, Our Chief Financial Officer.
Today's conference call will include forward looking statements on Department Securities Litigation Reform Act with 1995, including statements regarding our research and development programs and financial outlook.
Actual results may differ from those indicated by these forward looking statements student numerous factors, including those disclosing the risk factor section of our FCC filings.
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 time.
Thanks, Martin and good afternoon, everyone and thanks for joining us today to review, our first quarter achievements and preview some upcoming milestones.
I'm very excited to have joined five prime three weeks ago, when I look forward to interacting with you on the call today and in the future.
In my remarks today, I'll discuss the Corona virus pandemic and how it's affected five prime.
Our strategic decision to advance the fight trial as a randomized phase two study and provide an update on the 155 program.
I want to David will also be providing updates on our clinical program and our finances.
[noise], let me start with how we're adjusting the pandemic when I joined five crimes. The entire team had already been working remotely for a couple of weeks.
Important to note at the five prime team at started this transition about a week before the shelter in place mandate.
And as a result, we were able to make sure our team had what they needed to be safe comfortable and as productive as well as possible.
So let me ask somebody the leadership team at five prime likely will have many long term benefits for our organization and our program.
And then illustration of our concern for the safety and well being of our employees their families and our community.
I'm immensely proud of our team who have been who continue to respond with resolve and agility to the many challenges of the krona virus and damage.
Because of all the great work from the five Prime team I'm pleased to report that we do not expect the krona bias fanned out they have an impact on our two lead programs EMA and 155.
We're closely monitoring depend on working with our partners. The plan, we will provide an update departs situation changes.
Joining the company I've spent a lot of time with the five prime team reviewing our programs and as you might imagine significant amount of time, it's about looking at <unk> and 155.
So I'll start with bema.
There's a significant unmet need and gastric cancer as it is the leading cause of cancer death globally and unfortunately, the last approval in first line metastatic gastric cancer with almost a decade ago.
We have five prime remain very committed to advancing therapies like bema that have the potential to address patient group, where the therapies are limited.
After discussing our options with potential partners scientific advisory and our five prime to it became very clear that the best decision for the Beamer program with the turned the fight trial into a phase two studies PFS is the primary endpoint.
The following main benefit.
Most importantly, this decision will allow us to generate phase two data sooner.
If the data are positive will allow us to reengage potential partner sooner and it might also allow us or partner to design is smaller and more efficient pivotal trial.
And the investigator not positive this decision will allow us to reallocate resources to other programs more quickly.
Hello, and we'll provide more detail shortly but let me close my comments on Veeva by saying that of the new member to five Prime I was thrilled to see our team come together and that's been making important decision. That's in the best interest for patients our employees and our shareholder.
Now, let me move on to 155.
This program remains on track to generate monotherapy data at the end of 2020.
It's also worth noting that we're closing in on our go through continued to be incurred by the results we are saying.
We're also planning to initiate a combo trial with Pembro in Q3.
Guiding the company through the be would decision in the 155 data read out our key near term priorities for us, but there are other.
I'm also working with the executive team to plan for the development of our preclinical assets. How this influences our long term vision for five plan.
We are advancing three novel late stage research programs and expect to bring one into preclinical development later this year.
We have established strong partnerships with companies like Seattle Genetics, Bristol Myers Squibb enzyme.
We continue to look to acquire programs that will leverage our clinical development expertise.
Before I turn it over to Hollander, David I'd like to thank Bill Rindo guided five prime through some challenging times over the last six months.
In the five prime executive team restructured the company in a way that allows us to have the necessary resources to invest in these important program and our team.
Let me close of the comments about the five prime team.
My first three weeks I've had the opportunity over video to meet every five prime employees and I'd love to each one of these conversations because then we have the team in place deliver on our mission, which is to improve the lives of patients with cancer ways never before possible.
I'll now turn the call over to Helen who will provide more details on our clinical program.
Hi, Thank you Tom.
Let's begin with an update on them or accuse map, our fts hard to be monoclonal antibody.
Bema is under evaluation in the fight trial, which is a randomized double blind frontline gastric cancer study that has enrolled more than 150 patients whose tumors that overexpressed FGF are to be.
As Tom highlighted today, we announced the strategic decision to convert to fight trial to a randomized phase two study.
We remain optimistic about the benefit being when they provide in the treatment of patients with gastric cancer.
Remain committed to both the patient and investigators who are participating in the fight study.
This commitment to patients investigator and BMS is best realize when meaningful an actionable results are made available as soon as possible.
Converting the trials with phase two will also allow us to analyze the data in more detail and provide more confidence in the next steps up to be my program.
Based on the event rate in the 154 patients enrolled to date, we expect efficacy and safety results to be available by the end of Twentytwenty to early 2021.
If the data positive there's a clear potential for smaller more efficient pivotal phase three trial.
