Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics third quarter 2022 earnings conference call. At this time, all participants are in listen only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this call is being recorded at the company's request. I will now turn the call over to your host, Eric Laub with Jounce Therapeutics. Please go ahead. Thank you, operator. This is Eric Laub, Vice President of Investor Relations at Jounce Therapeutics. Good morning, and welcome to the Jounce Therapeutics third quarter 2022 financial results conference call. This morning, we issued a press release which outlines the topics that we plan to discuss today. The release is available in the Investors and Media section of our website at www.jouncetx.com. Speaking on today's call will be our CEO and President, Dr. Richard Murray, who will review our pipeline progress and key milestones, followed by our COO, Hugh Cole, who will provide an update on business development activities. Our CMO, Dr. Elizabeth Trehu, will provide an update on our clinical activities, and our CSO, Dr. Dmitri Wiederschain, will then discuss our discovery programs. Lastly, our CFO, Kimberlee 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 10, 2022, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. With that, I'll now turn the call over to Rich. Thanks, Eric. Good morning, and thank you for joining our call today. As disclosed in our press release this morning, we have a number of updates to discuss on our call. We continue our progress and execution through the third quarter as we advance our proof of concept INNATE clinical trial and build our pipeline of oncology candidates. Our goal is to strive for a meaningful immunotherapy for patients who have few options. This is at the heart of our approach to novel mechanisms guided by biomarkers. To achieve this goal, our near-term focus remains on our JTX-8064 or LILRB2 ILT-4 program and the ongoing INNATE clinical trial in various cancer types. We look forward to sharing details of our ongoing INNATE trial today. Although we intended to present phase I and phase II INNATE data at ESMO IO, we will present phase I data at the meeting and will share observations on phase II on our call today. We recently made this decision after reviewing the most recent data for ESMO IO and based on our stated goal to present a complete and interpretable picture of the phase II data, which we have now determined we will not have by year-end. Beth will expand upon the reasons for this and give you an overview of the data we have seen to date. Turning to our discovery efforts, we have two preclinical posters at the SITC Meeting being presented today in Boston, which Dimitri will highlight. At this time, I'd like to briefly turn the call over to Hugh to discuss our recent milestone achievement. Hugh? Thanks, Rich. As recently announced, we earned a $15 million clinical milestone under our GS-1811 license agreement with Gilead, which highlights the progress of this program. As a reminder, this program is an antibody targeting CCR8 and is aimed at depleting T-regulatory cells in the tumor microenvironment. It was discovered using our translational science platform and is another nice example of how we've been able to bring forward therapies across different immune cell types. With GS-1811 and other T-reg targeting programs now in the clinic, we are looking forward to seeing whether the strategy of T-reg depletion becomes a successful part of I/O therapy in the future. To date, we have earned a total of $40 million of the $510 million in development and regulatory milestones possible under the Gilead license agreement. Partnerships have always been an important part of our strategy and capital sources at Jounce, and we expect that to continue as we advance our pipeline. With that, I'll turn the call over to Beth to discuss our clinical programs in more detail. Thanks, Hugh. I'm pleased to be able to provide an update for you this morning on our ongoing INNATE study. As a reminder, we completed the phase I dose escalation for both monotherapy and in combination with pimivalimab, pimi, our PD-1 inhibitor, selected 700 milligrams as the recommended phase II dose, and initiated the phase II expansion cohorts for both monotherapy and combination treatment in 7 different indications. We have announced that the INNATE phase I data will be presented as a poster at this year's ESMO IO conference in December. Dose escalation data will include safety, PK, receptor occupancy, and preliminary efficacy data. We continue to execute well on the INNATE study and investigators remain very engaged. We have completed enrollment of the first 10 patients in stage 1 of all current phase II combination cohorts and are nearing completion of enrollment in stage 1 of the phase II monotherapy cohort in ovarian cancer. While the ovarian combination cohort was enrolling, patients were not being enrolled in the monotherapy arm and we were pleased to see this enrollment quickly pick up again after we completed the ovarian combination enrollment. We are announcing today