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Jounce Therapeutics, Inc. (JNCE) Q1 2021 Earnings Call Transcript

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JNCE earnings call for the period ending March 31, 2021.

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Jounce Therapeutics, Inc. (JNCE 2.84%)
Q1 2021 Earnings Call
May 4, 2021, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics First Quarter 2021 Earnings Conference Call. [Operator Instructions]. I will now turn the call over to your host, Malin Deon with Jounce Therapeutics. Please go ahead.

Malin Deon -- Manager, Investor Relations & Corporate Communications

Thank you, operator. Good morning, and welcome to the Jounce Therapeutics first quarter conference call. This morning we issued a press release which outlines the topics that we plan to discuss today. The release is available in the Investors and Media section of our website at www.jouncetx.com.

Speaking on today's call will be our CEO and President, Dr. Rich Murray, who will review our pipeline progress, and key milestones, followed by our CSO, Dr. Dmitri Wiederschain, who will discuss our discovery efforts. Our CMO, Dr. Beth Trehu will then provide an update on our clinical activities, and lastly, our CFO, Kim Drapkin will review our first 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, May 4, 2021, 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.

Richard Murray -- Chief Executive Officer and President

Thanks, Malin, and good morning everyone.

Jounce has made meaningful progress at the start of 2021, as we continue to advance our two proof of concept studies, grow our discovery and development IO pipeline, and add to our strong balance sheet. We're at an exciting point in Jounce's development and remain committed to progressing new mechanisms that target different immune cell types in the tumor microenvironment. Our translational science platform, and biomarker approach are integral to our commitment to bring the right therapy to the right patients.

I'd like to take a few minutes to provide updates from the quarter. At the start of the year, we announced that enrollment commenced in INNATE, our Phase 1 clinical trial of our highest priority program, JTX-8064, LILRB2, also known as ILT4 inhibitor. INNATE is moving quickly through the necessary dose escalation portion of the trial, toward the opening of eight tumor specific expansion cohorts. We plan to include JTX-8064 monotherapy, as well as combination with our own PD-1 inhibitor, JTX-4014, or an approved PD-1 inhibitor.

JTX-4014 will now be known as pimivalimab or pimi. We continue to believe that the myeloid and macrophage biology, harnessed by the potential effect of JTX-8064 via the LILRB2 mechanism, provides a new opportunity to bring benefits to patients. Enrollment also continues in SELECT, our Phase 2 randomized proof of concept trial of vopratelimab in combination with our PD-1inhibitor, pimi. The key feature of this study is the biomarker selection of patients, utilizing TISvopra an 18 gene signature that includes genes relevant to both CD8 and CD4 T-cell biology.

We believe it's clear from our own clinical data, as well as that of competitors that a rigorous patient selection strategy may be critical to optimize the benefits of an ICOS agonist in a PD-1 inhibitor. We look forward to reporting clinical data from the SELECT trial in 2022. As Beth will mention in more detail, we're also pleased to present two trials and progress posters on both INNATE and SELECT at the upcoming ASCO meeting in June.

We continue to progress JTX-1811, our potential first-in-class antibody, designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. We licensed the program to Gilead in 2020, and remain on track for the IND filing in the first half of this year.

The under-development programs we continue to make progress advancing our earlier stage pipeline. Our broad discovery pipeline includes multiple programs targeting diverse immune cell types, and PD-1 or PD-(L)1 inhibitor 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 from our efforts.

Additionally, during the first quarter, we added more than $90 million to our balance sheet through a follow-on offering, and through the use of our now completed ATM program. This capital infusion strengthens our balance sheet and gives us the runway to complete our key proof of concept studies, while also driving new discovery programs forward.

We remain excited for what lies ahead for Jounce. With critical milestones laid out for the remainder of this year and beyond. To reiterate, we plan to evaluate safety, and determine recommended Phase 2 dose for JTX-8064, and open tumor specific expansion cohorts in the second half of 2021, continue enrollment to enable reporting of efficacy, and related biomarker data for vopra and pimi, from the SELECT trial in 2022. Continue IND enabling activities for JTX-1811, and anticipate an IND clearance at 2021, and continue to advance our discovery pipeline of potential first-in-class programs with the goal of the new IND every 12 to 18 months. I would like to take a moment now to welcome the newest member of our management team. Dr. Dmitri Wiederschainside who was appointed as Chief Scientific Officer in April. Dmitri has more than 15 years of pharmaceutical industry experience as a scientific leader and drug developer and brings a broad knowledge likes of contemporary immuno-oncology approaches, tumor immunology, and cancer biology. His expertise with preclinical target discovery and first in human research will provide invaluable contributions in our work to deliver the right immunotherapies to the right patients. We're excited to have Dmitri on the Jounce team.