The treatment arms and structure of the fight studies will remain unchanged all enrolled patients will continue to receive modified full fox six and either bema or placebo in a double blind design and the trial will continue to be monitored by the independent DMC.
As is typical for a phase two trial the primary endpoint will become PFS.
Patients will continue to be followed for overall survival, which remains a key endpoint.
Gastric cancer, the devastating cancer from the patient perspective life expectancy with advanced stage disease, I mean, 12 months or lessen the U.S. and this hasn't changed appreciably in a decade.
Many patients do poorly with the frontline treatment and so don't have the opportunity to seek late line therapies.
Newly diagnosed patients desperately need better frontline therapy, and bema remains the only FGF hard to be targeted drug in the clinic with the safety profile to be combined with chemo and the efficacy data as a single agent.
We are extremely appreciative of the contributions to this trial from patients investigators and the employs a fine grind and I are partner in China.
Screening of over 900 patients globally, and 15 months illustrates both the enthusiasm for bema. The support for this study and the desire for new therapies and gastric cancer.
We look forward to the clarity than a near term data read out will bring to the being a program and remain committed to generating this data with the continued help with the investigators patients center staff that pipeline.
Turning now to a P.T. 155. This is our first in class C. D 80 FC fusion protein that has two complementary mechanism of action directed at the T cell.
One to directly stimulate T cells by engaging CD 28.
And to to inhibit see feel like for checkpoint activity.
I think he won five five different than a teacher delay for inhibitor like if you on the map or T cell agonists like my close GITR oxforty or four when BB that are only expressed on T cells that are already activated.
One of the targets rescue T 155, a CD 28, which is constitutive lease spreads on both naive and memory T cells. So at P.T. Once lifelock has the added potential of being able to activate naive T cells.
In the phase one trial were seeing dose dependent proliferation of both central and effective memory T cells and the blood and based on this data. We think we're now enrolling patients at doses, where there's the potential for efficacy.
Enrollment so far has been minimally impacted by co. Good as the trial being conducted in Australia, and South Korea that we remain on track to generate the data that should enable us to make a preliminary evaluation of single agent activity by the into 2020.
We also expect to initiate enrollment in the combination dose escalation of S.P.T. 155, and Pembrolizumab in patients with PD, one treated non small cell lung cancer in the third quarter.
Moving on to pay 150, monoclonal antibody targeting tumors that over express b seven each for.
We completed enrollment of SD 850 in combination with Pembrolizumab in a phase one be cohort of patients with ovarian cancer that over expresses b seven a tour.
We do not plan to advanced the development of the combination independently.
We plan to submit for full dataset from both the long term follow up of the phase one be monotherapy arms.
And the combination arm at a future scientific meeting.
Finally, turning to BMS 986 to five eight.
An antibody targeting immune checkpoint receptor Tim three based on BMS is monitoring of the Kobe at 19 situation, we no longer anticipate that BMS may move this trial into phase two before 2021.
I'd like to close by saying we work at five time because of a commitment to discovering drugs with novel mechanisms of action to fight incurable cancers. It's an exciting time right. Now is we're closing in on having meaningful and actionable data on two of these novel therapies, the CD HDFC protein and bema and we look forward to sharing these.
Results with patients investigators in the community.
I'll now turn the call over to David.
Thanks Ellen.
Details regarding our financial results can be found in the press release that we issued this afternoon.
Into our cash position, we finished the quarter with a strong balance sheet cash cash equivalents in marketable securities totaled 142.7 million as at March 30, Onest 2020, compared to 157.9 million as of December 30, Onest 2019. This decrease was primarily attributed to call.
Quarterly operating expenses that exceeded quarterly operating quarterly revenues.
Collaboration license revenue for the first quarter of 2020 increased by 3.1 million were 58%.
To 8.4 million from 5.3 million for the first quarter of 29 team.
The increase was primarily related to license revenues earned from the Seattle Genetics license agreement signed in February 2020, and collaboration and license revenue from our collaboration was I lab.
These increases were partially offset by the completion of our immuno oncology research collaboration with BMS and progress pursuant to our performance obligation under the original collaboration with BMS.
Research and development expenses for the first quarter of 2020 decreased by 13.2 million or 42% to 18.6 million from 31.8 million for the first quarter of 2019. The decrease was primarily related to lower compensation costs, resulting from the October 2019 restructure.
Offering lower manufacturing directed towards or at P. 850 program, lower preclinical and allocated costs lower clinical services and specialty lab services related to our Kabir up and our FDIC 150 clinical studies reduce companion diagnostics expenses relate directed towards our EBIT development.
Graham add decrease in miscellaneous research and development expenses. These decreases were partially offset by increased clinical trial expenses, primarily related to being though.
General and administrative expenses for both the first quarter 2020, and the first quarter 2019 were 10.5 million.