that we have met the criteria to expand an additional cohort in second and third line PD-1 inhibitor-resistant head and neck cancer in addition to our previously announced tumor types of PD-1 inhibitor naive ovarian and PD-1 inhibitor-resistant renal cancer. In addition, the PD-1 inhibitor-resistant non-small cell lung cancer and announced today PD-1 inhibitor naive sarcoma cohorts did not meet the criteria to advance from stage 1 to stage 2. The remaining two combo cohorts still in stage 1 in first-line PD-1 inhibitor-naive head and neck cancer and PD-1 inhibitor-resistant cutaneous squamous cell carcinoma, along with the ovarian monotherapy cohort still have the potential to meet criteria to advance from stage 1 to stage 2. Furthermore, we started enrollment in October in stage 1 of a new combo cohort in PD-1 inhibitor-resistant biliary tract cancers, or BTC, based on a clinically meaningful and durable confirmed response in a PD-1 inhibitor-resistant patient in phase I in combination with PIMI. Durvalumab has recently been approved in combination with chemotherapy in first-line BTC and we see PD-1 inhibitor-resistant BTC as a potential differentiated opportunity for JTX-8064 plus PIMI. In response to frequent questions, we would like to provide more details on our internal criteria for cohort expansion. In Simon's two-stage design, our goal in the first 10 patients is to avoid rejecting a potentially active drug. As typical in the first stage of Simon's two-stage, we set the bar on the low side. Our internal criteria to expand from stage one to stage two for each combo cohort is a 10% or greater response rate, confirmed or unconfirmed, with the exception of the first line head and neck cohort, which requires at least a 20% response rate. We believe our decision criteria are appropriate given the small sample size and the fact that the expected response rate for PD-1 inhibitor monotherapy in most cohorts is in the single digits. In addition to meeting the numerical response criteria, we consider additional factors such as the duration and best response to prior therapy, the time elapsed since prior therapy, the tumor size at baseline, and the overall quality of the response in INNATE. For example, although we have met the numerical response criteria in the second and third line head and neck cohort, we are waiting for additional qualitative data before deciding whether to expand. Proof of concept is based on confirmed responses in the full 29 patients in an expanded cohort and requires a response rate with a confidence interval that excludes the PD-1 inhibitor benchmarks. Moving on to the ovarian and renal cancer cohorts that previously met our stage one criteria for expansion. The ovarian combination expansion over-enrolled to 35 patients and renal expansion is near completion with 26 out of 29 patients enrolled. An important observation in the INNATE study so far is the time that it is taking for efficacy data to mature. Consistent with data from Merck's MK-4830 data published in January 2022, we have seen patients with stable disease with tumor reductions less than 30% at week 9 become responders at week 18, which means potential confirmation then has to wait until at least 27 weeks. In addition to confirmed responses, we have seen patients with partial responses at 9 weeks develop progressive disease at 18 weeks due to new lesions, and have observed one pathologically confirmed case of pseudoprogression in PD-1 inhibitor-resistant non-small cell lung cancer. As a result of these observations, we aim to ensure that the data we report includes enough time for responses to be confirmed and to mature. We believe any new mechanism may have its own inherent kinetics, especially in patients with significant prior therapy history. In summary, in the preliminary data in over 80 patients across all combination cohorts, we believe we have seen signs of clinical activity of JTX-8064, but not broad activity leading to rapid proof of concept. These results to date raise the possibility that the efficacy of a LILRB2 inhibitor in combination with a PD-1 inhibitor may be more tumor specific or may require biomarker enrichment or selection and also reflect the importance of waiting for additional data. We expect to be able to assess and share clinical and biomarker data in the following way. We would first emphasize that the timing of data from any of the INNATE cohorts, whether the initial 8 cohorts or subsequent additional cohorts, such as those we have described today, will depend on when enrollment begins in stage 1 and then stage 2, and will require the data to be sufficiently mature for full interpretation. This is consistent with prior guidance that we want the data that we present to be meaningful and interpretable. We will continue to provide updates on the progress of the study on our quarterly earnings calls. We expect to be in position to share additional results from the phase II portion in the first half of 2023. The specific timing and forum for this will be determined as the study proceeds and more data becomes available to