Q3 2020 Jounce Therapeutics Inc Earnings Call

November 6, 2020

[music].

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics third quarter 2020 earnings Conference call.

Currently all participants on a listen only mode.

Later, we will conduct a question and answer session and instructions will follow at that time.

As a reminder, this conference call is being recorded at the company's request.

I will now turn the call over to your host Mallon dealing with Jounce Therapeutics. Please go ahead.

Thank you operator, good morning, and welcome to the Jounce Therapeutics third quarter Conference call.

This morning, we issued a press release, which outlines the topics that we plan to discuss today.

The release is available in the investors and media section of our website at Www Dot Jounce, TX Dot com.

Speaking on today's call will be our CEO and President Dr. Rich Mary who will discuss our progress and key milestones followed by our CMO Dr. battery, who who will provide an update on our clinical activities Lastly, our CFO Kim Drapkin will review our third quarter financial results. We will then open the.

Call for your questions.

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 statements 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 statements as a result of various important factors, including the risk factors discussed in our <unk> S E C filings.

In addition, any forward looking statements represent our views only as of today November six 2020 and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future we specifically disclaim.

Any obligation to do so even if our views change with that I will now turn the call over to rich.

Thanks, Marilyn and good morning, everyone.

As you all know we provided an update on our go program earlier this week and mentioned important pipeline prioritization changes.

Were pleased to share more detail on this with you today.

This strategic shift reflects our view of the unmet medical needs to find by patients responsiveness for Io therapy.

And further emphasizes our vision of bringing meaningful and long lasting impact to cancer patients.

When thinking about the impact we.

We believe the landscape can be broken down into two distinct patient populations.

One patients with PD, one inhibitor sensitive tumors and two patients with PD, one inhibitor resistant tumors.

Both have significant and unmet medical need represent large and growing market opportunities, but may differ and how to bring that spring forward long lasting therapeutic benefit.

The hallmark benefit.

I O therapies in solid tumors to date I've had the most significant impact on certain patients within an overall PD one inhibitor sensitive tumor type.

After his non small cell lung cancer for melanoma.

But unfortunately at the individual patient level, it's still a minority of patients that benefit from checkpoint therapy.

Visions with PD, one inhibitor resistant tumors, either crews that as resistance from the outset or developed resistance overtime. After initially receiving benefit.

Overall patients and the PD one inhibitor resistant tumors are the most difficult to treat and chemo is still largely to standard of care.

Given the increased use of PD, one inhibitors in frontline metastatic disease, and the fact that most patients will initially or ultimately progress.

Scope of the PD, one inhibitor resistant market continues to grow.

To better progress or Immunotherapies to meet the needs of cancer patients. We think about our current pipeline in reference to these two popular patient populations as follows.

For the patients with PD, one inhibitor sensitive tumors, we believe a biomarker driven approach in combination a PD one inhibitor and novel mechanism.

The best chance to benefit patients beyond todays current regiments.

Our goal for a select trial predicted biomarker study and separately, our Gtx 86, and for macrophage program targeting low RV to four I LT for a new mechanism.

Position us well to address the patients in the PD one inhibitor sensitive population.

[laughter].

For the patients for PD, one inhibitor resistant tumors, whether primary or acquired.

I believe novel mechanisms and approaches will be needed.

In this context Gtx 86 before isn't novel program to convert the immuno suppressive macrophages to an anti tumor state and.

And we believe could be an important mechanism for these patients.

Our early discovery programs also focus on novel mechanisms to address this patient population.

Hi, viewing our pipeline in biomarker approach through this lens, we can prioritize our resources and design our studies to address each of these distinct patient populations.

I would now like to take a few minutes to provide updates from the quarter.

Earlier this week, we announced that an early look at the interim data from emerge did not meet pre specified criteria for expansion of the study.

Based on the interim data read out we will not be expanding patient enrollment in the Merck.

Our focus in the PD, one inhibitor resistant population will shift to a strategy of targeting other immune cell types. In addition to T cells, beginning with our Gtx 86, before our little RV two program.

As we discussed on the book recall update we will continue to follow the overall survival of you merged patients still on study and monitor Biomarkers.

We're also we also announced that enrollment commence in our select study.

We look forward to reporting preliminary efficacy data from the select trial in late 2021.

We also expect to begin enrollment in our phase one dose escalation study a gtx 80 64 by year end.

We're also pleased to announce that supporting preclinical biomarker data for Gtx 86 before will be presented at next week's 2020 City annual meeting.

In September jobs, and Gilliatt announced a license agreement with a worldwide rights to Gtx 18 11.

Our potential first in class antibody designed to selectively deplete immunosuppressive.

Tumor infiltrating T regulatory cells.

After clearing HSR process ideally I'd transaction closed in October 2020.

We believe this out license further validates our pipeline and ability to generate value from our translational science platform.

In connection with the closing we received an $85 million upfront license fee.

And gilliatt invested $35 million and jumpstart.

We continue to progress Gtx 18, 11, two I'd clearance and we are on track for I'd filing in the first half of 2021.

Beyond our development programs, we continue to make progress advancing our early stage pipeline. Despite the challenges presented by the COVID-19 pandemic.

A broad discovery pipeline includes multiple programs targeting myeloid cells stromal cells and other PD one inhibitor resistance mechanisms.

These are all active targeted areas for our discovery engine and we expect to see more valuable novel programs like Gtx 86, before MTS 18, 11 emerge through our efforts.

Before turning the call over to best to go into more detail on our programs I'd like to take a moment to acknowledge and thank dr., Bob Tepper, a longtime member of our board of directors.

Due to professional commitments a third rock ventures, Bob is stepping down from his board role at jobs we.

We sincerely thank Bob for his contributions and leadership as he has been an integral part of the Johns team since our inception.

I'll now turn the call over to Beth to discuss our clinical activities in more detail.

Thanks, Rich and good morning, everyone.

We have made great progress accounts this quarter and I'm very proud of the work our team has done to enable us to initiate our next clinical study select.

Despite the challenging times, we live in we continue to execute new trials and stay focused on our overarching goal of helping cancer patients.

We are on track to begin enrollment before year end in our first clinical trial with J T X 80, 64, our exciting new macrophage program.

With the upcoming K T X 80, 64 trial initiation, we're set up for multiple clinical read outs in 2021 and beyond.

I would now like to provide more detail about our ongoing and soon to be initiated clinical programs.

The select trial, which we recently initiated will enroll approximately 75 immunotherapy naive second line non small cell lung cancer patients, who will be selected using the predictive kiss hope for biomarker and randomized to vote prep plus our PD one inhibitor.

Okay T X 40, 14 persist K T X 40 14 alone.

Kids Oprah is an 18 gene signature that includes genes relevant to both TD eight and Cdfour T cell biology.

The CD eight related genes contribute potential predictive value for PD, one inhibitors well the CD four related genes are indicative of the presence of activated and therefore, I coast, Hi, Cdfour T cells, which are required for the activity of Oprah.

