Almonertinib Mesilate

BASKING RIDGE, N.J. & RAHWAY, N.J.--( BUSINESS WIRE )--The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy. Overall survival (OS) data were immature at the time of the analysis and the trial will continue to further assess OS, a secondary endpoint. Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. NSCLC accounts for approximately 85% of all lung cancers worldwide with up to 70% of NSCLC cases diagnosed at an advanced stage and EGFR-activating mutations occur in 14% to 38% of all NSCLC tumors worldwide. 1,2,3 Following initial treatment for metastatic EGFR-mutated NSCLC with an EGFR TKI, many patients experience disease progression and currently available therapies in the second-line setting are limited, highlighting the need for new approaches to improve outcomes. 3,4 Data from the HERTHENA-Lung02 trial will be presented at an upcoming medical meeting and shared with global regulatory authorities. “ These results from HERTHENA-Lung02 demonstrate the potential of patritumab deruxtecan to become an important treatment option for certain patients with EGFR-mutated non-small cell lung cancer with prior tyrosine kinase inhibitor treatment,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “ We plan to share these findings with regulatory authorities to discuss next steps.” “ We are encouraged by these results demonstrating a statistically significant progression-free survival improvement compared to platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who received prior tyrosine kinase inhibitor treatment,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “ Together with Daiichi Sankyo, we are committed to helping patients with previously treated EGFR-mutated non-small cell lung cancer, where there is a high unmet need.” The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials with no new safety signals identified. The majority of interstitial lung disease (ILD) events were low grade (grade 1 and 2). There were two grade 5 ILD events observed. About HERTHENA-Lung02 HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg every three weeks) versus four cycles of pemetrexed and platinum chemotherapy in patients with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (e.g., osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy. Patients in the comparator arm without disease progression after four cycles of pemetrexed and platinum chemotherapy are able to continue treatment with maintenance pemetrexed with no restriction on the number of cycles. The primary endpoint of HERTHENA-Lung02 was PFS as assessed by blinded independent central review (BICR). Secondary endpoints included OS, objective response rate, duration of response, clinical benefit rate, time to response, disease control rate, and safety. Patients enrolled in the study underwent brain imaging to allow for assessment of intracranial endpoints, including intracranial PFS as assessed by BICR. HERTHENA-Lung02 enrolled 586 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About EGFR-Mutated Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 5 Lung cancer is the most common cancer and the leading cause of cancer-related deaths worldwide. 5 Approximately 85% of lung cancer is classified as NSCLC with EGFR-activating mutations occurring in 14% to 38% of all NSCLC tumors worldwide. 1,3 NSCLC is diagnosed at an advanced stage in up to 70% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy. 2,6 Following initial treatment for metastatic EGFR-mutated NSCLC with an EGFR TKI, many patients experience disease progression and currently available therapies in the second-line setting are limited, highlighting the need for new approaches to improve outcomes. 3,4 About HER3 HER3 is a member of the HER family of receptor tyrosine kinases. 7 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment. 8 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival. 9,10 There is currently no HER3 directed therapy approved for the treatment of any cancer. About Patritumab Deruxtecan Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02 , a phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan versus pemetrexed plus platinum chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; HERTHENA-Lung01 , a phase 2 trial in metastatic or locally advanced NSCLC with an activating EGFR mutation previously treated with at least one EGFR TKI and one platinum-based chemotherapy-containing regimen; HERTHENA-PanTumor01 , a phase 2 trial in 10 locally advanced or metastatic solid tumor types, including melanoma, gastric and head and neck cancer, among other types of cancer, previously treated with at least one prior systemic therapy; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024 , the global co-development and co-commercialization agreement was expanded to include MK-6070 which they will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com . Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/ . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). _______________________________ References: 1 Economopoulou P, et al. Ann Transl Med . 2018; 6(8):138. 2 Guo H, et al. Front Oncol . 2021; 11: 761042. 3 Pretelli G, et al. Int J Mol Sci . 2023; 24, 8878. 4 Janne PA, et al. Cancer Discov . 2022; 12(1):74-89. 5 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet . Accessed July 2024. 6 Hardstock F, et al. BMC Cancer . 2020; 20(1):260. 7 Mishra R, et al. Onco Rev . 2018; 12(355):45-62. 8 Scharpenseel H, et al. Scientific Reports . 2019; 9:7406. 9 Gandullo-Sánchez L et al. J Exp Clin Cancer Res . 2022; 41:310. 10 Yu H.A., et al. Annals of Oncology . 2024; 35(5): P437-447.

