Jounce Therapeutics, Inc. (NASDAQ:JNCE) Q2 2022 Earnings Conference Call August 4, 2022 8:00 AM ET
Company Participants
Eric Laub – Vice President-Investor Relations
Richard Murray – Chief Executive Officer & President
Beth Trehu – Chief Medical Officer
Dmitri Wiederschain – Chief Scientific Officer
Kim Drapkin – Chief Financial Officer
Conference Call Participants
Edward Tenthoff – Piper Sandler
Boris Peaker – Cowen
Steven Seedhouse – Raymond James
David Dai – SMBC
Swayampakula Ramakanth – HCW
Nick Abbott – Wells Fargo
Operator
Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Second Quarter — 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduction a question-and-answer session and instructions will follow at that time. As a reminder, this conference is being recorded at the company’s request.
I will now turn the call over to your host, Eric Laub with Jounce Therapeutics. Please go ahead.
Eric Laub
Thank you, operator. This is Eric Laub, 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 & Media section of our website at www.jouncetx.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 Trehu who will provide an update on our clinical activities. Our CSO, Dr. Dmitri Wiederschain will then discuss our discovery programs. And lastly, our CFO, 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 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 SEC filings. In addition, any forward-looking statements represent our views only as of today August 4, 2022, 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.
Richard Murray
Thanks, Eric. Good morning, 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 INNATE and SELECT clinical trials today.
We’re encouraged by the important overall progress we’ve made in the second quarter and are pleased to announce that we’ve completed enrollment in SELECT, tracking to report data later this year. As previously announced, we met the pre-specified expansion criteria in two of the seven INNATE combination cohorts enabling the continuation of enrollment from the first 10 patients to the full 29 patients in each. We’re pleased with the pace of that continued enrollment.
The remaining combination cohorts are either continuing patient enrollment to complete the first stage or waiting for patient data to mature. We persist in 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 seven to nine in Geneva Switzerland.
As we previously stated, our objective is to provide comprehensive data sets with as much follow-up in biomarker data as possible. Given the medical meeting submission deadlines, this venue makes the most sense to us to report these important clinical data. Beth will provide more details on our clinical studies in a few moments.
Across the field, the use of PD-1 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-1 inhibitor resistant markets continues to increase as there are more patients who are resistant to the therapy than benefit from it.
Unfortunately, there are a few alternatives for these patients in many tumor settings. We see this resistance as a fundamental scientific and medical problem that is in the way of broader and more durable impact IO could have for cancer patients.
As scientific evidence continues to point to the myeloid immune cell lineage as being causal to at least some aspects of IO resistance, we have prioritized discovery work on the LILRB or ILT receptors. In a similar approach, key regulatory cells are thought to create immune suppressive barriers in the tumor microenvironment.
We licensed our lead T regulatory cell program an antibody targeting CCR8 to Gilead. This antibody the fourth brought through IND by Jounce is now called GS-1811 and is being developed by Gilead.
Under the license agreement, we’re 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 JTX-1484 is an anti-LILRB4 or ILT3 program currently in IND-enabling studies.
LILRB4 is expressed on immunosuppressive myeloid cells in the tumor microenvironment with both overlapping and distinct cell types and biology compared to LILRB2. Dmitri 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, Jigar Raythatha has replaced Perry Karsen as Chairman of the Board. Perry has served as Chair since April 2016 and remains on the Board. I would like to recognize Perry’s leadership, contributions and commitment to Jounce during his time as Chair. Perry was one of our first independent Board members and was instrumental in building the Board’s strength and expertise. Thank you Perry and we look forward to your continued involvement.
I’d also like to congratulate Jigar as the Chair of the Board. Jigar joined our Board in 2021, he is a former member of the Jounce 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. Hugh Cole is being promoted from Chief Business Officer and Head of Corporate Development to Chief Operating Officer. Dr. Haley Laken is being promoted from SVP of Program and Portfolio Strategy to Chief Development Officer. Both Hugh and Haley are impactful leaders within Jounce 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 at Jounce 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 INNATE and SELECT, while continuing our robust novel discovery efforts, identifying and progressing new mechanisms to benefit cancer patients, particularly in the 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.