The threshold for the biomarker has been optimized to predict for merchants I close I see before T cells in the peripheral blood, which had been associated with clinical benefit in patients treated with Oprah plus or minus nivolumab.

We believe that the Tis spoke with biomarker is ideal for patient selection is a select randomized trial due to its potential predictive value for both Oprah and PD one inhibitors.

We expect approximately 20% of second line non small cell lung cancer patients to be eligible for the trial based on Tis spoke breath and are pleased with the rate of patient screening to date.

Select is powered to demonstrate the superiority of Oprah plus J T X 40, 14 to J T X 40 14 alone.

The primary endpoint is mean percent change from baseline tumor size of all measurable existing and new lesions averaged over nine and 18 weeks, which was chosen for two reasons first.

First several publications have indicated that percent change from baseline in tumor size at early time points, maybe an early predictor of overall survival for chemo and other types of cancer therapy potentially better then persist overall response rate.

This may be especially true with Io therapy in which durable tumor reductions that do not meet RECIST response criteria may still result in meaningful clinical benefit and improved survival.

Second using percent change from baseline as a continuous variable rather than categorical RECIST response criteria creates an opportunity to establish statistical significance with a smaller sample size, which we felt was appropriate for this proof of concept study.

We're also measuring and we'll report on all the traditional efficacy end point as well.

Including overall response rate nine.

Nine month, and median progression free survival disease control rate duration of response and overall survival.

Safety and Biomarkers will also be part of the final study the data.

I would now like to turn to Jay T X 86, before I leave macrophage program.

Gtx 80, 64 is a little RP to ER I L. T. Four antagonist antibody, which we view as a macrophage checkpoint inhibitor designed to reprogram immunosuppressive M. Two macrophages to immune stimulant Tory M macrophages.

When will it be to binds to its like ends which include a chilly GE on tumor cells, and a Chile, a and b on immune cells. It induces an immuno suppressive state analogous to the effect of PD, one finding to PD L. One on T cells.

Like the PD, one PDL one interaction the little our B to H delayed t. interaction plays a role in maternal fetal tolerance, a fundamental immunosuppressive biology.

Gtx 80, 64 interferes with the binding of little R. B to auto a bit like and resulting in an immune stimulator a state with production of pro inflammatory cytokine improved antigen presentation and T cell activation.

This biology suggests the potential to overcome PD one inhibitor resistance.

The first clinical data on another little R. B, two inhibitor, suggesting safety and preliminary signs of efficacy in heavily pretreated PD. One experienced patients was recently presented at ESMO 2020.

We're excited about the potential for J T X 80, 64 to benefit this difficult to treat patient population and expect to be the second clinical program for this target when we begin patient enrollment by the end of 2020.

Our upcoming clinical study with J T X 80, 64 will be a dose escalation study with monotherapy and in combination with our own PD, one inhibitor K T X 40 14.

Our trial is designed to demonstrate proof of concept early with multiple tumor specific expansion cohorts at a predefined target dose.

These expansion cohorts will include both Gtx 80, 64, monotherapy and combination with J T X 40, 14, and both PD, one inhibitor sensitive and resistant patients.

At the city meeting next week, we will have a poster providing preliminary information on our approach to predictive biomarkers and indication selection for J T X 80 64.

We will provide more specifics on the trial design after enrollment commences and in 2021, we will begin to guide on when Readouts will be available on the phase one study of J T X 80 64.

Before I close I would like to highlight the opportunities that we now have to combine drugs from our own pipeline with the inclusion of J T X 40, 14 in both select and the JD TTX 80, 64 phase one study.

Jay T X 40, 14 has all the preclinical characteristics of the typical PD one inhibitor.

And demonstrated a 17% RECIST response rate in heavily pretreated patients in a small phase one study.

With a preliminary safety profile similar to approved PD one inhibitors.

Of note the patients enrolled in our phase one trial of J T. X 40, 14, who were required to be PD. One inhibitor naive were more challenging to treat 10 patients enrolled in the first clinical trials of PD, one inhibitors as patients with all the typically io responsive tumors in which PD one.

And PDL one inhibitors are approved were excluded.

We therefore expect K T X 40, 14 to contribute similar efficacy to approved PD one inhibitors in our combination studies.

We are excited to be initiating studies with approaches beyond T cell focus therapies and to potentially make a difference in the lives of patients not currently served by today's approved therapies.

Our team has always done a great job in execution, which has jones is well positioned to be an io leader with multiple clinical programs across novel areas of biology.

And with the potential to improve outcomes.

Now I would like to turn the call over to Kim who will provide a financial update.

Thanks, Beth and good morning, everyone.

As we reported in this mornings press release cash cash equivalents and investments as of September Thirtyth 2020 totaled 105.3 million compared to 170.4 million as of December 31st 2019.

The decrease was primarily due to operating costs incurred during the period.

Not included in the September 32020 cash balance is the 120 million we received upon the closing of the gilliatt agreements in October 2020.

This additional capital provides us with a strong balance sheet.

Turning to the PNM during the third quarter of 2020, we incurred 18 million in research and development expenses compared to $15.1 million for the same period in 2019.

The increase in R&D expenses was due to I., India, enabling costs for Gtx 18 11.

External clinical and regulatory costs associated with the select clinical trial and increased employee compensation costs.

Partially offset by decreased lab consumables and travel expenses.

General and administrative expenses were $7.1 million for the third quarter of 2020 compared to 6.5 million for the same period in 2019.

The increase in general and administrative expenses was primarily due to increased employee compensation costs, partially offset by decreased facility expense.

Net loss for the third quarter of 2020, with 24.9 million or a net loss per basic and diluted share of 73 cents as compared to a net income of 98.9 million for the same period in 2019 or net income per basic share of $2 to 99 cents.

And net income per diluted share of $2.90.

The increase in net loss was primarily attributable to no license and collaboration revenue in the third quarter 2020, and the increase in operating expenses.

We are reiterating our financial guidance and continue to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately 80 million to 95 million.

In closing we continue to have the flexibility to drive our innovative immunotherapy pipeline, while efficiently executing against our strategic plans and goals.

We expect our existing cash cash equivalents and investments to be sufficient to enable the funding of our operating expenses and capital expenditure requirements into 2023.

I'll now turn the call back to rich for final remarks.

Thanks, Jim.

In conclusion jobs is on track to achieve the milestones we set for 2020 and importantly by year end. We also plan to initiate the phase one trial of Gtx 86, before our little RBC program.

With the recent closure of our deal with deal yet, we're also well capitalized with a cash runway into 2023.

This will allow us to continue to fund our high quality discovery engine, while executing on multiple clinical trials and advancing our wholly owned pipeline.

With multiple clinical programs 2021 is poised to be a strong year of execution and results including.

