Q2 2022 Jounce Therapeutics Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Okay.
Good morning, ladies and gentlemen, and walking through the Jounce Therapeutics second quarter.
Two earnings conference call at this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
Reminder, disruptors are being recorded at the company's request I will now turn the call over to your host Eric Wold with Johnson Therapeutics. Please go ahead.
Thank you operator this is Eric <unk>, Vice President of Investor Relations at Jounce Therapeutics, Good morning, and welcome to the Jounce Therapeutics second quarter 2022 financial results 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. Richard Murray, who will review our pipeline progress and key milestones followed by our CMO Dr. Beth <unk>, who will provide an update on our clinical activities. Our CSO. Dr. Dmitry Vitor, Shane will then discuss our discovery programs and lastly, our <unk>.
So Kim Drapkin will review, our second 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 1095.
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 SEC filings. In addition, any forward looking statements represent our views only as of today August 4th.
22, 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'll now turn the call over to rich.
Thanks, Eric.
And thank you for joining our call today.
As disclosed in our press release. This morning, we've made significant progress advancing our pipeline and look forward to sharing more details on our ongoing and select clinical trials today.
We're encouraged by the important overall progress we've made in the second quarter.
Pleased to announce that we've completed enrollment and select tracking to report data later this year.
As previously announced we met the pre specified expansion criteria and two of the seven and eight combination cohorts, enabling the continuation of enrollment from the first 10 patients to the full 29 patients in each well.
We're pleased with the pace of that continued enrolment.
The remaining combination cohorts are either continuing patient enrollment to complete the first stage or waiting for patient data to mature.
We persist.
Striving for a meaningful immunotherapy for patients who have few options.
This is at the heart of our approach to novel mechanisms guided by Biomarkers.
Our plan is to submit clinical data abstracts for both innate and select to the ESMO immuno oncology Congress 2022 being held from December 7th Tonight in Geneva, Switzerland.
As we've previously stated our objective is to provide comprehensive datasets with as much follow up and biomarker data as possible.
Given the medical meeting submission deadlines. This venue makes the most sense to us to report these important clinical data.
Matt will provide more details on our clinical studies in a few moments.
Across the field the use of PD, one inhibitors continues to grow and expand into earlier lines of therapy, including non metastatic settings.
As a result, the size and scope of the PD one inhibitor resistant markets continues to increase.
There are more patients who are resistant to the therapy didn't benefit from it.
Unfortunately, there are a few alternatives for these patients in many tumor settings.
We see this resistance is a fundamental scientific and medical problem.
This is the way a broader and more durable impact Io could have for cancer patients.
Our scientific evidence continues to point to the myeloid immune cell lineage is being causal to at least some aspects of Io resistance.
We have prioritized discovery work on the well RMB or Iot receptors.
And a similar approach T regulatory cells are thought to create immune suppressed immune suppressive barriers in the tumor microenvironment.
We licensed our lead T regulatory cell program, an antibody targeting <unk> to gilead.
This antibody the forest brought through <unk> by Charles is now called <unk> 18, 11 is being developed by Gilead.
Under the license agreement, we are entitled to receive milestone payments from Gilead upon the achievement of specified clinical regulatory and sales milestones along with tiered royalty payments.
Our next potential internal clinical program Gtx $14 84 is an anti low <unk> four or <unk> three program currently in IND, enabling studies.
Well, our before is expressed on immune suppressive myeloid cells in the tumor microenvironment with both overlapping and distinct cell types and biology compared to <unk>.
Dmitry will provide more details on our discovery efforts and this program.
On another note, we're sharing some internal promotion and changes to the board of directors.
On the board front <unk> has replaced Perry Carson as chairman of the board.
<unk> served as chair since April 2016, and remains on the board.
I would like to recognize <unk> leadership contributions and commitment to <unk> during his time as chair.
Perry was one of our first independent board members and was instrumental in building the board strength and expertise. Thank.
Thank you Perry and we look forward to your continued involvement.
I'd also like to congratulate Jaeger as the chair of the board.