Beth Trehu
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 INNATE trial of JTX-8064, our LILRB2 inhibitor. Last year, we completed the Phase I dose escalation for both monotherapy and combination with pimi selected 700 milligrams as the recommended Phase 2 dose and initiated the Phase 2 expansion cohorts for both monotherapy and combination treatment in seven different indications.
As a reminder each of the expansion cohorts is a Simon 2-stage design for the combination cohorts. The first stage consists of 10 patients per cohort. Each cohort must meet pre-specified criteria based on radiographic response before resuming enrollment of the additional 19 patients for a total of 29 per 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 JTX-8064 in combination with our PD-1 inhibitor pimi to be greater than what would be expected with a PD-1 inhibitor alone.
The response rates for PD-1 inhibitor monotherapy are different for each INNATE indication and are all quite low generally in the single digits. This reflects the high unmet need in patients who have failed a PD-1 inhibitor or have tumor types where PD-1 inhibitors alone have minimal impact.
As previously announced to date, we have met the expansion criteria in two of the seven combination cohorts. The indications that have met this pre-specified criteria and are currently enrolling up to 29 patients are third and fourth line PD-1 inhibitor naive platinum resistant ovarian cancer and second and third line PD-1 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-1 inhibitors and PD-1 inhibitor naive ovarian cancer and PD-1 inhibitor experienced renal cell carcinoma have reported response rates of approximately 9% and 13%, respectively.
In addition to response rate assessment, an important aspect of INNATE 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 JTX-8064 to clinical activity in these combination cohorts. There is a growing body of evidence that biomarkers expressed by immunosuppressive macrophages are a negative prognostic factor in many cancers regardless of treatment. And that high levels of tumor associated macrophages relative to interferon gamma are a negative predictor of response to PD-1 inhibitors.
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 JTX-8064 to clinical activity.
Let me now take a few minutes to update you on the trial status. Enrollment is going well across INNATE. 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 in 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 in 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 2022 ESMO-IO meeting. The data will include all 31 Phase I dose escalation patients, nine of whom were in combination and at least 80, Phase II combination treatment patients from INNATE. We plan to present complete Phase I monotherapy and combination dose escalation data, including the respective safety, PK/PD biomarker and preliminary efficacy data. Phase II data will include safety, preliminary efficacy based on RECIST 1.1, pharmacodynamic and potential predictive biomarker correlation with efficacy within each cohort by prior PD-1 inhibitor history and in a cross cohort analysis.
Now, on to our other Phase II program, Vopratelimab, our ICOS 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 in Ukraine during these challenging times.
In SELECT, we are studying two doses of Vopra in combination with Pimi, compared to Pimi alone in biomarker selected patients with metastatic non-small cell lung cancer, who are PD-1 inhibitor naive and have progressed on a platinum-based chemotherapy regimen. This trial seeks to address two important questions. One, will Vopra plus a PD-1 inhibitor in biomarker-selected patients, result in greater activity than a PD-1 inhibitor alone; and two, which dose of Vopra should we choose for further development.
The predictive biomarker selection of patients, utilizes TIS vopra, an RNA-based 18 gene signature that includes genes relevant to both PD-1 and ICOS biology. Only patients with a value above the biomarker threshold are enrolled and the trial is designed to show the statistical superiority of vopra, plus our PD-1 inhibitor Pimi, versus Pimi alone.
The primary endpoint is the mean change from baseline in tumor size, averaged over nine in 18 weeks and the secondary endpoints are the more common overall RECIST response rate, progression-free survival, overall survival, and duration of response, which represents all of the standard regulatory endpoint. All endpoints will be based on independent central radiology review.
The doses we are exploring, 0.1 milligram per kilogram and 0.03 milligram per kilogram, demonstrated differentiated patterns of pulsatile target engagement in prior studies. The hypothesis we are testing is that the sustained target engagement required for antagonist antibodies is not ideal for an agonist molecule like vopra 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 vopra in combination with Pimi, will be based on the totality of the data, including RECIST response rate, where there is strong benchmark data for PD-1 inhibitors.