Hi, Andy for Gtx 18, 11 in the first half of 2021 and transitioning the program to gilliatt to begin clinical studies.

Executing across multiple clinical trials, including select with the data readout in late 2021 in later this year initiating the phase one gtx 86 before trial.

And continuing to work on advancing multiple new targets from our discovery pipeline for patients in the PD, one inhibitor sensitive and resistant populations.

With that we would now like to open the call for your questions operator.

Thank you Sir as a reminder to ask a question you would need to press star one on your telephone.

So what are your question. Please press the pound key please.

Please stand by while we compile the kibali roster.

I show our first question comes from the line of Mike Olson from Baird. Please go ahead.

Hey, guys. Thanks for taking the question.

Just on 86 before you mentioned the potential biomarker to select patients.

You have some more detailed at cincy, so I'm not sure how much you're willing to comment at this point, but should we be thinking of something similar to or to Oprah we're kind of looking at a gene signatures.

So yeah, it's a little too early for me to comment on that I think what you'll see it fits he is our approach to exploring biomarkers using a human history culture, which are slices of human tumor that we actually can evaluate.

Oh, yes, and and you'll see sort of some you know also the process that we go through to try to understand indications potential indications and sort of pair that with where potential biomarkers might be taking us, but we're not giving any details at this point and as you know Mike we usually incorporate.

Multiple potential predictive biomarkers and Pharmacodynamic biomarkers into our studies. So it will really depend on the data that comes out of this first study that will let us know if there's a a good predictive biomarker to take forward.

Yes.

Got it and then maybe just sticking with 80 64 in the maybe you guys can just comment on the competitive landscape.

And I realize it's early but are there any differentiating features of 80 64.

We're.

Or should we also think about just the strategy in terms of the.

Firms of the path forward, maybe that's a way to differentiate from one of the other products out there. Thanks.

Sure I'll take that one Mike you know as we look at that the the kind of the binding of the inhibitory antibodies to the targets.

Our view is that appropriate kind of potency specificity binding antibodies. So we'll RB two are going to be more similar than they are different.

And and part of that is really due to the nature of these receptors is a little group of these receptors in humans. The binding there they're all very very similar to each other so with that being with that being said.

There's two maybe two things to point out. So we think the differentiation is really going to be in how we take for word you know different indications different lines of therapy.

Perhaps guided by the Biomarkers as best referred to Louisiana. So you know as you as we see the sit you folks are poster next week.

One could envision that being a tool leading us to a differentiated passed in the clinical programs. The other the other comment I'll make is that well RB two is one of this group of inhibitory receptors prime.

Primarily on the myeloid myeloid cells and so there are kind of broader strategies that we have in discovery around that whole family. We think this is a group of receptors that are really.

Kind of been under the radar screen in terms of their potential for.

You know for immunotherapy, but.

But that would be more of a layout of the pipeline in the future.

Great. Thank you.

Sure. Thanks. Thank you. Our next question comes from the line of Jim Birchenough from Wells Fargo Securities. Please go ahead.

Good morning.

So Jim this morning to.

The 80 64, R&D being filed them can you tell us what it will be filed.

Yeah. So we don't usually comment on that Nick all I can tell you is that we're on track to start enrolling patients before the end of the year.

Okay fair enough [laughter] [laughter].

[laughter] between pension and.

Then just going back to Tim Vocera can you talk about the logistics to Spok brand does that present, a challenge for recruiting patients in what must be very highly competitive space.

Sure. So we've actually been really really pleased by the investigator engagement and enthusiasm about the study and about their just screening that's going on so basically patient sign up prescreening consent form that allows their tissue to be submitted for screening and then.

And their physician is informed about whether they are to spoke of positive or not at that point. They complete the rest of the screening for the study.

For every clinical trial, there's a screening period and that they have to pass the eligibility criteria. As you know have certain labs correct for eligibility the turnaround time for the test is a week or less so we have not found that to be a barrier as I said, there seems to be a lot of enthusiasm the investigators are doing.

A lot of screening and and we've also opened the pre screening even two sites that are actually actively and going to enroll patients in the trial, but have been identified as referral site for some of the trial sites. So you know recognizing that when you have a predictive biomarker it all it always.

Does pose a challenge to enrollment, but we've put a lot of measures in place that we believe will help to mitigate that.

Okay, and then maybe just following up on that so is this on the archival tissue or is this on fresh tissue in DC yeah.

Yeah. That's a great question. So because these are PD, one inhibitor naive patients who have only had their frontline chemotherapy and as you know even if people respond to chemotherapy. They usually progressed rather quickly we didnt feel it was necessary to get fresh tumor biopsies. So we're using archival tumor but.

In most cases, it will be you know less.

Less than a year before.

Before they they you know get screened for this study so we felt that that was sufficient.

Okay, great. Thank you very much.

You're welcome.

Thank you.

Next question comes from the line of Cory Kasimov from JP Morgan. Please go ahead.

Hi, This is gavin on for Cory I actually had a follow up from the last question on just the Oprah.

Is there any reason to suggest that I mean, you you said that 20% of the lung cancer patients are eligible eligible for the trial. There any reason to believe that there's geographic differences in the patient population for Fortis Oprah.

And then also does this first line timo.

Have an impact on expression of tis built but to your knowledge.

Sure. So we don't have any reason to believe there would be a geographic difference.

You know lung cancer, the the primary risk factor for lung cancer is smoking no matter, where you live and so we don't believe there's any reason.

To put there to be a geographic difference with respect to your second question, which was sorry I just play.

So what was your second question Devin.

The potential impact oh outlets, chemo or or or other first line.

Regimen, such as E GSR treatment.

Sure. These patients are only allowed to have had a platinum containing regimen not targeted therapy and so we don't expect the targeted therapy to have any impact if anything.

Chemotherapy has there have been reports, suggesting that chemotherapy may make tumors, a little bit more hot but we don't have any direct data on the difference between totally treatment naive and chemo treated tumors regarding to spoke for but we don't have any reason to believe that it would have a sick.

And if it can impact on that.

Great. Thank you.

Welcome.

Thank you. Our next question comes from the line of Steve Steve House from Raymond James. Please go ahead.

Hey, good morning. Thank you just regarding the primary endpoint of select can you maybe comment on the powering assumptions there basically what tumor size reduction Delta power for and what is the power and then I wanted to clarify the detail regarding.

Using this as a continuous variable from week nine to 18, I think you said.

Can you just clarify what how many tumor measurements patients are actually having.

And at what time points.

Sure sure. So I'll answer the second question first so they will have their CP scans, obviously pre treatment and then at nine weeks and then at 18 weeks and so.

Because io, sometimes can take a little bit longer responses deepen overtime. We felt it was important to include the 18 week scan data.

But we felt that averaging the two would give us kind of the best estimate of the of the of the tumor response to treatment. We're not we're not really stating right now what exactly the target differences, but you know at some point we.

