Aankondiging • Dec 02
Burning Rock Biotech Limited, Annual General Meeting, Dec 23, 2025 Burning Rock Biotech Limited, Annual General Meeting, Dec 23, 2025, at 10:30 China Standard Time. Location: 6/f, building 10c, pujiang smart plaza, no. 2168 chenhang highway, minhang district, shanghai China Aankondiging • Sep 24
Riken Genesis Co., Ltd. Announces OncoGuide OncoScreen Plus CDx System Now Approved in Japan as A Companion Diagnostic for Capivasertib in Breast Cancer Riken Genesis Co., Ltd. and Riken Genesis Co., Ltd. announced that the OncoGuide OncoScreen Plus CDx System based on OncoScreen™? Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW). The CDx System is a combination medical device consisting of the OncoGuide™? OncoScreen™? Plus CDx Kit and the OncoGuide™? oncoScreen™? Plus CD x Analysis Program, designed to be used with a next-generation sequencer. It enables the detection of PIK3CA, AKT1, and PTEN alterations in a single test. This diagnostic tool is intended to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor (HR)-positive, HER2-negative breast cancer who have progressed following endocrine therapy and whose tumors carry one or more PIK3CA, AK T1, or PTEN gene alterations. The approval of this CDx system supports the use for patient selection for capivasertib in combination with fulfilrant. With the introduction of this CDx System into clinical practice, access to precision diagnostics for breast cancer patients in Japan is expected to improve, ultimately expanding therapeutic opportunities. Riken Genesis will begin preparations for insurance coverage, aiming to ensure timely and equitable access for all eligible patients. Aankondiging • Dec 04
Burning Rock Biotech Limited, Annual General Meeting, Dec 31, 2024 Burning Rock Biotech Limited, Annual General Meeting, Dec 31, 2024, at 10:00 China Standard Time. Location: 6/f, building 10c, pujiang smart plaza, no. 2168 chenhang highway, minhang district, shanghai China Aankondiging • Oct 11
NMPA Approves Burning Rock and Dizal's First Co-Developed NGS-Based Companion Diagnostic for Lung Cancer in China Burning Rock Biotech Limited announced that the companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through their collaboration, has been approved by the National Medical Products Administration (NMPA) of China. This marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China. The approval of this CDx test is the result of the simultaneous development of Burning Rock's independently developed LungCure CDx (a kit for the combined detection of 9 human gene mutations) and Dizal's innovative EGFR exon20ins targeted therapy - sunvozertinib, providing an innovative precision treatment solution for non-small cell lung cancer patients with EGFR exon20ins. Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval was based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed objective response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 61%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in = second-line (WU-KONG1 Part B) and first-line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2). On March 11, 2022, the National Medical Products Administration (NMPA) officially approved the registration of the company's Human Nine-Gene Mutation Joint Detection Kit (reversible termination sequencing) (commercially known as "LungCure CDx") as a Class III medical device product. This test kit is Burning Rock’s second NMPA-approved companion diagnostic multi-gene tumor mutation co-detection test kit based on high-throughput sequencing technology and meeting companion diagnostic standards. It can be used for in vitro detection of multiple mutation statuses of EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET genes in non-small cell lung cancer patients, including point mutations, insertions/deletions, fusions (rearrangements), amplifications, etc., to comprehensively guide targeted therapy for non-small cell lung cancer. "LungCure CDx" has undergone rigorous clinical validation, enhancing the detection capability of rare mutation types. At the same time, "LungCure CDx" has entered into companion diagnostics development strategic partnerships with several well-known domestic and international pharmaceutical companies to jointly promote the development of standardized and precise diagnosis and treatment in oncology. Aankondiging • Aug 19
