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Edited Transcript of JNCE.O earnings conference call or presentation 8-Mar-18 1:00pm GMT

Q4 2017 Jounce Therapeutics Inc Earnings Call

CAMBRIDGE Mar 9, 2018 (Thomson StreetEvents) -- Edited Transcript of Jounce Therapeutics Inc earnings conference call or presentation Thursday, March 8, 2018 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Elizabeth G. Trehu

Jounce Therapeutics, Inc. - Chief Medical Officer

* Kimberlee Cobleigh Drapkin

Jounce Therapeutics, Inc. - CFO and Treasurer

* Komal Joshi

Jounce Therapeutics, Inc. - Head of IR & Strategic Finance

* Richard Murray

Jounce Therapeutics, Inc. - CEO, President and Director

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Conference Call Participants

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* Boris Peaker

Cowen and Company, LLC, Research Division - MD and Senior Research Analyst

* Chuan Fu

JP Morgan Chase & Co, Research Division - Analyst

* James William Birchenough

Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst

* Michael Eric Ulz

Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst

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Presentation

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Operator [1]

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Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Fourth Quarter and Full Year 2017 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded at the company's request.

I will now turn the call over to your host, Komal Joshi, with Jounce Therapeutics. Please go ahead.

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Komal Joshi, Jounce Therapeutics, Inc. - Head of IR & Strategic Finance [2]

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Thank you, Crystal. Good morning, and welcome to the Jounce Therapeutics Fourth Quarter and Full Year 2017 Financial Results Conference Call. This morning, we issued a press release, which outlines the topics that we plan to discuss today. The release is available in the Investors and Media section of our website at www.jouncetx.com.

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, March 8, 2018, 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.

Leading today's call is our CEO and President, Dr. Rich Murray, who will discuss Jounce's key value drivers for 2018 and provide an update on our clinical and preclinical development activities; followed by our CFO, Kim Drapkin, who will review our full year 2017 financial results and provide 2018 financial guidance. We will then open the call for your questions. Our Chief Medical Officer, Dr. Beth Trehu, will also be available during the Q&A portion.

With that, it is my pleasure to turn the call over to Rich.

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Richard Murray, Jounce Therapeutics, Inc. - CEO, President and Director [3]

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Thanks, Komal. Good morning, everyone, and thank you for joining us.

2017 was an important year of execution for Jounce and our first year as a publicly traded company.

I'd like to start this morning's call with a quick review of some of our accomplishments from the past year. We launched our IPO in January of 2017, raising $117 million in gross proceeds and allowing us to maintain a strong financial position to execute on our strategy. We expanded our team, including our board, as well as our facilities and capabilities to support broader pipeline mission.

On the clinical front, we executed on the development of our lead program, JTX-2011, achieving several milestones. We established our safety profile, identified our Phase II dose, and initiated enrollment of the Phase II monotherapy and combination therapy cohorts. We now plan to leverage that great progress and momentum into 2018 around 4 key value drivers.

First, with JTX-2011, we are pleased to announce today that 2 of our Phase II combination cohorts of our ICONIC trial, gastric cancer and triple negative breast cancer, have met their enrollment targets, with completion of at least 1 efficacy assessment. This has enabled submission of an abstract for the 2018 ASCO Annual Meeting.

Consistent with patient needs, the gastric and triple negative breast cancer tumor types, where advanced cancer patients have the fewest options, enrolled the fastest. As we previously mentioned, combination cohorts continue to enroll faster than monotherapy, consistent with clinical practice and the IO landscape.

We've also been pleased with the ongoing investigator support to facilitate the overall pace of trial enrollment.

For our second value driver this year, we're pleased to announce that we plan to expand our JTX-2011 program beyond the ongoing PD-1 inhibitor combination cohorts and initiate a new JTX-2011 and CTLA-4 inhibitor combination within the adaptive ICONIC trial in 2018. As a reminder, Jounce initially prioritized development of JTX-2011 based on the seminal work on the ICOS target from 2 of our cofounders, Drs. Pam Sharma and Jim Allison, which was subsequently supported by our Translational Science Platform.

