Q1 2020 Earnings Call
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Good morning, ladies and gentlemen, and welcome to the job that's either first quarter 2020, earning conference call.
That's all participants and all that not only though.
Conducted question answer session and instructions will follow at that time.
As a reminder, copper is being recorded at the company's acquired.
I'll now turn the call it with your house hormone Joshi, which also Peter Please go ahead.
Thank you operator, good morning, and welcome to the jumps Therapeutics first quarter Conference call. This morning, we issued a press release, which outlines the topics that we plan to discuss today.
We need to the available in the investors immediate section of our website at Www Dot Jounce T X dot com.
Speaking on today's call will be our CEO and president Dr. Rich Murray who'll discuss our pipeline progress.
Key milestones followed by our CMO Dr. bets tree, who will provide an update on our clinical activity and lastly, our CFO Kim Drapkin well with you our first quarter financial results.
Well then open the call for your question.
Before we begin I would like to remind everyone that today's discussion will include statements about our future expectations plans and prospects that constitute forward looking statement for the purposes of the safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these forward looking statement as a result of various important factors, including the risk factors discussed in our SEC filings.
In addition, any forward looking statements represent our views only as of today may six 2020 and should not be relied upon as representing our views as it any subsequent date.
Well, we may elect to update forward looking statements at some point in the future, we specifically disclaim any obligation to do so even if arby's change.
With that I will now turn the call over to rich.
Thanks, and good morning, everyone.
The short to 2020, there's certainly been a reminder to us so why we're in this business and the importance of making it into two <unk> patients lives.
It's been inspiring not surprising to witness or industry coming together collaborative swiftly as world works to combat the cobot 19th.
Specifically at Joe's we've been operating with an abundance of caution as we follow hill and she guidelines, including working from home and maintaining our research lab operations for T. priority activities.
The teams working from home to manage our clinical trials have done an outstanding job of adapting to every challenge going after them.
Come up with creative solutions to mitigate risk.
Patients your trial activities.
However, given the challenging funds.
Patient enrollment in the Burj phase two trial in the initiation deviation of the select phase two trial I've been modestly impacted by government 90.
We now expect to delay approximately two to three months for both trials.
I'd like to think or employees for their dedication to our mission and making a difference for cancer patients.
In a few moments that will provide additional color on the impacted Kogan tag team on our trucks.
Today I'll cover how emerge.
Coming select trials focus on critical unmet medical needs of the respective patient populations in non small cell lung cancers in the opportunities for Josh.
We continue to analyze samples and generate new translational data from the ongoing patients with highly durable clinical benefit in that box right.
Based on further mechanistic insights into the role of Vikas invoked.
And long term of your memory I'll provide a perspective on where and how the Oprah. They help me best helps you should feel these unmet needs.
Finally, before handing off the bat.
I'll provide an update on our next potential first in class development program.
If you have teaching 11, which is currently in 90 days studies.
As a reminder, both booker programs emerge and select.
Are focused on two distinct non small cell lung cancer populations.
As you approach is based on strong scientific underpinnings.
The ongoing emerged trial is enrolling second and third why I O experienced non small cell lung cancer patients will progress on both the PD, one inhibitor and platinum based therapy.
Either accommodation were sequentially.
For these patients the standard of care is those taxes for clinical trials.
What we believe is most important regarding doesn't paxil in this setting the uniformly short duration of benefit.
Low impact to overall survival.
The regulatory gold standard clinical benefit.
This creates an opportunity for new and different mechanisms in these stations to cheap durable.
We believe our merged trial, a new Io combination with a unique dosing schedule has a strong scientific rationale to bring that durable benefit.
That's will give us a bit more background and review the mechanistic rationale of this nomination, including the important Pharmacodynamic Biomarkers of Oprah hypothesize Cdfour T cells.
Turning to our upcoming select trial, we will employ the predictive biomarkers chips bopera.
We believe can be used to select the patients more likely to generate like outside cdfour T cells on vote for treatment.
We identified just Oprah.
That's a potential predictive biomarker based on iconic data.
So I wouldn't rule second line I O naive non small cell lung cancer patients outside the U.S.
As PD, one inhibitors have become firmly established as a treatment for non small cell lung cancer, we will bring vocal on board as combination in the Io naive to vote for selected patients in a randomized trial.
If we achieve proof of concept Barbara plus a PD one inhibitor. It just vote for selected audio naive patients could become a combination of choice for PD, one inhibitors as class.
We believe there that the opportunity to bring true benefit to patients isn't durability, specifically overall survival.