With that, I'll turn the call over to Dmitri to say a few words.

Dmitri Wiederschainside -- Chief Scientific Officer

Thanks, Rich. I'm thrilled to join Jounce at such a pivotal moment in the Company's journey to discover, develop, and commercialize important new immuno therapies. After many years of building the oncology in IO Pipeline at Sanofi, my goal was to join a vibrant science-oriented and fast-paced organization that understands what it takes to succeed in IO, has resources to do so, and is ready and able to forward integrate the company. Coming from a large pharmaceutical company setting and seeing many Biotech companies through business development activities, I believe Jounce is that place.

With JTX-8064 and JTX-1811 as good examples, we hope to continue to create new important options for patients and value to Jounce shareholders. At our upcoming R&D Day in late June, I look forward to sharing more about the exciting science behind our pipeline translational work and particularly the opportunities around the myeloid cell focus as exemplified by LILR family.

With that, I'll turn it over to Beth to discuss our clinical programs in more detail.

Elizabeth Trehu -- Chief Medical Officer

Thanks. Dmitri, and good morning everyone. 2021 is a year of clinical execution for Jounce and we remain focused on our two ongoing proof-of-concept studies in INNATE and SELECT. These trials are key to our belief that novel mechanisms and biomarker strategies are necessary to bring clinical benefit to patients who do not optimally benefit from T-cell checkpoint inhibitors. I would now like to provide more detail on both ongoing trials beginning with JTX-8064, a LILRB2 inhibitor. JTX-8064 is designed to reprogram immunosuppressive or M2 macrophages to immune stimulatory or M1 macrophages, to enhance or restore anti-tumor immune activity. We view JTX-8064 as a macrophage checkpoint inhibitor with the potential to reverse PD-1 or PD-L1 inhibitor resistance as well as to further improve outcomes in PD-1 inhibitor sensitive tumors. Thereby having the potential to provide clinical benefit to a wide range of cancer patients.

We are very pleased with the pace of enrollment in the INNATE trial. Our trial is designed to progress quickly through dose escalation and demonstrate proof-of-concept in expansion cohorts that will enroll patients with specific tumor types. These tumor types were selected based on a variety of factors, including macrophage biology, potentially predictive RNA signatures, and the opportunity for differentiated development pathways. An important part of our tumor selection process involved an examination of the unmet need and opportunities in both PD-1 inhibitor experienced and naive patients as we explore the best opportunity for JTX-8064 to make a difference for patients with cancer.

At last month's AACR Conference, we presented data describing how expression profiles of LILRB2 mRNA our proprietary tumor-associated macrophage or TAM signature and an interferon gamma signature were used to identify tumor types that may benefit most from JTX-8064 treatment alone or in combination with PD-1 inhibitors.

This data was used to inform the tumor types and expansion cohorts of the INNATE trial. We remain on track for the opening of 8 expansion cohorts. One with JTX-8064 monotherapy and seven in combination with PD-1 inhibitors. These planned expansion cohorts will study JTX-8064 in 3 subsets of patients in order to identify the best and most rapid development paths for JTX-8064 alone or in combination with PD-1 inhibitors. First, patients who have progressed on PD-1 inhibitors and may now be PD-1 inhibitor resistant, these patients have very few treatment options and repeat immunotherapies have been largely unsuccessful. We believe the JTX-8064 has the potential to restore responsiveness to PD-1 inhibitors and bring the durable benefits of immunotherapy to these patients.

Second PD-1 inhibitor naive patients with tumors that don't typically respond to PD-1 inhibitors. This is also an area of high unmet need in which T-cell directed immunotherapy has not had a significant impact, and we believe that JTX-8064 alone or with the PD-one inhibitor may make immunotherapy a viable option for these patients.

