11/4/2021

speaker
Operator

Good day, ladies and gentlemen, and welcome to Jounce Therapeutics' third quarter 2021 earnings conference call. At this time, all participant lines are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference is being recorded at the company's request. I will now turn the call over to your host, Eric Laub, with Jounce Therapeutics. Please go ahead.

speaker
Eric Laub
Vice President, Investor Relations

Thank you, operator. This is Eric Lau, Vice President of Investor Relations at Jounce Therapeutics. Good morning and welcome to the Jounce Therapeutics third quarter 2021 earnings 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 CMO, Dr. Beth Trehu, who will provide an update on our clinical activities. Our CSO, Dr. Dimitri Vetershin, will then discuss our discovery efforts. And lastly, our CFO, Kim Drakken, 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 purpose of the safe harbor provisions under the Private Securities Litigation and 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 represents our views only as of today, November 4th, 2021, and should not be relied upon as representing our views 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.

speaker
Dr. Richard Murray
President and Chief Executive Officer

Thanks, Eric. Good morning, and thank you for joining us today. Johnson's had a very productive quarter as we've made significant progress across all areas of the company. We continue to build momentum as we head into the new year with data expected in 2022 from two ongoing clinical studies, new candidates progressing from our active discovery efforts, and a cash runway that allows us to reach new inflection points. We are pleased to report that we are now actively recruiting patients in the monotherapy and combination therapy expansion portion of the innate study, testing JTX8064, plus or minus pimavalimab, our own PD-1 inhibitor, in eight distinct cohorts across seven tumor types. We continue to advance patient enrollment in our select study. which employs our stringent patient selection strategy and have continued our commitment to build our discovery pipeline. We're at an exciting time in Johnson's development and remain committed to progressing new mechanisms that target different immune cell types within the tumor microenvironment. This is now evident in our myeloid and macrophage programs and our program licensed to Gilead, which targets T regulatory cells. We also believe Johns represents the next generation of immuno-oncology by unlocking a precision medicine approach through the continued execution of our translational and biomarker efforts. Biomarker selection and targeting key checkpoints on different immune cell types not only differentiates us, but is integral to our mission to bring the right immunotherapy to the right patients. At the beginning of this year, we announced that enrollment had commenced in an eight. the clinical study of JTX8064, our highest priority program. JTX8064, an inhibitor of the macrophage checkpoint LIL-RB2, also known as ILT4, is being tested as a monotherapy and combination therapy along with primivalumab, or PIMI. We move quickly through the necessary monotherapy and combination therapy dose escalation for safety in all comorbid cancer patients. while establishing safety and PKPD to allow for dose selection. We determined 700 milligrams as the preliminary recommended phase two dose for the mono and combo expansion cohorts, and we recently announced enrollment for monotherapy and combination therapy expansion in well-defined patient populations in eight cohorts across seven tumor types. We look forward to delivering further milestones with this program and reaffirm our belief that the myeloid and macrophage biology targeted by GTF-8064 via the LLRB2 mechanism provides a new opportunity to bring benefit to patients, especially patients with PD-1 inhibitor-resistant tumors. As we've previously mentioned, these patients tend to have few therapeutic options and represent a growing patient population. due to primary or acquired resistance to prior PD-1 inhibitor treatment. We anticipate presenting the first clinical data from this program in 2022. Patient enrollment continues to advance in the SELECT study. Our Phase II randomized proof-of-concept trial of ovotelamab, our ICOS agonist, in combination with PIMI. The key feature of this study is the biomarker selection of patients utilizing TIS-VOCRA, an 18-gene signature that includes genes relevant to both CD8 and CD4 T-cell biology. We believe from our own clinical data and from others that a rigorous patient selection strategy may be critical to optimize the benefit of an ICOS agonist. We look forward to reporting clinical data from the select trial in 2022. We ended our quarter in a strong financial position and are situated to fund our two wholly-owned proof-of-concept studies, Innate and Select, to pass their reflection points while continuing our robust novel discovery efforts, identifying and progressing new mechanisms that target a diverse set of immune cell types within the tumor microenvironment. With a goal of a new IND every 12 to 18 months, we are on track to nominate another development candidate. In June, John successfully opened the IND for GS1811, formerly JTX1811. And in August, the clinical study was initiated by Gilead. We are extremely pleased to now have four internally developed candidates in the clinic in the past five years. We remain fully committed and on track to achieve all the milestones set out for 2021, from the clinic to our discovery efforts. Before turning the call over to Beth, I'd like to welcome back to Chounce, Jigar Raythapa. In September, we announced that Jigar joined our board of directors. His experience and skills are highly relevant and synergistic with the needs of our board. As a former team member of Chounce, Jigar has an intimate working knowledge of our science, as well as an understanding of what we are working to achieve. We look forward to his continued contributions now as a board member. I'll now turn the call over to Beth to provide a clinical update. Beth?

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