In this setting, response rates for PD-1 and PD-L1 inhibitors range from 14% to 20% and we expect the response rate for Pimi alone to be similar to or better than this. The response rate for Vopra plus Pimi for at least one dose level will need to be meaningfully better than the response rate for Pimi alone and supported by data from other endpoints.
I would also like to mention that a manuscript on our first-in-human Phase I/II ICONIC trial of vopra alone and with nivolumab, 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 patientsm 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 Dmitri.
Dmitri Wiederschain
Thanks, Beth. We focused on the utilization of our translational science platform to address the problems that patients with cancer are facing today namely resistance to 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 targets 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-1 or L1 directed therapies. JTX-8064 which targets immunosuppressive macrophages and other myeloid cells in the TME, serves as an example of our 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 JTX-1484, as our newest development candidate. IND-enabling studies are well underway and we’ve continued to advance towards submitting an IND next year.
JTX-1484 binds to and inhibits LILRB4 or ILT3 another LILRB family member that is highly expressed on some of the key myeloid cells, including myeloid derived suppressor cells and tolerogenic dendritic cells that orchestrate immune suppression in the TME, including resistance to checkpoint inhibitors. The LILRB4 target is distinct from other LILRB family members with respect to its ligand specificity, as well as temporal and spatial pattern of expression on immune cells.
Therefore, we see this program as complementary to our ongoing efforts to target LILRB2 with JTX-8064. We have submitted two preclinical abstracts, one on JTX-1484 and one on the LILRB family for consideration for this year’s annual SITC meeting. We look forward to the opportunity to share this preclinical data. Additionally, our pipeline of monospecific LILRB targeted antibodies is further strengthened by the ongoing efforts to develop potent and specific blockers of LILRB1, an inhibitory receptor that is expressed not only on myeloid cells, but also on certain subsets of T and NK cells.
Having these high-quality building blocks to target three important members of the LILRB family has enabled us to explore multi-targeted approaches pre-clinically by leveraging our knowledge and growing expertise in the LILRB biology. We’re confident that the LILRB family, as well as other targets that we are currently pursuing represent attractive opportunities in immuno-oncology with the potential to improve upon and restore responsiveness to PD-1 or L1 inhibitors. In addition to our efforts in the LILRB 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. Kim?
Kim Drapkin
Thank you, Dmitri. As we reported in this morning’s press release cash, cash equivalents and investments as of June 30, 2022 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 IND for GS-1811 and $0.4 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 INNATE 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 was $33.5 million, resulting in a basic and diluted net loss per share of $0.65 as compared to a net loss of $4 million for the same period in 2021, resulting in a basic and diluted net loss per share of $0.08.
The increase in net loss is 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 runway 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.
Richard Murray
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’s SITC and ESMO IO meetings to be a busy time for us. As Beth and Dmitri described, we’re working hard to build an IO pipeline which looks to address the growing unmet need faced by cancer patients. I’d 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 Jounce 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?
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from Edward Tenthoff with Piper Sandler. Your line is open.
Edward Tenthoff
Great. Hi. Thanks. Good morning, everybody and congrats on all the progress. Looking forward to the data in the fall here. So two quick questions if I may on your LILRB franchise. I’m really trying to understand sort of how the profile differentiates between the LILRB2 and LILRB1. And is it something where ultimately you may have a future combination, or are these really expressed differentially? Thanks for explaining.
Dmitri Wiederschain
Thanks for the question. That’s a great question. That’s something that we’re actively working on and addressing in the labs. We believe that LILRB 1, 2 and 4 have differentiated expression profiles. They are expected in 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 at the SITC meeting where we submitted an abstract for — just a few days ago. Clearly, we see plenty of opportunities for a combination of our highly potent and specific LILRB1 2 and 4 blockers in a clinical setting. But also, as we pointed out, we have an active effort on LILRB multitargeted approaches using innovative biological scaffolds. Thanks for the question.
Operator
Our next question comes from Boris Peaker with Cowen. Your line is open.
Boris Peaker
Great. My first question is on INNATE. When will you hear from ESMO to confirm that you’re included in the meeting? And part of that is can you help us interpret — how should we be interpreting the ESMO data update?