us. I would also like to remind you that we will present the complete SELECT data at ESMO IO. SELECT is a randomized phase II study evaluating two different vopratelimab doses in combination with PIMI versus PIMI alone. The two doses under investigation have different patterns of pulsatile target engagement, which we believe may be important for an agonist antibody. We believe the results for the low dose cohort are encouraging, with a 40% response rate versus 27.8% for PIMI alone, and 80% six-month landmark progression-free survival versus 36% to date for PIMI alone by independent central radiology review, as will be presented at ESMO IO. In addition, there is pre-clinical data and biological rationale for improved activity with pulsatile target engagement by an agonist. As the PFS and OS data continue to mature, we plan to pursue a partnership to enable further development of vopra 0.03 mg per kg in combination with a PD-1 inhibitor. This remains an important year of execution and key milestones for Jounce, and we would not be here without the dedication of our team, our valued investigators, and most importantly, the patients who put their trust in our drugs to make a difference in their lives. We look forward to reporting on our continued progress as we focus on the collection of high-quality clinical and biomarker proof of concept data to guide our programs. I will now turn the call over to Dmitri. Thanks, Beth. Later today, our teams will be presenting two preclinical posters at SITC here in Boston, and I encourage you to stop by. One poster will focus on preclinical characterization of JTX-1484, our LILRB4 ILT3 inhibitor, and the other will highlight characterization of the expression and function of LILRB1, LILRB2, and LILRB4 on human immune cells in tumor and blood samples across different cancer types. We believe our work highlights multiple combination opportunities as well as multi-targeted approaches that could be deployed for this important family of immunoinhibitory receptors. We're excited to be adding to the growing body of data that points to LILRB positive myeloid cells, including tumor-associated macrophages and their contribution to resistance to PD-1 or PD-L1-directed therapies. JTX-8064, our most advanced LILRB blocker, which targets immunosuppressive macrophages and other myeloid cells in the TME, serves as an example of our patient-centric, biomarker-driven approach in discovery and through development. This approach is key to the value-generating programs we are pursuing. Our newest development candidate, JTX-1484, is advancing through IND-enabling studies towards the goal of submitting an IND next year. As mentioned earlier, JTX-1484 binds to and inhibits LILRB4 or ILT3, a LILRB family member that is highly expressed on some of the key myeloid cells, including myeloid-derived suppressor cells and tolerogenic dendritic cells that orchestrate immune suppression in the TME, including resistance to checkpoint inhibitors. As our SITC poster helps demonstrate, the LILRB4 target is distinct from other LILRB family members with respect to its ligand specificity as well as temporal and spatial pattern of expression on immune cells. Therefore, we see this program as complementary to our ongoing efforts to target LILRB2 with JTX-8064. Additionally, our pipeline of monospecific LILRB-targeted antibodies is further strengthened by the ongoing efforts to develop potent and specific blockers of LILRB1, an inhibitory receptor that is expressed not only on myeloid cells, but also on certain subsets of T and NK cells. Having these high-quality building blocks to target three important LILRB family members has enabled us to explore both combinations and multispecific approaches preclinically by leveraging our knowledge and growing expertise in LILRB biology. We're confident that the LILRB family, as well as other targets that we're currently pursuing, represent attractive opportunities in immuno-oncology with the potential to improve upon and restore responsiveness to PD-1 or PD-L1 inhibitors. In addition to our efforts in the LILRB family, we continue to add to and diversify our discovery pipeline into other exciting areas of immunobiology. Lastly, I am pleased to share with you today that our manuscript describing preclinical development of GS-1811, our CCR8 targeted antibody for selective depletion of intratumoral T-regulatory cells, which is now licensed to Gilead, has been published in the peer-reviewed journal, OncoImmunology. We are proud to have collaborated with our Gilead colleagues on this publication. I will now turn the call over to Kim for a discussion of our third quarter financial results. Kim? Thank you, Dmitry. As we reported in this morning's press release, cash equivalents, and investments as of September 30, 2022 were $130.3 million, compared to $220.2 million as of December 31, 2021. The decrease was due to cash burn from operating expenses incurred during the period. The $15 million milestone earned under the Gilead license agreement in October is expected to be received in the fourth quarter of 2022. Turning