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5/4/2021
Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics first quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded at the company's request. I will now turn the call over to your host, Malin Dion, with Jounce Therapeutics. Please go ahead. Thank you, Operator.
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 in 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. Dimitri Wiederschein, 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 Trafkin, 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.
Thanks, Malin, and good morning, everyone. Johnson's 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 Johnson'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 N8, our phase one clinical trial of our highest priority program, JTX8064, a LIL-RB2, also known as ILT4, inhibitor. N8 is moving quickly through the necessary dose escalation portion of the trial towards the opening of eight tumor-specific expansion cohorts. We plan to include JTX8064 monotherapy as well as combination with our own PD-1 inhibitor, JTX4014, or an approved PD-1 inhibitor. JTX4014 will now be known as pimavelumab, or PIMI. We continue to believe that the myeloid and macrophage biology, harnessed by the potential effect of JTX8064 via the LIL-RB2 mechanism, provides a new opportunity to bring benefit to patients. Enrollment also continues in SELECT. our Phase II randomized proof-of-concept trial of Vopratilumab in combination with our PD-1 inhibitor, Phimi. The key feature of this study is the biomarker selection of patients utilizing TIS-Vopra, 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 and 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 in progress posters on both INAT and SELECT at the upcoming ASCO meeting in June. We continue to progress JTX1811 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. Beyond our 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-L1 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 ballot 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 Jones, with critical milestones laid out for the remainder of this year and beyond. To reiterate, we plan to evaluate safety and determine recommended Phase II dose for JTX8064 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 PIME from the select trial in 2022. Continue IND enabling activities for JTX1811 and anticipate an IND clearance in 2021. And continue to advance our discovery pipeline of potential first-in-class programs with the goal of a 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. Dimitri Wiederschein, who was appointed as Chief Scientific Officer in April. Dimitri has more than 15 years of pharmaceutical industry experience as a scientific leader and drug developer, and brings a broad knowledge 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 Dimitri on the Jounce team. With that, I'll turn the call over to Dimitri to say a few words.
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