Well, well well talk about that more I think what's important is that we have a sample size that with our assumptions would be sufficient to demonstrate statistical superiority. If at some point you know if we look at the data and it's certainly heading in the right direction, but we were wrong about our assumptions for.

Tick really about the response rate to the PD, one inhibitor or the tumor shrinkage with the PD one inhibitor and we do have an opportunity to do a onetime sample size re adjustment.

Got it and then I think I know the answer to this but maybe just to clarify on the call here. The the this is not sequenced treatment. This is treating.

With the.

The PD one inhibitor in combination.

Both the nine and 18 week time point, everyone will have received the same.

Cumulative dose of PD, one inhibitor Kurt.

Correct correct correct that's correct.

Okay. Thank you and then just the on the little every two seems like just through our conversations over the past week that this is really becoming a focus for investors a lot happening in the field I'm just curious if its possible I know you don't know for sure you haven't even started the startup as a possible.

Data from that phase one study could be sort of in the next new clinical data you have even before the end of 2021, when you've guided select data would be available.

Yeah, it's still a little too early to say Steve.

You know as well.

We will definitely provide more detail about the study design after.

After we announced that we had started enrollment and then once we get a sense of how things are progressing well, we'll guide to when we would have data, but right now it's a little bit too early to say.

Okay I appreciate that and then just lastly, the.

[noise] curious in the wake of of the emerge read out that you reported are there any future plans to pursue the Oprah plus particularly for inhibitor or have you more or less moved on past that hypothesis and focused on PD, one combination through select or or obviously GSK is moving heading heading back maybe that's it.

Okay, just curious your thoughts there.

Sure. So we're you know we're we're always following the science. So we certainly will look at the data as it matures.

And always be looking for things that we think make sense. However, as weve stated.

Really if you look at all of the things that have failed when they're just you know another T cell based mechanism, adding onto a PD one inhibitor or you know whatever you adds a PD one inhibitor in the a and the PD one resistant space.

It really it we think it makes sense to start looking at a completely different mechanism of action in combination probably with PD, one inhibitors and you know in the data that was presented recently looked really encouraging in PD, one experienced patients and therefore, you know since we have gtx 86.

Before and that target looks like you know, even just biologically like it could help to restore or to overcome PD. One inhibitor resistance that really I think it's a bigger focus for US right. Now also the safety profile you know looks really good as well so right now that's where we're going to focus our efforts on.

The PD one experience patient population and I don't know rich if you wanted to add anything to that.

Yeah, I think that's I think that's right. That's I think maybe see though the way to think about it is you know we think it's the right decision to not continue.

Enrollment as the merger was originally designed we are going to follow the O.S., we are going to follow the biomarkers, but but as I stated that the science is really leading us at least in the PD one resistant population to these other types of mechanisms that.

Let you be on T cells.

As well as a result.

Combo.

Got it. Thank you appreciate the questions.

Thanks.

Thank you. Thank you.

Thank you I show No next question comes from the line of offer he from H.C. Wainwright. Please go ahead.

Hey, good afternoon.

Hi, Thanks for taking my question I.

I just had a.

Quick one on the Eighteeng 11 program, so could you remind us.

What else you guys need to be done before the fire the item the.

Sure I can I can take that one you know primarily like any monoclonal antibody program, it's really.

The CMC path and the manufacturing and analytical.

Analytical work around the around the drug manufacturer that is usually you that on that kind of tail end of the timing for the IB. So so were progressing that as we've mentioned, it's our it's our it's our role in this in this deal to to get the IB filed and open but we're primarily in those.

Kind of last phases of making sure we have a material ready to go.

Thank you for that.

Mhm.

Thank you.

I sure next question comes from the line of Veterinary July from Roth Capital markets. Please go ahead.

Thanks, Mike. Thanks for taking my question just had one quick when you add back I think on the last call you provided some commentary around North Africa with their anti war I program that kind of give you guys. Some confidence. It's just wondering in terms of clinical shy of you moving fired from my desk very lucky patterns to.

Latin America is doing and then they ultimately announced a partnership with MGM.

The little targeting I guess on a multi point in Q antibodies. So just wondering you know based on your knowledge. What you think you'd expect from adult targeted agent versus a single alipay like trying to get at.

Hi.

Sure I'll address the first one and then ill turn it over to rich. So as I've said, we plan to you know demonstrate proof of concept as quickly as possible, but also we recognize that we do need to differentiate from Merck. So I think our trial is.

Really designed to do that to look at as I mentioned that both monotherapy and combination with our own PD. One inhibitor look at PD, one inhibitor sensitive and resistant patients and you know certainly include some cohorts that are differentiated from what Merck is doing.

Rich would you like to speak to the the bi specific her.

Yes, sure so yeah first.

First I think it's important that we we don't want to comment too much on that I mean us.

What we heard about from a press release, rather than a scientific presentation, but the the nature of the entire family of the low receptors. We think is very very interesting biology, and if you.

You need to have specificity for what you're targeting beyond that there are commonalities between well Rd, one little RV too and some distinction. So I think there's you know.

Got it.

A growing opportunity to look at these features that might be in common as well as you know this thing. So for example, well our b one.

To be expressed on NK cells.

So that's different for a little while the war so that whole family, we believe is going to be.

Very interesting one and it could be kind of central and the myeloid got an non adaptive so I'm kind of Roe.

But it's really hard for us to comment beyond that generality, given we you know we havent seen any data on that.

Thank you an x. I guess, one quick follow up here on the Ken Ken I'm, you mentioned that your current cash balances and of course, I think the $120 million Missy Gilliatt and so I was just wondering if your cash runway at does include that.

Thanks, Ed right, yes, when thinking about the cash we have into 2023 that does include the upfront of 85 million from gilliatt as well as the $35 million equity investment what it does not include our any potential milestones that we may earn in the future under the gilliatt deal.

And you may recall that up to 685 million and potential milestone $510 million of those our development and regulatory. So we were pleased that you know there are earlier stage milestones and you know our hope is that we will earn these and the runway will be even further but we do not include milestones in our projections.

Thanks, Ken This is another follow up here, but just confirming actually had the I indeed able in settings, you handing over the program to go yet who will take over are you anticipating having to pay for any of the research studies or anything after that.

No. It's a complete out license and so our expenses basically and on the development side as soon as we file the I.N.D. and then gilliatt takes it from there and they're responsible to develop and pay for the future development.

[noise] and that's why we get considering that the milestones that you guys I appreciate it.

Thanks Bye.

Thank you.

Our last question comes from the line of Jim Birchenough from Wells Fargo Securities. Please go ahead.

Hey, Thanks for taking the follow up just a question on on the.

Select trial, the lift human clinical trials on comp base two dose levels of Oprah can you just elaborate on that please.

Sure.

After we.

Analyze all the data from the iconic trial, where we had patients dosed at <unk> 0.3 makes for Qig every three weeks, which resulted in sustained target engagement or finding of Oprah too I cause all the time.

