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8/5/2021
call is scheduled to start momentarily. Please continue to stand by and thank you for your patience. Thank you. Thank you. Thank you. Thank you. Good morning ladies and gentlemen. and welcome to the Johns Therapeutics Second Quarter 2021 Earnings Conference call. At this time, all participants are on 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 is being recorded at the company's request. I will now turn the call over to your host, Mark Kior, with Johns Therapeutics. Please go ahead.
Thank you, Operator. Good morning, and welcome to the Johns Therapeutics second 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 and media section of our website at www.johnstx.com. Speaking of today's call will be our CEO and President, Dr. Rich 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 efforts. And lastly, our CFO, Kim Drapkin, will review our second 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, August 5th, 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'll now turn the call over to Rich.
Thanks, Mark, and good morning, everyone. John set a very productive second quarter as we've made important progress across all areas of the company. In parallel with our ongoing pipeline efforts, the I.O. sector as a whole recently seen exciting new advances for PD-1 or PD-L1 inhibitors and I.O.-I.O. combinations. While this is great news for some patients, Most of the added benefit primarily occurs in the PD-1 inhibitor naive patient settings. Still sorely lacking are the desired advances for the PD-1 inhibitor resistant patients, a growing and unmet need, as more and more patients do not respond to the wide and growing adoption of PD-1 inhibitor therapy as a first IO-based treatment. We believe that our approaches aimed at innate immune system cells, such as macrophages, have the potential to address this challenging gap of effective treatment for PD-1 inhibitor resistant tumors. By identifying and inhibiting key checkpoints of the innate immune system, new populations of T cells can be primed and directed to the tumor, something T cell checkpoints alone cannot do. For patients This might mean a recharged and more comprehensive immune response, and one that may overcome that significant barrier of treating PD-1 inhibitor resistance or non-responsiveness. This substantial unmet need is why we consider JTX8064, our low RB2 or ILT4 inhibitor, to be our highest priority program. JTX8064 aims to convert immunosuppressive macrophages to an anti-tumor state and can create a bridge between the innate and the T-cell arm of the immune system. As a reminder, innate, our phase one clinical trial studying JTX8064, has moved quickly through the necessary monotherapy dose escalation portion of the trial. Beth will share some of that progress with you in a few moments. More broadly, we've made significant progress this quarter across our pipeline. One of these accomplishments was the FDA clearance of our fourth internally generated IND, resulting in our first milestone under the Gilead License Agreement of JTX 1811. That $25 million milestone allows us to extend our cash runway through the third quarter of 2023. further solidifying the strength of our balance sheet. With runway through this period, we are well-positioned to fund our two wholly-owned POC studies, Innate and Select, past their inflection points, while continuing our robust first-in-class discovery efforts that now include additional targets of the low RV family. During the quarter, we presented two Trials in Progress, or TIPS, posters at ASCOB and continue to enroll patients in innate and select. Enrollment in both trials is on track. We also made key employee hires, most notably our chief scientific officer, Dr. Dimitri Vidershan. Together, under Dimitri's leadership, we continue to focus on identifying and progressing new mechanisms that target a diverse set of immune cell types in the tumor microenvironment. We were pleased to be able to share these exciting advancements at our first virtual R&D day in June. Now turning to SELECT. Enrollment also continues to progress in our Phase II randomized proof-of-concept trial of volpertilumab in combination with our own PD-1 inhibitor, PIBI, in IO-naive non-small-cell lung cancer patients. The key feature of this study is a rigorous biomarker selection of patients. utilizing TIS-VOPRA, an 18-gene signature that includes genes predictive for both a PD-1 inhibitor response via CD8 cells, as well as the unique pharmacodynamic effect of VOPRA via CD4 cells. We believe this biomarker selection is more stringent than the typical PD-L1 IHC scores, and we look forward to sharing data in 2022. Beyond our development programs, we continue to make progress advancing our early-stage pipeline. Our discovery engine and approach has been both productive and value-generating, and we expect to see more novel programs like JTX 8064 and JTX 1811 emerge from our efforts. Looking ahead, we remain committed to achieving the milestones we laid out for the remainder of this year and beyond. As I mentioned earlier, we achieved our JTX1811 goal for the year when the FDA cleared our IND. This CCR8 program, now referred to as GS1811, is now in Gilead's hands, and we look forward to following its progress through development. Looking ahead, we plan to evaluate safety and determine the recommended phase two dose for JTX8064 and open tumor-specific expansion cohorts in the second half of 2021, now expected in Q3 2021. Continue enrollment to enable reporting of efficacy and related biomarker data for GOPRA and TIBI from the select study in 2022, 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'll now turn the call over to Beth to provide a clinical update. Beth?
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