Finally, PD-1 inhibitor naive patients with tumors, for which PD-1 inhibitors are approved, but there is still much room for improvement. By combining a macrophage targeting agent with a T-cell directed therapy, we hope to improve clinical outcomes beyond what is achievable with PD-1 inhibitors alone. We will provide the details on tumor types and scientific rationale for the expansion cohorts in a trials in progress poster at ASCO. Once we have selected the dose and opened these expansion cohorts, we will provide guidance on the timing of data readouts.

I would now like to turn to an update on vopratelimab. And our first biomarker patient selection trial SELECT. Screening and enrollment is on track to report data from the SELECT trial in 2022. As a reminder, we plan to enroll approximately 75 immunotherapy naive second-line non-small-cell lung cancer patients, who will be selected using the predictive TIS Vopra biomarker and randomized to vopra plus our PD-1 inhibitor pimi versus pimi alone. We believe the TIS Vopra biomarker will select more appropriate patients for both the CD8 mediated benefit of a PD-1 inhibitor as well as for the potential CD4 related benefit of vopra. We expected approximately 20% of second-line non-small-cell lung cancer patients to be TIS Vopra positive, and we are pleased that screening to date has validated this projection. Details of the SELECT trial will be provided in a Trials in Progress poster at ASCO.

Before closing, I would like to take a moment to thank our team, our investigators, and the patients whom we may have the privilege to treat. Now, more than ever, it is imperative to execute on our mission of delivering long-lasting benefit to cancer patients. We believe that our translational science biomarker approach and commitment to new mechanisms targeting different immune cells brings us closer to achieving this target. We look forward to our continued progress in 2021 and to delivering on our important upcoming milestones.

I will now turn the call over to Kim for discussion of our first quarter financial results.

Kim Drapkin -- Chief Financial Officer

Thanks, Beth, and good morning everyone.

As we reported in this morning's press release, cash, cash equivalents and investments as of March 31, 2021 increased to $271.3 million compared to $213.2 million as of December 31, 2020. This increase was primarily due to the $90.8 million in aggregate net proceeds from sales under our follow-on public offering and our ATM offset by operating costs incurred during the period.

Turning to the P&L, we recognized $1.5 million in license revenue during the first quarter of 2021, which was comprised of non-cash revenue related to research and transition services performed under our license agreement with Gilead. No revenue was recognized during the same period in 2020. During the first quarter of 2021, we incurred $20.5 million in research and development expenses compared to $19.6 million for the same period in 2020. The increase in R&D expenses was due to increased expenses from manufacturing and IND enabling activities performed for our development programs, offset by decreased clinical and regulatory costs, attributable to reduced spending on vopra.

General and administrative expenses were $7.6 million for the first quarter of 2021, compared to $7.5 million for the same period in 2020. The increase in G&A expenses was primarily the result of increased stock-based compensation expense. Net loss for the first quarter of 2021 was $26.5 million, resulting in a basic and diluted net loss per share of $0.58 as compared to a net loss of $26.4 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.78.

We are reiterating our financial guidance and continue to expect gross cash burn on operating expenses and capital expenditures for the full year 2021 to be approximately $95 million to $110 million. We have always maintained a strong balance sheet, and expect our existing cash, cash equivalents and investments to be sufficient to enable the funding of our operating expenses, and capital expenditure requirements through the second quarter of 2023.

The combination of our experienced team, financial resources, and innovative science puts us in a strong position to move beyond our next set of inflection point, and continue to execute against our strategic plans and goals. Jounce continues to focus on patients first, and we are proud of the IO pipeline, we are building to address the growing unmet medical need faced by cancer patients. We look forward to updating you on our progress as the year progresses.

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

Questions and Answers:

Operator

[Operator Instructions]

And our first question coming from the line of Steve Seedhouse with Raymond James. Your line is open.

Ryan Deschner -- Raymond James Financial Inc -- Analyst

Good morning. This is Ryan Deschner on for Steve. I just wanted to ask you guys seeing any surprises so far in ILT4 treated patients with respect to the pharmacology, the molecule, or is it --- excuse me, trends in humans as expected?

Elizabeth Trehu -- Chief Medical Officer

Thanks for the question. We don't usually report on data from ongoing clinical trials. All I can tell you is, as I said, enrollment is going very well, and I think as we've said, we think our molecule is more similar than different to Merck's molecule. So we would expect something similar to what they saw in their Phase 1 study.