Burning Rock Biotech Announces Expected Delisting of American Depositary Shares Burning Rock Biotech Limited announces that, on August 19, 2024, it intends to submit requests (a) to the London Stock Exchange (the "LSE"), to cancel the admission to trading on the Main Market of its American Depositary Shares representing the class A ordinary shares of the Company (the "ADSs"), and (b) to the UK Financial Conduct Authority, to cancel the listing of the ADSs on the Official List. As a result of sustained low volume of trading and liquidity in the ADSs on the LSE, and taking into account the costs associated with maintaining such listing in place, the Company is seeking the delisting and cancellation of admission to trading of the ADSs from the LSE. It is anticipated that the Delisting will take effect on or about September 18, 2024. Following the Delisting, the ADSs will continue to trade on the Nasdaq Global Market. Aankondiging • May 24
Burning Rock Biotech Limited to Report Q1, 2024 Results on May 29, 2024 Burning Rock Biotech Limited announced that they will report Q1, 2024 results at 9:30 AM, US Eastern Standard Time on May 29, 2024 New Risk • Apr 20
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.7% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 23% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (2.7% increase in shares outstanding). Market cap is less than US$100m (US$75.9m market cap). Reported Earnings • Mar 31
Full year 2023 earnings released: CN¥6.38 loss per share (vs CN¥9.35 loss in FY 2022) Full year 2023 results: CN¥6.38 loss per share (improved from CN¥9.35 loss in FY 2022). Revenue: CN¥537.4m (down 4.6% from FY 2022). Net loss: CN¥653.7m (loss narrowed 33% from FY 2022). New Risk • Mar 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 26% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$81.9m market cap). New Risk • Jan 27
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CN¥677m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CN¥677m free cash flow). Earnings have declined by 26% per year over the past 5 years. Aankondiging • Jan 05
Burning Rock Announces Receipt of Notification from NASDAQ Burning Rock Biotech Limited (the ‘Company’ or ‘Burning Rock’) announced that it has received written notification from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (‘NASDAQ’) dated December 29, 2023, indicating that for the last 30 consecutive business days, the closing bid price for the Company’s American depositary shares (the ‘ADSs’) was below the minimum bid price of USD 1.00 per share requirement set forth in NASDAQ Listing Rule 5450(a)(1). The NASDAQ notification letter has no current effect on the listing or trading of the Company’s securities on NASDAQ. Pursuant to the NASDAQ Listing Rules 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until June 26, 2024, to regain compliance with NASDAQ’s minimum bid price requirement. If at any time during the compliance period the Company’s closing bid price is at least USD 1.00 for a minimum of 10 consecutive business days, Nasdaq will provide the Company with a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance by June 26, 2024, subject to the determination by the staff of NASDAQ, the Company may be eligible for an additional 180-day compliance period. The Company’s business operations are not affected by the NASDAQ notification letter. The Company intends to monitor the closing bid price of its ADSs between now and June 26, 2024 and will take all reasonable measures in order to regain compliance with the NASDAQ minimum bid price requirement. Reported Earnings • Dec 01
Third quarter 2023 earnings released: CN¥1.71 loss per share (vs CN¥2.23 loss in 3Q 2022) Third quarter 2023 results: CN¥1.71 loss per share (improved from CN¥2.23 loss in 3Q 2022). Revenue: CN¥127.6m (down 18% from 3Q 2022). Net loss: CN¥175.0m (loss narrowed 24% from 3Q 2022). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in the US. Aankondiging • Nov 23
Burning Rock Biotech Limited, Annual General Meeting, Dec 20, 2023 Burning Rock Biotech Limited, Annual General Meeting, Dec 20, 2023, at 10:00 China Standard Time. Location: 6/F, Building 10C, Pujiang Smart Plaza, No. 2168 Chenhang Highway, Minhang District Shanghai China Agenda: To ratify the appointment of Ernst & Young Hua Ming LLP as auditor of the Company for the fiscal year ending December 31, 2023 and to authorize the directors of the Company to determine the remuneration of the auditor; to re-elect Wendy Hayes, Min-Jui Richard Shen and Zhihong (Joe) Zhang as directors of the Company; and to authorize each of the directors of the Company to take any and all actions that might be necessary to effect the foregoing resolutions as such director, in his or her absolute discretion, thinks fit. Aankondiging • Nov 21
Burning Rock Biotech Limited to Report Q3, 2023 Results on Nov 30, 2023 Burning Rock Biotech Limited announced that they will report Q3, 2023 results Pre-Market on Nov 30, 2023 Aankondiging • Oct 16