We determined based on some reports in the literature and then also some additional preclinical data that for an agonist molecules such as appropriate probably better to have more pull subtitle target engagement, so pulsatile dosing and target engagement so into select trial as in the emerged trial.

We're looking at two different doses with what we believe will be differentiated patterns of target engagement. So one dose is 0.1 make pig and the other 0.03 make per keurig, both given every six weeks.

And although the 0.1 make partake data in the emerged trial actually looked better than the 0.0 sorry.

We don't really have sufficient data to make a decision at this point about which doses preferable. So we're continuing to explore both doses in the select trial.

And the final analysis, we'll look at the two dose levels combined and then individually compared to Jay take 40 14 alone.

Thank you very much.

Welcome.

Thank you.

Ladies and gentlemen, thank.

Thank you for participating in today's conference. This does conclude the program you may now disconnect have a good day.

Thank you.

You're welcome.

[music].

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics third quarter 2020 earnings Conference call.

Currently.

On a listen only mode later.

Well.

The question and answer session and instructions will follow at that time.

As a reminder, this conference call is now recorded at the company's request.

I will now turn the call with your host malady on what John Therapeutics. Please go ahead.

Thank you operator, good morning, and welcome to the Jounce Therapeutics third quarter Conference call. This morning, we issued a press release, which outlines the topics that we plan to discuss today.

The release is available in the investors and media section of our web site at Www Dot jobs, TX Dot com.

Speaking on today's call will be our CEO and President Dr. Rich Mary who will discuss our progress and key milestones followed by our CMO Dr. about trade you, who will provide an update on our clinical activities Lastly, our CFO Kim Drapkin will review our third quarter financial results. We will then open the.

Call for your questions.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including the risk factors discussed in our FCC filings.

Any obligation to do so even if our views change with that I will now turn the call over to rich.

Thanks, Matt and good morning, everyone.

As you all know we provided an update on our corporate program earlier this week and mentioned important pipeline prioritization changes.

Were pleased to share more detail on this with you today.

This strategic shift reflects our view of the unmet medical needs defined by patients responsiveness, Alright, I O therapy.

And further emphasizes our vision of bringing meaningful and long lasting impact to cancer patients.

When thinking about the impact of bio we.

We believe the landscape can be broken down into two distinct patient populations.

One patients with PD, one inhibitor sensitive tumors and two patients with PD, one inhibitor resistant tumors.

Okay, how significant an unmet medical need represent large and growing market opportunities, but may differ and how to bring that spring forward long lasting therapeutic benefit.

A hallmark benefit.

I O therapies in solid tumors to date I've had the most significant impact on certain patients within an overall PD one inhibitor sensitive tumor type.

Non small cell lung cancer melanoma.

But unfortunately at the individual patient level, it's still a minority of patients that benefit from checkpoint therapy.

Patients with PD, one inhibitor resistant tumors, either crews that as resistance from the outset.

Or developed resistance overtime after initially receiving benefit.

Overall patients and the PD one inhibitor resistant tumors are the most difficult to treat and chemo is still largely the standard of care.

Given the increased use of PD, one inhibitors in frontline metastatic disease, and the fact that most patients will initially or ultimately progress.

Scope of the PD, one inhibitor resistant market continues to grow.

To better progress or Immunotherapies to meet the needs of cancer patients. We think about our current pipeline in reference to these two pockets patient populations as follows.

For the patients with PD, one inhibitor sensitive tumors, we believe a biomarker driven approach in combination a PD one inhibitor and novel mechanism.

The best chance to benefit patients beyond today's current regimen.

Our goal for a select trial predicted biomarker study and separately, our Gtx 86 for macrophage program targeting well RV too or I also before a new mechanism is.

Position us well to address the patients in the PD. One then you get are sensitive population.

Sure.

For the patients for PD, one inhibitor resistant tumors.

Whether primary or acquired.

Believe novel mechanisms and approaches will be needed.

In this context Gtx 86 before isn't novel program to convert immuno suppressive macrophages, so an anti tumor state.

And we believe could be an important mechanism for these patients.

Our early discovery programs also focus on novel mechanisms to address this patient population.

Hi, viewing our pipeline and biomarker approach through this lens, we can prioritize our resources and design our studies to address each of these distinct patient populations.

I would now like 60 minutes to provide updates from the quarter.

Earlier this week, we announced that an early look at the interim data from merge did not meet pre specified criteria for expansion of the study.

Based on the interim data read out we will not be expanding patient enrollment in the Merck.

Our focus in the PD, one inhibitor resistant population will shift to a strategy of targeting other immune cell types. In addition to T cells, beginning with our JPS 80 system for our little RV two program.

As we discussed on the bulk recall update we will continue to follow the overall survival of the merged patients still on study and monitor Biomarkers.

We're also we also announced that enrollment some ads you know select study.

We look forward to reporting preliminary efficacy data from the select trial in late 2021.

We also expect to begin enrollment in our phase one dose escalation study a gtx 80 64 by year end.

We're also pleased to announce that supporting preclinical biomarker data for Gtx 86 before will be presented at next week's 2020 City annual meeting.

In September jobs, and Gilliatt announced the license agreement.

Worldwide rights, the Gtx 18 11.

Our potential first in class antibody designed to selectively deplete immunosuppressive tumor.

Tumor infiltrating T regulatory cells.

After clearing HSR process, yes.

Yeah transaction closed in October 2020.

We believe this out license further validates our pipeline and ability to generate value from our translational science platform.

In connection with the closing we received an $85 million upfront license fee.

And gilliatt invested $35 million and jumpstart.

We continue to progress Gtx 18, 11 <unk>.

<unk> clearance and we are on track for I'd filing in the first half of 20.1.

You know what our development programs, we continue to make progress advancing our early stage pipeline. Despite the challenges presented by the COVID-19 pandemic.

Our broad discovery pipeline includes multiple programs targeting myeloid cells stromal cells and other PD one inhibitor resistance mechanisms.

These are all active targeted areas for our discovery engine and we expect to see more valuable novel programs like Gtx 86, before you had JC actually exceed 11 emerge through our efforts.

Before turning the call over to Beth to go into more detail on our programs I'd like to take a moment to acknowledge and thank dr., Bob Tepper, a longtime member of our board of directors.

Due to professional commitments a third rock ventures, Bob is stepping down from his board wallet jobs.

We sincerely thank Bob for his contributions and leadership.

He's been an integral part of the jobs team since our inception.

I'll now turn the call over to Beth to discuss our clinical activities in more detail.

Thanks, Rich and good morning, everyone.

We have made great progress a jump this quarter and I'm very proud of the work our team has done to enable us to initiate our next clinical study select.

Despite the challenging times, we live in we continue to execute new trials and stay focused on our overarching goal of helping cancer patients.

We are on track to begin enrollment before year end and our first clinical trial with J T X 80, 64, our exciting new macrophage program.