Responders from our I. I taught a trial continued to show remarkably durable benefit.
Along with the continued presence of the vote for specific TD biomarker.
For now over two years of ongoing therapy.
The on Barbara. We're also excited to continue the advancement of our next product candidate Gtx 18 11.
I'm pleased to announce today that target for Gtx 18, 11 is CCR eight.
The key MACOM receptor enrich on intra tumoral T regulatory cells.
All right was one of our tough choices of T regulatory targets coming from our systematic interrogation of the tumor microenvironment using or discovery engine.
As a reminder, Gtx 18, 11 is a monoclonal antibody intended to selectively deplete tumor resident T regulatory cells in the tumor micro environment.
To do so the program has two key elements.
First the target would be optimally express at high levels on the majority of intra Tumoral T regulatory cells and more minimally expressed elsewhere.
Second the antibody would impose a functional impairment on the tumor T regulatory cells and or be able to selectively deplete though.
When Gtx 18, 11 binds to CCR eight it targets the T regulatory cells for depletion by enhanced antibody dependent cellular cytotoxicity.
We believe T regulatory cells impose immunosuppression onto an active immune response that may be distinct from the PD one axis.
To that point Gtx 18, 11 is active in some preclinical tumor models, where there was no PD one inhibitor activity.
And it can be burst PD, one inhibitor resistance in those models when in combination.
We're looking forward to presenting scientific data supporting the development of Gtx 18, 11 at the June portion of the HCR virtual annual meeting.
And we expect to file and I'd for this exciting programs in the first half of 20.1.
[noise] Gtx 18 Elevens development.
With translation of our key learnings from iconic into emerge and select.
Represent our commitment to bringing novel programs into clinical testing for patients who are not sufficiently benefited from todays Io therapy.
With that I'll now turn the call over to bet to further discuss our clinical activities in more detail.
Thanks, Rich and good morning, everyone.
That's our lead program Oprah advances, we continue to believe that the role that I costs and CD for T cells play is critical to a more comprehensive immune response to cancer beyond the current CB eight focus of PD one inhibitors.
Resting T cells that have not been exposed to any antigen expressed low levels of icon and they're not active.
However, once TD four T cells her crime like exposure to antigens, they become activated and expressed high levels of icon.
We refer to these cells has I coast, Hi, CD for T cells.
As we have further characterize T cells, which emerged to devote opera and not PD. One inhibitors. We have learned that they actually include three distinct sub populations.
One subset 'cause CD for T helper cells or T. H, one cells that either kill tumor cells directly for encouraged tumor cell, killing to their influence on T.D.A.T. cells.
A second subset CD for people that killer helper cells, which play an integral role in antibody production by B cells.
The third subset, which we think is very important for durable benefit from Io therapy.
He central memory cells.
We believe that by extending these cells that produce long term onion memory vote for may be able to extend the durability of responses.
When I can assist Upregulated couponing. Its presence is increased on all three of these cell populations I live with play an important role in the comprehensive immune response separate from that perhaps complementary to PD one inhibitor activity.
The central role that these cells made clay and our demonstration and iconic that their proliferation and sustained activation is associated with durable clinical benefit led to the two development paths for gopro represented by the emerge and select trial.
I would like to spend a few minutes to provide an update on the emerge trial.
The emerged trial employs induction of I Cotai CD for T cells with if the Linden that followed by administration of copra in PD, one experienced patient with non small cell lung cancer.
As rich mentioned there has been an impact on a merchant home, it's been data release, owing to covert 19.
Our clinical operations and medical affairs teams have done an outstanding job and have come up with creative solutions to minimize delay, including virtual site initiation visits and virtual training on P.B.M.C. processing for our critical I close I see before biomarker.
Due to their efforts and the high unmet needs in the emerging population. This study continues to progress and we saw no impact on enrollment until very recently when the number of patients in screening started to decrease somewhat.
We are there for currently projecting a modest delay to completing the targeted enrollment for the interim analysis, but still expects to complete enrollment midyear 2020.
As you May recall, our interim analysis is planned to include clinical response data through at least 18 weeks on all patients plus biomarker data.
Which means that the complete dataset will not be available until approximately six months after the last patients enrolled.
And we have been on track to deliver that in the second half of 2020.
No due to the recent impact of Cobot 19, our timeline to complete the interim analysis of preliminary efficacy and biomarker data has shifted into early 2021.
Again, this will allow us as planned to have a robust dataset with all the valuable patients having at least two on treatment scans.