Ryan Deschner -- Raymond James Financial Inc -- Analyst

Okay. And then maybe real quick, can you talk about the stopping criteria for SELECT and when the interim analysis is expected?

Elizabeth Trehu -- Chief Medical Officer

There -- yeah, there isn't an interim analysis in SELECT. Our expectation is to complete the study and report data in 2022.

Ryan Deschner -- Raymond James Financial Inc -- Analyst

Okay. Thank you very much.

Elizabeth Trehu -- Chief Medical Officer

Welcome.

Operator

And our next question coming from the line of Swayam Ramakanth with H.C. Wainwright. Your line is open.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Thank you. This is RK from H. C. Wainwright. I have a couple of questions. Beth, regarding the INNATE study which is going to have about seven different combinations between 8064 and the PD-1 inhibitor, and in the first dose you hope that it could be either 4014 or an approved PD-1 inhibitor. How would you, and what is the criteria in deciding which expansion cohort will get what PD-1 inhibitor?

Elizabeth Trehu -- Chief Medical Officer

Sure. That's a great question. What we -- as I mentioned, we'll have a Trials and Progress poster at ASCO. That's where we will introduce the tumor -- the specific tumor types that we're including in this study, and then later in June, we expect to have an R&D Day and that's when we'll get into a little bit more detail, will describe which PD-1 inhibitor and which cohort, the scientific rationale for each cohort, more detail about the lines of therapy, and that kind of thing for each cohort.

So stay tuned, we'll be providing detail on all of that very soon.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Sure. And then just a follow-up. Within the trial itself, you were talking about three subgroups of patients that you're going to be investigating. And my question is more on the PD-1 naive subset and also that PD-1 naive but minimal to poor response subgroup. In -- within those subgroups, I don't know if it is too early in the expansion cohort, but would you think about how to sequence the combination, or that is not a question now, you'll just want to go ahead and just do a straight combination, and then think about sequencing the drugs later?

Elizabeth Trehu -- Chief Medical Officer

Yeah. And we believe giving them on the same day makes sense. Merck certainly saw very encouraging data in their study, where they were -- the drugs were given on the same day. So we obviously as you know we collect a lot of pharmacodynamic biomarkers in our study, as well as the potential predictive biomarkers. So we certainly will be analyzing our PK, and our receptor occupancy data, and the PK of the companion molecules throughout the study, to see if there is any suggestion that we would need to do sequencing.

But maybe I'll ask Rich to comment on that as well. Rich, I think you're on mute.

Richard Murray -- Chief Executive Officer and President

Yeah. Thanks, Beth. Sorry about that. Okay. Yeah, thanks for that question. Just a follow-up on Beth, so a little bit. I think as we continue to study the mechanism, we really believe that there is kind of the simultaneous action of these antibodies, but of course, will be on board in terms of dosing throughout the dosing cycle. So we are still to pursue the mechanistic kind of underpinnings of what we see. But I think all of that work really translates into dosing molecules on the same day.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Great.

Elizabeth Trehu -- Chief Medical Officer

And, but that being said, it's -- they're both inhibitors.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Yeah.

Elizabeth Trehu -- Chief Medical Officer

So yeah, once you achieve that concentration that maintains inhibition of binding to the ligand, at that point I don't know that sequencing really becomes that relevant.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

True. True.

Elizabeth Trehu -- Chief Medical Officer

That was it.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Yeah. One last question from me before I step back into the queue. Beyond 8064 and 4014, and obviously 1811 will be moving on turn into the hands of Gilead, come second half, thinking about early stage pipeline, I understand you'll talk more in June in your R&D Day, but with with Jounce's experience of bringing novel molecules to the forefront. What sort of molecules should we expect that you could be unveiling later in the year?

Richard Murray -- Chief Executive Officer and President

Yeah, sure. I think what we'll give, as Dmitri alluded to in late June is the kind of direction of where we anticipate new programs to come from. We've been stating we're very inrested in the myeloid related cell biology. LILRB2 is our -- 8064 is our first example, but there are other LILR family members, other mechanisms associated with overall myeloid cell function, that we think are very important areas to pursue.