The key takeaway from their work was that patients undergoing anti-CTLA-4 treatment had a better outcome if there was a persistent increase in the CD4-positive, ICOS-high T cells in the blood and tumor. That important relationship with treatment outcome implicated ICOS in the sequence of events leading to tumor reduction. When brought back to the lab, this finding was supported by animal tumor studies.

Now that we've demonstrated the safety profile of JTX-2011 in combination with a PD-1 inhibitor in our ongoing studies, we're excited by this potentially important new combination.

Third, we expect to file the IND this year for JTX-4014, our internal PD-1 inhibitor. Given our belief that combination therapy will be a mainstay of cancer immunotherapy, we view 4014 as an important enabler for our pipeline.

And the fourth value driver is our next development candidate, reflecting our continued efforts to build first-in-class immunotherapy programs. We have advanced our first tumor-associated macrophage candidate, coming from our Translational Science Platform, into IND-enabling studies. Immunosuppressive macrophages are prevalent in certain tumor types across indications and are believed to add an additional layer of immunosuppression within the tumor microenvironment.

Our goal is to convert, but not deplete, immunosuppressive macrophages to an immunostimulatory state, thus engaging the innate immune system in the response to cancer. Additionally, this lead macrophage candidate could become a Celgene-optioned program. We're excited about the potential to modify the tumor microenvironment in this way and expect to provide more details on these efforts as the program progresses.

Having laid the groundwork for what to expect at a high level in 2018, I'd like to focus on 2 areas: first, the IO treatment landscape, to provide some context; and second, the abstract we submitted to ASCO 2018.

2018 represents a pivotal year for Jounce as we progress our pipeline, especially for JTX-2011. We wanted to take a few moments today to provide some context around our view of the broader immuno-oncology landscape.

We acknowledge the fast pace and evolving results in IO, and we believe 5 key patterns have emerged thus far.

First, when IO responses occur, they are more durable than previous standards of care. Second, response rates to approved PD-1 inhibitors can vary significantly by indication. Third, response rates increase as you move up to earlier lines of therapy in a given tumor type. Fourth, advanced, relapsed/refractory patients are the most difficult to treat, but also represent a significant unmet medical need and potentially a faster path to approval. And finally, using biomarkers to select patients may improve response rates.

Critical to our mission at Jounce, we're focused on a biomarker approach with the aim to match the right therapy to the right patients. In ICONIC, we use biomarkers to enrich for patients who may be more likely to benefit from JTX-2011. Additionally, we are assessing other exploratory biomarker methods to aid in interpretation of the clinical data.

In ICONIC, we're evaluating JTX-2011 alone and in combination with nivolumab across multiple solid tumor types in areas of high unmet medical need. Using our Translational Science Platform, we selected the tumor types for the Phase II parts of ICONIC based on a higher prevalence of ICOS-positive immune cells within those tumor types, as shown in preclinical results.

The Phase II patients in each ICONIC cohort are all advanced, relapsed/refractory cancer patients with no standard treatment options. Our goal is to either move forward quickly in the relapsed/refractory patient populations or move into earlier lines of therapy as data supports.

In the gastric and triple negative breast cancer cohorts, the patients are advanced but are predominantly IO naïve. Responses to PD-1 inhibitors in these types of patients to date have been low.

In the other cohorts, such as head and neck cancer, melanoma, non-small cell lung cancer, almost all patients enrolled have progressed on the standard of care PD-1 inhibitors, an increasing patient population with extremely limited treatment options. At the Cowen investor conference on Monday, March 12, we will provide additional context on the gastric and triple negative breast tumor types and the available therapy options for those patients.

I'd like to now take a moment to thank our program team and our investigators, who are driven by our vision to deliver novel immunotherapies to cancer patients. They've collectively done an excellent job in the execution of a rather complex trial, enabling us to submit our 2018 ASCO abstract, which contains the following: Phase II monotherapy and combination safety data in all tumor types; preliminary efficacy data, which includes gastric cancer from both Phase I monotherapy and combination cohorts; and triple negative breast cancer from the Phase II combination cohorts.

Although we did not have specific gastric and triple negative breast cancer cohorts in Phase I, we will provide the preliminary efficacy data from the patients with these tumor types who enrolled in the Phase I.