Burning Rock Biotech Limited Receives Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test Burning Rock Biotech Limited announced that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA. OverC™ MCDBT is intended for early detection of multiple cancer types in adults of either sex, aged 50-75 years old, at average risk for cancer. OverC™ MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in the case-control study, THUNDER, and achieved a superior tissue traceability capabilities-the prediction accuracy of TPO1 (primary traceability organ) and TPO2 (primary and secondary traceability organs) was 83.2% and 91.7%, respectively. The technology and validation data have been released on Annals of Oncology in March 2023, showing an impressive performance of ELSA-seq using cfDNA in cancer detection and origin prediction. Reported Earnings • Sep 01
Second quarter 2023 earnings released: CN¥1.54 loss per share (vs CN¥2.50 loss in 2Q 2022) Second quarter 2023 results: CN¥1.54 loss per share (improved from CN¥2.50 loss in 2Q 2022). Revenue: CN¥146.3m (up 12% from 2Q 2022). Net loss: CN¥131.2m (loss narrowed 50% from 2Q 2022). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. New Risk • Aug 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable next year (CN¥368m net loss next year). Share price has been volatile over the past 3 months (9.8% average weekly change). Aankondiging • Aug 04
Burning Rock Biotech Limited to Report Q2, 2023 Results on Aug 31, 2023 Burning Rock Biotech Limited announced that they will report Q2, 2023 results Pre-Market on Aug 31, 2023 Aankondiging • Jun 29
Burning Rock Biotech Limited Announces Management Changes, Effective June 30, 2023 Burning Rock Biotech Limited announced the resignation of Dr. Shaokun (Shannon) Chuai as a director from the board of directors of the Company and as the Company’s Chief Scientific Officer, effective June 30, 2023. Dr. Shaokun (Shannon) Chuai will continue to serve as a senior advisor to the Company. Dr. Zhihong (Joe) Zhang, the Company’s Chief Technology Officer since March 2016, has been appointed as a new director of the Board, effective June 30, 2023. Aankondiging • May 31
Burning Rock Biotech Limited Reiterates Revenue Guidance for the Full Year 2023 Burning Rock Biotech Limited reiterated revenue guidance for the full year 2023. For the period, the company expects revenue guidance of approximately 20% growth over 2022. Reported Earnings • May 31
First quarter 2023 earnings released: CN¥1.81 loss per share (vs CN¥2.50 loss in 1Q 2022) First quarter 2023 results: CN¥1.81 loss per share (improved from CN¥2.50 loss in 1Q 2022). Revenue: CN¥142.5m (up 5.2% from 1Q 2022). Net loss: CN¥185.3m (loss narrowed 29% from 1Q 2022). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Reported Earnings • Mar 29
Full year 2022 earnings: EPS and revenues miss analyst expectations Full year 2022 results: CN¥9.32 loss per share (further deteriorated from CN¥7.65 loss in FY 2021). Revenue: CN¥563.2m (up 11% from FY 2021). Net loss: CN¥971.2m (loss widened 22% from FY 2021). Revenue missed analyst estimates by 4.7%. Earnings per share (EPS) also missed analyst estimates by 73%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in the US. Aankondiging • Jan 20
Burning Rock Biotech Limited Revises Revenue Guidance for Full Year of 2022 Burning Rock Biotech Limited revised revenue guidance for full year of 2022. For full-year revenue growth for 2022 to be approximately 10% compared to that of 2021. This represents an upward revision compared with the Company’s previous guidance on the full-year revenue growth of 5% as announced on November 15, 2022 in its financial results for the third quarter of 2022. Aankondiging • Jan 18
Burning Rock Biotech Limited Provides Earnings Guidance for Fourth Quarter Year of 2022 Burning Rock Biotech Limited provided earnings guidance for fourth quarter year of 2022. For the period, Company currently expects its revenues for the fourth quarter of 2022 to drop single digit compared to the corresponding period in 2021, with revenues from its central-lab and in-hospital segments dropping double digit, due to severe Covid-related disruptions, while revenues from its pharma service segment achieving continued strong growth, growing at triple digit compared to the same period in 2021. Aankondiging • Jan 04