So, we'll provide a bit of depth on that. And Dmitri as hit the ground running here, and will provide that update in late June, and then we'll stick to our kind of pattern of how we identify specific molecules, once we're at the stage of the development candidate, then we will announce that kind of progression as things move into the IND enabling stages. So stay tuned. A lot of focus on the myeloid cell biology. We're very excited about that. And again, stay tuned for late June on that one.

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Thank you, Rich, and the team. Thank you.

Richard Murray -- Chief Executive Officer and President

Sure. Thanks.

Operator

Our next question coming from the line of Colleen Casey [Phonetic] with Baird. Your line is open.

Unidentified Participant

Hi, good morning. Thanks so much for taking our questions. Is there any update you can provide on how many escalation dosing cohorts you've cleared and then for the ASCO update, could we expect any safety data from any of study or will that be focused almost on the trial design?,

Elizabeth Trehu -- Chief Medical Officer

Hi Colleen, it's Beth. So, in terms of the dose escalation cohorts, I think what's important is we are still on track to open the expansion cohorts both monotherapy and combination in the second half of the year. So other than that, I'm not going to go into detail on those, but we are doing really well on track. We will be opening expansion cohorts in the second half of the year. And regarding the Trials in Progress poster, ASCO does not allow inclusion of any data in these posts, it really has to be strictly a description of the scientific rationale, the study [Technical issues] sort kind of thing.

Unidentified Participant

Great. That makes sense. Helpful. Thank you. And in light of the interesting data you you guys presented at AACR, can you comment on how you're thinking of incorporating potential biomarkers into the expansion cohorts of the INNATE study. I guess could some of those expansion cohorts, potentially use biomarkers as a screening criteria or will that still be more exploratory?

Elizabeth Trehu -- Chief Medical Officer

Sure. That's a great question. So, at this point, in all the expansion cohorts, we're collecting both archival tumor tissue and a fresh biopsy pre-treatment, and we will be screening those for a whole panel of potential predictive biomarkers that include both RNA signature, some of which we've commented on in our prior posters and also some IHC. So we have, I think, we're in a great position, because we have a number of these biomarkers that we've already identified. So we're going to be testing them retrospectively looking back at the samples and doing analysis to see if they correlate with clinical outcomes.

If we see something that looks like it correlates, the next step would be to either enrich or select. Though I would say what you could look at these expansion cohorts now is the hypothesis generating. And then the next stage would be something where we would either enrich or select, with whichever one of those biomarkers looks the most promising. Rich, did you want to add anything?

Richard Murray -- Chief Executive Officer and President

Yeah, yeah. Just as a reminder that biomarkers that Beth is speaking to, that really is a kind of a collected set of what we think are the appropriate either PD are potentially predictive biomarkers that have come directly from our mechanistic and tumor-related work within Jounce. So, we kind of serve up that set that we think are worthy of being tested coordinated to the trial as Beth mentioned, and should we find those correlations with clinical data, then we move to the next stage.

Unidentified Participant

Great, that's very helpful. And if I can just add one more quick one. Are there are any other potential combination regimens that you think could be interesting, with 8064 beyond PD-1?

Elizabeth Trehu -- Chief Medical Officer

Sure. And that' is something that, I think, you know Coleen even after we are in the clinic, our research teams are still very, very active on the same program. So that's an active area of investigation. Thank you for that question.

Unidentified Participant

Great, thank you.

Operator

And our next question coming from the line of Boris Peaker with Cowen. Your line is open.

Boris Peaker -- Cowen & Co. -- Analyst

Great, thanks for taking my question.

My first one is on 8064. You mentioned that your drug is relatively similar to Merck's drug. I'm just wondering if you could also maybe compare in terms of the patients you're enrolling in the INNATE studies, how that may differ from the patients that Merck is enrolling in their initial studies.

Elizabeth Trehu -- Chief Medical Officer

Sure, Boris. So in the dose escalation phase like Merck, we are enrolling all comers. No specific tumor types, no kind of enrichment or selection. So I would say the dose escalation parts of the study are probably very similar. Then, we are doing these expansion cohorts in specific tumor types and we're being very specific there and down to the line of therapy, the type of prior therapies allowed for each of those. Merck is also doing expansion cohorts in their study, They opened 9 expansion cohorts on January of 2020, and we don't know as much about those as we know about the dose escalation patients.