As this emerged data is our next clinical milestone we thought it would be helpful to provide some context that starts with understanding the outcomes with ddos attack, so and with PD one inhibitors in second line non small cell lung cancer and focusing on the nature of the benefit.
The checkpoint inhibitors have brought to patients.
From the approval of the first checkpoint inhibitor immunotherapy has brought significant clinical benefit to cancer patients through the durability of clinical benefit an improvement in overall survival.
PD, one and PDL one inhibitors were approved in second line I O naive non small cell lung cancer based on comparison to Ddos attack. So.
In this setting ddos attacks or provides response rate of approximately 6% to 14% median overall survival of six to 9.6 month and significant toxicity.
Single agent PD, one and PDL, one inhibitors without biomarker selection produced marginally better response rate than Ddos attack, So but were approved based on meaningful improvement in overall survival.
Now, let's turn to outcomes for patients in second and third line non small cell lung cancer, who are PD, one experience like the patience and emerge where ddos attack. So has become standard of care by default.
There is no randomized clinical trial data to provide response and survival benchmarks in this population.
However, kale feedback suggest that clinical benefit from Ddos attack, so, especially overall survival. In this population is likely know better and probably worse than in the PD. One naive patients I just referenced that's one would expect in a leader in light of therapy.
Based on the durable responses and iconic we believe that Oprah in combination has the potential to improve outcomes for these patients, including the durability of clinical benefits and overall survival.
The duration of follow up built into our interim analysis will allow us to share data from emerge on these critical measures of efficacy for Immunotherapies.
I would now like to turn to the second so for development path represented by the selects trials using Biomarkers selection and what we believe it's a move towards precision medicine in I O.
Tim is an 18 gene signature originally developed as a predictive biomarker for PD. One inhibitors that includes genes associated with TV for T cell activation and pits Oprah has been optimized for prediction of I Cotai TV for T cell emergence in patients.
Treated with Oprah and to PD one inhibitor.
We expect to enroll approximately 75 immunotherapy naive second line non small cell lung cancer patients, who will be selected using the predictive Tim Boeker biomarker and randomized to Volcker, plus Jay T X 44 team, our PD, one inhibitor versus K T X.
40 14 alone.
We estimate that approximately 20% of second line non small cell lung cancer patients will be above the to spoke for threshold and potentially eligible for the trial.
With that selective biomarker, we expect results with J. T X 44 team to be better than those for PD, one inhibitors in unselected patients, but even better for both for plus K T. X 40, 14, because hes bopera is predicted for the vote for specific I close I see.
Before T cell emergence.
The trial is therefore powered to demonstrate superiority of Gopro plus K T X 44 teams to take T X 40 14 alone.
We believe that a positive result may positions Oprah as the combination partner of choice for PD, one inhibitors with just spoke for selection in multiple tumor types and lines of therapy.
As rich mentioned Cobot 19 has resulted in a two to three months delay in initiation of the select trial. Despite this shift we still expect to report select clinical data in 2021.
Before turning the call over to Kim I would like to reiterate how proud I am as our team and their dedication to helping patients and their community. Despite these unprecedented and challenging times.
No more than ever it is imperative to execute on our mission of delivering long lasting benefit to patients.
And we believe that our translational science, coupled with precision medicine approach to Io brings us closer to achieving this.
We look forward to our continued progress in 2020 and execution on are important upcoming milestones.
No I would like to turn the call over to Kim for a discussion of our first quarter financial results Tim.
Thanks, and good morning, everyone.
We recorded in this morning properly cash cash equivalent and investments as of March 31st 2020 totaled 148.6 million compared to 170.4 million as of December 31st 29 team.
The decrease was primarily due to operating costs incurred during the period.
Turning to the piano during the first quarter 2020, we incurred 19.6 million in research and development expenses compared to 17.3 million for the same period and 29 team.
The increase in R&D expenses would do to external clinical and regulatory cost associated with the emerge and select clinical trials and increased employee compensation costs, partially offset by lower I, India, enabling expensive.
General and administrative expenses were 7.5 million for the first quarter of 2020 compared to 7.2 million at the same period in 2019.
The increase in DNA expenses is primarily the result of increased professional service fees.
Net loss for the first quarter 2020 was 26.4 million.
Or a net loss per basic and diluted share a 78 cents.
As compared to a net loss of 12.4 million for the same period in 2019.
Or net loss per basic and diluted share a 38 cents.
The increase in net loss was primarily attributable to know license and collaboration revenue in the first quarter 2020, and an increase in operating expenses.
We continue to monitor any changes in impact to our business given the cobot 19 pandemic apparently continue to affect gross cash burn on operating expenses capital expenditures for the full year 2020 to be approximately 80 million to 95 million.