Net loss for the first quarter 2020 was 20.1 million or 57 cents per basic and diluted share compared to a net loss of 35.4 million or one dollar and two cents per basic and diluted share for the first quarter of 29 team.
Looking ahead, we expect full year 2020, net cash used in operating activities to be between 77, and 82 million and estimates.
Ending 2020 with cash cash equivalents marketable securities between 77 and 82 million.
Back to turn the call back.
Right.
Michelle I think it's Tom here I think I think we can we can open up the line for questions.
As a reminder to ask a question you need to press star one on your telephone <unk>.
Withdraw your question press the pound key.
And by what we can probably Q and a roster.
Our first question comes from Jonathan Chang of STB Leerink. Your line is open.
Hi, guys, David room, Sean for Jonathan Hey, Thanks for Thanks for taking our question first one I guess could you just provide an update on how the business development discussions around the merits is a map or going and did you get any indication from potential partners and these discussions.
That said a phase two study might.
Do more attractive to them.
Hey, David it's been a time here and thanks for the question I I, just I'm just going to say this out like once before we start answering questions were all in different places right now I'm. So I'm going to do my best to three hours the question to the appropriate person.
As you try to navigate sort of the remote working from home. Please so let me let me start JV with your question. So obviously this decision was one that we didn't take lightly and you may recall that in last quarters earnings. We spent a fair bit of time talking about.
Options that we had in front of this for the Beamer program.
So when I joined the team just about a month ago. The team was well underway and thinking through many different options that we had as you'd expect we talked to put central partners can you talk to advisors and you leverage the expertise that existed at five prime as we contemplated this decision is moving the fight trial to us.
Two studies, so and to answer your direct question. We did we did talk to many parties and potential partners is one of them.
The the main the main reason we've taken this decision if we wanted to be able to revealed the data sooner. So that we can dive into a deeper to better determine next steps with immuno program I missed this clearly it's something that allows us to do that some yeah. Let me let me maybe ask John Pelling exceed like the out a little bit because the decision.
We've made here.
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Yeah, I I think you covered it well Tom I mean, I'm. So you know that you're right. The short answer is that that that is what we would hear people people would like to see phase two data and and so I think yeah that was but that wasn't the main component I mean, I think as we've talked about it's this is the way that we can all see the data.
And and then make better decisions about how to move forward and as he talked about I mean, I think one of the things is that.
Certainly if if we see good data then a factor phase three trial, but you know more precisely design.
No. So we don't think in the long run this really change kinds lines, but.
We'll see.
Got it thanks, and then I guess, a second question given that most patients of the 150 or I guess all of them already enrolled could you talk about other considerations on timing of the read out.
And what you can expect to see.
In terms of PFS and OS for all patients or.
Well the sort of be an early read on.
Got population, just I guess give some color there and and how they current cold and situation might impact that.
Okay, Great. Let me give it all started again and then lapel and add a little bit too. So our plan right now is to to be able to I'm sure data at the end of this year or early 2021, and as you've mentioned that it's an event based trial with now PFS is the primary endpoint, but clearly we're going to.
Oh.
Oh, that's events that would be extraordinarily meaningful to determine the value of this program. So.
Our plan right now is to two to reveal the data you know the ended this year or early 2021, maybe Allen is there anything more you'd like to add to that.
No I mean, I I think you've got that the timing right you know that we paused enrollment at the end of November except for in Japan. So we've been wanting to get some safety data in Japan, but so that's why we have more than 150, but you know November to now it's six months and that is you know about the median PFS on on modified full Fox, so events or commit starting to come in.
In and out and that's why we're being a bit bag in terms of when when exactly will have the data, but yes. It is important still even though PFS is the primary that we will be collecting a wes and I think we'd like as you know it won't be a readout on on Oh last on all 150, something patients hopefully they live longer than that but but you know we said we have enough to.
Especially 150 patient phase two trial is clearly enough to low power a phase two trial well so.
We feel good about this decision.
Got it that's really helpful. Thanks, Colin and Dot Com nice to meet you over the phone. Thanks, guys. Thanks, David.
Our next question comes from pets and the route of Guggenheim. Your line is open.
Hey, this is Paul on threats or thanks for taking the question I have two on FTT 155. So you mentioned closing in a dose can you also remind us of what kind of data we like that.
Monotherapy data update later this year and then secondly for the combination of FTT ones I tie with Pembro in Q3 initiation can you provide more color on the design and possible timing of results for this as part of the study. Thank you.
Yeah. Thanks, Paul Yeah, I'll start and then obviously Helen's got much more experience with our one 5.5 program that we're quite excited about so.
As you know this is this is a potential therapy that has a really important dosing window and so we're making sure that we find the right place and you've got 10 different can different doses that we tried at this point and I'm. We're encouraged by what we're saying and then as you mentioned, Paul we're planning to.