<unk> joined our board in 2021.
As a former member of the <unk> management team and has the relevant experience knowledge and understanding to step into the chair role at this important time.
Internally, we promoted two of our management team members to new roles.
Q call is being promoted from Chief business Officer, and head of corporate development to Chief operating officer.
Dr. Haynesville, making is being promoted from SVP of program and portfolio strategy to Chief Development Officer.
Both you and Haley our impactful leaders within <unk>, and we congratulate them on their respective promotions.
We are eager to continue our robust clinical and discovery productivity across our pipeline.
We're excited for what lies ahead a challenge as we work towards our key data Readouts this year.
Our current financial position enables our continued growth and execution beyond the proof of concept inflection points of a Nate and select while continuing our robust novel discovery efforts identifying and progressing new mechanisms to benefit cancer patients.
Particularly in settings, where patients have few therapeutic options.
With that I'll turn the call over to Beth to discuss our clinical pipeline and science in more detail.
Thanks, Rich, we are making great progress on our two proof of concept studies and I am very pleased to be able to provide some updates on both trials for you. This morning.
Let's begin with the <unk> trial of Gtx 80, 64, our <unk> inhibitor.
Last year, we completed the phase one dose escalation for both monotherapy and combination with Sandy selected 700 milligrams as the recommended phase two dose and initiated the phase two expansion cohorts for both monotherapy and combination treatment in seven different indications.
As a reminder, each of the expansion cohorts is a Simon two stage design.
For the combination cohorts. The first stage consists of 10 patients per cohort.
Each cohort must meet Prespecified criteria based on radiographic response before resuming enrollment of the additional 19 patients for a total of 29 for combination cohort.
Subsequent to this year's initial data readout. Our goal is to demonstrate clinical proof of concept on the full set of 29 patients for each expansion cohort.
To establish proof of concept we require the response rate of Gtx 80, 64 in combination with our PD, one inhibitor timmy to be greater than what would be expected with a PD one inhibitor alone.
The response rates for PD, one inhibitor monotherapy are different for each indication and they're all quite low generally in the single digits.
This reflects the high unmet need in patients who have failed a PD one inhibitor or have tumor types, where PD one inhibitors alone have minimal impact.
As previously announced to date, we have met the expansion criteria and two of the seven combination cohorts.
The indications that have met the pre specified criteria and are currently enrolling up to 29 patients.
Our third and fourth line PD, one inhibitor nave platinum resistant ovarian cancer.
And second and third line PD, one inhibitor resistant clear cell renal cell carcinoma.
There is significant unmet medical need in both ovarian and renal cell carcinoma.
Data from previously published studies with PD, one inhibitors and PD, one inhibitor naive ovarian cancer and PD, one inhibitor experienced renal cell carcinoma have reported response rates of approximately 9% and 13% respectively.
In addition to response rate assessment and important aspect of the Nate is the evaluation of the correlation of Pharmacodynamic and predictive biomarkers with efficacy.
Analysis of potential predictive Biomarkers may help us to understand the contribution of J P. S. <unk> 64 to clinical activity in these combination cohorts.
There is a growing body of evidence that biomarkers expressed by immuno suppressive macrophages are a negative prognostic factor in many cancers, regardless of treatment and with high levels of tumor associated macrophages relative to interferon gamma or a negative predictor of response to PD one inhibitor.
<unk>.
If we observe an association of improved clinical outcomes with Biomarkers typically linked to worse outcomes, particularly in the combination cohorts. It will help isolate the contribution of J P at $80 64 to clinical activity.
Let me now take a few minutes to update you on the trial status enrollment is going well across it Nate.
Enrollment of the full 29 patients in the ovarian cohort is nearing completion and enrollment in the renal cohort is also going well.
We have not yet met the point for expansion and the remaining combination cohorts as they are either still enrolling up to 10 patients or have completed stage, one enrollment and we are awaiting patient data.
In the ovarian cohorts, we prioritized enrollment in the combination cohort over the monotherapy cohort.
