Announcement • 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 Announcement • 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. Announcement • 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 Announcement • 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. Announcement • 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. Board Change • Aug 07
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Director Licen Lisa Xu was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • May 30
First quarter 2024 earnings released: CN¥14.26 loss per share (vs CN¥18.09 loss in 1Q 2023) First quarter 2024 results: CN¥14.26 loss per share (improved from CN¥18.09 loss in 1Q 2023). Revenue: CN¥125.6m (down 12% from 1Q 2023). Net loss: CN¥121.5m (loss narrowed 34% from 1Q 2023). Announcement • 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 21
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 Share price has been volatile over the past 3 months (9.5% average weekly change). Shareholders have been diluted in the past year (2.7% increase in shares outstanding). Market cap is less than US$100m (€71.3m market cap, or US$75.9m). Reported Earnings • Mar 30
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 • Jan 26
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. Minor Risk Share price has been volatile over the past 3 months (8.6% average weekly change). Announcement • 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. New Risk • Dec 01
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -CN¥677m This is considered a minor 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: Minor Risks Less than 1 year of cash runway based on current free cash flow (-CN¥677m). Currently unprofitable and not forecast to become profitable next year (CN¥290m net loss next year). Share price has been volatile over the past 3 months (8.9% average weekly change). Market cap is less than US$100m (€86.8m market cap, or US$94.4m). 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 13% growth forecast for the Biotechs industry in Germany. Announcement • 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. Announcement • 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 Announcement • 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 Germany. Announcement • 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 Announcement • 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. Announcement • 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 15% growth forecast for the Biotechs industry in Germany. Reported Earnings • Mar 29
Full year 2022 earnings released: CN¥9.32 loss per share (vs CN¥7.65 loss in FY 2021) 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 is forecast to grow 23% p.a. on average during the next 3 years, compared to a 27% growth forecast for the Biotechs industry in Germany. Announcement • 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. Announcement • 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. Board Change • Jan 12
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.