Beth Trehu
So the — hi, Boris, this is Beth. The abstract submission date is September 27. So usually they — I think the abstracts will be published on December 1. So we don’t usually announce that our abstract has been submitted but that’s sort of the time frame. So we’ll be submitting the end of September. And then the meeting is December 6 through 9.
Boris Peaker
Got it. So we could see from the publication of ESMO December 1 whether you’re included or not, just to be clear?
Beth Trehu
Correct.
Boris Peaker
Got it. And in terms of interpreting the data can you help us understand I guess there’s both for the cohorts the two cohorts in ovarian and clear cell that you’ve brought up. And what about the other type cohorts that aren’t fully enrolled?
Dmitri Wiederschain
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 I don’t expect we’ll have full 18-week data on everybody from those cohorts. But our goal and one of the reasons we decided to submit to ESMO IO, our goal is to have as robust a dataset as possible. So we’ll be presenting the data by cohort even for the cohorts that have not gone beyond 10 patients we’ll be presenting the data by whether — breaking it down by the PD-1 experienced patients the ones that are resistant or the PD-1 inhibitor naive patients and then also looking at a cross-cohort analysis. And an important part of the data presentation will be the correlation or association with various potential predictive biomarkers.
Boris Peaker
Great. Thank you very much, Beth.
Beth Trehu
You’re welcome.
Operator
One moment for our next question Our next question with Steven Seedhouse from Raymond James.
Steven Seedhouse
Thank you. Good morning. Thanks for taking the question. First, I just want to ask the – so the response criteria where you are looking for greater response than what you’d expect for PD-1, PD-L1 inhibitor alone. I just wanted to be specific so the expectation is 9% for instance in third or fourth line ovarian. Does that mean you’d only require one response, or in that case are you looking for two before you enroll the Stage 2?
Beth Trehu
So thanks, Steve. We haven’t talked about our criteria for moving from Stage 1 to Stage 2. In ovarian, we’re in almost complete with the 29 patients. And so it’s really the best way to think about it is what we need to see in the 29 patients. And the final proof of concept data, we think we’ll have in early 2023. But with that data, we would need to see a response greater than meaningfully greater than 9% in 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-1 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%.
Steven Seedhouse
Okay. Thanks for the clarifying. That was my misunderstanding about the stages where you’re looking for that specific response rate. So – and the other thing you commented on just the enrollment in the mono versus combo ovarian cohorts. I just want to make sure I understand that right. I know you commented but – so are you enrolling the full Stage 1 and Stage 2 for combo and then pivoting to prioritizing enrollment in the mono, or is there some sort of – about there?
Beth Trehu
Sure. So what happened – the monotherapy ovarian cohort opened in August, right? So, that started enrolling. When we opened the combo ovarian cohort the investigators tended to prioritize that. So we decided to prioritize the ovarian combo. It met the criteria to move from 10 to 29 patients, who are 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.
Steven Seedhouse
Make sense. Okay. Thank you. And then I just wanted to clarify the response criteria for expanding enrollment from 10 to 29. Is that confirmed RECIST response or something else?
Beth Trehu
Yeah. So we haven’t shared those criteria. They were internal criteria that we use. We really think, it’s important to focus on our success criteria for a full set of 29 patients. There’s so much with really small data sets that can – things can be quite misleading. So we really want to make sure we’re focusing on the responses in the 29 patients. And those will be based on confirmed RECIST responses? Yes.
Steven Seedhouse
Thank you, Beth. Appreciate it.
Beth Trehu
You’re welcome.
Operator
One moment for our next question. Our next question David Dai with SMBC. Your line is open.
David Dai
Hey, great. Thanks for taking my questions and congrats on the progress. First question is just around 8064. Could you clarify if any of the indication to stop enrollment because it has not met the pre-specified response criteria?
Beth Trehu
No. All the cohorts are still open and could potentially expand. 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.
David Dai
Got it. That’s helpful. So second question just around the – INNATE signature vopratelimab for 8064 what we saw from your slides before was that renal cell carcinoma has high INNATE immune signature whereas the ovarian cancer has medium to low levels of the INNATE signature. So, could you help us understand a little bit more about the biomarker process based on the fact that you’re enrolling additional patients for ovarian and renal cell carcinoma?