As enrollment and the ovarian combo cohort is near completion, we will now shift our efforts to completing enrollment in the first stage of the monotherapy cohort.
As rich mentioned, we plan to submit an abstract to the December 2020 to ESMO Io meeting.
The data will include all 31 phase one dose escalation patient nine of whom were in combination and at least 80 phase II combination treatment patients from mandate.
We plan to percent complete phase, one monotherapy and combination dose escalation data, including the respective safety PK PD biomarker and preliminary efficacy data.
Phase II data will include safety and preliminary efficacy based on resist one one pharmacodynamics and potential predictive biomarker correlation with efficacy within each cohort by prior PD, one inhibitor history and in a cross cohort analysis.
Now onto our other phase III program for <unk>.
<unk> agonist in the select trial, which is a randomized phase II proof of concept trial.
We are pleased to have completed enrollment and are proud of the efforts of our team and the investigators have made to keep treating patients and Ukraine. During these challenging times.
And select we're studying two doses of Oprah and combination with penny compared to <unk> alone.
Biomarker selected patients with metastatic non small cell lung cancer, who are PD, one inhibitor naive and have progressed on a platinum based chemotherapy regimen.
This trial seeks to address two important questions one will vote breath, plus a PD one inhibitor in biomarker selected patients result in greater activity than a PD one inhibitor alone.
And to which dose of both breast should we choose for further development.
The predictive biomarker selection of patients utilizes <unk> Oprah and RNA based ATM gene signature that includes genes relevant to both PD, one and <unk> biology.
Only patients with a value above the biomarker thresholds are enrolled and the trial is designed to show the statistical superiority of Oprah plus our PD, one inhibitor <unk> versus <unk> alone.
The primary endpoint is the mean change from baseline in tumor size averaged over 9% and 18 weeks and the secondary endpoints are the more comments overall resist response rate progression free survival overall survival and duration of response, which represent all of the standard regulatory endpoint.
All endpoints will be based on independent Central Radiology review.
Okay.
The doses, we are exploring 0.1 milligrams per kilogram and 0.03 milligram per kilogram demonstrated differentiated patterns of pulsatile target engagement in prior studies.
A hypothesis, we are testing is that the sustained target engagement required for antagonist antibodies is not ideal for an agonist molecule like both Brett and that a dose that results in a more pulsatile pattern of target engagement may be more efficacious than one with sustained target engagement.
As rich mentioned, we are on track to present, the complete study data with an abstract submission to ESMO Io.
Since we will be reporting the complete study data this year I would like to provide some guidance for expectations and interpretation of data from this randomized phase II study.
Our decisions regarding further development of <unk> in combination with <unk> will be based on the totality of the data, including resist response rate, where there is strong benchmark data for PD one inhibitors.
In this setting response rates for PD, one and PDL, one inhibitors range from 14% to 20%.
We expect the response rate for <unk> alone to be similar to or better than this.
The response rate for Gopro, plus penny for at least one dose level will need to be meaningfully better than the response rate for <unk> alone and supported by data from other endpoints.
I would also like to mention that a manuscript on our first in human phase one two iconic trial of <unk> alone and with Nikola map accompanied by a thoughtful editorial was recently published in clinical cancer research I'd like to congratulate the team on this work.
Our team has done an incredible job during unprecedented times executing on both clinical trials I would like to take a moment to thank all the investigators study teams and especially the patients who put their trust in our medicines to make a difference in their lives without their bravery, we would not be able to advance these important.
Medicines, we look forward to reporting on our continued progress this year.
I will now turn the call over to Dmitry.
Thanks Beth.
We are focused on the utilization of our translational science platform.
Address the problems that patients with cancer are facing today, namely.
Namely resistance with T cell checkpoint inhibitor therapy.
We believe that our ability to dissect the tumor microenvironment at the molecular level.
Using immune cell type specific gene signatures will lead us to target that may be important for overcoming resistance to checkpoint blockade.
The growing body of data points to suppressive myeloid cells, including tumor associated macrophages and their contribution to resistance to PD, one or <unk> directed therapies.
