Burning Rock Biotech Limited

Good day and thank you for standing by. Welcome to Burning Rocks 2021 First Quarter Endings Conference Call. At this time, all participants are in a listen-only mode. After speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. Before we begin, I'd like to remind you that this conference call contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 as amended and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as will, expects, anticipates, future, intents, Thank you for your attention. all of which are difficult to predict and many of which are beyond Burning Rock's control. Fault-looking statements involve risks, uncertainties, and other factors that could cause actual results to differ materially from those contained in any such statements. Burning Rock does not undertake any obligation to update any fault-looking statement as a result of new information, future events, or otherwise, except as required under applicable law. And now I'd like to hand the conference over to the management team of Burning Rock. Thank you. Please go ahead.

Thank you. Welcome to Burning Rock's earning call. I'm Yusheng Han, the CEO and founder of Burning Rock. And today we also have our CEO, Shannon Chai, our CTO, Zhou Zhang, and our CFO, Leo Li, in this call. The burning rock is a Chinese molecular diagnostic leader for precision oncology. There are two parts of our business. The first one is early detection using liquid biopsy for pan-cancer. And the second is for therapy selection and MRG. We will turn to page four. So today we're going to recap the recent programs for dose early detection and therapy selection. So for early detection, We are very excited to launch the multi-omic 22 cancer test, which is called Present. And the second thing is that the PREDICT trial for nine cancer tests is going well, smoothly. And our COO, Shannon Tsai, will talk about these two trials in detail. And in the meantime, The preparation of commercialization of the safe cancer test is ongoing, and we are continuously building our commercial and operating team and optimizing the SOPs. Nothing significantly important to report for the safe cancer so far, but if you have any questions, welcome to us at the Q&A session. And for the therapy selection, we have great news that finally the result of a liquid biopsy card of SEQC2 is published in Nature Biotech Knowledge, which proves that burning wax quality is the top tier level in the world. And our CTO, Joe, will talk about that in detail. And after that, our CFO, Leo, will talk about the financial numbers. So let's turn to Shannan first about the early detection part. Shannan?

All right. Thanks, Yusheng. So if we go to page six, this is to recap the product development roadmap for our early detection programs. So we started with the proof of concept on lung cancer, and the study and the methodology has been actually most recently accepted for publication. and a manuscript is pending publication right now. And then we moved on to three cancer tests which we presented the data last year in January in the AACR special conference on liquid biopsy We were able to achieve 95% specificity and 81% sensitivity. And then most recently, I think a lot of you are familiar with our six cancer test results that we released last year in November on the East Asia. The six cancer tests include or covers lung cancer, colorectal cancer, liver, ovarian, pancreatic, and esophageal. and the data showed that we were able to maintain our 81% sensitivity while improving the specificity to about 98%. And we also were able to achieve a reasonably good accuracy for TOO analysis, tissue of origination analysis from this as high as about 81% accuracy from the six cancer tests. in the results we released last year. And then for the six cancer tests, after the Thunder study, which was the case control study to validate the specificity and sensitivity of the product, we also were planning to move on to a prospective interventional study for asymptomatic populations. So that study is currently under planning and I'm going to show you an overview in later pages. And today, we really wanted to focus on the most recent, very exciting progresses that we are making on the NYE cancer test and looking forward to the 22 cancer test. As Yusheng has mentioned, for the NYE cancer test, our current status is that the PREDICT study that we started earlier is going very smoothly. The progress is as expected. And also for the 22 cancer tests, first of all, the 22 cancer will eventually cover about 80% of China's cancer incidence altogether. And then for this 22 cancer test, we have just kicked off a large clinical development study a few weeks ago in May 2021, and it's called Prescient. So in the later pages, I'm going to tell you a little bit about the design and timeline for both the PREDICT study and the Prescient study. So if we go to page seven, this is sort of an overview of the clinical programs that we are looking at for our early detection programs. So for each product or each version or each generation of our products, there are roughly four phases for the product development or clinical development. The first is the assay development in which we do the panel design, the marker selection, and also the assay chemistry finalization. And then we do the