Burning Rock Received FDA Breakthrough Device Designation for Its Overc(Tm) Multi-Cancer Detection Blood Test Burning Rock announced that its OverC(TM) Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration, which is the third of its kind globally. Under the FDA's Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer. This program is designed to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review. OverC(TM) MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer. OverC(TM) MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in the case-control study, THUNDER, and will be further validated in prospective interventional studies among asymptomatic population. Test results of "Detected" with the top one or two predicted tissues of origin of cancer-associated signals may indicate the presence of cancer and should be followed up by diagnostic tests suggested by qualified healthcare professionals in accordance with professional guidelines. Test results of "Undetected" do not rule out the presence of cancer, and individuals should continue with guideline-recommended standard of care screening tests. Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, thus improving patients' survival and quality of life while reducing social burden of the disease. Burning Rock started development of multi-cancer early detection technology based on DNA methylation in 2016, and the technology and validation data have been presented at ASCO, ESMO and other medical conferences, as well as journals such as Nature Biomedical Engineering, demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin. In May 2022, Burning Rock received CE mark for its OverC(TM) MCDBT manufactured in both the US and China facilities. Major Estimate Revision • Nov 23
Consensus revenue estimates fall by 13% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from CN¥609.3m to CN¥532.7m. Forecast losses increased from -CN¥7.13 to -CN¥9.86 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target down from US$7.56 to US$6.60. Share price was steady at US$2.30 over the past week. Reported Earnings • Nov 17
Third quarter 2022 earnings: Revenues and EPS in line with analyst expectations Third quarter 2022 results: CN¥2.67 loss per share (further deteriorated from CN¥1.64 loss in 3Q 2021). Revenue: CN¥154.6m (up 22% from 3Q 2021). Net loss: CN¥231.5m (loss widened 36% from 3Q 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) were also in line with analyst expectations. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 6 non-independent directors. Independent Director Wendy Hayes was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 09
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: CN¥2.50 loss per share (further deteriorated from CN¥1.96 loss in 2Q 2021). Revenue: CN¥130.8m (up 2.8% from 2Q 2021). Net loss: CN¥262.1m (loss widened 29% from 2Q 2021). Revenue missed analyst estimates by 14%. Earnings per share (EPS) also missed analyst estimates by 4.2%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Aankondiging • Oct 25
Burning Rock Biotech Limited to Report Q3, 2022 Results on Nov 16, 2022 Burning Rock Biotech Limited announced that they will report Q3, 2022 results Pre-Market on Nov 16, 2022 Major Estimate Revision • Sep 09
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -CN¥6.28 to -CN¥7.13 per share. Revenue forecast unchanged at CN¥613.2m. Biotechs industry in the US expected to see average net income decline 58% next year. Consensus price target of US$7.71 unchanged from last update. Share price rose 15% to US$3.59 over the past week. Major Estimate Revision • Sep 07
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -CN¥6.28 to -CN¥7.10 per share. Revenue forecast unchanged at CN¥611.9m. Biotechs industry in the US expected to see average net income decline 58% next year. Consensus price target down from US$10.69 to US$7.71. Share price was steady at US$3.20 over the past week. Reported Earnings • Sep 01
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: CN¥2.50 loss per share (down from CN¥1.96 loss in 2Q 2021). Revenue: CN¥130.8m (up 2.8% from 2Q 2021). Net loss: CN¥262.1m (loss widened 29% from 2Q 2021). Revenue missed analyst estimates by 14%. Earnings per share (EPS) also missed analyst estimates by 4.2%. Over the next year, revenue is forecast to grow 34%, compared to a 42% growth forecast for the Biotechs industry in the US. Aankondiging • Sep 01
Burning Rock Biotech Limited Provides Revenue Guidance for the Fiscal Year 2022 Burning Rock Biotech Limited provided revenue guidance for the fiscal year 2022. For the year, the company expects revenue of approximately RMB 620 million (USD 92.6 million) for now, and would like to highlight the risks of further Covid related impact in the second half of 2022 which is beyond the Company's control and inherently difficult to forecast. Aankondiging • Aug 05