to the P&L, no revenue was recognized during the third quarter of 2022 or 2021. During the third quarter of 2022, we incurred $23.8 million in research and development expenses, compared to $23.3 million for the same period in 2021. The increase in R&D expenses was due to increased manufacturing activities and lab supply purchases to support research activities, partially offset by decreased external clinical and regulatory costs for our vopratelimab development program. General and administrative expenses were $7.7 million for the third quarter of 2022, compared to $6.9 million for the same period in 2021. The decrease in G&A expense was attributable to increased compensation costs due to increased headcount. Net loss for the third quarter of 2022 was $31 million, resulting in a basic and diluted net loss per share of $0.60, as compared to a net loss of $30.1 million for the same period in 2021, resulting in a basic and diluted net loss per share of $0.59. The increase in net loss is attributable to increased operating expenses in the third quarter of 2022 as compared to 2021. We continue to look for opportunities to contain costs in this difficult market environment. While investing in both our clinical and discovery programs, we work to identify areas in which we can continue to create value but also decrease expenses. We are reiterating our guidance that cash is expected to provide runway into the first quarter of 2024. Based on our current operating and development plans, we continue to expect to be on the lower end of our growth cash burn guidance for the full year of 2022 of approximately $115 million-$130 million. I'll now hand it back to Rich for some final words. Thanks, Kim. At Jounce, we're driven by science and are motivated to address the growing unmet medical need of cancer patients today. It is exemplified by the extraordinary effort behind our research, discovery, and development. I would like to take a moment to thank the Jounce employees, clinical investigators, and patients for their unyielding commitment and continuing efforts to bring the right immunotherapy to the right patients. With that, we'd like to now open the call for your questions. Operator? If you would like to ask a question, please press star one one. Our first question comes from Steven Seedhouse with Raymond James. Your line is open. Hey, good morning. Thanks so much. Obviously, my questions are on INNATE. It just didn't sound like it, but is any part of this decision for competitive reasons, or can we just take sort of the statements basically implying the data is still immature at face value? Yeah. Yeah. No. Hi, Steve. Thanks. Sorry. Go ahead, Rich. Yeah. Hi, Steve. Yeah, that's right. The way Beth laid that out, that's really, you know, what we see, and that's what we wanted to communicate today on the call. Okay. The confidence interval that you mentioned for stage two exceeding the relevant PD-1 comp, I was hoping you could just put some numbers on that to sort of help us understand the buffer in the stats there. Like, if the PD-1 precedent is a 5% response rate, I mean, what do you need to see in 30 or 35 patients to meet what you would call PO, you know, proof of concept criteria in stage two? Yeah. It really depends. We have to wait till we actually see the data. It depends on the variability in the data. The confidence interval is, you know, it's a number that comes once we have all the data and when we see what the 95% confidence interval is, the idea is it's got to be above that 5%, response rate. I can't give you any more specifics than that. All right. Our feeling is any response rate with a confidence interval that excludes that PD-1 inhibitor benchmark is something that could potentially be used, you know, to inform a registration path. That's our goal, to find, you know, efficacy that could support registration. Okay. To be clear, I mean, it seems like you don't precisely have that in hand yet, but you believe that that may be forthcoming from one or more of these cohorts, which is why you're waiting to present the data. Correct. Is that fair? Absolutely. It's still possible for the two cohorts that are, you know, that have already expanded. We think it's encouraging that we've met criteria to expand another cohort. We've started a new cohort in biliary tract cancers based on a really encouraging response that we saw in phase I. We still think there's a lot of potential. It's just, you know, too early, and we need more time for the data to mature. Okay. Last question from me, just on predictive biomarkers. I'm wondering if you've done any work there or if between now and when you present the data in the first half of 2023, if that work will be important for just clarifying, like, in responders versus non-responders across the tissue types, if there's some phenotype or profile in the biomarkers that's showing a trend that could be another path forward. If you're not going forward- Yeah. in a specific tumor type, maybe on predictive biomarkers. Thanks for taking the question. Yeah, absolutely. Actually, our team has done a