analytical validation to validate the performance analytically including using reference materials or clinical samples to validate the performance specifications. And then we move on to the case control study. And for this one, you can sort of think of the CCGA studies from Grail. It's similar to what we're laying out here as the case control study. In these studies, they are real clinical studies. cases and controls or healthy controls. And in these studies, we will be able to validate the sensitivity, specificity, and TO accuracy, the key statistical performance features for the OA detection products. And then after that, eventually, we would want to move on to the asymptomatic population in which we will be able to to validate again the sensitivity specificity to accuracy in these eventually intended to use population. And for this one, you can sort of compare that to the Pathfinder trial from GRIL as well, in which it's testing gallery on the asymptomatic population in a prospectively recruited cohort. So for our three cancer tests, after we finished the essay development and analytical validation, we didn't move on to the clinical development, so we moved forward to the six cancer tests. And for the six cancer tests, we have so far completed the essay development and analytical validation, as well as the case control study, which was what we mentioned in the last page as the thunder study. were able to show in a training and a pre-specified validation cohort the 81% of sensitivity and 98% of specificity. And then, again, a prospective interventional study on the asymptomatic population for the sixth cancer test is currently under planning. We hope that we will be able to disclose more details about that study once it's finalized and released or kicked off in the near future. And then, in the meanwhile, in a parallel, we are also moving on to cover more cancer types, of course. So for that night cancer test, we have already finished the assay development, which means that we have finalized the chemistry and also the marker selection, the panel design, et cetera. And the analytical validation for that product is currently ongoing. And in the meanwhile, we were able to start the enrollment on the case control, the predict study in parallel to sort of shorten the development time overall. and the PREDICT study, if you might recall, actually contains two phases. And in phase two, it does contain a factor of testing or validating among a small asymptomatic cohort or healthy controls. So that's why over here, we are sort of standing that a little bit beyond the case control study, even though it's not fully powered. to test on the healthy or asymptomatic population. So in the later pages, I will be able to give you more details of how the two phases of this study will work out. And then for the 22 cancer test, we are actually working on developing this next generation of the product in the meanwhile, and it's currently under the assay development stage. However, because we collected a lot of information or preliminary results from the previous versions of the products, we were able to finalize the design of that depression study as the case control study that we are planning for the 22 cancer tests. So that's why we have kicked off the enrollment of this study so we will be able to recruit samples, clinical samples for future testing or validation for these 22 cancer tests in parallel with the product development efforts. So if we move on to page eight, this outlines the study design of the PREDICT study. Again, it covers nine cancer types, which are listed on the upper right here. Overall, this study contains more than 14,000 participants, about 55% of them coming from cancer, about 10%, less than 10% coming from benign diseases, and the rest from healthy controls. One thing we wanted to point out is that more than 75%, at least 75% of the cancer participants will be from stage 1 to 3. So most of the cases we will focus primarily on the early stage patients we wanted to know or be able to assess our sensitivity among the early stage patients because that's what really matters. And then in terms of the study design, as I mentioned, there will be two phases. The phase one will be an open label design which means that for Phase 1, we will divide the Phase 1 samples into the pre-specified training and testing steps. And within the training, we will be able to customize or tune or model and cut off and then to be able to report the results or performances on the validation set within the Phase 1 cohorts. And then after that, the model, both the assay and the model will be locked and then we move on to phase two sample processing. So in phase two, we will have a totally independent set of data to test or to validate the performance of the locked model or method from phase one and to be able to have a rather for the accurate assessment of the model performance for the night cancer test. And then one thing we also wanted to point out is that for predict study participants, we are planning for a 12-month follow-up, especially on the healthy controls, which will have a positive testing result so that we will be able to have a positive predictive value assessment among these healthy control cohorts over the follow-up. So on the next page, we listed out the objectives and timeline