Jounce Therapeutics, Inc. (JNCE) CEO Rich Murray on Q3 2020 Results - Earnings Call Transcript
Jounce Therapeutics, Inc. (NASDAQ:JNCE) Q3 2020 Earnings Conference Call November 6, 2020 8:00 AM ET
Company Participants
Malin Deon - Investor Relations
Rich Murray - Chief Executive Officer and President
Elizabeth Trehu - Chief Medical Officer
Kim Drapkin - Chief Financial Officer
Conference Call Participants
Mike Ulz - Baird
Gavin Weiss - JPMorgan
Steve Seedhouse - Raymond James
Arthur He - H.C. Wainwright
Zegbeh Jallah - ROTH Capital Markets
Jim Birchenough - Wells Fargo Securities
Operator
Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Third Quarter 2020 Earnings Conference Call. Currently, all participants are in a listen-only mode. [Operator Instructions] I will now turn the call over to your host, Malin Deon with Jounce Therapeutics. Please go ahead.
Malin Deon
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 & Media section of our website at www.jouncetx.com.
Speaking on today’s call will be our CEO and President, Dr. Rich Murray, who will discuss our progress and key milestones followed by our CMO, Beth Trehu, 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 SEC filings. In addition, any forward-looking statements represent our views only as of today, November 6, 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.
Rich Murray
Thanks, Malin and good morning everyone. As you all know, we provided an update on our vopra program earlier this week and mentioned important pipeline prioritization changes. I am very 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 to current IO therapy, and further emphasizes our vision of bringing meaningful and long lasting impact to cancer patients.
We are thinking about the impact of IO. We believe the landscape to be broken down into two distinct patient populations: one, patients with PD-1 inhibitor sensitive tumors, and two, patients with PD-1 inhibitor resistant tumors. Both are significant and unmet medical need represent large and growing market opportunities, but may differ and how to bring best bring forward long-lasting therapeutic benefit, the hallmark benefit of IO. IO therapies in solid tumors to-date has had the most significant impact on certain patients within an overall PD-1 inhibitor sensitive tumor type, such as non-small cell lung cancer for melanoma. But unfortunately, at the individual patient level, it’s still a minority of patients that benefits from checkpoint therapy. Patients with PD-1 inhibitor resistant tumors can either present as resistant from the outset or develop resistance overtime after initially receiving benefit. Overall, patients and the PD-1 inhibitor resistant tumors are the most difficult to treat and chemo is still largely the standard of care.
Given the increased use of PD-1 inhibitors in frontline metastatic disease and the fact that most patients will initially or ultimately progress, the scope of the PD-1 inhibitor resistant market continues to grow. To better progress our immunotherapies to meet the needs of cancer patients, we think about our current pipeline in reference to these two patient populations as follows. For the patients with PD-1 inhibitor sensitive tumors, we believe a biomarker driven approach and combination of PD-1 inhibitor and novel mechanism have the best chance to benefit patients beyond today’s current regimen. Our vopra SELECT trial, a predictive biomarker study and separately, our JTX-8064 macrophage program targeting LILRB2 or ILT4, a new mechanism, position us well to address the patients in this PD-1 inhibitor sensitive population.
For the patients with PD-1 inhibitor resistant tumors whether primary or acquired, we believe novel mechanisms and approaches will be needed. In this context, JTX-8064 is a novel program to convert immunosuppressive macrophages to an anti-tumor state and we believe could be an important mechanism for these patients. Our early discovery programs also focused on novel mechanisms to address this patient population. By 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 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 this interim data readout, we will not be expanding patient enrollment in EMERGE. Our focus in the PD-1 inhibitor resistant population will shift to a strategy of targeting other immune cell types in addition to T-cells, beginning with our JTX-8064, our LILRB2 program. As we discussed on the vopra call update, we will continue to follow the overall survival of the EMERGE patients still on study and monitor biomarker. 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 1 dose escalation study of JTX-8064 by year end. We are also pleased to announce that supporting preclinical biomarker data for JTX-8064 will be presented at next week’s 2020 Citi Annual Meeting.