Gtx, $80, 64, which targets immunosuppressive macrophages and other myeloid cells in the <unk> serves as an example of a patient centric biomarker driven approach in discovery and through development.
This approach is key to the value generating programs we are pursuing.
We are very excited about our discovery activities and have announced our most recent advancement having selected <unk> 84 is our newest development candidate.
IND, enabling studies are well underway and we continue to advance towards submitting an IND next year.
Gtx $14 84 bind to and inhibits Lula are before or Iot III.
Another family member that is highly expressed on some of the key myeloid cells.
Including myeloid derived suppressor cells and tolerance shining dendritic cells.
Orchestrate immune suppression in the CME.
Including resistance to checkpoint inhibitors.
The Blue bar before target is distinct from other <unk> family members with respect to ligand specificity as well as temporal and spatial pattern of expression on immune cells.
Therefore, we see this program is complementary to our ongoing efforts with targeted <unk> with Gtx <unk> 64.
We have submitted two preclinical abstracts, one on Gtx $14 84, and one on the little RV family for consideration for this year's annual meeting.
We look forward to the opportunity to share this preclinical data.
Additionally, our pipeline of modest specific with RB targeted antibodies is further strengthened by the ongoing efforts to develop a potent and specific blockers of Lula <unk> one.
Inhibitory receptor that is expressed not only on myeloid cells.
Also on certain subsets of T and NK cells.
Having these high quality building blocks the targets three important members of the <unk> family has enabled us to explore multi targeted approaches pre clinically by leveraging our knowledge growing expertise in <unk> biology.
We're confident that the <unk> family as well as other targets that we're currently pursuing represent attractive opportunities in immuno oncology.
The potential to improve upon and restore responsiveness to PD, one or <unk> inhibitors.
In addition to our efforts in the lobby family, we continue to add to and diversify our discovery pipeline into other exciting areas of biology.
I will now turn the call over to Kim for a discussion of our second quarter financial results Tim.
Thank you Dmitry.
We reported in this morning's press release cash cash equivalents and investments as of June 32022 were $162 3 million compared to $220 2 million as of December 31, 2021.
The decrease was due to cash burn from operating expenses incurred during the period.
Turning to the P&L no revenue was recognized during the second quarter of 2022 compared to $25 4 million of revenue recognized during the second quarter of 2021.
The 2021 revenue was comprised of a $25 million clinical development and regulatory milestone for FDA clearance of the IMD for <unk> 18, 11 at <unk>.
$4 million related to noncash revenue for the performance of research and transition services, both under the Gilead license agreement.
During the second quarter of 2022, we incurred $26 2 million in research and development expenses compared to $22 1 million for the same period in 2021.
The increase in R&D expenses was due to increased manufacturing activities performed increased clinical and regulatory expenses for <unk>.
And increased payroll and lab supplies.
General and administrative expenses were relatively flat at $7 5 million for the second quarter of 2022 compared to $7 3 million for the same period in 2021.
Net loss for the second quarter of 2022 with $33 5 million, resulting in a basic and diluted net loss per share of <unk> 65.
As compared to a net loss of $4 million for the same period in 2021.
Hoping in a basic and diluted net loss per share of <unk>.
The increase in net losses attributable to increased operating expenses and no revenue recognized under the license agreement with Gilead in the second quarter of 2022.
Given current market conditions, both in our sector and more broadly we are making an effort to decrease our cash burn and extend our runway.
While we continue to invest in both our clinical and discovery programs. We have identified areas in which we can continue to create value, but also decrease expenses.
As a result of these efforts our cash on hand, now provides one way into the first quarter of 2024.
Based on our current operating and development plans, we now expect to be on the lower end of our gross cash burn guidance for the full year 2022 of approximately $115 million to $130 million.
I'll now hand, it back to rich for some final words.
Thanks Kim.
The combination of our clinical execution innovative science and financial resources enables us to move beyond our next set of inflection points slated for this year.