Burning Rock Biotech Limited to Report Q2, 2022 Results on Aug 31, 2022 Burning Rock Biotech Limited announced that they will report Q2, 2022 results Pre-Market on Aug 31, 2022 Aankondiging • Aug 03
Burning Rock Biotech Limited, Annual General Meeting, Sep 08, 2022 Burning Rock Biotech Limited, Annual General Meeting, Sep 08, 2022, at 10:00 China Standard Time. Location: Shanghai office at 5/F, Building 1, No. 138 Xinjunhuan Road, Minhang District Shanghai China Agenda: To ratify the appointment of Ernst & Young Hua Ming LLP as auditor of the Company for the fiscal year ending December 31, 2022 and to authorize the directors of the Company to determine the remuneration of the auditor; to re-elect Feng Deng, Leo Li and Licen Lisa Xu as directors of the Company; to approve, confirm and ratify the adoption of the 2022 Long-term Equity Incentive Plan and the grant of options thereunder, the vesting of which is tied to the Company’s future stock performances. The 2022 Long-term Equity Incentive Plan and the grant of options thereunder are intended to replace the Company’s 2021 Long-term Equity Incentive Plan and the share incentive awards granted thereunder, which were approved by the Company’s board of directors on November 3, 2021 and shareholders on December 28, 2021; and to consider any other matters. Major Estimate Revision • Jul 15
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -CN¥6.23 to -CN¥9.71 per share. Revenue forecast unchanged at CN¥616.9m. Biotechs industry in the US expected to see average net income decline 65% next year. Consensus price target down from US$12.61 to US$10.74. Share price fell 11% to US$3.19 over the past week. Aankondiging • Jul 15
Burning Rock Biotech Limited Announces Board Changes Burning Rock Biotech Limited announced the resignation of Ms. Yunxia Yang as a director from the board of directors of the Company and a member of the compensation committee of the Board. Mr. Feng Deng, an existing director of the Board, has been appointed as a new member to the compensation committee to fill the vacancy created by Ms. Yang’s resignation. Aankondiging • Jul 01
Burning Rock Biotech Limited Launches Prospective Interventional Validation Study on Multi-Cancer Early Detection - the PREVENT Study Burning Rock Biotech Limited announced the launch of the PREVENT (a Prospective multi-canceR Early-detection and interVENTional) study, China's first prospective interventional study to evaluate the performance of Burning Rock's early cancer detection test, OverC(TM), in the asymptomatic population. The study is expected to enroll 12,500 asymptomatic individuals, to evaluate the performance of the OverC(TM) test in detecting 6 cancers (lung, liver, colorectal, esophageal, pancreatic and ovarian cancers). These 6 cancer types cover approximately 50% of China's total cancer incidence, and 62% of cancer mortality. The study is led by Dr. Weimin Li, head of the West China Hospital of Sichuan University. Aankondiging • Jun 24
Burning Rock Announces Changes to Board Composition Burning Rock Biotech Limited announced the resignation of Mr. Jing Rong as a director from the Board, and the appointment of Dr. Licen Lisa Xu as an independent director to the Board. Dr. Xu has over 15 years of experience in driving the productization and lifecycle for life science and biomedical products, from conceptualization and research to development and commercialization. She is the chief commercial officer of FlashDx Inc., a molecular diagnostics point-of-care solution company, and an independent board member of Ribbon Biolab, a company specialized in the production of synthetic DNAs. Dr. Xu served as a vice president on strategic product management and lifecycle management at Roche Diagnostics, a subsidiary of Roche Holding AG for the development of diagnostic tests, instruments and digital solutions, and a vice president on strategic marketing and product management at Illumina Inc. Dr. Xu has a Ph.D. degree in molecular biology from University of Zurich and a master of science degree in biophysics from Tsinghua University, and completed the business executive education program from Wharton Business School, University of Pennsylvania. Aankondiging • Jun 22
Burning Rock Biotech Limited (NasdaqGM:BNR) announces an Equity Buyback for $10 million worth of its shares. Burning Rock Biotech Limited (NasdaqGM:BNR) announces a share repurchase program. Under the program, the company will repurchase up to $10 million worth of its shares. The program will continue for 12 months. Aankondiging • Jun 16