What I can say is in the dose escalation, we will have far fewer patients than Merck did, because we were able to leverage some of their data and reduce the amount of dose escalation cohorts. However, once we get into the expansion cohorts, those are really dictated by the specific eligibility for each cohort, Merck has theirs and we have ours, so there -- unless we do cohorts that are at exactly the same patient population, I would expect them to be potentially different, and I'll finish just by saying since the molecules do appear to be quite similar, we believe that the way that we can differentiate is through the tumor types that we're exploring as well as our biomarker strategy.

Boris Peaker -- Cowen & Co. -- Analyst

Got you. And maybe speaking about biomarker switching to vopra for the TIS Vopra biomarker, what clinical development would you have to do in order to get the diagnostic test for the biomarker approved?

Elizabeth Trehu -- Chief Medical Officer

Sure. When you develop a drug that's with a companion diagnostic, the companion diagnostic is actually developed by the company that makes the biomarker, but it's a very collaborative process. This is done on the NanoString platform. So, it's a well-recognized process, and we know what the development takes, there is a whole path through a different part of the FDA, that's well mapped out. So if that's what we do going forward, there is no particular extra complications there. We know what we need to do to take that forward. Rich, did you want to add anything.

Richard Murray -- Chief Executive Officer and President

Yeah, yeah and maybe just add to kind of on the business side of that. There are kind of different stages of investment that one would that take in the kind of journey to get to a companion diagnostic. So clearly we're at the clinical stage where we're running the assay in a manner that's consistent and appropriate with that, but we'll be able to stage gate our investment on that kind of path, which would then go to the next stage should the data warrants kind of readiness for starting on the route to readiness for commercialization of that biomarker and assay.

Boris Peaker -- Cowen & Co. -- Analyst

Great, thank you very much for taking my questions.

Elizabeth Trehu -- Chief Medical Officer

Welcome.

Operator

Our next question coming from the line of Nick Abbott with Wells Fargo Securities. Your line is open.

Nick Abbott -- Wells Fargo Securities -- Analyst

Good morning. Thank you for taking my question. Well Dmitri, welcome to the team. I look forward to meeting you virtually later on in the year. A couple of questions for me, first on SELECT, so can you remind us the correlation between the TIS vopra signature, any oncogenic drivers along and I'm just sort of thinking or maybe that control obviously one variable which is its interest both the patients for which we don't know what PD-1 inhibitor will do in that subset of patients, but then on top of that, I'm wondering what spectrum of different oncogenic drivers you might expect to see.

Richard Murray -- Chief Executive Officer and President

Yeah, I think, I can take that one, Nick. I think, we don't have a TIS vopra related kind of correlation to specific oncogenic drivers. However, we know of course that there are oncogenic drivers in these patients and they will follow that route to a specific therapy, should they have the right kind of driver and mutation of such, but as we look at that kind of potential overlap with TIS Vopra, TIS Vopra is really telling us much more kind of the state of activation of the CD8 cells and we believe the CD4 cells. So that's really kind of the uniqueness about this biomarker, we're kind of getting both angles on that CD8 and CD4, and then you know whether that kind of overlaps with mutations or not, we think the TIS Vopra score makes the patients more likely to be benefiting from this combo therapy, so we don't have that kind of direct correlation to the oncogenic drivers. Of course, if those patients have those drivers, they will be going down the route of a particular line of therapy for that particular drug.

Elizabeth Trehu -- Chief Medical Officer

Yeah, that's right. In addition, Nick, we actually exclude patients with EGFR mutations, that being the biggest class of oncogenic drivers that generally patients with those mutations don't do as well with PD-1 inhibitors. So we're excluding them and then as Rich mentioned, the patients with other drivers would be likely to go down a different path of therapy targeting the mutations.

Richard Murray -- Chief Executive Officer and President

Yeah, I think we'll also learn Nick, as we get these larger data sets from all the patients enrolled, how all these things kind of overlap or not with each other. So that kind of data will emerge as these as the dataset fills out.

Nick Abbott -- Wells Fargo Securities -- Analyst

Okay, thanks. And then on 8064 for that PD-(L)1 experience of tumors, do you think there is a difference in the role of myeloid cells in the setting for primary required resistance to PD-(L)1 inhibitor, and how do you think about studying both those populations potentially in the expansion cohorts in the eight?