We're looking forward to this year city and ESMO Io meetings to be a busy time for us.
As Beth Dmitry described we are working hard to build an io pipeline, which looks to address the growing unmet need faced by cancer patients.
I would like to personally thank all of our hard working employees, who bring their enthusiasm to work every day to make these programs possible.
We're privileged to be working on this mission together at channels and are fortunate to have such dedicated employees collaborators and clinical investigators.
We look forward to updating you on the programs as the year progresses.
With that we'd now like to open the call for your questions operator.
Ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone keypad will pause for a moment, while we compile our Q&A roster.
Our first question comes from Edward <unk> with Piper Sandler Your line is open.
Great. Thanks, Good morning, everybody and congrats on all the progress looking forward to the data.
The fall here. So two quick questions. If I may on your little RMB franchise.
I'm really trying to understand sort of how the profiles different differentiate.
And between the low RB till everyone.
Ed.
Something where ultimately you may future combination or are these really express differentially thanks for explaining.
Thanks for the question.
Great question.
It's something that we're actively working on and addressing in the labs, we believe that.
Little RMB, one two and four have differentiated expression profiles.
They are expressed on different types of immune cells in the tumor microenvironment.
More importantly, we do believe that they have both overlapping but also distinct biological functions and we're looking forward to presenting some of these data.
It fits the meeting where we submitted an abstract for just a few days ago.
Clearly.
We see plenty of opportunities for combination of our highly potent and specific <unk>, one two and four blockers in the clinical setting, but also as we pointed out we have an active effort on large multi targeted approaches using.
Biological scaffolds, thanks for the question.
Yes.
Obama for our next question.
Our next question comes from Boris <unk> with Cowen Your line is open.
Greg My first question is on an eight.
Here are from asthma to confirm that you are included in the meeting.
And part of that is can you help us with how we should be interpreting knee.
No data update.
So the.
Hi, Boris this is Beth the abstract submission date is September 27.
So.
Usually I think the abstracts will be published on December 1st.
So we don't usually.
<unk> announced that abstract has been submitted.
But that's sort of the timeframe. So we will be submitting the end of September .
And then the meeting is December six Tonight.
Got it so we could see from the publication of abstract on December 1st whether you included or not just to be clear.
Correct.
Got it and in terms of interpreting the data can you help us understand.
I guess for both for the.
Cohorts for two cohorts in ovarian.
Clear cell.
And what about the other cohorts are fully enrolled.
Sure. So the data we will present will include patients from every cohort.
There, obviously will be more patients from the ovarian and renal cell cohorts although.
Don't expect we'll have full 18 week data on everybody from from those cohorts, but our goal and one of the reasons, we decided to to submit to ESMO Io. Our goal is to have as robust a dataset as possible. So we will be presenting the data by cohort.
Even for the cohorts that have not gone beyond 10 patients will.
We will be presenting that data by weather.
Breaking it down by the PD, one experienced patients the ones that are resistant or the PD one inhibitor naive patients.
And then also looking at a cross cohort analysis and an important part of the data presentation will be the correlation of our association with various potential predictive biomarkers.
Great. Thank you very much.
Youre welcome.
One moment for our next question.
Our next question comes Steven Steve House of Raymond James.
Okay. Thank you good morning, Thanks for taking the question.
First I just wanted to ask the so the response criteria, where you are looking for greater response than what you would expect for PD, one PDL one inhibitor alone.
Wanted to.
Please specific so the expectation is 9% for instance.
In third or fourth line ovarian because I mean, you would only require one response or in that case are you looking for to before you enroll the stage two.
So thanks, Steve we haven't we haven't talked about our criteria for moving from stage one to stage two.
In ovarian wherein.
Almost complete with the 29 patients and so it really is the best way to think about it is what we need to see it.
The 29 patients and that the final proof of concept data, we think will happen in early 2023, but with that data, we would need to see a response greater than.
Meaningfully greater than 9%.
And the ovarian cancer patients and greater than 13% in the renal cell carcinoma patients.