fantastic job. We have all the predictive biomarker data on the patients. By the time we get their clinical data, we have the biomarkers. It's just, again, the biomarkers need to be interpreted in the context of mature clinical data. We absolutely will do an analysis of the biomarker correlation with the clinical outcomes once we have the mature clinical data set. I think it is one of the strengths of the study that we have multiple predictive biomarkers that we're analyzing in correlation with the efficacy. We just need to wait for the efficacy data to mature before we can do a really good analysis there. Thanks so much. Our next question comes from Boris Peaker with Cowen. Your line is open. Great. I have 2 questions. First, I don't know if you can make any comments on the timing of Merck's competitor MK-4830 data. When should we be expecting it. Second, since you completed the stage 1 portion for all indications at this point, I mean, is it reasonable to expect that on the next update, whenever that next update comes around, some of these indications will be discontinued? First of all, regarding Merck, we don't know when they will be presenting data next. We continue to be encouraged by, you know, the breadth and depth of their program, and this target and the fact that they have added some phase II studies where there is a control arm, so they're randomized studies. With respect to your second question, you know, again, because the data takes longer to mature, I mean, sometimes we, as I mentioned, we don't see the first response till 18 weeks, then we have to wait for 27 weeks. You know, sometimes we have people who are stable for quite some time. We will, if any cohorts close or meet the criteria to expand, we will certainly announce them on our next earnings call. I can't be sure that, you know, we will know that more cohorts are closed by that time. Great. Thank you for taking my questions. You're welcome. Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open. Great. Thank you very much, and congrats on the progress. Appreciate all the detail on the update. Looking forward to seeing the presentation or the poster over at SITC a little bit. I wanted to get a sense, kind of you mentioned partnering in the past and partnering in the future. Would you consider partnering different components of the LILRB family, or is that something where there's really more of an opportunity to maybe keep those assets to do future internal combination? I know it's early to be kind of thinking through that, but just maybe at a high level, you can share your thoughts. Thank you. Hi, this is Hugh. I think the answer is all of the above to some extent. I mean, we do always think strategically about our programs and what would be good partners for our programs and what would be the right time point for those partnerships. The LILRB family is, of course, a very interesting group of targets and that, you know, one could think about partnerships that would include more than one of those potentially. It is early to you know get into any more specifics like that. We always you know think ahead about partnerships, and we're always out there talking to potential partners about different types of opportunities. That's really all I would say for now. Great. Thanks so much. Our next question comes from David Dai with SMBC. Your line is open. Hey. Great. Thanks for taking my questions and, also congrats on the progress so far. I have two questions. One is just on the, ovarian cancer patients. Clarifying around the enrollment of these patients, are you enrolling mostly platinum-resistant ovarian cancer, or are you also including the platinum refractory population in the stage one, stage two? The requirement is that they be platinum resistant. We're not requiring platinum refractory, so we have a mix of patients, but it's second, third line ovarian cancer, that has, progressed on a-- or that is platinum resistant. Got it. That's helpful. Another question on the response you see in the biliary tract cancer. Could you share some additional color on the depth of response and durability of response of that patient? Sure. That patient actually had failed both, had a best response of progressive disease to first line chemo and then to second line nivolumab in combination with chemo. The patient came into our study never having had responded to anything. Then the patient had, by 9 weeks, a partial response. The other important thing, that was then confirmed on the subsequent scan, but the important thing is, when this patient entered the study, they had liver and bone metastases and were very cachectic with really terrible bone pain requiring narcotics. By 9 weeks, all of those things were getting better, and by 18 weeks when the partial response was confirmed, the patient had gained 30 pounds and was off pain medications. This patient was able to return to work as a farmer, so not someone who sits on Zoom calls all day like us. He had a really, really meaningful clinical response. He remained in a partial response for a little over six months. At that point, he had