Elizabeth Trehu -- Chief Medical Officer

Yeah, I think that's a great question. I'm not sure there's enough data right now to know the difference between which cell types are playing a primary role in primary and acquired resistance, and that's why we're planning to study those two groups of patients. So you could -- the PD-1 resistant, the patients who have failed the PD-1 inhibitor, you could say, some of them might be primary, some of them might be secondary, and we'll certainly be collecting that data. And then the tumor types that are PD-1 naive, that where PD-1 inhibitors aren't approved, you could think of those as kind of primary PD-1 resistant.

So we think it's important to look at both and we'll be analyzing the data based on what kind of resistance they have.

Nick Abbott -- Wells Fargo Securities -- Analyst

Terrific. Thank you very much.

Elizabeth Trehu -- Chief Medical Officer

You're welcome.

Operator

Our next question coming from the line of Zegbeh Jallah with ROTH Capital. Your line is open.

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Good morning, guys. Thanks for taking my question. The first one here is just on the enrollment for SELECT. I know you can't say much but I was just wondering if you're finding second line IO naive patients as easily as you thought you would by going ex-U.S.

And then another follow-up to that is that, I mean I know that there is not too much that can be done, but I was just wondering if you could perhaps while we wait for data, look at probable tissues from tissue bank to learn a little bit more about TIS vopra signature because I believe most of the original analysis was done based on tissues from the iconic study.

Elizabeth Trehu -- Chief Medical Officer

Yeah, that's a great question Zegbeh. We also worked with NanoString to get some additional tests, data, but to your point, first of all, we did have some setbacks related to COVID. I really think that COVID impact is really the only negative impact on the study. In terms of the screening rate, we're quite happy with that. And also, we've been very pleased, that as we predicted, 20% percent of these patients are TIS vopra positive. So that was our prediction based on prior analysis, and that's what we're seeing in the study.

So the patients are definitely there. There are a lot of places where patients don't have access to PD-1 inhibitors. We have to screen five patients to find one, but that's actually not too bad when you think about the rates of some of the other target -- the biomarkers for targeted therapies, which are in the single digits.

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Thank you. That was...

Richard Murray -- Chief Executive Officer and President

And maybe...

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Nice color.

Richard Murray -- Chief Executive Officer and President

Yeah. Sorry Zegbeh. But maybe to the other part of your question, there is TIS data available and thus we can kind of dial in the TIS vopra specific cut-off point in other types of tumors as well. So kind of more to come on that in terms of the science, but it's not unlike the sense you get, certain tumor types and we're highly infiltrated, have more activated immune cells, other tumor types down the other end of the spectrum and may not have that. So that's kind of the way to think about TIS vopra.

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Thank you. Very helpful. And then just a follow-up here regarding your comment about multiples emerge cohort [Phonetic]. Just curious because I got excited when you said multiple cohorts, I thinking multiple shots on go here, but in terms of the cohorts, I know you can't say too much now because you have the Trials in progress poster but from a risk perspective, we're just curious how much are you pushing the envelope with some of the cohorts in terms of, how much you really think you have data to support it versus the other solutions, like one of the many things that people typically do with cohort expansions?

Elizabeth Trehu -- Chief Medical Officer

Sure. So I think actually all of the cohorts are really grounded in the science. So I think they all have an equal potential to show good results. And then what we've done is as we've described, of those seven combination cohorts, some of them are in the PD-1 experience, some of them are PD-1 naive, and some of them are in tumor types that respond to PD-1, some are in tumor types that typically don't. So I think we've got a really good distribution, and the goal is to really cast a wide net, but all based on the science. All of these are absolutely rooted in the science, and then they're just exploring different settings in which that mechanism might work.

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Thank you. And I think this is related to a follow-up question as well. Just regarded -- just trying to understand what cells might work, and things like that myeloid cells might drive resistance and things like that. So I think this time do you have to go very large specifics wondering if you're going to be doing such large studies in the future, because you're just trying to, like you said cast a wide net? Is that what we're going to expect from your other programs, just very huge studies?

And then, just so I can hop off follow up here, you guys seem to still be the only one that's focused on -- really going after novel biomarkers, so a follow up question is just how complex is the biomarker strategy in terms of development, and what you anticipate from a commercialization perspective, because I'm just wondering why not a lot of people are still actively pursuing novel biomarkers beyond the ones that we typically know like PD-1s.