With the upcoming K T X 80, 64 trial initiation, we are set up for multiple clinical read outs in 2021 and beyond.

I would now like to provide more detail about our ongoing and soon to be initiated clinical programs.

The select trial, which we recently initiated will enroll approximately 75 immunotherapy naive second line non small cell lung cancer patients, who will be selected using the predictive pis they'll provide a marker and randomized to vote prep plus our PD one inhibitor.

T X 40, 14 versus Gtx 40 14 alone.

Just spoke about is an 18 gene signature that includes genes relevant to both TD eight and Cdfour T cell biology.

The threshold for the biomarker has been optimized to predict for merchants I close I see before T cells in the peripheral blood, which have been associated with clinical benefit in patients treated with Oprah plus or minus nivolumab.

We believe that the Tis spoke with biomarker is ideal for patient selection in the select randomized trial due to its potential predictive value for both Oprah and PD one inhibitors.

We expect approximately 20% of second line non small cell lung cancer patients to be eligible for the trial based on Tis spoke breath and are pleased with the rate of patient screening to date.

Select is powered to demonstrate the superiority of vote prep plus J T X 40, 14 to J T X 40 14 alone.

The primary endpoint is mean percent change from baseline tumor size of all measurable existing and new lesions averaged over nine and 18 weeks, which was chosen for two reasons first.

This may be especially true with Io therapy in which durable tumor reductions that do not meet RECIST response criteria may still result in meaningful clinical benefit and improved survival.

We are also measuring and we'll report on all the traditional efficacy end point as well.

Including overall response rate nine.

Nine month, and median progression free survival disease control rate duration of response and overall survival.

Safety and Biomarkers will also be part of the final study the data.

I would now like to turn to Jay TX 86, before I leave macrophage program.

J T X 80, 64 is a little RP to ER I L. T. Four antagonist antibody, which we view as a macrophage checkpoint inhibitor designed to reprogram immunosuppressive EM tool that Cretaceous to immune stimulant Tory M. One macrophages.

When little RFP to binds to its like ends which include a chilly G on tumor cells, and a Chile, a and b on immune cells. It induces an immuno suppressive state analogous to the effect of PD, one finding to PD L. One on T cells.

Like the PD, one PDL, one interaction the little RB to a chilly g. interaction plays a role in maternal fetal tolerance, a fundamental immunosuppressive biology.

J T X 80, 64 interferes with the binding of little RB to all of its like and resulting in an immune stimulator a state with production of pro inflammatory cytokine improved antigen presentation and T cell activation.

This biology suggests the potential to overcome PD one inhibitor persistence.

The first clinical data on another little RB two inhibitor, suggesting safety and preliminary signs of efficacy in heavily pretreated PD. One experience patient was recently presented at ESMO 2020.

We're excited about the potential for J T X 80, 64 to benefit it's difficult to treat patient population and expect to be the second clinical program for this target when we begin patient enrollment by the end of 2020.

Our upcoming clinical study with J T X 80, 64 will be a dose escalation study with monotherapy and in combination with our own PD, one inhibitor J T X 40 14.

Our trial is designed to demonstrate proof of concept early with multiple tumor specific expansion cohorts at a predefined target dose.

These expansion cohorts will include both Gtx 80, 64, monotherapy and combination with J T X 40, 14, and both PD, one inhibitor sensitive and resistant patients.

At the city meeting next week, we will have a poster providing preliminary information on our approach to predictive biomarkers and indication selection for J T X 80 64.

We will provide more specifics on the trial design after enrollment commences and in 2021, we will begin to guide on when Readouts will be available on the phase one study of J T X 80 64.

Before I close I would like to highlight the opportunities that we now have to combine drugs from our own pipeline with the inclusion of J T X 40, 14 in both select and the JD Gtx 80, 64 phase one study.

Okay T X 40, 14 has all the preclinical characteristics of a typical PD one inhibitor and demonstrated a 17% RECIST response rate in heavily pretreated patients in a small phase one study.

With a preliminary safety profile similar to approved PD one inhibitors.

PDL one inhibitors are approved were excluded.

We therefore expect K T X 40, 14 to contribute similar efficacy to approved PD, one inhibitors and our combination studies.

We are excited to be initiating studies with approaches beyond T cell focus therapies and to potentially make a difference in the lives of patients not currently served by today's approved therapies.

Our team has always done a great job and execution, which has jumped well positioned to be an io leader with multiple clinical programs across novel areas of biology.

And with the potential to improve outcomes.

Now I would like to turn the call over to Kim who will provide a financial update.

Thanks, Beth and good morning, everyone.

As we reported in this mornings press release cash cash equivalents and investments as of September Thirtyth 2020 totaled $105.3 million compared to 170.4 million as of December 31st 2019.

The decrease was primarily due to operating costs incurred during the period.

Not included in the September 32020 cash balance is.

The 120 million we received upon the closing of the Gilliatt agreement in October 2020.

This additional capital provides us with a strong balance sheet.

Turning to the PNM during the third quarter of 2020, we incurred 18 million in research and development expenses compared to $15.1 million for the same period in 2019.

The increase in R&D expenses was due to eye and be enabling costs for Gtx 18 11.

External clinical and regulatory costs associated with the select clinical trial and increased employee compensation costs.

Partially offset by decreased lab consumables and travel expenses.

General and administrative expenses were 7.1 million for the third quarter of 2020 compared to 6.5 million for the same period in 2019.

The increase in general and administrative expenses was primarily due to increased employee compensation costs, partially offset by decreased facility.

Net loss for the third quarter of 2020 with $24.9 million or net loss per basic and diluted share of 73 cents as compared to a net income of 98.9 million for the same period in 2019 or net income per basic share of $2 to 99.

Ben and net income per diluted share of $2.90.

The increase in net loss was primarily attributable to no license and collaboration revenue in the third quarter 2020, and an increase in operating expenses.

We are reiterating our financial guidance and continue to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately 80 million to 95 million.

In closing we continue to have the flexibility to drive our innovative immunotherapy pipeline, while efficiently executing against our strategic plans and goals.

We expect our existing cash cash equivalents and investments to be sufficient to enable the funding of our operating expenses and capital expenditure requirements into 2023.

I'll now turn the call back to rich for final remarks.

Thanks, Jim.

In conclusion jobs is on track to achieve the milestones we set for 2020 and importantly by year end. We also plan to initiate the phase one trial of Gtx 86, before our low RBC program.

With the recent closure of our deal with Gilliatt, We're also well capitalized with a cash runway into 2023.

This will allow us to continue to fund our high quality discovery engine, while executing on multiple clinical trials and advancing our wholly owned pipeline.

With multiple clinical programs 2021 is poised to be a strong year of execution and results, including filing the IB for Jake yet to 18 11, and the first half of 2021 and transitioning the program to gilliatt to begin clinical studies.