We've always maintained a strong balance sheet and that batch. We're also reiterating our previous guidance and expect our existing cash cash equivalents and investments to be sufficient to enable the funding of our operating expenses.
Capital expenditure requirement through the end of 2021.
Additionally, we continue to have the ability to drive our innovative immunotherapy pipeline, while efficiently executing against our strategic plans and goal.
With that I'll hand, the call cigarettes for a final thoughts.
Thanks Kim.
We have our trials reflect the scientific progress that stems from our translational science platform.
Driving new therapies to the clinic. So that we can continue to envision a future with longer and broader durable benefit to patients who do not have those options today.
We remain excited for what lies ahead for jobs with critical milestones laid out for the remainder of this year and beyond.
To reiterate we plan to presented preclinical data on our CCR eat program Gtx 18 11.
The 2028, you see our meeting in June.
While also continuing hi, Andy enabling activities with an expected I'd filing in the first half of 2021.
Initiate the select phase two trial of Oprah and Gtx 40, 14 using artists both for a biomarker.
Complete the merge enrollment midyear 2020 and conduct the interim analysis are preliminary efficacy and related biomarker data in early 2021.
And continue to work on advancing multiple new targets from our discovery pipeline.
With that we would now like to open the call for your questions operator.
Thank you.
As a reminder to ask the question. Please press Star then one I hear telephone which are the question press the pound King.
Our first question comes from the seed House at Raymond James Your line is that okay.
Hi, Good morning. This is a neil on for Steve I'll take it for taking the question I just have a couple in relation to Gtx 18, you level.
Oh just closed.
No it might be a little too early but I still want to test.
Do you or what do you expect to Schervish oncologic indication might be target or have you. It most likely probably starts with the basket trial and and other one is do see had been rusticated as a monotherapy or combo and its later then called <unk>, which oh. Thank you.
Sure I'll take that.
As we as we you have evaluated CCR eight expression on T regulatory cells across a variety of tumor types.
All that data will be coming up in are you see our poster presentation, so well kind of direct everyone towards that Ah. So that we could really talk about the data we're looking at which tumor types are most relevant so I don't want to a kind of short circuit that particular information that will weigh out.
Let's remind me. The next question. So that was the tumor that was the tumor type and then.
Ah if it's going to be skills.
Well no.
Yeah, sorry, you know we have shown we have shown and data that we have disclosed that there is monotherapy activity in a preclinical tumor models that are PD one resistant. So we think there's an opportunity there.
We have also shown is that best mechanism of depleting T. Regs seems to work well in concert with PD. One inhibitors. So both of those are both of those directions makes sense for us and we'll we'll be pursuing those pursuing those clinically.
Excellent thanks for taking the question.
Thank you know and their next question comes from death, each had a party am H.C. Wainwright Your line is that well Ben.
Hi, Good morning, everybody this is or leases for Debjit I hope everyone is seeing see unhealthy.
We just have one question since cohort one and be much study was completed with a while back have you observed any biomarkers signals, which give you confidence on the likely to be profile for the combination. Thank you.
Hi, this is that.
We actually.
You know.
We're not really doing a lot of looking at data are doing any analyses. We we enrolled the cohort sequentially, but we plan to do all of the analysis at the very and so that we make sure we have the complete picture.
When we do report the data, though it will be clinical data and all the relevant biomarker data.
Okay got it thank you.
Thank you.
Question comes from Cory Kasimov of JP Morgan Your line is that open.
Hey, good morning. This is turned her on her Corey so her to emerge interim analysis I'm just curious if any of those delays are gonna have an impact on the quality of data.
No just being able to contain procreate follow up scans received therapy et cetera. Thank you.
Sure sure that's a great question.
As of now we're actually we're collecting almost all the samples on some C.T. scans may be delayed a little bit but as far as we can tell right. Now we don't believe there will be any impact on the quality of the data.
Great. Thank you.
Thank you and our next question comes on Board Speaker of Cowen. Your line is now open.
Hi, Good morning, just following up on the impact of covered 19, I'm just curious for the emerge as well as select study how frequently do these patients need to visit the physicians how often do they have to go to the doctor and just want to understand kind of the burden on the patients in any kind of sort of risk of exposure here.
Sure so.
Through the first four doses of iffy, they're doing it the invoke FRE and alternating sequence to they come in for treatment every three weeks and that's the only visit required other than getting their cat scan then won the once the if he's done then they come in every six weeks for Gopro.