Part B the combo trial with Pembro in Q3.
And let me, let me have colon cancers. The if you can the part about when we would expect to see some of that data.
Yeah. So Paul you know, what we're doing the dose escalation and you've heard me described that that trial previously that we do a standard three plus three on a monotherapy dose escalation and then now that we're in a dose level, where we think we'd see some activity we're doing for lack of a better word backfill or terms exploratory pacing.
That we think specifically a tumor types that are more more likely to give us answer we want the reason, we're saying ended the year because every enrolling patients and again knock on wood cobot hasn't affected our timelines. Today. Then you can imagine these patients will enroll over the next couple of months and then we need a few months to get those scan results and down and we want to be clear.
This will be data that we will be looking out before the ended the year and we will be making strategic decisions about where to go next we don't want to promise that will be saying anything publicly because that you know we're always committed to presenting our data at a scientific a form in general, but again, how we how we might communicate something at the ended the year.
Externally and.
We have committed one way better in terms of the combination.
This is a combo that we think we'll have synergy both efficacy, but that also likely could be toxicity. So it doesnt mean, we need to start at a lower dose.
Ling and we've worked side by side with them our team and their team from the from the beginning so they've been involved in the discussions all along the way about different options and I can honestly say they are very supportive of this decision I think so so there really was not any.
Any.
Any difficulty with that and and again to understand the reasons and I think they just like us would like to get some data. So I think we're all aligned on that.
You know in terms of 155, and I'm and I hope I didn't that.
It's.
The effect on T. Rags I think is is as you know and humans somewhat somewhat controversial I, specifically mentioned in our call that we but we're we have right now back are the blood P.D. markers. So we have we are just now getting back our our tumor samples and our tissue samples and then we should have some more information.
That's right and I don't have anything to share with you about that.
It's pretty much all.
As a reminder to ask a question please press star than one.
Our next question comes in the gym Berchenall Wells Fargo <unk>.
So if nixon mickelson gym, so so soon and.
Home welcome to the team. So my first question is going back to fight so to the futility analysis on or not be postponed to know or canceled now with the decision to me, but if they're supposed to trial.
And nice to meet Ya, Yeah, I I think the the the decision here that we've taken it to use to convert the fight trial to see to study and the timeline that we've we've articulated our data at the end of this year, we 21 with the really significant benefit.
Being able to look at the data much more deeply.
So we have not than we do not plan to do if utility analysis that is we're not but it's not something we're pursuing any longer.
Okay. Thank you.
And then on one fight fight for these immunologically.
The whole warm patience or you're going to be enrolling is that to a single dose Oh, Oh, Oh, you are you going to do.
Escalation, but obviously you know starting up whatever it is those going a little 10.
Hmm yeah.
Yeah, I think only one this one and I think you can answer that question.
Yeah Yeah.
So the way we're doing the trial is a is average Joes escalates, which is three plus three national patients as we clear cohort. So you can say you know as we clear 280 milligrams. The next three patients go in at 560, and additional patience going it 280, and we continue up as we do that and we and we want to do that probably for the reason.
You're getting too because we want we want to get some we'd like to get a better sense of the therapeutic window and we also want to make sure that this since this is an I.O. drug that we have a certain number of patients at each dose level to get that some longer term safety data, we really want to finish our dose escalation.
With the data that will really informed inform well the next steps in terms of that therapeutic window safety. So.
That's clear. Thank you and then just on on F.T.A. 151 time, you said you can communicate the data by mid twenties on today's comment you said, we'll be submitting tool publication. So are you going to do both or if you decided not to Ah just released talk blind date trends.
Submit the data just stuff publications presentation at a meeting.
Hello.
Yeah, So I I think what you're <unk>, you're right you want me. Her today was that we are not taking this forward anymore and that was what we committed to with kids state, whether or not and we're going to continue with the one five vote program and right. Now there was no planned to do that alone you know you've heard me safety.
Worn it's still true we still have patience and on treatment. So there are some patients were getting benefits and that and that's the data that we would like to present in a scientific porn.
Right.
Exxon Thank you.
To the beach in it.
Think so.
There are no further questions like to turn the call back over to Tom Civic really <unk>.
Alright, Thanks, Michelle and I think for all the question today and for joining us on the call I'd like to close by thanking the five crying team for their focus an agility dirty you challenging times.
You heard today, we're pleased to report we've converted to fight trials to a phase to study with results available in late 2020 or early 21.
Or 155 program is on track, we're closing in on a dose and expect of Monotherapies data.
You're in our research programs are progressing nicely.
Or continued financial discipline allows us to resources to advance he's important programs and we continue to continue to strive to improve lives that patients with cancer ways never before possible, but thanks for joining us today and they say.
Ladies and gentleman <unk> today's conference call. Thank you <unk> you may now disconnect everyone have a great that.
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