Executing across multiple clinical trials, including select what the data readout in late 2021.

And later this year initiating the phase one Gtx 80 64 trial.

And continuing to work on advancing multiple new targets from our discovery pipeline for patients in the PD, one inhibitor sensitive and resistant populations.

With that we would now like to open the call for your questions operator.

Thank you Sir as a reminder to ask a question you would need to press star one on your telephone.

So which are your question. Please press the pound key please.

Please stand by while we compile the culinary roster.

I show our first question comes from the line of Michael from Baird. Please go ahead.

Hey, guys. Thanks for taking the question.

Just on 80 64, you mentioned the potential biomarker to select patients.

You have some more detailed at 50, so I'm not sure how much you're willing to comment at this point, but should we be thinking of something similar to you or to Oprah.

We're kind of looking at gene signatures.

And and you'll see sort of some you know also the process that we go through to try to understand indications potential indications and sort of pair that with where potential biomarkers might be taking us.

But we're not giving any details at this point as you know like we usually incorporate.

Couple potential predictive biomarkers and Pharmacodynamic biomarkers into our studies. So it will really depend on the data that comes out of this first study that will let us know if theres a predictive biomarker to take forward.

Got it and then maybe just sticking with the 64 on the maybe you guys can just comment on the competitive landscape and I realize it's early but are there any differentiating features of 80 64.

Or or.

Where should we go also thinking about just the strategy in terms of the.

Terms of the path forward, you'll maybe that's a way to differentiate from one of the other products out there. Thanks.

Sure I'll take that one Mike.

As we look at the the kind of the binding of the inhibitory antibodies to the targets.

Our view is that appropriate kind of potency specificity binding antibodies to lobby to are going to be more similar than they are different.

And and part of that is really due to the nature of these receptors is a little group of these receptors in humans. The binding they are all very very similar to each other so with that being with that being said.

There's two maybe two things to point out. So we think the differentiation is really going to be in how we take for word you know different indications different lines of therapy.

Perhaps guided by the Biomarkers as best referred to so you know as you as we see the since you folks are poster next week, one could envision that being a tool leading us to a differentiated passed in the clinical programs. The other the other comment I'll make is that.

Well RB two is one of this group of inhibitory receptors.

Primarily on the myeloid myeloid cells and so there are kind of broader strategies that we have in discovery around that whole family. We think this is a group of receptors that have really.

Kind of been under the radar screen in terms of their potential for.

For immunotherapy.

But that would be more of a layout of the pipeline in the future.

Great. Thank you.

Thank you. Our next question comes from the line of Jim Birchenough from Wells Fargo Securities. Please go ahead.

Good morning.

Jim This morning.

The 80 64, R&D being filed can you tell us which will be filed.

Yes, so we don't usually comment on that Nick all I can tell you is that we're on track to start enrolling patients before the end of the year.

Okay fair enough.

Yes.

Sounds good thank you.

Then just going back to vote.

Can you talk about the logistics.

Bespoke brand does this present a challenge for recruiting patients must be very highly competitive space.

Sure. So we've actually been really really pleased by the investigator engagement and enthusiasm about the study and about their to screening that's going on so basically patient sign up a pre screening consent form that allows their tissue to be submitted for screening and.

And their position isn't informed about whether they are just spoke of positive or not at that point. They complete the rest of the screening for the study.

For every clinical trial, there's a screening period and that they have to pass the eligibility criteria and have certain lab for eligibility. The turnaround time for the test is a week or less so we have not found that to be a barrier as I said, there seems to be a lot of enthusiasm. They investigators are doing.

A lot of screening and and we've also opened the pre screening even two sites that are actually actively going to enroll patients in the trial, but have been identified as referral sites.

Some of the trial sites.

So recognizing that when you have a predictive biomarker it all it always does pose a challenge to enrollment, but weve put a lot of measures in place that we believe will help to mitigate that.

Thanks for that and then maybe just following up on that.

This on the archival tissue or is this on the fresh tissue in DC because yes.

Yeah. That's a great question. So because these are PD, one inhibitor naive patients who have only had their frontline chemotherapy and as you know even if people respond to chemotherapy. They usually progress rather quickly we didnt feel it was necessary to get fresh tumor biopsies. So we're using archival tumor but.

In most cases it will be less.

Less than a year before.

Before they they you know get screened for this study so we felt that that was sufficient.

Okay, great. Thank you very much.

You're welcome.

Thank you.

Next question comes from the line of Cory Kasimov from JP Morgan. Please go ahead.

Hi, This is gavin on for Cory I actually had a follow up from the last question on the Oprah.

Is there any reason to suggest that I mean, you said that 20% of the lung cancer patients are eligible eligible for the trial is there any reason to believe that there's geographic differences in the patient population for Fortis Barbara.

And then also does does burst like T mobile.

Have an impact on expression of tests built prior to your knowledge.

Sure. So we don't have any reason to believe there would be a geographic difference.

Lung cancer, the the primary risk factor for lung cancer is smoking no matter, where you live and so we don't believe there's any reason.

Hi, there to be a geographic difference.

With respect to your second question, which was sorry, I just blank.

So what was your second question given.

The potential impact oh outlets came out or or or other first line.

Regimen, such as E GSR treatment.

Sure. These patients are only allowed to have had a platinum containing regimen not targeted therapy. So we don't expect the targeted therapy to have any impact if anything.

Chemotherapy has there have been reports, suggesting that chemotherapy may make tumors, a little bit more hot but we don't have any direct data on the difference between totally treatment naive and chemo treated tumors regarding to spoke about but we don't have any reason to believe that it would have a sick.

Net ticket impact on that.

Great. Thank you.

Welcome.

Thank you. Our next question comes from the line of Steve Powers from Raymond James. Please go ahead.

Using this as a continuous variable for a week nine to 18 I think you said.

Can you, maybe just clarify what how many tumor measurements patients for actually having.

And at what time points.

Sure sure. So I'll answer the second question first so they will have their CP scans, obviously pre treatment and then it nine weeks and then at 18 weeks and so.

Because I know, sometimes can take a little bit longer responses deepen overtime. We felt it was important to include the 18 week scan data.

But we felt that averaging the two would give us kind of the best estimate of the of the of the tumor response to treatment were not we're not really stating right now what exactly the target differences, but you know at some point we were.

Clearly about the response rate to the PD, one inhibitor or the tumor shrinkage with the PD one inhibitor and we do have an opportunity to do a onetime sample size re adjustment.

Got it and then I think I know the answer to this but maybe just to clarify on the call here. The the this is not sequenced treatment. This is treating.

With.

The PD one inhibitor in combination.

At both the nine and 18 week time point, everyone will oversee the same.

Cumulative dose of PD, one inhibitor Kurt.

Correct correct correct that's correct.

Okay. Thank you and then just on the little every two seems like just through our conversations over the past week that this is really becoming a focus for investors a lot happening in this field I'm just curious if its possible I know you don't know for sure you haven't even started the startup is it possible that.