So we've tried to keep it we always try to keep the burden to a minimum so they're basically coming in once every three weeks for their treatment plus the P.T. scam.
Gotcha and is this all down in the outpatient setting where do they have to go to hospital for any ER visits yeah. That's that's a great question, yes, it's all in the outpatient setting and I think we've been fortunate not all of our site are located in hospital. You know there are some a lot of cancer centers.
Actually are kind of on their own campus are separate so most of the patients don't have to go into a hospital, they're able to go to the cancer center or their physicians office without going to the hospital.
Great. Thank you very much for taking my question.
Thank you all and again, ladies and gentlemen, if he would like to ask a question at this time goes far them, one I hear touched on telephone.
Our next question comes from Jeff Berson half of Wells Fargo. The line if that open.
Good morning.
Hey competition. This morning, thanks to the uptake so quick question on select and that's the virtual training you mentioned.
It is a to qualify the site and just more generally how do how do you Anshul compliant lithia, it's critical that identifying the right patient here, so de send them spike samples and flow cytometry, I say that used to using can you can you just sort of describe how these patients get hurt cooking and how youre.
Qualifying them, but this is having somebody show up.
Sure as it did of course.
Sure. So maybe a dress two different things what I referred to with respect to a month just were doing virtual training on the P.B.M.C. processing, which is what we use to assess the I could say city for T cells, and that's actually going really really well we have a video that we've created where our staff.
Show people exactly how to do it and then there on the phone well the people are there on a zoom called watching the people in the lab do the processing. So that's gone extremely well and when we've had very positive feedback from the labs now going to select.
These be predictive biomarker tests of Oprah is something that is obtained from archival tumor samples. So these are samples that are already in existence at the hospital or the patients doctors office and so we ask for those to be sent to a central testing lab and.
That's where the analysis is done on the Nanostring platform and then a result is sent back to the physician. So every single there's no no issue of quality control or processing at the site, they just and either slides or tissue block and then its analyzed.
One central lab on the Nanostring platform and they provide a result back to the site.
So that's very painful.
You're welcome it.
And then into all the different Citicorp subsets, obviously, you mentioned follicular helper central memory.
And T H ones, so what about the.
The wrong to help subset or are they just sort of records. So two exploratory but I checked 17 for example, I figured that fairly well.
<unk>.
So.
In terms of the these other subsets what happens to those.
Yeah, I'll take I'll take that net yeah Fair question, you know we've [noise].
What do we kind of panel the analysis of these cells, which you know we've been calling them I Trust high Cdfour cells group for sometime now.
To take that down a level or two and granularity southern certain set of markers.
That we've characterized them T H ones as an example that you mentioned its each one and that's the expression of the transcription factor called feedback.
And I think you know universally that would be accepted as a marker of the G.H. one lineage.
Within that within that there may be various flavors of that T. H, one lineage and you know we don't have all the all that information again.
And you don't likewise for the memory cells and the people liquor helper cells, there's always kind of a and at least in our view kind of a meeting edge of markers that are being you know evaluated debated in the typically starting the academic community and we follow suit in characterizing all those.
So we're not excluding any of these other subsets of subsets, but what we can say for now is that.
The CD for cells are really you know.
Specializing into a kind of a highly orchestrated set upsells that we could really start to understand their function teach ones cellular immunity to for looking or help ourselves humeral immunity to central memory, which you know we believe the so pivotals without more durable effect that we've come to appreciate for <unk>.
Yes.
Thanks, Richard and then just last one for me tend to.
PCL rate can you remind us what the like and also not receptor and has there been any therapeutic interventions targeting high is that the receptor older likens.
Yeah, Yeah sure there, there's a small molecule small molecules against them. So that there that chemo kind chemical unlike and that binds to CCR eight there have been small molecules against CCR rate, you know not not not surprising to decouple protein.
Receptor, but what really distinguishes our approach here is making an antibody that's not always simple to make antibodies against the.
Against the.
Receptor and so.
Because the receptor is so enrich if not selective to T T regulatory cells in the tumor. We can also you know supercharge the antibody for the property of depletion. So so we think that's the kind of the extra step if you will that will create a very.
Very different kind of therapeutic hypothesis as to what we're doing studies or what were doing to these cells. So the programs really kind of based on the antibody having that property and the really highly highly enriched nature of the receptor being on the T. Rex in the tumor.
Okay. Thank you.
<unk>.
Thank you know and ladies and gentlemen, this does conclude our question answer session, ladies and gentleman. Thanks for participating on today's call. Brian that does conclude todays program may now disconnect everyone have a great day.
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