for PREDICT. So of course, the primary objective will be to test the to train and validate the sensitivity specificity NTO analysis of our CFDNA methylation-based model for these nine types of cancers. And then for the secondary objectives, we, of course, wanted to learn about the performance among different types of cancers and also among different stages of cancers. And also we wanted to know whether and other biomarkers, including protein biomarkers that we are processing in parallel in these PREDICT samples, whether they will help in any way, which we do expect they might help in at least some of the cancer types, and how do they help and how do we combine them with the methylation markers. That's something we will explore from the PREDICT data. And then last but not least, we will have a chance to evaluate the PPV in this cohort as well after the 12-month follow-up period. And then in terms of the timeline, we expect the Phase I enrollment to finish, to complete by 2022. And then we will be able to have a readout of the Phase I data by the end of 2022. And then by the end of 2023, we will have the readout for Phase II data. and by 2024, we will be able to finish the follow-up and have the complete data set for the PREDICT study. On page 10, we wanted to briefly mention the kind of attention that the PREDICT study has attracted among the Chinese oncology community. And this is the picture of the PREDICT Dr. Jia Fan, when he presented as a keynote speech on the National Oncology Conference on Standardized Diagnosis and Treatment Conference that was held a couple of weeks ago in Beijing. And the predict study design and also the news was announced during that conference by Dr. Jia Fan, and it has attracted a lot of interest. and attention from the community so far. And then moving on to the next page, page 11 lays out the study design for depression study. So compared to the PREDICT study, depression study actually has two dimensions of expansion. The first is obviously extending from the nine cancer types to the 22 cancer types which are listed on the upper right again. and also it has similar design but not divided into the two phases. However, it has another dimension of extension is that beyond methylation and protein markers, we will profile other omics of biomarkers in the prescient samples as well. We won't be able to disclose too much detail on what exactly are we testing there, but the expansion will be, the exploration from the prescient study will be focused not just on the cancer type expansion but also on the omics combination. And then on page 12, again, the objective for depression study as to we will be able to validate the methylation plus protein markers among the 22 cancer types. And then we will be able to assess different types The performance among different stages and different types of the cancer. And then very importantly, we will be able to evaluate the potential combination, including methylation protein and other genetic epigenetic biomarkers from the prescient study. In terms of the timeline, we expect to complete enrollment for prescient by 2023. and then for depression study, we will divide it again into specified training and validation sets. So by the end of 2023, we expect to be able to lock the model for the 22 cancer types from the training set. And then in another year, we will have the study read out for the validation set. So on page 13, this is again to introduce to you the principal investigators for PREDICT and Crescent. We are very proud that we have successfully attracted the top tier oncologists in China to lead for the PREDICT and PRESSION trials. So on top, Dr. Jia Fan is the leading PI for the PREDICT trial. He is a fellow of the Chinese Academy of Sciences and also the president of the Shanghai Zhongshan Hospital. So for those of you who are not very familiar with the Chinese hospitals, Shanghai Zhongshan Hospital is one of China's are the world's largest comprehensive academic hospital. And it performs more than 100,000 operations each year and serves about 169,000 inpatients per year. And in 2019, it was ranked top five among China's general hospitals. So on the bottom line, Dr. Jie He, he is the leading PI of our prescient study and he is also a fellow of the Chinese Academy of Sciences and also president of the hospital called Cancer Hospital of the Chinese Academy of Medical Sciences. This hospital is arguably the top cancer specialist hospital in China. So we are very proud that these top oncologists are leading our predict and present studies. And it actually reflects the sharply growing interest and acknowledgement from the oncologist community in China for cancer early detection, especially in the past year or so. It did attract a lot of attention in this field. and also we think high quality of cohorts and data will ensure timely recruitment and of course successful operation of the study which will serve as a key in establishing a leadership position and maintaining our leadership position in the development of our cancer early detection products. So we are excited to share with you these PIs and their results. their level among the oncologist community in China. So with that, I think I'll pass to our CTO, Dr. Zhou Jian, to tell you more about our recent results released from the SQC2 study. Zhou.