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3/2/2022
Good morning, ladies and gentlemen, and welcome to the Jones Therapeutics Fourth Quarter and Full Year 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 fly 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 Loft with Jones Therapeutics. Please go ahead.
Thank you, Operator. This is Eric Welb, Vice President of Investor Relations at Jounce Therapeutics. Good morning and welcome to the Jounce Therapeutics fourth quarter and full year 2021 financial results conference call. This morning, we issued a press release which outlines the topics that we will 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 Wiederschein, will then discuss our discovery programs. And lastly, our CFO, Kim Drapkin, will review our fourth quarter and year-end 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, March 2, 2022, 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 if our views change. With that, I'll now turn the call over to Rich.
Thanks, Eric. Good morning, and thank you for joining today. 2021 was an important year of remarkable execution for us at Jones as we advanced our two wholly-owned proof-of-concept stage clinical programs, JTX 8064 and Bopratilumab, advanced our fifth internally-derived development candidate into IND enabling studies, and continue to drive exciting new programs from our discovery engine. We anticipate 2022 to be a pivotal year as we look to report clinical data from innate and select and advance our discovery pipeline. Our teams continue to stay focused on making a significant positive impact on the lives of cancer patients, especially in the settings where patients have few therapeutic options. On that particular note, As the use of PD-1 inhibitors continues to grow and expand into earlier lines of therapy, including non-metastatic settings, the size and scope of the PD-1 inhibitor resistant market continues to grow. While recognizing the important impact of PD-1 inhibitors, more patients are resistant to the therapy than benefit from it. In many tumor settings, the only next option for these patients is either chemotherapy, which is not particularly effective, or an experimental therapy. We believe PD-1 inhibitor resistance defines one of the most challenging problems as well as opportunities in IO research. Scientific data continues to mount that specific immune cell types, myeloid cells as an example, may be key to the mechanisms of PD-1 inhibitor resistance. This highlights the importance of our translational science platform whereby we are able to interrogate and deconstruct the complexity of all the immune cell types in human tumors, allowing for a systematic way to prioritize discrete cell type associated mechanisms. As such, our efforts into the myeloid system have led us to the low receptor, or ILT, family, with LIL-RB2 in the lead. JTX 8064 blocks the function of low RB2 or ILT4 on tumor-associated macrophages and other myeloid cells and aims to convert immunosuppressive macrophages to an anti-tumor state and initiate T-cell responses. We believe it may create a bridge between the innate and adaptive immune systems. This is something T-cell checkpoint inhibitors cannot do alone, and the science tells us it may result in the potential to reverse PD-1 inhibitor resistance. We've stayed true to our initial scientific mission of investigation, discovery, and development of therapies that target different cell types in the tumor microenvironment. And our growing pipeline reflects this differentiated approach. We believe this is the best way to bring a positive impact to the particular challenges that cancer patients face. As we reflect on the highlights of 2021, we began the year with the initiation of the innate trial of JTX8064 in dose escalation as monotherapy and in combination with our PD-1 inhibitor, chemovalimab, or PIMI, in advanced solid tumors. In April, we presented the preclinical data at AACR, which supported our thesis that JTX8064 has the potential to reverse PD-1 inhibitor resistance. In June at ASCO, our teams presented trials-in-progress posters on INATE, as well as our Phase II select clinical trial. Also in June, we earned our first milestone payment of $25 million under the Gilead License Agreement with the FDA clearance of the IND of GS1811, formerly JTX-ATE11, an anti-CCR8 antibody. We also announced continued pipeline expansion with the addition of two new programs targeting LIL-RB4 and LIL-RB1 at our R&D date. In October, we announced the completion of both the mono and combo dose escalation portions of the innate study. We initiated the mono and combo expansion cohorts at the recommended phase two dose of JTX8064. Currently, there are eight Phase II tumor-specific expansion cohorts ongoing, one monotherapy, and seven combination therapy cohorts that make up the innate trial. It's our intention to announce a meaningful body of data from the innate trial this year. We've also continued enrollment in our randomized Phase II proof-of-concept trial of volpratilumab, or Vopra, in combination with PIMI. The SELECT trial is a randomized phase two study and on small cell lung cancer with a stringent biomarker selection of patients that we believe to be the most appropriate for both the VOPRA and PD-1 inhibitor mechanisms. It's a direct result from learnings from our clinical trials, and we believe best position in io-naive patients. We expect the clinical data readout from the full trial in the second half of this year. Our discovery team has advanced our new LRB4 program, now called JTX1484, into IND-enabling studies, and we are targeting an IND submission for this program in 2023. Our discovery engine continues to target the low-receptor family and other myeloid-based targets, as well as creating additional opportunities from other immune cell types. We're also excited by our new efforts to leverage our robust discovery of highly specific antibodies into the discovery and development of rationally designed bispecific and multispecific antibody formats, which may ultimately further enhance clinical benefit. We ended 2021 in a strong financial position and are situated to fund jounce past the proof of concept inflection points of innate and select while continuing our robust novel discovery efforts identifying and progressing new mechanisms. 2022 is expected to be an important year for John's and for the patients we hope to help. We head into the year with the momentum of both the innate and select proof of concept trials and expect data from both trials this year. I'll now turn the call over to Beth to provide a clinical pipeline update.
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