Beth Trehu
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. So 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 LILRB2, our 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 we’ll be analyzing all of the clinical data in its association with this panel of biomarkers. And these include both gene signatures and IHC.
The ones we’ve talked about have been things like LILRB2 itself. Some of its ligands, the LILRB2 or TAM to interferon gamma ratio, which as I’ve mentioned, is a poor predictor for PD-1 inhibitor response and then things like CD163 which is an IHC marker for tumor-associated macrophages.
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-1 inhibitors. And so, if we see benefit in the patients who have high levels of those, which would suggest that JTX-8064 is contributing to the efficacy and help to isolate the effect in a combination with a PD-1 inhibitor.
David Dai
Okay. That’s helpful, and thank you Beth.
Beth Trehu
You’re welcome.
Operator
[Operator Instructions] Our next question comes from Swayampakula Ramakanth with HCW. Your line is open.
Swayampakula Ramakanth
Thank you, and good morning folks, and thanks for taking the questions. Richard, when you first started talking about LILRB2, it is the big players, was just Merck and yourself. But over time, we have seen additional players come into the LILRB space. I do understand that you have three molecules within that in development. But, I’m just trying to understand how — strategically how are you thinking to maintain that leadership within the LILRB space? And do you plan to bring additional molecules or try to move these molecules which are currently in pre-clinical and clinical stages, a little bit faster than your competition.
Richard Murray
Yes. Sure, RK. This is Rich. I can take that one. As we look at the LILR family, as Dmitri mentioned just a few moments ago, there are overlapping similarities and mechanisms but importantly also distinctions. In addition to the distinction of function that we can characterize, there are different ligands. So, there’s a different way to kind of stimulate the immunosuppressive 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 and lines of therapies and different indications that we think could really allow us to be very assertive in one area and create a leadership position.
As Beth had mentioned, the biomarker analysis is going to be quite important for us as well. If in some places, in some circumstances, the biomarker becomes important or necessary, we think that’s also really an opportunity for differentiation for our molecules.
One final note that Dmitri alluded to is, we believe the myeloid cell system is quite important in creating immunosuppressive barriers. So while we’ve spoken much about the LILRB receptors, we have other myeloid targets in hand. And so, there’s a way to really go after that cell lineage, we think through our highly specific monotherapy agents as well as constructed bispecific agents that we think really go after that cell type that maybe creating such a barrier for the immune system.
Swayampakula Ramakanth
Thanks for that. One additional question. Any update you can give us on the molecule, CCR8 molecule that Gilead is developing, and in terms of like data expectations over the next six to 12 months?
Richard Murray
Yes, I can take that one as well, RK. So when we filed the IND and opened that IND, we were quite pleased with how that was taken up by Gilead. For us, we really can’t comment from their progress internally that would really be more of a direct question for them. But we were certainly pleased when Gilead had their R&D Day, what’s now called GS-1811, was part of that whole presentation. And so, we’re happy with the way that is moving forward. And of course that allows for a potential for milestones coming down the road, which are not included in our current financial forecast.
Swayampakula Ramakanth
Thanks Richard. Thanks for taking the question.
Operator
One moment for our next question. Our next question comes from Nick Abbott with Wells Fargo. Your line is open.
Nick Abbott
Good morning, and thanks for taking my question. Rich, I’m here in the west coast, I’m going to ask a silly question first, which is just on the cash runway Rich is this the corporate jet that’s going? I mean, what are you doing to extend the cash runway? Are some programs not going to move ahead as fast as they were? Just maybe a little bit of clarity on that please.
Richard Murray
Yeah. Sure, Nick. I think generally speaking, 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 swim lanes if you will of key programs, but also adjust our timing. And as our timing adjusts, we can look at what we’ve planned versus what we’re seeing in the actuals. So I will mention we worked really hard across the company to look at that 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.
Kim can comment on this as well.
Kim Drapkin
Sure. So to specifically answer your question Nick it’s not the private jet. We’ve never had that, no. And also importantly we’ve 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 you know your doses, your timing things like that you’re 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.