In September, Jounce and Gilead announced the license agreement for the worldwide rights to JTX-1811, our potential first-in-class antibody designed to selectively deplete immunosuppressive tumor infiltrating T regulatory cells. After clearing the HSR process, the Gilead transaction closed in October 2020. We believe this out-license further validates our pipeline and ability to generate value from our translational size platform. In connection with closing, we received an $85 million upfront license fee and Gilead invested $35 million in Jounce stock. We continue to progress JTX-1811 to IND clearance and we are on track for IND filing in the first half of 2021. Beyond our development programs, we continued 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 in other PD-1 hibitor resistance mechanisms. These are all active targeted areas for our discovery engine and we expect to see more valuable novel programs like JTX-8064 and JTX-1811 EMERGE through our efforts.
Before turning the call over to Beth to go into more detail on our programs, I would like to take a moment to acknowledge and thank Dr. Bob Tepper, a longtime member of our Board of Directors. Due to professional commitments at Third Rock Ventures, Bob is stepping down from his board role at Jounce. We sincerely thank Bob for his contributions and leadership as he has been an integral part of the Jounce team since our inception.
I will now turn the call over to Beth to discuss our clinical activities in more detail.
Elizabeth Trehu
Thanks, Rich and good morning everyone. We have made great progress at Jounce this quarter and I am 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 JTX-8064, our exciting new macrophage program. With the upcoming JTX-8064 trial initiation, we are setup for multiple clinical readouts 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-naïve second-line non-small cell lung cancer patients, who will be selected using the predictive TISvopra biomarker and randomized to vopra plus our PD-1 inhibitor JTX-4014 versus JTX-4014 alone. TISvopra is an 18 gene signature that includes genes relevant to both CD-8 and CD-4 T-cell biology. The CD-8 related genes contribute potential predictive value for PD-1 inhibitors, while the CD-4 related genes are indicative of the presence of activated and therefore ICOS hi CD-4 T-cells, which are required for the activity of vopra. The threshold for the biomarker has been optimized to predict for emergence of ICOS hi CD4 T cells in the peripheral blood, which have been associated with clinical benefit in patients treated with vopra plus or minus nivolumab. We believe that the TISvopra biomarker is ideal for patient selection in the SELECT randomized trial due to its potential predictive value for both vopra and PD-1 inhibitors. We expect approximately 20% of second line non-small cell lung cancer patients to be eligible for the trial based on TISvopra and are pleased with the rate of patient screening to-date.
SELECT is powered to demonstrate the superiority of vopra plus JTX-4014 to JTX-4014 alone. The primary endpoint is mean percent change from baseline tumor size of all measurable existing and new lesions averaged over 9 and 18 weeks, which was chosen for two reasons. First, several publications have indicated that percent change from baseline in tumor size at early time point maybe an early predictor of overall survival for chemo and other types of cancer therapy, potentially better than resist overall response rate. This maybe especially true with IO therapy in which durable tumor reductions that do not meet resist 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 resist 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 are also measuring and will report on all the traditional efficacy endpoints as well, including overall response rate, 9 months 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 data.
I would now like to turn to JTX-8064, our lead macrophage program. JTX-8064 is a LILRB2 or ILT4 antagonist antibody, which we view as a macrophage checkpoint inhibitor designed to reprogram immunosuppressive M2 macrophages to immune stimulatory M1 macrophages. When LILRB2 binds to its ligands, which include HLA-G on tumor cells and HLA-A and B on immune cells, it induces an immunosuppressive state analogous to the effect of PD-1 binding to PDL-1 on T-cells. Like the PD-1 PDL-1 interaction, the LILRB2 HLAG interaction plays a role in maternal fetal tolerance of fundamental immunosuppressive biology. JTX-8064 interferes with the binding of LILRB2 to all of its ligands resulting in an immune stimulatory state, with production of pro-inflammatory cytokines, improved antigen presentation and T-cell activation. This biology suggests the potential to overcome PD-1 inhibitor resistance. The first clinical data on another LILRB2 inhibitor suggesting safety and preliminary signs of efficacy in heavily pretreated PD-1 experienced patients was recently presented at ESMO 2020. We are excited about the potential for JTX-8064 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 JTX-8064 will be a dose escalation study with monotherapy and in combination with our own PD-1 inhibitor, JTX-4014. Our trial is designed to demonstrate proof-of-concept early with multiple tumor-specific expansion cohorts at a pre-defined target dose. These expansion cohorts will include both JTX-8064 monotherapy and combination with JTX-4014 and both PD-1 inhibitor sensitive and resistant patients. At the SITC meeting next week, we will have a poster providing preliminary information on our approach to predictive biomarkers and indication selection for JTX-8064. 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 1 study of JTX-8064.