Burning Rock Biotech Limited Presents Latest Clinical Data from Thunder Study At 2022 ASCO Annual Meeting Burning Rock Biotech Limited presented the final results from the multi-center case-control THUNDER study (THe UNintrusive Detection of EaRly-stage cancer, NCT04820868) in a poster entitled "Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies" at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. This is a comprehensive review of clinical performance after the four-year THUNDER study. Through a rigorous "three-stage" design: marker discovery and panel validation, model training and validation (retrospective), and independent validation (prospective), the THUNDER study evaluated the performance of a previously described cfDNA methylation-based technology ELSA-seq in early detection and localization of six types of cancer in lung, colorectum, liver, esophagus, pancreas, and ovary. In the study, a customized panel of 161,984 CpG sites was constructed and validated by public and in-house (cancer: n=249; non-cancer: n=288) methylome data, respectively. The study used the cancer-specific methylation regions for cancer detection as it can differentiate cancer signals from non-cancer signals, and identify the source (the tissue of origin) of the detected cancer signal. In the model training and validation (retrospective) phase, the cfDNA samples from 1,693 participants (cancer: n=735; non-cancer: n=958) were collected and approximately three-quarter of the samples were used to establish two multi-cancer detection blood test (MCDBT-1/2) models with different cut-offs (cancer: n=399; non-cancer: n=626). About a quarter of the samples were used to build a validation set to test the two multi-cancer detection blood test models (cancer: n=301; non-cancer: n=123). In the independent validation (prospective) phase, both models was blindly validated on a prospectively enrolled, independent validation set(cancer: n=473; non-cancer: n=473) to test the stability of high-dimensional modeling more rigorously. The study showed that the sensitivity of MCDBT-1 was 69.1% at a specificity of 98.9% in the independent validation set. MCDBT-2 yielded a higher sensitivity (75.1%) and a slightly lower specificity (95.1%) compared to MCDBT-1. The study also showed that ELSA-seq can accurately trace the tissue of origin (identify where the cancer is located in the body). For MCDBT-1, the accuracy of top prediction origin (TPO) was 89.7% in the training set, 82.8% in the validation set, 83.2% in the independent validation set, respectively. MCDBT-2 model also showed high TPO accuracy, with the TPO accuracy reaching 79.4% in the independent validation cohort. Finally, an interception model was applied using such indicators as cancer incidence, distribution of cancer stage at diagnosis, five-year survival rate and tumor progression rate in China, to infer stage-shift and survival benefit and to demonstrate potential public health benefit of ELSA-seq in real-world application. Based on the interception model imputation, these two models achieved sensitivities of 70.6% and 77.5% in detecting the six cancers, respectively. MCDBT-1 decreased late-stage incidence by 38.7%-46.4% (shift from stage III-IV towards stage I-II), and increased 5-year survival rate by 33.1%-40.4%. The THUNDER study has laid a foundation for extending non-invasive cfDNA methylation detection to more types of cancer in future and once again proved the excellent performance and broad application prospects of ELSA-seq in the early detection of multiple cancers. Burning Rock looks forward to collaborating with medical experts to take forward the clinical validation and development of the multi-cancer detection products, thus through detecting more cancers at the early stage to improve the survival rate of cancer patients, and reduce the social and economic burden stemming from cancer. Reported Earnings • Jun 01
First quarter 2022 earnings: Revenues miss analyst expectations First quarter 2022 results: Revenue: CN¥135.5m (up 27% from 1Q 2021). Net loss: CN¥261.4m (loss widened 53% from 1Q 2021). Revenue missed analyst estimates by 2.1%. Over the next year, revenue is forecast to grow 26%, compared to a 40% growth forecast for the industry in the US. Aankondiging • May 31
Burning Rock Biotech Limited Provides Revenue Guidance for the Full Year 2022 Burning Rock Biotech Limited provided revenue guidance for the full year 2022. For the year, company expects revenue to be approximately RMB 620 million (USD 97.8 million), implying a 22% growth over full year 2021. Given the strong first quarter business performance and assuming that the impact of COVID-19 dissipates over time in China. Aankondiging • May 17
Burning Rock Biotech Limited to Report Q1, 2022 Results on May 31, 2022 Burning Rock Biotech Limited announced that they will report Q1, 2022 results Pre-Market on May 31, 2022 Reported Earnings • May 01