Elizabeth Trehu -- Chief Medical Officer

Sure. So I think PD-1 is a good example -- PD-(L)1 is a good example of where a biomarker made a huge difference. It's really what catapulted pembrolizumab or KEYTRUDA forward. If the data is strong enough without a biomarker, that's fine. I mean if a large percentage of your patients respond, and do well, then you don't need a biomarker. We just think it's really important to incorporate it early on, in case you really do need it to find the patients that benefit, and obviously you don't want to treat people with something that's not going to provide benefit to them. So you want to find the right patients, the right therapy for the right patients.

Rich, did you want to add to that?

Richard Murray -- Chief Executive Officer and President

Yeah. Maybe Zegbeh another way to think about this is the biomarkers that we now take for as being relatively common, were all directed at PD-1 inhibitors, CD8 cell biology, T-cell activation, and such. And as you know, many of our discovery programs appointed a different immune cell types, and so there is a set of biomarkers that may be -- become more established for the myeloid cells, and for the macrophages, and perhaps other cell types.

So I think that's perhaps the way to see this kind of cascade of biomarkers. They link to certain cell types, and behaviors and biology of the different cell types.

Elizabeth Trehu -- Chief Medical Officer

And then in terms of the clinical development program, Zegbeh, for a molecule like this, it is possible that it could be active in multiple different tumor types. If you look at the PD-1 inhibitors, so this could develop into a very large development program. Yes, I mean we're planting the seeds in all these different cohorts now. There are additional things that we might want to look at in the future. We could expand these within the study. We could do additional studies in these tumor types. I think we're planting the seeds for potentially very large development program.

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Thanks guys, and congrats again on the progress.

Elizabeth Trehu -- Chief Medical Officer

Thank you.

Richard Murray -- Chief Executive Officer and President

Thanks.

Operator

[Operator Instructions] Our next question coming from the line of Ted Tenthoff with Piper Sandler. Your line is open.

Edward Tenthoff -- Piper Sandler -- Analyst

Great. Thank you very much. So a quick question, I'm very much looking forward to the Posters at ASCO, as well as the R&D business, and that's going to be great update. Is the plan with respect to the 8064 or in the extension study is to do signal findings and with those cohorts be able to be expanded on success and potentially in the form registrational paths?

Elizabeth Trehu -- Chief Medical Officer

Great question, Ted. Yes. These are initially for signal finding, but each expansion cohort is actually designed as a Simon 2-stage design. So we have particular triggers that would lead to further expansions, and if we see encouraging data then the next step to see if they could potentially become registration trials would obviously be discussion with FDA, but we do think some of them may have that potential, if the data is strong enough.

Edward Tenthoff -- Piper Sandler -- Analyst

Great. And I like the new name, Pimi.

Elizabeth Trehu -- Chief Medical Officer

Did you have another question?

Edward Tenthoff -- Piper Sandler -- Analyst

No, I was just saying I like the new name for the PD-1...

Elizabeth Trehu -- Chief Medical Officer

Oh, pimi.

Edward Tenthoff -- Piper Sandler -- Analyst

Pimi.

Elizabeth Trehu -- Chief Medical Officer

Yeah.

Edward Tenthoff -- Piper Sandler -- Analyst

Thanks, guys.

Richard Murray -- Chief Executive Officer and President

Thanks.

Elizabeth Trehu -- Chief Medical Officer

Okay. Thank you.

Operator

That's all the time we have for our question-and-answer session today. [Operator Closing Remarks]

Richard Murray -- Chief Executive Officer and President

Thanks.

Duration: 48 minutes

Call participants:

Malin Deon -- Manager, Investor Relations & Corporate Communications

Richard Murray -- Chief Executive Officer and President

Dmitri Wiederschainside -- Chief Scientific Officer

Elizabeth Trehu -- Chief Medical Officer

Kim Drapkin -- Chief Financial Officer

Ryan Deschner -- Raymond James Financial Inc -- Analyst

Ramakanth Swayampakula -- H. C. Wainwright & Co., LLC -- Analyst

Unidentified Participant

Boris Peaker -- Cowen & Co. -- Analyst

Nick Abbott -- Wells Fargo Securities -- Analyst

Zegbeh Jallah -- Roth Capital Partners, LLC -- Analyst

Edward Tenthoff -- Piper Sandler -- Analyst

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