We will also provide available data on ICOS-positive patient enrichment by immunohistochemistry as well as other exploratory biomarkers and methods that we included in the trial.

Between submitting the ASCO abstract and the meeting itself, data will mature. We therefore expect to provide data on additional patients, longer-term follow-up and additional biomarker information. We will continue to report preliminary efficacy data from additional cohorts as target enrollment is met.

Coming up at the AACR on Monday, April 16, we'll be highlighting the scientific and translational work that supported the inclusion of gastric cancer and triple negative breast cancer in the ICONIC trial in 2 poster presentations.

In summary, we believe that Jounce has a unique approach with our Translational Science Platform that positions us well for the future, with potential first-in-class targets, capabilities to interrogate the tumor microenvironment, informed biomarker efforts and an evolving oncology pipeline aimed at addressing important unmet needs.

We're excited by the science, pipeline progress and further growth of the company and expect to communicate more on our 4 value drivers throughout the year.

Now I'd like to turn the call over to Kim Drapkin, our CFO, for a discussion of our full year 2017 financial results and to provide 2018 guidance. Kim, please go ahead

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Kimberlee Cobleigh Drapkin, Jounce Therapeutics, Inc. - CFO and Treasurer [4]

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Thank you, Rich. Good morning, everyone.

Jounce continues to operate from a strong financial position to support the activities that Rich outlined earlier, including advancing our lead clinical program, advancing our development candidates and maintaining our investments in our discovery platform.

As we reported in this morning's press release, we ended 2017 with cash, cash equivalents and investments totaling $257.9 million compared to $257.4 million for 2016. This increase was primarily driven by the net proceeds of $106.4 million from our IPO and was offset by cash used for operating and investing activities throughout the year. Overall, Jounce utilized $105.9 million in net cash for full year 2017 consistent with our financial guidance.

Turning to the full year P&L. Our collaboration revenue was $71.6 million in 2017 compared to $37.2 million for 2016. This is in line with our previously stated revenue guidance of approximately $70 million to $75 million. Recall that collaboration revenue, currently noncash, reflects the recognition of the Celgene upfront payment of $225 million received in July 2016.

During 2017, we incurred $67.8 million in research and development expenses compared to $34.9 million for 2016. The increase in R&D expenses was primarily driven by the following: increased employee compensation costs related to higher headcount; clinical costs related to the ICONIC trial; and external research and development costs primarily attributable to the manufacture of clinical trial materials and related activities.

General and administrative expenses were $23.1 million for 2017 compared to $16.8 million for 2016. The increase in G&A expenses is the result of increased employee compensation costs related to higher headcount, facilities costs and other costs attributable to operating as a public company. In addition, the increase in G&A expenses for the full year 2017 was offset by $2 million of legal and accounting costs written off during 2016 as a result of the postponement of our IPO for a period in excess of 90 days, and as a result, the previously capitalized costs were written off to G&A expenses.

And finally, for the year ended 2017, we reported a net loss of $16.4 million, or $0.57 per basic and diluted share, as compared to a net loss of $13.7 million for 2016, or $11 per basic and diluted share. The decrease in net loss per share from the full year 2016 to the full year 2017 is primarily due to an increase in shares of common stock outstanding post IPO.

Looking ahead, we expect cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80 million to $100 million. We expect to record approximately $50 million to $60 million in collaboration revenue in 2018 from the continued recognition of the Celgene upfront payment received in 2016.

Given the strength of our balance sheet, we continue to expect our existing cash, cash equivalents and investments will be sufficient to enable us to fund our operating expenses and capital expenditure requirements for at least the next 24 months.

We are very encouraged by the progress that we've made during the past year. As we build on this momentum, we aim to work towards key value inflection points throughout 2018 while continuing to establish a broad and diversified portfolio focused on bringing the right therapies to the right patients.

We are also pleased with the working relationship we have established with our global strategic partner, Celgene, and look forward to continuing this productive collaboration.

With that, I will now turn the call back over to Rich.

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Richard Murray, Jounce Therapeutics, Inc. - CEO, President and Director [5]

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Thanks, Kim.