I think it's also helpful to understand not just the benchmark for PD one inhibitors, but also for standard of care. So in these patients the standard of care for ovarian cancer response rates range from 4% to 14%.
And in renal cell carcinoma for this patient population the standard of care would deliver about 17%.
Okay. Thanks for clarifying that was my misunderstanding.
The stages, where are you looking for that specific response rates. So any other thing you commented on just the enrollment in the mono versus combo ovarian.
Cohorts I just wanted to make sure I understand that right. I know you commented, but so are you enrolling the full stage, one and stage two for combo, and then pivoting to prioritizing enrollment in the mono or.
Is there some sort of.
Arthur.
Sure So what happened there.
Monotherapy for monotherapy ovarian cohort opened in August right. So thats started enrolling when we opened the combo ovarian cohort.
Investigators tended to prioritize that so we decided to prioritize the ovarian combo.
It met the criteria to move from 10 to 29 patients were now almost finished with enrollment of the full 29 patients and so once that's complete then we will really focus on trying to complete enrollment in the first stage of the monotherapy cohort.
Makes sense okay. Thank you.
I just wanted to.
Clarify the response criteria for expanding enrollment from 10 to 2009 is that confirmed resist response or something else.
Yes, so we haven't we haven't shared those criteria they were internal criteria that we use.
Really think it's important to focus on our success criteria for a full set of 29 patients theres. So much with what's really small datasets.
Things can be quite misleading. So we really want to make sure we're focusing on that the responses in the 2009 patients.
And those will be based on confirmed resist responses, yes, okay.
Thank you Matt I appreciate it.
One moment for our next question.
Our next question comes from David Dai with <unk>. Your line is open.
Hey, great. Thanks for taking my questions and congrats on the progress.
First question I guess is around 864 could.
Could you clarify if any of the indications stopping enrollment because it has not met the pre specified response criteria.
No all the cohorts are still open.
And could potentially.
Extend.
Some have completed enrollment of the first 10 patients and we're just waiting for data to mature and then some have not completed the first 10 patients yet.
We have not closed any cohort.
Got it.
Helpful.
Second question just around the <unk> to make sure. He MA for 2064, what we saw from from your slides before was that immuno cell carcinoma has high <unk> you.
Immune signature.
As the ovarian cancer is medium to low levels.
Can you share so could you help us understand a little more about the biomarker hypothesis based on this.
The fact that you're enrolling additional patients for ovarian.
<unk> carcinoma.
Sure. So first of all for that heat map I think.
All of the tumors that we selected are actually what we would consider high.
Ovarian may look a little lower than renal cell in terms of the intensity on the heat map, but it is also a tumor that has high levels of the gene signatures that we were using for selection of indications, which were little RB two or tumor associated macrophage signature and an interferon gamma signature.
In terms of the predictive biomarkers that we're going to be looking at these have all been pre specified will be analyzing.
All of the clinical data.
And its associated.
<unk> with this panel of Biomarkers and these include both gene signatures and IH C. The ones, we've talked about have been things like lube RB two itself.
Some of its ligand.
The little RB two or Tam to interferon gamma ratio, which as I've mentioned is a poor predictor for PD. One inhibitor response, and then things like CD 163, which is in IHT marker for tumor associated macrophages, and so I think the general theme is high levels of immunosuppressive macrophages.
Generally predict poor outcomes for patients either with regular standard of care or with PD, one inhibitors and so if we see benefit in the patients who have high levels of those.
Wood, which suggests that <unk> hundred 64 is contributing to the efficacy and help to isolate the effect of the combination with a PD one inhibitor.
Okay. That's helpful to think about.
Youre welcome.
One moment for our next question.
Our next question comes from <unk> <unk> with <unk>. Your line is open.
Thank you.
Good morning folks thanks for taking my question.
Yes.
Richard.
First started talking about.
Malibu too.
<unk>.
Yes.
The big the big players versus just Merck can do ourselves.
But over time, we have seen.
Chanel players come into the lobby.
<unk>.
I do understand that you have.