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 JTX-4014 in both SELECT and the JTX-8064 Phase 1 study. JTX-4014 has all the preclinical characteristics of a typical PD-1 inhibitor and demonstrated a 17% resist response rate in heavily pretreated patients in a small Phase 1 study with a preliminary safety profile similar to approved PD-1 inhibitors. Of note, the patients enrolled in our Phase 1 trial of JTX-4014 who were required to be PD-1 inhibitor naïve were more challenging to treat than patients enrolled in the first clinical trials of PD-1 inhibitors, as patients with all the typically IO responsive tumors in which PD-1 and PD-L1 inhibitors are approved, were excluded. We therefore expect JTX-4014 to contribute similar efficacy to approved PD-1 inhibitors in our combination study. We are excited to be initiating studies with approaches beyond T-cell focused 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 on execution, which has Jounce 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.
Kim Drapkin
Thanks, Beth and good morning everyone. As we reported in this morning’s press release, cash, cash equivalents and investments as of September 30, 2020, totaled $105.3 million compared to $170.4 million as of December 31, 2019. The decrease was primarily due to operating costs incurred during the period. Not included in the September 30, 2020 cash balance is the $120 million we received upon the closing of the Gilead agreements in October 2020. This additional capital provides us with a strong balance sheet.
Turning to the P&L 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 IND-enabling costs for JTX-1811 external clinical and regulatory cost associated with the SELECT clinical trial, and increased employee compensation cost 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 cost partially offset by decreased facility expense.
Net loss for the third quarter of 2020 was $24.9 million or a net loss per basic and diluted share of $0.73 as compared to a net income of $98.9 million for the same period in 2019 or a net income per basic share of $2.99 and net income per diluted share of $2.90. The increase in net loss was primarily attributable to know 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 equivalence, and investments to be sufficient to enable the funding of our operating expenses and capital expenditure requirements into 2023.
I will now turn the call back to Rich for final remarks.
Rich Murray
Thanks, Kim. In conclusion, Jounce is on track to achieve the milestones we set for 2020, and importantly by year-end. We also plan to initiate the Phase 1 trial of JTX 8064, our LILRB2 program. With the recent closure of our deal with Gilead, we are also well capitalized with the 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 IND for JTX-1811 in the first half of 2021, and transitioning the program to Gilead to begin clinical studies, executing across multiple clinical trials including SELECT with the data readout in late 2021. And later this year initiating the Phase 1 JTX-8064 for trial, and continuing to work on advancing multiple new targets from our discovery pipeline for patients in the PD-1 inhibitor sensitive, and resistant populations.
With that we would now like to open the call for your questions, Operator.
Question-and-Answer Session
Operator
Thank you, sir. [Operator Instructions] Our first question comes from the line of Mike Ulz from Baird. Please go ahead.
Mike Ulz
Hey, guys. Thanks for taking the question. Just on 8064, you mentioned the potential biomarker to SELECT patients, who have some more detailed at SITC. So I’m not sure how much you’re willing to comment at this point, but should we be thinking you have something similar to TISvopra, we are kind of looking at gene signatures?
Elizabeth Trehu
So, yes, it’s a little too early for me to comment on that. I think, what you will see it SITC is our approach to exploring biomarkers using human histoculture, which are slices for human tumor that we actually can evaluate. And you’ll see sort of some also the process that we go through to try to understand indication potential indications and sort of paired that with where potential biomarkers might be taking us, but we’re not giving any details at this point. 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 is a good predictive biomarker to take forward.
Mike Ulz
Got it. And then maybe just sticking with 8064, and maybe you guys can just comment on the competitive landscape. And then, I realize it’s early but are there any differentiating features of 8064 or should we be also thinking about just the strategy in terms of the past forward, maybe that’s a way to differentiate from one of the other products out there? Thanks.