I think what I'll do is maybe take a moment to correct a statement that I think I may have said incorrectly about the ASCO abstract. So I'm going to go back through that as to the 2018 ASCO abstract: Phase II monotherapy and combination safety data in all tumor types; preliminary efficacy data, which includes gastric cancer from both Phase II monotherapy and combo cohorts; triple negative breast cancer from the Phase II combination cohort.

And although we did not have specific gastric and triple negative breast cancer cohorts in Phase I, we will provide the preliminary efficacy data from the patients with these tumor types who did enroll in the Phase I.

We'll also provide available data on ICOS-positive patient enrichment by immunohistochemistry as well as other exploratory biomarkers and methods that we included in the trial.

Okay. With that correction, I'd like to put some closing comments. Last month marked Jounce's 5-year anniversary, and it's really remarkable to see how far we've come. We opened our labs in 2013, with a focus on great science, building an exceptional team and a strong culture to develop first-in-class immunotherapies, none of which would have been possible without the dedicated group of hardworking employees who make Jounce what we are today.

In just 5 years, through the establishment of our Translational Science Platform, we've successfully developed a differentiated immunotherapy approach and believe that our innovative pipeline reflects that work.

As Kim alluded to, we aim to build a sustainable, multiproduct company. Our mission begins with helping cancer patients, and our goal, first and foremost, is to deliver novel immunotherapies to these patients. And of course, I'd like to take this opportunity to thank the patients who have enrolled in our trial.

I'm excited about what's to come from our team and our approach at Jounce, and I look forward to sharing more with you in 2018 and beyond.

We would now like to open the call for your questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Jim Birchenough from Wells Fargo Securities.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [2]

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Looking forward to the ASCO update. Maybe as a bit of a preview to what you might say Monday, could you give us some sense of expectations for what we see with PD-1 inhibition by itself in gastric and triple negative breast cancer and what you think the threshold for success is? And then a second part to the question. Just as you've gone through the screening for those 2 cohorts, have you seen ICOS expression levels in line with what you would have expected overall? And could you remind us what the rate of ICOS-positive tumors are across those 2 cohorts? And then finally, just on the PD-1 program, what triggers an option by Celgene? And give a general sense of, if they were to do that, when that might happen. Is that more of a 2018 or 2019 event?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [3]

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Thanks, Jim. This is Beth Trehu. I'll take the first 2 questions and then turn it over to Rich. So we will be providing more color at Cowen, as we mentioned. But the response rates, as you know, KEYTRUDA is approved in third-line gastric cancer based on a response rate of 13%. There is no approval for any PD-1 inhibitor in triple negative breast cancer, but the most recent KEYTRUDA data was about 5% response rate. It's important to not just focus on response rate, since, obviously, the importance of immunotherapy is the quality and the durability of the responses. But for us, in terms of what success looks like, there are a few key points. We think, obviously, the drug needs to have an acceptable safety profile. We have to have a demonstration of drug activity because of, obviously, our biomarker approach, biomarker data that informs and helps to identify responsive patients and also enhances our understanding of the mechanism of the drug. And we'll be looking for clinically meaningful efficacy compared to the relevant benchmark in similar-stage patients. I think that's -- those were your 2 questions. So I'll turn it over to Rich regarding the 4014 program.

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Richard Murray, Jounce Therapeutics, Inc. - CEO, President and Director [4]

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Okay, great. For the Celgene, Jim, I think we have mentioned we -- the option is tied to the ICONIC study. The option terms were predetermined in the agreement. We're not providing specificity on that exact timing beyond that. We've got a very good relationship with Celgene, and the option criteria has been agreed to in the contract.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [5]

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I just missed it, guys, on the rate of ICOS positivity that you would expect for gastric and triple negative and what you saw in screening for ICONIC.

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [6]

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Yes, thanks, Jim. Sorry about that. Yes, so the rate in the archival tumor samples, which are what we first look at in terms of the patient enrichment, have actually been very much in line with our expectations. Some are translational work, both looking at RNA and then looking at actual tumor samples from patients not in the trial. We estimated the positivity in gastric cancer to be about 30% to 40% ICOS high, and in triple negative breast cancer, a little bit lower than that. And the archival tumor samples have been consistent with our expectations, and we'll be providing information on the fresh tumor biopsies as well in our ASCO data.