<unk>.
Molecules within that.
In development.
But I'm just trying to understand how.
Strategically how are you thinking now to maintain.
And that leadership, the timberland RV space.
<unk>.
You plan to bring additional molecules are tied to more of these molecules which are currently.
In preclinical and clinical stages.
A little bit.
Faster than your competition.
Yes sure Jay this is rich I can take that one.
As we look at the little family is Dmitry.
As I mentioned, just a few moments ago there are overlapping.
<unk> and mechanisms, but importantly also also distinctions.
In addition to the distinction of function that we can characterize there are different by gas. So there's a different way to kind of stimulate the immuno suppressive effect.
Through those receptors. So as we kind of elucidate that biology linked to different ligands that can start to direct us to.
What we think are smart combination types of first lab experiments.
As well leading to clinic.
As well as indications so we think as with many immunotherapies, there's always an opportunity in lines of therapies and different indications that we think.
Could you know really allow us to be very very assertive in one area and create a leadership leadership position.
As Beth mentioned, the biomarker analysis is going to be quite important for us as well.
Some places in some circumstances of biomarker becomes important are necessary. We think thats also really an opportunity for for differentiation for our for our molecules.
One final note.
That dmitry alluded to is we believe the myeloid cell system is quite important in creating immuno suppressant barriers. So while we have spoken much about the <unk> receptors. We have other myeloid targets in hand, and so there's a way to really go after that cell lineage, we say through our highly specific.
Monotherapy agents as well as constructed by specific agents that we think really go after that cell type that may be creating such a barrier.
For for the immune system.
Alright, thanks for that.
One additional question.
Any update you can give us on the.
On the molecule CCR a molecule that Jimmy it is.
Developing.
In terms of like data expectations or the mix.
Six to 12 months.
Yes, I can take that one as well.
So when we file the IND and open that A&D, we were quite pleased with how that was taken up by by by Gilead.
For us we.
We really can't comment.
Their progress internally that would really be more of a direct question for them.
We're certainly pleased when gilead had their R&D day.
What's now called <unk> hundred 11.
Was was part of that part of that whole presentation and so.
We're happy with the way that is that is moving forward and of course that that allows for a potential for milestones coming down the road, which are not included in our current financial forecast.
Thanks. Thanks.
Richard Thanks for taking my questions.
One moment for our next question.
Our next question comes from Nick Abbott with Wells Fargo. Your line is open.
Hey, good morning.
Taking my question.
Really on the West Coast, particularly question first which is just on the cash runway rich is this the corporate jet that's going.
What are you doing to extend the cash runway.
Program is not going to move ahead as well.
Just maybe a little bit of clarity on that please.
Yes.
Yes, sure Nick I think.
Generally speaking I think.
I think everyone given the state of the market is looking very hard at this and so what we've done is to maintain the value generation kind of swim lanes. If you will of key programs, but also adjust our timing and our as our timing adjusts we can look at.
What we plan versus what we're seeing in the actual so I will mentioned, we've worked really hard across the company to look at that very very hard.
We are within the range that we originally gave at the lower end of the range, which we're happy to report today, Tim can comment on this as well sure. So to specifically answer your question Nick its not the private jet we've never had that.
And also importantly, we have not cut any programs. We've really just tried to take a hard look think about the market conditions think about ways in which we can extend our runway and as with any financial forecast as you get closer and dosing.
Doses youre timing things like that Youre able to refine it and we just took a really hard look at it just given the conditions and feel good about where we are.
Okay. Thanks, and then maybe just sort of going back to we've had several questions on 8064.
It's really what is this meaningful increases.
Okay.
<unk>, we expect to see with PD, one monotherapy with standard of care.
You already have cohorts that have been reached potentially responsive patients.
You could argue they really need to see a pretty high bar of efficacy.
And that needs to be backed up by correlative science.
That's why you will see activity. So maybe if you can just give me your thoughts on.
What youre thinking in terms of what you need to see and then.