Rich Murray
Sure, I’ll take that one, Mike. As we look at the kind of the binding of the inhibitory antibodies to the targets. Our view is that appropriate kind of potency specificity binding antibodies to LILRB2 are going to be more similar than they are different. 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, they’re all very, very similar to each other. So with that being said, there’s maybe two things to point out. So we think the differentiation is really going to be in how we take forward different indications, different lines of therapy, perhaps guided by the biomarkers as best referred to, So as we see the SITC poster next week, one could envision that being a tool, leading us to a differentiated passed in the clinical programs. The other comment I’ll make is that LILRB2 is one of this group of inhibitory receptors, primarily on the myeloid cells, and so there are kind of broader strategies that we have discovery around that whole family. We think this is a group of receptors that it really kind of been under the radar screen in terms of their potential for Immunotherapy, but that would be more of a layout of the pipeline in the future.
Mike Ulz
Great. Thank you.
Rich Murray
Sure. Thanks.
Operator
Thank you. Our next question comes from the line of Jim Birchenough from Wells Fargo Securities. Please go ahead.
Unidentified Analyst
Good morning. It’s Nick on for Jim this morning. First, has the 8064 IND being filed or can you tell us when it will be filed?
Elizabeth Trehu
Yes. So we don’t usually comment on that, Nick. All I can tell you is that we are on track to start enrolling patients before the end of the year.
Unidentified Analyst
Okay, fair enough. It’s fair enough. Thank you. And then just moving back to TISvopra, can you talk about the logistics of TISvopra and does it present any challenge for recruiting patients in what must be every highly competitive space?
Elizabeth Trehu
Sure. So we’ve actually been really, really pleased by the investigator engagement and enthusiasm about the study, and about there test screening, that’s going on. So, basically patient sign of pre-screening consent form that allows their tissue to be submitted for screening. And then their position is informed about whether they are TISvopra 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 test the eligibility criteria and have certain lab checked for eligibility. The turnaround times for the test is a weak 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 screening, and we’ve also opened the pre-screening even to sites that aren’t actually actively and going to enroll patients in the trial, but have the nice apply this referral site for some of the trial sites. So, recognizing that when you have a predictive biomarker it always does pose a challenge to enrollment, but we have put a lot of measures in place that we believe will help to mitigate that.
Unidentified Analyst
Thanks. And then maybe just following up on that, so is this on the archival tissue or is this on the fresh tissue in difficult markets?
Elizabeth Trehu
Yes, that’s a great question. So, because these are PD-1 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 didn’t feel it was necessary to get fresh tumor biopsies. So, we’re using archival tumor but in most cases, it will be less than a year before they get screened for this study. So we felt that that was sufficient.
Unidentified Analyst
Okay, great. Thank you very much.
Elizabeth Trehu
You are welcome.
Operator
Thank you. Our next question comes from the line of Cory Kasimov from JPMorgan. Please go ahead.
Gavin Weiss
Hi, this is Gavin on for Cory. I just had a follow-up. Last question on TISvopra, is there any reason to suggest that, I mean you said that 20% of the lung cancer patients are eligible for the trial? Is there any reason to believe that there is geographic differences in the patient population for TISvopra. And then also does this first-line chemo have an impact on the expression of TISvopra to your knowledge?
Elizabeth Trehu
Sure. So, we don’t have any reason to believe there would be a geographic difference lung cancer the primary risk factor for lung cancer is smoking no matter where you live. And so, we don’t believe there’s any reason for there to be a geographic difference. With respect to your second question, which was, sorry, I just blanked. What was your second question, Gavin?
Gavin Weiss
The potential impact?
Elizabeth Trehu
It’s chemo, sure, sure.
Gavin Weiss
Other first-line regimen such as EGFR treatment?
Elizabeth Trehu
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 TISvopra, but we don’t have any reason to believe that it would have a significant impact on that.
Unidentified Analyst
Great. Thank you.
Elizabeth Trehu
Welcome.
Operator
Thank you. Our next question comes from the line of Steve Seedhouse from Raymond James. Please go ahead.