Data from that phase one study could be sort of like the next new clinical data you have even before the end of 2021, when you've guided select data would be available.

Yeah, it's still a little too early to say Steve.

You know it.

We will definitely provide more detail about the study design.

After.

After we announced that we've started enrollment and then once we get a sense of how things are progressing well, we'll guide to when we would have data, but right now it's a little bit too early to say.

Okay I appreciate that and then just lastly, the.

Curious in the wake of the emerge readout that you reported are there any future plans to pursue the Oprah plus CTO at four inhibitor or have you more or less moved on past that hypothesis and focused on PD, one combination through select or or obviously GSK is moving ahead in head and neck, maybe that's it.

Just curious your thoughts there.

Sure. So we're you know we're we're always following the science. So we certainly will look at the data as it matures.

And always be looking for things that we think make sense. However, as weve stated.

Really if you look at all of the things that have failed when they're just you know another T cell based mechanism, adding onto a PD one inhibitor or you know whatever you add to a PD one inhibitor in the a and the PD one resistant space.

It really it we think it makes sense to start looking at a completely different mechanism of action in combination comparably with PD, one inhibitors and you know in the data that was presented recently looked really encouraging and PD one experienced patients and therefore, you know since we have gtx 86.

Before and that target looks like.

Even just biologically like it could help to restore or to overcome PD. One inhibitor resistance that really I think it's a bigger focus for US right. Now also the safety profile looks really good as well so right now that's where we're going to focus our efforts on the PD one experience patient population and.

I don't know rich if you wanted to add anything to that.

Yes, I think that's I think that's right. That's I think maybe see though the way to think about it is we think it's the right decision to not continue.

Enrollment as the merger was originally designed we are going to follow the Io S., we are going to follow the biomarkers, but.

But as best stated that the science is really leading us at least in the PD one resistant population to these other types of mechanisms that get you be on T cells.

As well as the T cell.

Combo.

Got it. Thank you appreciate the questions.

Thanks.

Thank you. Thank you.

Thank you I show No next question comes from the line of offer he from HC Wainwright. Please go ahead.

Hey, good afternoon, everyone.

Thanks for taking my question I just had a quick one on the 18 11 program. So could you remind us.

What else you guys need to be done before the fire that Andy.

Sure I could I could take that one.

Primarily like any monoclonal antibody program, it's really.

The CMC path and the manufacturing and.

Analytical work around the around the drug manufacturer that is usually have that on that kind of tail end of the timing for the IB. So.

So were progressing that.

As we've mentioned, it's our it's our it's our role in this and this deal to to get the IB filed and open.

But were primarily in those kind of last phases of making sure we have a material ready to go.

Thank you for that.

Thank you.

I show. Our next question comes from the line of Zack July from Roth Capital markets. Please go ahead.

Thanks, Mike. Thanks for taking my question just had one quick when you add back I think on the last call you provided some commentary around North Africa with their anti war.

Program that kind of gives you guys. Some cavada just wondering in terms of your clinical shai the moving part I like to like death marriage Lorton patterns to Latin America is doing and then ultimately announced a partnership with MGM led anecdotal targeting I guess.

For Q.

Q antibodies. So just wondering you know based on your knowledge. What you think you would expect them adulterated aging versus a single Alipay flight targeted antibody.

Yes.

Sure I'll address the first one and then turn it over to rich. So as I've said, we plan to you know demonstrate proof of concept as quickly as possible.

But also we recognize that we do need to differentiate from Merck. So I think our trial is really designed to do that to look at as I mentioned that both monotherapy and combination with our own PD, one inhibitor bucket PD, one inhibitor sensitive and resistant patients and.

And you know certainly include some cohorts that are differentiated from what Merck is doing.

Rich would you like to speak to the the bi specific her.

Yes, sure so yeah first.

First I think it's important that we we don't want to comment too much on that I mean, that's.

What we heard about from a press release, rather than at a scientific presentation, but the.

The nature of the entire family of the low receptors. We think is very very interesting biology, and if you.

You need to have specificity for what you're targeting beyond that there are commonalities between well RV, one well RV to add some distinction so I think there's no.

Kind of a growing opportunity to look at these features that might be in common as well as distinct. So for example, well RB one.

To be expressed on NK cells.

So thats different hello, everyone. So that whole family, we believe is going to be.

Very interesting one and it could be kind of central and the myeloid kind of non adaptive so kind of Roe.

But it's really hard for us to comment beyond that generality, given we you know we havent seen any data on that.

Thank you and actually just one quick follow up here after Ken Ken You mentioned that your current cash balances and of course I think the 129 that Missy gilliatt until I was just wondering if your cash runway at does include that.

Thanks, but yes, when thinking about the cash we have into 2023 that does include the upfront of 85 million from gilliatt as well as the $35 million equity investment what it does not include our any potential milestones that we may earn in the future under the gilliatt deal.

And you may recall that up to $685 million and potential milestone $510 million of those our development and regulatory so we were pleased that there are earlier stage milestones.

Hope is that we will earn these and the runway will be even further but we do not include milestones in our projections.

Thanks, Ken This is another follow up here, but just confirming out there the I indeed able known settings you handing over the the program to go yet who will take over are you anticipating having to pay for any of them user studies or anything after that.

No. It's a complete out license and so our expenses basically and on the development side as soon as we filed the I.N.D. and then gilliatt takes it from there and they're responsible to develop and pay for the future development.

And that's why we get considering that the milestones that you could get I appreciate it.

Thanks Bye.

Hi.

Thank you.

Our last question comes from the line of Jim Birchenough from Wells Fargo Securities. Please go ahead.

Hey, Thanks for taking the follow up just a question on the.

Select trial, the lift human clinical trials on comp phase two dose levels of Oprah can you just elaborate on that please.

Sure. After we you know.

Analyzed all the data from the iconic trial, where we had patients dosed at <unk> 0.3 makes for Qig every three weeks, which resulted in sustained target engagement or binding of Oprah too I cover all the time, we determined based on some reports in the literature and then also some additional preclinical data that.

For an agonist molecules such as Oprah, it's probably better to have more pull subtitle target engagement, so pulsatile dosing and target engagement. So in the select trial as in the emerged trial were looking at two different doses with what we believe will be differentiated patterns of target engagement.

So one dose is 0.1 make pig and the other 0.03 Meg per keurig, both given every six weeks.

And although the 0.1 make partake data in the emerged trial actually it looks better than the 0.0 sthree.

We don't really have sufficient data to make a decision at this point about which doses preferable. So we're continuing to explore both doses in the select trial.

And the final analysis, we'll look at the two dose levels combined and then individually compared to Jay take 40 14 alone.

Thank you very much.

Welcome.

Thank you.

Ladies and gentlemen, thank.

Thank you for participating in today's conference. This does conclude the program you may now disconnect have a good day.

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