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Operator [7]

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And our next question comes from Cory Kasimov from JPMorgan.

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Chuan Fu, JP Morgan Chase & Co, Research Division - Analyst [8]

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This is Shawn on for Cory. Can you maybe just provide a little bit more detail in regards to what we will see in the abstract versus the actual ASCO presentation? I know you guys mentioned previously that by cohort, there would be somewhere around 15 to 20 patients per. Would that be 9 weeks of follow-up time? So just wondering if that was the data that was submitted to ASCO and that's the data that we will see in the abstract.

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [9]

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Thanks. So yes, the target enrollment for the cohorts -- for the combination cohorts was 15 patients per cohort, although we did have some over-enrollment to try to make sure we had sufficient ICOS-high subjects. So what drove the data for the abstract was the completion of the target enrollment for the gastric and triple negative breast cancer combo patients. So we'll have at least 15 patients with at least 1 efficacy assessment. That's what drove the abstract. The single-agent cohorts, as I think Rich mentioned -- and it's not surprising since they're in the same patient populations, the enrollment in the single agent cohort was not as robust as the combination. But we think it's important to include the single agent data that we have in gastric cancer because it's very complementary to what you see with combination. And then as Rich mentioned, just to be complete, we'll include data from any gastric or triple negative breast cancer patients who enrolled in either the mono or the combo parts of the Phase I study. And then by the time of the presentation, if it's accepted, we will have additional data -- we'll have longer-term follow-up data on the patients included in the abstract. And we'll also have data from additional patients because, as I mentioned, some of these cohorts have over-enrolled as we've wanted to make sure we had a sufficient number, at least 10 actually, ICOS-high patients based on a fresh biopsy. So you can expect more than the 15 patients of target enrollment by ASCO itself.

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Chuan Fu, JP Morgan Chase & Co, Research Division - Analyst [10]

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Okay, perfect. And then just sort of curious, given that the seminal work for ICOS was sort of done in the backdrop of CTLA-4 initially, I'm kind of curious why the initial clinical foray then was decided to go forward in combination with PD-1 versus CTLA-4 initially?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [11]

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Yes. That's a good question. I think a lot of that was driven initially by the fact that there were more concerns about the safety profile with CTLA-4 inhibitors, and we wanted to make sure that we were giving our drugs the best possible chance in terms of a safety -- a safe combination. I think, secondly, when we started the trial, the PD-1 inhibitors were already clearly dominating the market and so we thought that was important. And then very importantly, we had preclinical data that suggested that the combination could be beneficial. So we really wanted to start with PD-1 inhibitors. I think we always intended to look at a combination with the CTLA-4 inhibitor, but wanted to make sure that we were comfortable with the safety profile in combination with PD-1 inhibitors before embarking on any new combinations.

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Operator [12]

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Our next question comes from Mike Ulz from Robert W. Baird.

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Michael Eric Ulz, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [13]

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Just in terms of the ASCO data, you mentioned providing some data on a number of biomarkers. Just curious if you can maybe give us a little -- be a little bit more specific on what biomarkers we should expect.

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [14]

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Yes. So in addition to the ICOS IHC, we've had some pharmacodynamic biomarkers in the trial. But true to our biomarker-driven approach, we had certain biomarkers that were included prospectively in the trial. But as data emerges, we are always doing what we call reverse translation and taking the data and interrogating it and going back to see how we can learn more about our drug. So we actually have developed some new biomarker methods that we will be sharing at the meeting. And I'm not going to go into any more detail than that. But, yes, it's things that we were -- that we've talked about before, but then also some new things.

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Michael Eric Ulz, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [15]

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Okay. Got it. And then just with respect to the ICONIC study and the additional cohorts in lung, melanoma and head and neck, do you think we can get that -- some preliminary data in 2018? Or is that, could that sort of slip into '19? And then as you think about next steps, will you be waiting to see data across all cohorts before you make any decisions on moving forward?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [16]

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So we're not guiding right now as to exactly when that data will be available. It's really driven, as Rich mentioned, by when we meet our enrollment target and also have at least 1 efficacy assessment on all of those patients so that we have a sufficient set of data to preferably submit to a medical meeting. And then in terms of next steps, as we've talked about, the ICONIC trial has an adaptive design, so we can make modifications to the trial based on emerging data, example of which is the addition now of the cohorts with CTLA-4 inhibitor. So it allows us a lot of flexibility, and we will continue to react and adapt based on emerging data from the study. And we'll give more guidance as things progress.