Steve Seedhouse
Hey, good morning. Thank you. Just regarding the primary endpoint SELECT, can you maybe comment on the powering assumptions there, basically what tumor size reduction delta is powered for and what is the power? And then, I wanted to clarify the detail regarding using this is a continuous variable from week 9 to 18? I think you said, can you just clarify how many tumor measurements patients were actually having and at what time points?
Elizabeth Trehu
Sure, sure. So I will answer the second question first. So, they will have their CT scans, obviously pre-treatment and then at 9 weeks and then at 18 weeks. And so, because IO sometimes can take a little bit longer, responses deepened 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 tumor response to treatment. We are not really stating right now what exactly the target differences. But at some point, we will, we will 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, if we look at the data and it’s certainly heading in the right direction, but we were wrong about our assumptions, particularly about the response rate to the PD-1 inhibitor or the tumor shrinkage with the PD-1 inhibitor. We do have an opportunity to do a one-time sample size readjustment.
Steve Seedhouse
Got it. And I think I know the answer to this, but maybe just to clarify on the call here. This is not sequence treatment this is treating with the PD-1 inhibitor in combination...
Elizabeth Trehu
Correct.
Steve Seedhouse
So, at both the nine and 18-week time points everyone would have received the same cumulative dose of the PD-1 inhibitor?
Elizabeth Trehu
Correct.
Steve Seedhouse
Correct. Okay
Elizabeth Trehu
Correct. That’s correct.
Steve Seedhouse
Okay, thank you. And then, just on the level two, it seems like just through our conversations over the past week, but this has really becoming focus for investors a lot happening in this field, I’m just curious if it’s possible, I know you don’t know for sure. You haven’t even started the study. But is it possible that data from that Phase 1 study could be sort of the next new clinical data. Do you have even before the end of 2021, when you have guided SELECT data would be available?
Elizabeth Trehu
Yes, it’s still a little too early to say, Steve. And we will definitely provide more detail about the study design, after we announced that we have started enrollment and then once we get a sense of how things are progressing. We’ll guide to when we would have data, but right now it’s a little bit too early to say.
Steve Seedhouse
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 vopra plus CTLA-4 inhibitor or have you more or less moved on pass that hypothesis and focused on PD-1 combination through SELECT or obviously GSK is moving head and neck maybe that’s an avenue. Just curious, your thoughts are?
Elizabeth Trehu
Sure. So, we are 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 we’ve stated, really if you look at all of the things that have failed, when they are just another T-cell based mechanism adding on to a PD-1 inhibitor or whatever you add to the PD-1 inhibitor in the in the PD-1 resistant space. It really we think it makes sense to start looking at a completely different mechanism of action in combination probably with TD-1 inhibitors and in the data that was presented recently looked really encouraging and PD-1 experienced patients, and therefore since we have JTX-8064 and that target looks like even just biologically like it could help to restore or to overcome PD-1 inhibitor resistance that really I think is 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-1 experienced patient population. And I don’t know, Rich, if you wanted to add anything to that.
Rich Murray
Yes, I think that’s right, that I think maybe see the way to think about it is, we think it’s the right decision to now continue the enrollment as the EMERGE was originally designed. We are going to follow the OS. We are going to follow the biomarkers. But, as Beth stated that the science is really leading us at least in the PD-1 resistant population to these other types of mechanisms that gets you beyond T-cells as well as the T-cell combo.
Steve Seedhouse
Got it. Thank you. Appreciate your questions.
Rich Murray
Thanks.
Elizabeth Trehu
Thank you.
Operator
Thank you. Next question comes from the line of Arthur He from H.C. Wainwright. Please go ahead.
Arthur He
Hey, good evening everyone. Thanks for taking my question. I just had a quick one on the 1811 program. So, could you remind us what else you guys need to be done before the, for the IND?
Kim Drapkin
Sure, I can take that one, Primarily like any monoclonal antibody program, it’s really the CMC path, and the manufacturing and in the medical work around the drug manufacturer that is usually that on that kind of tail-end of the timing for the IND. So we are progressing that as we have mentioned, it’s our, role in this deal to, to get the IND filed an open, but we’re primarily in those kind of last phases of making sure we have material ready to go.
Arthur He
Thank you for that.
Operator
Thank you. Our next question comes from the line of Zegbeh Jallah from ROTH Capital Markets. Please go ahead.