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: CN¥7.65 loss per share (down from CN¥6.88 loss in FY 2020). Revenue: CN¥507.9m (up 18% from FY 2020). Net loss: CN¥796.7m (loss widened 69% from FY 2020). Revenue exceeded analyst estimates by 1.2%. Earnings per share (EPS) missed analyst estimates by 103%. Over the next year, revenue is forecast to grow 22%, compared to a 44% growth forecast for the pharmaceuticals industry in the US. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 7 non-independent directors. Independent Director Wendy Hayes was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Major Estimate Revision • Mar 29
Consensus EPS estimates fall by 219% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from CN¥665.7m to CN¥619.6m. Losses expected to increase from CN¥1.95 per share to CN¥6.23. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target down from US$21.43 to US$13.31. Share price rose 7.5% to US$9.50 over the past week. Recent Insider Transactions Derivative • Mar 28
COO & Director notifies of intention to sell stock Shaokun Chuai intends to sell 121k shares in the next 90 days after lodging an Intent To Sell Form on the 23rd of March. If the sale is conducted around the recent share price of US$9.18, it would amount to US$1.1m. Shaokun currently holds 2.60m shares (0.024912765597214896 of the company). There have been no trades via on-market transactions or options from company insiders in the last 12 months. Aankondiging • Feb 22
Burning Rock Biotech Limited to Report Q4, 2021 Results on Mar 22, 2022 Burning Rock Biotech Limited announced that they will report Q4, 2021 results Pre-Market on Mar 22, 2022 Aankondiging • Dec 29
Burning Rock Biotech Limited Provides Revenue Guidance for 2021 Burning Rock Biotech Limited provided revenue guidance for 2021. The Company expects its 2021 revenue to be at or slightly above RMB 500 million. Reported Earnings • Nov 18
Third quarter 2021 earnings released The company reported a soft third quarter result with increased losses and weaker control over costs, although revenues improved. Third quarter 2021 results: Revenue: CN¥126.6m (up 2.2% from 3Q 2020). Net loss: CN¥170.5m (loss widened 34% from 3Q 2020). Reported Earnings • Sep 01
Second quarter 2021 earnings released: CN¥2.33 loss per share (vs CN¥2.68 loss in 2Q 2020) The company reported a soft second quarter result with increased losses and weaker control over costs, although revenues improved. Second quarter 2021 results: Revenue: CN¥127.3m (up 19% from 2Q 2020). Net loss: CN¥242.1m (loss widened 121% from 2Q 2020). Recent Insider Transactions Derivative • Jun 05
COO & Director notifies of intention to sell stock Shaokun Chuai intends to sell 121k shares in the next 90 days after lodging an Intent To Sell Form on the 27th of May. If the sale is conducted around the recent share price of US$33.30, it would amount to US$4.0m. Since June 2020, Shaokun's direct individual holding has decreased from 4.63m shares to 4.59m. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • May 27
First quarter 2021 earnings released: CN¥1.65 loss per share (vs CN¥3.15 loss in 1Q 2020) The company reported a mediocre first quarter result with increased losses and weaker control over costs, although revenues improved. First quarter 2021 results: Revenue: CN¥106.6m (up 58% from 1Q 2020). Net loss: CN¥171.4m (loss widened 117% from 1Q 2020). Aankondiging • May 26
Burning Rock Biotech Limited Reiterates Earnings Guidance for the Full Year 2021 Burning Rock Biotech Limited reiterated earnings guidance for the full year 2021. The company announced that assuming there are no additional COVID-19 related restrictions imposed in China, which might negatively affect patient volumes and cancer testing, its full year 2021 revenues is expected to be approximately RMB 610 million (USD 93.1 million), implying a 41.9% growth over full year 2020. Aankondiging • May 20
Burning Rock Announces the Launch of China’S First Prospective Pan-Cancer Multi-Omics Early Detection Study Burning Rock Biotech Limited announced the launch of the PRESCIENT (Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT) study, the first blood-based, pan-cancer early-detection study in China using a multi-omics approach. The study is going to be led by Professor Jie He, Fellow of the Chinese Academy of Sciences and head of the China National Cancer Center, and Professor Jie Wang. Both are residing physicians at the National Cancer Center and the Cancer Hospital of the Chinese Academy of Medical Sciences. The study is expected to enroll 11,879 participants across 22 cancer types as well as healthy controls. These 22 cancers account for 88% of cancer incidence and 93% of cancer mortality in China[1]. Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, thus improving patients’ survival and quality of life while reducing social burden of the disease. The National Cancer Center will work with other leading clinical centers, including Beijing Cancer Hospital, Jilin Cancer Hospital, and Hubei General Hospital on the PRESCIENT study. Professor Jie He said, “Early cancer detection and treatment brings significant social and economic benefits as they play a key role in ensuring people’s health and well-being and improving cancer patients’ survival and quality of life. With support from the National Cancer Center, PRESCIENT is the first blood-based cancer screening and early detection study using a multi-omics approach in China. It is designed to advance clinical application of pan-cancer early detection for the benefit of the wider population.” Burning Rock's latest product development progress was reported at mini-oral presentation at the European Society for Medical Oncology Asia Meeting (ESMO Asia) in November 2020. The sensitivity and specificity of Burning Rock’s Elsa-seq early detection assay in six cancer types (lung cancer, colorectal cancer, liver cancer, esophageal cancer, pancreatic cancer, and ovarian cancer) were 80.6% and 98.3%, respectively (validation set). This assay also achieved a high accuracy in the tissue of origin result. Recent Insider Transactions Derivative • Mar 19
COO & Director notifies of intention to sell stock Shaokun Chuai intends to sell 200k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of March. If the sale is conducted around the recent share price of US$25.50, it would amount to US$5.1m. Since June 2020, Shaokun has owned 4.63m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • Mar 13
Full year 2020 earnings released: CN¥6.88 loss per share (vs CN¥14.23 loss in FY 2019) The company reported a soft full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: CN¥429.9m (up 13% from FY 2019). Net loss: CN¥471.9m (loss widened 41% from FY 2019). Analyst Estimate Surprise Post Earnings • Mar 13
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 1.6%. Earnings per share (EPS) also surpassed analyst estimates by 122%. Over the next year, revenue is forecast to grow 42%, compared to a 1,676% growth forecast for the Biotechs industry in the US. Is New 90 Day High Low • Feb 23
New 90-day high: US$39.58 The company is up 52% from its price of US$26.05 on 24 November 2020. The American market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 16% over the same period. Aankondiging • Feb 09
Burning Rock Biotech Limited to Report Q4, 2020 Results on Mar 11, 2021 Burning Rock Biotech Limited announced that they will report Q4, 2020 results Pre-Market on Mar 11, 2021 Is New 90 Day High Low • Jan 16
New 90-day high: US$34.30 The company is up 23% from its price of US$27.91 on 16 October 2020. The American market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 19% over the same period. Is New 90 Day High Low • Dec 29
New 90-day low: US$23.46 The company is down 3.0% from its price of US$24.23 on 29 September 2020. The American market is up 14% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 19% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$3.82 per share. Recent Insider Transactions Derivative • Dec 12
COO & Director notifies of intention to sell stock Shaokun Chuai intends to sell roughly 70.00k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of December. If the sale is conducted around the recent share price of US$25.52, it would amount to US$1.8m. Since June 2020, Shaokun has owned 4.63m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Major Estimate Revision • Nov 27
Analysts update estimates The 2020 consensus revenue estimate increased from CN¥412.8m to CN¥423.3m. The company's losses in 2020 are expected to worsen with analysts lowering their EPS forecasts from -CN¥2.65 to -CN¥3.10. The Biotechs industry in the US is expected to see an average net income growth of 7.0% next year. The consensus price target was lowered from US$214 to US$211. Share price is up 8.0% to US$28.00 over the past week. Is New 90 Day High Low • Oct 14
New 90-day high: US$29.00 The company is up 2.0% from its price of US$28.30 on 16 July 2020. The American market is up 11% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$3.12 per share. Aankondiging • Jul 21
Burning Rock Biotech Limited to Report Q2, 2020 Results on Aug 11, 2020 Burning Rock Biotech Limited announced that they will report Q2, 2020 results at 9:00 AM, China Standard Time on Aug 11, 2020