Burning Rock Biotech Limited

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Thank you. Welcome to Burning Rock 2021 Annual Conference Call. I'm Yusheng Han, the CEO and founder of Burning Rock. And today we have our COO, CTO, and CFO in the meeting. So let's turn to the page three first. And I will recap the highlights of 2021 and our recent progress. Then I will go through the outlook of 2022. After that, our COO, Shannon, will elaborate on our product line, especially early detection and MRD. Then our CFO, Leo, will work you through the financials. The Burning Rock started with the therapy selection business in 2024 and has grown to the market leader in this segment. The leading position has laid a good foundation and given us advantages moving forward to new business of early detection, MRD, and pharmaceutical collaboration. We have strong branding on our technology and product quality which help us attract talent. In the network we have built across thousands of colleges and hundreds of hospitals enable us rapid initiation of R&D starters on new products such as as well as fast distribution when they go to the market. The existing high testing volume makes it possible for us to continue lowering the cost. that's why we aim to tackle the therapy selection, MRD, and early detection market in parallel in the coming few years. Let's turn to page four and recap our 2021 and recent progress. For therapy selection, we recorded 38 volume increase in 2021 and reached 70K units despite of the COVID influence. And in-hospital model growth was and Xiaozhi Hu, Xiaozhi Hu. We have talked several times about our tumor-informed MRB technology via profit. It has shown very promising performance with the sensitivity on par with what has been shown in Matara and Archer's publication. And we have some exciting readouts that will be released in AACR, and Shannon will elaborate more on that. For pharma collaborations, the growth trend continues, and new contact value reached are the 183 million in 2021, which is 5.7 times versus 2024 year. In terms of early detection, the nine cancer test development is on track, and the first large cohort will read out in 2022. The commercialization of six cancer early detection is almost ready. We will collaborate with our partner hospital to start commercialization once the COVID lockdown is released. And let's turn to page five. In page five, I will talk about what we can expect in 2022. For therapy selection, new product line will start to contribute revenue, including DetermineX, which we license in from OncoSight, and MyChoice HRD Plus, which we license in from Mirage. The trend of in-hospital model growth will continue with more new contract of hospital and more type of product contracted with existing hospitals. With the growing top line, we expect the operation efficiency of therapy selection better than before. For MRD, we launched the commercialization in March based on the solid data we have accumulated. The initial feedback from the market is quite positive. And as I said one minute ago, we will release the data on lung cancer baseline and ASDR and additional studies in other types of cancers are under planning. The business of pharmaceutical collaboration will continue to grow and contribute higher value to our revenue this year. For early detection, we have two large product development studies going on, each over 10,000 subjects, which you might have already known. And the first intent of EU's population, multi-cancer interventional study in China, will launch in China. Then let's turn to page six. I'll spend probably one minute explaining the meaning of the new approved 19K. Although it's still a small panel, it's a very minimal step compared with existing approved panels. First, the DNA input is only 30 nanograms, which means that much lower than all the other capture sequencing base kit, meaning it can be applied to small samples from pulmonary puncture biopsy. and the second meaning is that it's the first case that copy number variation is approved and the gene mat is included in that. And also, it's a case with open side detection of fusion. So, that's basically the overlook of 2022. I will turn to Shannon about the product line development. Thank you.