Zegbeh Jallah
Good morning. Thanks for taking my question. Just had one quick one on the, Beth, I think on the last call you provided some commentary around Merck effort with their ILT4 our program, that kind of give you guys some confidence, just wondering in terms of your clinical trials you are moving forward, I would somewhat diverse compares to what Merck is doing. And then they also miss may announce a partnership with Celgene whether dual targeting our ILT4 and ILT2 antibody. So just wondering based on your knowledge, what you think you would expect from a targeted agent versus a single ILT4 well targeted antibody?
Elizabeth Trehu
Sure, I will address the first one, and then turn it over to Rich. So, as I have said, we plan to 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, as I mentioned at both monotherapy and combination with our own PD-1 inhibitor look at PD-1 inhibitor sensitive and resistant patients. And certainly include some cohorts that are differentiated from what Merck is doing. Rich, would you like to speak to the biospecific?
Rich Murray
Sure. Yes, sure. So first, I think it’s important that we don’t want to comment too much on that. I mean that’s what we heard about from a press release rather than a scientific presentation. But 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 will LILRB1 and will our LILRB2 and some distinction. So, I think there is kind of a growing opportunity to look at these features that might be in common, as well as distinct. So for example, LILRB1, it seems to be expressed on k-cells. So that’s different LILRB1. So that whole family, we believe is going to be a very interesting one, and it could be kind of central in the myeloid going to non-adaptive cell kind of realm, but it’s really hard for us to comment beyond that generality given we haven’t seen any data on that.
Zegbeh Jallah
Thank you. And actually just one quick follow up here after Kim. Kim, you mentioned that your current cash balances include, I think the one in $120 million that you received from Gilead. And so, I was just wondering if your cash runway does include that?
Kim Drapkin
Thanks, Zegbeh. Yes, when thinking about the cash we have into 2023 that does include the upfront of $85 million from Gilead as well as the $35 million equity investment? What it does not include are any potential milestones that we may earn in the future under the Gilead at the deal and you may recall that of the $685 million in potential milestones $510 million of those are development and regulatory. So we were pleased that there are earlier stage milestones and our hope is that we will earn these and the runway will be even further. But we do not include milestones in our projections.
Zegbeh Jallah
Thanks, Kim, and I suppose another follow-up here, but just confirming after the IND enabling settings you are handing over the program to Gilead, who will take over, are you anticipating having to pay for any of the research these or anything after that?
Kim Drapkin
No, it’s a complete out license. And so, our expenses basically end on the development side. As soon as we file the IND, and then Gilead at takes it from there and are responsible to develop and pay for the future developments.
Zegbeh Jallah
That’s why we did consider in the milestones that you could get. I appreciate it.
Kim Drapkin
Thanks. Zegbeh.
Rich Murray
Thank you.
Operator
Our last question comes from the line of Jim Birchenough from Wells Fargo Securities. Please go ahead.
Jim Birchenough
Hey, thanks for taking the follow-up. Just a question on Paul the SELECT trial the listing on clinical trials I have got Phase 2 dose levels of vopra? Can you just elaborate on that please?
Kim Drapkin
Sure. After we analyzed all the data from the iconic trial, where we had patients dosed at 0.3 mix per keg every three weeks, which resulted in sustained target engagement or binding of vopra to ICOS all the time. We determined based on some reports in the literature, and then also some additional pre-clinical data that for and agonist molecule such as vopra probably better to have more pulsatile target engagement, so pulsatile dosing and target engagement. So, in the SELECT trial as in the EMERGE trial, we are looking at two different doses with what we believe will be differentiated patterns of target engagement. So one doses 0.1 mg/kg and the other point 03 mg/kg both given every 6 weeks. And although the 0.1 per keg data in the EMERGE trial actually looked better than the 0.3, we don’t really have sufficient data to make a decision at this point about, which doses preferable. So we are continuing to explore both doses in the SELECT trial. And the final analysis will look at the two dose levels combined, and then individually compared to JTX-4014 alone.
Jim Birchenough
Thank you very much.
Kim Drapkin
You are welcome.
Operator
Thank you. Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program. You may now disconnect. Have a good day.