one new lesion, and the decision was made to allow him to remain on treatment and radiate that lesion, and he remains on study doing well. All right. Thanks. Thanks so much for the color here. You're welcome. Our next question comes from Arthur He with H.C. Wainwright. Your line is open. Hey, good morning, everyone. This is Arthur He on for RK. Most of my question on the INNATE has been asked. I just want to follow up on the SELECT program. For these 0.3 cohorts, could you tell us how the baseline characterization for the patients compared to the 1 mg cohort? Yeah, that's an excellent question, Arthur. Thank you. We saw really no differences across the cohorts, across the monotherapy in either of the vopra combo cohorts. They were very well balanced. We've looked very hard to see if there's a reason why that low dose cohort did so much better, aside from the fact that it's a lower dose. We don't see any other reasons and we really do believe there's a good biological rationale why a lower dose should result in constant target engagement is a good thing for an agonist antibody. Awesome. Yeah, Arthur, there'll be a lot more information on our poster at ESMO IO on all that. Okay. Awesome. I guess on the ESMO poster, we're also talking about the duration of the response as well, or? Correct. Just to- Yes. Okay. We'll report on the duration of response, I guess, where there was really, you know, a very nice improvement in PFS for the patients in the low dose arm. We're also seeing that borne out by the number of patients who are remaining on study. All of that will be included at ESMO IO. Awesome. I guess regarding the milestone getting from the Gilead, I don't think you guys break down the milestone previously. Just curious, if for this one is related to what kind of achievement can you guys disclose or? Hi, this is Hugh. No, we can't disclose any more details than that. As we said, it is, you know, the program is in the clinic, it's a clinical milestone. We have disclosed that there's a total of $510 million in development and regulatory milestones, and we've now achieved $40 million of those. You know, we'll obviously keep a close eye on the program and as it continues to move along, there's the opportunity for further milestone payments. Gotcha. Yeah. Thanks for taking my question and then congrats on the progress. Thank you. Our next question comes from Colleen Kusy with Baird. Your line is open. Hi, good morning, and thanks for taking our questions. Can you clarify, were your original plans for the data at ESMO to have follow-up of 18 weeks for all patients, but based on a better understanding of the mechanism and what you're seeing so far, the rationale is really you need 27 weeks to have a more meaningful data set? Another question, just based on the mechanism and the data that you've seen so far, do you have any comments on the potential of adding chemo to JTX-8064 and PD-1 or any other combination regimens? Do you see a role for that? Thank you. To your first question, we expected, and we do have 18 data on the majority of the patients. Yes, it's really needing to wait for 27 weeks to really get a really full picture. We always knew we would have some patients who still had just 9-week data, but that the majority would have 18-week data. So really, it's primarily this need to wait longer to make sure that you know, responses that appear at 18 weeks are confirmed. To your second question, that's a great question. We have you know, done preclinical work, and we've done a lot of thinking about other potential combinations, including chemotherapy, you know, combining with standard of care. Our number one priority is to first demonstrate that JTX-8064 is adding benefit over what you would expect with a PD-1 inhibitor alone. Once we have the final data, and we know how, you know, the magnitude of that difference, then we'll be able to think about other combinations to make sure we'll do whatever we think is the best thing for registration path, so we certainly could combine with chemo. Given the excellent safety profile of the combination, we think that will be very, very doable. Great. That's helpful. Thank you. Then a quick follow-up, just on the preclinical data that you'll present at SITC for JTX-1484, can you just help us? What should we keep in mind as we compare the profile for that drug versus some of the other ILT3 assets that are in development? Hey, Colleen, this is Dmitri. Thanks for the question. Yeah, I mean, first and foremost, we believe that the LILRB4 target is quite interesting, potentially distinct from other LILRB4 family members with respect to ligand specificity and also pattern of expression on immune cells. You know, we continue to study the mechanism of action of our molecule. We believe there are signs of molecular differentiation that are emerging on JTX-1484, and look forward to presenting these data when it matures. Great. Thanks for taking our question. There are no further questions. Thank you for your participation. This does conclude the program, and you may all disconnect. Everyone, have a great day.