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Operator [17]

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Our next question comes from Boris Peaker.

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Boris Peaker, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [18]

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My first question is, how many patients, I'm just curious, will have fresh biopsy at ASCO? And will you have data comparing the ICOS expression level in archival versus fresh biopsy?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [19]

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Yes. So we expect to have fresh biopsy data on all -- most, if not all, of the patients on whom we report. Sometimes there are challenges just with the quality of the biopsy. So we'll have data on everybody for whom we have evaluable tissue. And yes, we will be presenting the correlation between the archival and the fresh biopsies.

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Boris Peaker, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [20]

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Got you. And in terms of monotherapy patients, we haven't talked much about that. But how many monotherapy-treated patients do you anticipate to see? And is -- are you planning to continue monotherapy in general? Or is going forward only in combo?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [21]

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So as I mentioned, the monotherapy cohorts have lagged a bit behind the combo cohorts in terms of enrollment. I think we'll have sufficient gastric cancer monotherapy data to -- as I said, it's complementary, I think, to the combination therapy data. And again, we'll provide more guidance about our future plans as the data emerges and as we present data.

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Operator [22]

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(Operator Instructions) And we do have a follow-up from Jim Birchenough from Wells Fargo Securities.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [23]

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So just want to make sure I understand for the ASCO presentation. At the time of ASCO, would we expect repeat scans on all patients? And then the other part of it is, to the extent different patients are going to be further along the treatment course, do you expect response rate to improve over time based on what you've seen preclinically? And then just a final question, just to confirm, is your a priori hypothesis that we'll see higher response rates in the ICOS-positive patients?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [24]

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Okay. So we certainly would have longer-term follow-up data on the patients who are included in the abstract. There may (inaudible) some patients who enroll later who may not have 2 efficacy assessments. But certainly most of the patients will have at least 2 efficacy assessments by the time of ASCO. And I think it's too early to talk about what we expect to see over time. So I think we'll wait until we see what we actually present at ASCO. But I do want to reiterate what we actually present will have more data than what you can expect to see in the abstract. And that's particularly true on the biomarker front because we did not have a lot of the fresh biopsy biomarker data by the time of the ASCO abstract submission, but we will in time for ASCO. So I think we'll have a much better picture of the relationship between archival and fresh, as I mentioned, and also the relationship to response. Regarding our hypothesis, we certainly -- our hypothesis has been that biomarker enrichment can help to improve response rate, but, as you know, we've incorporated a number of potential predictive biomarkers into the study. And so, as we've previously stated, there is a point in the study, when we have sufficient data, that we will make a determination about which is potentially the best predictive biomarker. We start with IHC, but we have a lot of other investigation going. And I think, we'll learn a lot from the exploratory biomarkers that we've included in the study.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [25]

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And then maybe one final question and that is on ICONIC and the flexibility of design, the adaptive design, is one of the possibilities to expand further these cohorts if you're seeing a signal? And could you potentially convert ICONIC to a registration-enabling study? Not saying -- not asking if you're going to, but just is that one of the options? Or do -- would you need to start a whole new study?

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Elizabeth G. Trehu, Jounce Therapeutics, Inc. - Chief Medical Officer [26]

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Sure. So absolutely, we can expand existing cohorts. That's written into the study and has been since the beginning. I think in terms of the potential to convert into a registration study, a lot of that depends on which cohort and the line of therapy and which path you pursue. So in a PD-1 inhibitor-failure population, if you feel there is no relevant control group, that's the situation where you could potentially move towards a registration path. Any situation in which a control group is required, it's more likely to require a new trial. But the ICONIC trial does give us the flexibility to do that, to enable us to move forward quickly in relapsed/refractory patients if that's the path that we choose, or to move into earlier lines of therapy within the ICONIC trial.

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Operator [27]

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And I am showing no further questions from our phone lines. Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. And you may all disconnect. Have a wonderful day.