Nick Abbott
Okay. Thanks. And then maybe just going back to — we’ve had several questions on 8064. And it’s really what is this meaningful increase is it Beth is it 2x, 3x, the ROI you expect to see with PD-1 monotherapy or standard of care. You only have cohorts that have been enriched of potentially responsive patients. So you could argue you really need to see a pretty high bar of efficacy and that needs to be backed up by correlated signs that supports why you’ll see activity. So maybe if you can just give me thoughts on what you’re thinking is and what you need to see? And then if it’s — how important is duration response, i.e. I mean, would you be ready to make a decision on a registration trial designed by early 2023, or do you need to see how these responses play out over time and that decision may be second half of 2023? Thanks.
Beth Trehu
Sure. That’s a great question Nick. Thank you. So first of all, yes, duration of response is very important. That’s obviously one of the differentiators for immunotherapy is that the responses tend to last longer than they do 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 rates high enough in these single-arm cohorts to give us the confidence to move forward. I think the next step would be a randomized study whether it’s Phase 3 study or Phase 2/3 study depends on the data and how clear the — and how rapid we think the path can be also what the degree of unmet need is. And so I think, it really is — we have to see a response rate that’s high enough for us to have confidence to go ahead and start a randomized study.
Nick Abbott
Okay, perfect. Thanks. And then I think — maybe last time you talked a little bit about CMC. I know you’re putting a lot of effort. And a lot of drug products require being — 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 product registration, quality, quantity?
Richard Murray
Yeah, sure. I can take that one Nick. Thanks for that. Yeah, we’ve — reflective of all of our programs as we kind of zero in on the doses necessary. We are always looking to create processes that are done in a proactive way such that they can be very scalable and very controlled. So we’ve not taken the approach to fly into Phase 1 and then create 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 a time. And so these processes from productivity to scalability are done in a very proactive way. That is reflective of the study. Of course, you feel the benefit of 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’s at least a year plus kind of lead time if you want to flip the switch. So really what it is a kind of early productivity and kind of manufacturability analysis that goes into everything we do, quite early, so that it becomes predictable as we scale.
Nick Abbott
Thanks Richard. And Beth I just wondering, what your response about, what do you think the earliest days you’d be able to move ahead on a registration trial? It sounds like probably towards the end of next year?
Beth Trehu
Yeah. I think as I mentioned Nick, the next step will be randomized trials. And 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 that’s what would trigger randomized trials.
Richard Murray
Yeah. And maybe Nick, just a quick comment back to the CMC question, that won’t be a gating factor for us. It will really be the clinical data that will be driving that.
Nick Abbott
Okay. Great. And then, last one really is just on sort of a two-parter really obviously Merck has a co-formulation of pembro and I keep forgetting the number — the full number move on to. You have Pimi obviously 8064.
Are you looking to co-formulate? There was a question earlier on competitive landscape. You’re in a very good position here. And then, as this program also expands broadly next year what are your thoughts on partnership and given current valuations and potential valuation of this program what sort of collaborative structure makes sense at this time.
Richard Murray
Yeah. So the way we look at that currently Nick is that we believe the combinations of the two are very, very quite manageable for us. And we’re using PMI for other things as well. So we’ll continue on that track certainly for the moment.
I mean, having said that, we are looking at very rationally designed types of bispecific kind of partners as well. On the — going to the partnership side of your question, I mean, we’re really looking to depending on the data move forward as rapidly as possible.
Now certainly there could be scenarios that might indicate Jounce could take programs forward further and with our analytics built around that of building more value as well as perhaps the types of partnerships that might need or be well served to happen sooner.
So based on, just the realities of taking multiple types of cohorts forward. So that really dictates the data outplay, the number of cohorts that really kind of moves the sliding on the scale as to how we’re thinking about partnerships. But inherent in all of those is that we really want to create and maximize the value for Jounce and the shareholders.
Nick Abbott
Okay. Thanks, Rich. That’s it for me.
Operator
And I’m not showing any further questions at this time. So this does conclude today’s conference. You may all disconnect. And have a wonderful day.
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