How important is duration of response I mean do you view would you be ready to make a decision on the registration trial design by early towards your three or do you need to see how these responses play out over time and that decision may be second half of 2020.
Sure. That's a great question Nick. Thank you. So first of all yesterday <unk> of response is very important thats. Obviously, one of the Differentiators for immunotherapy is that the responses tend to last longer than they did with chemotherapy. So that will be an important part of our decision making.
I guess the way to think about it is we need to see response.
Response rates high enough in these single arm cohorts.
Two.
Give us the confidence to move forward I think the next step would be a randomized study whether it's.
Phase III study or a phase III study.
<unk>.
Pins on the data and how clear.
And how rapid we think the path can be also what the degree of unmet need is.
And so I think.
It really is that we.
We have to see a response rate that's high enough for us to have confidence to go ahead and start a randomized study.
Okay terrific. Thanks, Pat and then I think maybe last time, we talked a little bit about CMC I know, you're putting a lot of assets.
A lot of junk product required so you're putting a lot of effort into that can you just give us an update on where you are in terms of being able to manufacture products.
Product registration quality quantity.
Yes, sure I can I can take that one Nick thanks for that yes.
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Reflective of all of our programs as we kind of zero in on the on the doses necessary.
Are always looking to create.
Processes that are done in a proactive way such that they can be very scalable and very control. So we've not taken the approach to.
Fly into phase, one and then create kind of an issue as you might want to expand that so we've got a lot of experience in our CMC group people, who have been through the drill many many a time and so these these.
Processes from productivity to scale ability are done in a very in a very proactive way.
That is.
Reflective of the study of course, you feel the benefit of that in a study that has many different cohorts and we're looking to see how many of those cohorts might move ahead of course, you have to be ready for that.
Since there is at least a year plus kind of lead time, if you want to flip the switch so really what it is is a kind of early productivity and kind of manufacture ability.
Analysis that goes into everything we do.
Early so that it becomes predictable as we scale.
Yes.
Thanks, Richard So just integrating your sponsor.
What do you think the earliest days you'd be able to.
Yes.
Move ahead on our registration trial, it sounds like probably.
Towards the end of next year.
Yes, I think.
As I mentioned, Nick the next step will be randomized trials.
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Based on the data next year.
We would plan to start randomized trials and the data we think that the final POC data will be.
In the early 2023, and Thats, what would trigger a randomized trials.
Yeah, and maybe Nick just a quick comment back to the CMC question.
Won't be a gating factor for us it will really be the clinical data that will be driving that.
Okay, Great and then I'll also and really assist on his.
Sort of a two part or really obviously you know Merck is a co formulation.
Kimbro and keep that keeps getting.
The number.
My phone number.
The lobby too.
You have plenty of <unk> 64.
Looking to the co formulate there was a question earlier on competitive landscape you are now.
Good position here and then.
This program will hopefully expand broadly next year, what are your thoughts on partnership and given current valuations on potential valuation of this program was a collaborative structure makes sense.
At this time.
Yes, so the way we the way we look at that.
Currently Nick is that we we believe the combinations of the two we're very very quite manageable for us and we're using pay me for other things as well.
So we will continue we will continue on that track certainly for the moment I mean, having said that we are looking at very rationally design types of types of bi specific kind of partners as well.
On the on the go into the partnership.
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Side of your question.
We're really looking to.
Depending on the data move forward as rapidly as possible now certainly there could be scenarios that might.
Indicate.
John's could take programs forward further and.
With our analytics built around that are building more value as well as perhaps.
The types of partnerships that might that might need are being well served to happen to happen sooner.
So based on just the realities of taking multiple types of.
Cohorts forward. So so that you don't really dictate the data out play the number of cohorts that.
That really kind of moves the moves the.
The sliding scale as to how we're thinking about how we are thinking about partnerships, but inherent in all of those is that we really want to create.
And maximize the value for Johnson the shareholders.
Okay. Thanks, Rich that's it for me.
And im not showing any further questions at this time. So this does conclude today's conference you may all disconnect and have a wonderful day.
Okay.
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