Okay, thank you, Yusheng. So let's move on to page 8. This is the overview of our early detection product development roadmap. This might look very familiar to you because we have actually shared this map for quite a few times in the past calls. So the overall program stays the same as previously communicated, where our six cancer products have entered commercialization. and now the development and validation work are now heavily going on for our nine cancer products. And then if we go to page nine, here we have a little bit more on details. In the most recent few months, we have two particular updates I think are worth mentioning. First, on our six cancer products, During our last quarter's call, I think we talked about the prospective and interventional studies on intended use population that we were planning on. So we are now happy to share that this study, which is now named PREVENT, has most recently obtained approval from the Human Genetic Resources Administration in China, and so it's now ready to start approval. And the second thing we want to share is that we had our first data readout on the night cancer product from the case control pilot validation study called PROMIS. The performance so far looked quite promising. Since the statistics are still being summarized and finalized, we couldn't share more details right here, but we are submitting the results from PROMIS to the ISMO conference this year, so please stay tuned on that if you're interested. And also on a side note, the PREDICT study, which we have talked about many times, it's a larger scale, two-phase case control cohort study. It was expected to have some data readout later this year. However, due to the recent COVID situation in China, we are having a mild delay on the enrollment speed, and we now expect to complete enrollment for PREDICT phase one in a few months. and we will have the data readout in 2023. So now let's go on to page 10. This page lists our publications on our early detection technology, also SEEK. At the bottom are some new information which are our two most recent posters which will be shown in the upcoming AACR conference. And on page 11, Here, we show a little bit more detail on one of the posters. In this poster, we well-released part of the analytical validation data for apoptosis zinc in six cancers. And we were able to demonstrate a limit of detection between 0.02% and 0.11% across different cancer types. Again, we invite you to pay close attention to our posters in ACR if you're interested. So now let's actually skip the next couple pages and jump to page 15 directly. And I would like to spend some time to talk about our progress on MRD. First of all, this graph on page 15 actually comes from an interesting review article from DocSmack DM on MRD applications on solid tumors. I think they are a good demonstration on the evolving The main message here is that MRD can potentially be used in two clinical scenarios. The first one is the so-called landmark analysis, where MRD status is assessed right after operation or other curative therapy for cancer patients. It serves as a highly significant predictor for prognosis. and almost unanimously in all studies across all cancer types this utility was proved again and again. The second is the so-called surveillance analysis where MRD status is assessed longitudinally and repeatedly along the way. The plausible hypothesis here is that such monitoring through MRD tests may be able to flag relapse events ahead of time before radiological science however that an earlier intervention based on MRD monitoring can lead to survival gain in the end is actually far less clear than the prognosis prediction effect itself and it has been there has been some reasons of conflicting conclusion published you know on the surveillance analysis utility so there's more debate on that and then on page 16, the InVigor 010 study shown here in our opinion is a very important study to demonstrate clinical utility of MRD beyond prognosis prediction based on the landmark analysis. Because in this study it was shown quite clearly even though from a retrospective analysis that only MRD positive patients benefited from the adjuvant immunotherapy but not the MRD negative patients. Of course, more evidence needs to be generated, and we're also seeing some conflicting data, such as from Empower 0410, so still a long way before a full consensus can be reached on MRD utility and industry standards. Nonetheless, it has shown great promises, and in Burning Rock, we are also actively collaborating with Chinese clinicians to validate our MRD technology and establish utility for our MRD products. On the right side on page 16 is a consensus on MRD applications for lung cancer by Chinese clinicians led by Dr. Li Yilong. And this was developed and published about exactly a year ago. So this is an example to show the fast adoption of MRD by Chinese doctors. And we are witnessing right now similar consensus being discussed and developed in other cancer types such as colorectal cancer. So let's skip page 17 and go directly to page 18. We wanted to show you some of our own progresses. On page 18, we outline Burning Rock's development and validation works for our MRD products. In the upcoming AACR conference, we have two posters showing our first data readout on our personalized MRD technology called ER-Profit on lung cancer and colorectal cancer, respectively. We have more details on the next two pages on that. In addition, as mentioned before, we have also launched our MRD product commercialization based on BR profit just a couple of weeks ago. So now I'll take a few minutes to talk a little bit about our MRD validation data itself. First on page 19, we compared our BR profit, which is again our personalized MRD approach with our fixed liquid biopsy panel on a group of lung cancer patients from the METL study. So very interestingly, we used both tumor-naive calling and tumor-informed calling for the fixed panels, and we compared both with the personalized approach. So this is meant to compare and contrast whether and how much the personalized approach is more sensitive than the fixed panel approach. As you can see here, while both fixed panel and BR-PROFIT generated highly significant prediction for prognosis, BR-PROFIT was still indeed more sensitive because it identified more MRD positive patients at the landmark and also it showed higher relapse rate among MRD negative patients. I also wanted to point out that what's being shown on this graph are just a subgroup enriched for patients who relapsed. In the full medical cohort, which we just most recently had the data, the full medical cohort containing about 200 patients, MRD negative patients assessed by Bioprofit actually achieved a 12-month recurrence-free rate of greater than 95%. So we were we are right now preparing for publishing this data somewhere later this year. So on the next page, on page 20, let's take a quick look on our data in colorectal cancer. Even though this is a smaller cohort, it showed similar results as in lung cancer. Their profits showed greater sensitivity than fixed panel approach when comparing their positive rate among preoperative baseline samples. And then for the landmark analysis, their profit actually showed greater specificity than the tumor naive calling approach. Again, we'll be able to show more details during our AACR poster presentation. So stay tuned if you're interested in more details. So now I'll turn to our CFO Liu to walk you through our financials.