GUANGZHOU, China, Aug. 22, 2024 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended June 30, 2024. Recent Business Updates Therapy Selection Presented study results on small-cell lung cancer and colorectal cancer at the ASCO in June 2024. “The efficacy and safety of high dose Almonertinib in untreated EGFR-mutated NSCLC with brain metastases, including biomarker analysis” and “Individualized tumor-informed circulating tumor DNA analysis for molecular residual disease detection in predicting recurrence and efficacy of adjuvant chemotherapy in colorectal cancer”. Pharma Services New companion diagnostics (CDx) collaboration announced with Bayer in China. Second Quarter 2024 Financial Results Total Revenues were RMB135.5 million (US$18.7 million) for the three months ended June 30, 2024, representing a 7.3% decrease from RMB146.3 million for the same period in 2023, as we transition from central-lab to more in-hospital based testing. Importantly, in-hospital segment continued its double-digit growth. Revenue generated from in-hospital business was RMB59.9 million (US$8.2 million) for the three months ended June 30, 2024, representing a 11.2% increase from RMB53.8 million for the same period in 2023, driven by an increase in sales volume.Revenue generated from central laboratory business was RMB48.8 million (US$6.7 million) for the three months ended June 30, 2024, representing a 26.4% decrease from RMB66.2 million for the same period in 2023, primarily attributable to a decrease in the number of tests, as we continued our transition towards in-hospital testing.Revenue generated from pharma research and development services was RMB26.9 million (US$3.7 million) for the three months ended June 30, 2024, representing a 2.6% increase from RMB26.2 million for the same period in 2023, primarily attributable to an increased development and testing services performed for our pharma customers. Cost of revenues was RMB40.1 million (US$5.5 million) for the three months ended June 30, 2024, representing an 12.5% decrease from RMB45.8 million for the same period in 2023, primarily due to (i) a decrease in cost of central laboratory business, which was in line with the decrease in revenue generated from this business; and (ii) a decrease in amortization expense for all kinds of business. Gross profit was RMB95.4 million (US$13.1 million) for the three months ended June 30, 2024, representing a 5.0% decrease from RMB100.4 million for the same period in 2023. Gross margin was 70.4% for the three months ended June 30, 2024, compared to 68.7% for the same period in 2023. By channel, gross margin of central laboratory business was 78.8% for the three months ended June 30, 2024, compared to 78.3% during the same period in 2023; gross margin of in-hospital business was 73.6% for the three months ended June 30, 2024, compared to 62.0% during the same period in 2023, primarily due to a decrease in amortization; gross margin of pharma research and development services was 48.2% for the three months ended June 30, 2024, compared to 58.0% during the same period of 2023, primarily due to a decrease in test volume of higher margin projects. Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB101.9 million (US$14.0 million) for the three months ended June 30, 2024, representing a 6.8% decrease from RMB109.4 million for the same period in 2023. Non-GAAP gross margin was 75.2% for the three months ended June 30, 2024, compared to 74.8% for the same period in 2023. Operating expenses were RMB206.7 million (US$28.4 million) for the three months ended June 30, 2024, representing a 12.5% decrease from RMB236.1 million for the same period in 2023. The decrease was primarily driven by budget control measures and headcount reduction to improve the Company’s operating efficiency. Research and development expenses were RMB65.0 million (US$8.9 million) for the three months ended June 30, 2024, representing a 32.2% decrease from RMB95.8 million for the same period in 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of our research and development department to improve operating efficiency; (ii) a decrease in the expenditure for research projects; and (iii) a decrease in amortized expenses for office building decoration.Selling and marketing expenses were RMB48.9 million (US$6.7 million) for the three months ended June 30, 2024, representing a 31.0% decrease from RMB70.8 million for the same period in 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of the sales department and improvement in operating efficiency; (ii) a decrease in conference fee; and (iii) a decrease in travel expense.General and administrative expenses were RMB92.8 million (US$12.8 million) for the three months ended June 30, 2024, representing a 33.5% increase from RMB69.5 million for the same period in 2023, primarily due to an increase in amortized expense on share-based compensation. Net loss was RMB108.0 million (US$14.9 million) for the three months ended June 30, 2024, compared to RMB131.2 million for the same period in 2023. Cash, cash equivalents, restricted cash and short-term investments were RMB533.0 million (US$73.3 million) as of June 30, 2024. About Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage. For more information about Burning Rock, please visit: ir.brbiotech.com. Safe Harbor Statement This press release contains forward-looking statements. These statements constitute “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,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. Non-GAAP Measures In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The company defines non-GAAP gross margin as gross margin excluding depreciation and amortization. The company presents these non-GAAP financial measures because they are used by management to evaluate operating performance and formulate business plans. The company believe non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization reflect the company’s ongoing business operations in a manner that allows more meaningful period-to-period comparisons. Contact: IR@brbiotech.com Selected Operating Data As of June 30,2023 September 30, 2023 December 31, 2023 March 31, 2024 June 30, 2024 In-hospital Channel: Pipeline partner hospitals(1)30 29 28 28 29 Contracted partner hospitals(2)50 55 59 59 59 Total number of partner hospitals 80 84 87 87 88 (1) Refers to hospitals that are in the process of establishing in-hospital laboratories, laboratory equipment procurement or installation, staff training or pilot testing using the Company’s products.(2) Refers to hospitals that have entered into contracts to purchase the Company’s products for use on a recurring basis in their respective in-hospital laboratories the Company helped them establish. Kit revenue is generated from contracted hospitals. Selected Financial Data For the three months ended RevenuesJune 30, 2023 September 30, 2023 December 31, 2023 March 31, 2024 June 30, 2024 (RMB in thousands)Central laboratory channel66,239 53,481 51,288 47,614 48,773 In-hospital channel53,835 54,496 28,809 57,387 59,872 Pharma research and development channel26,194 19,589 40,988 20,622 26,888 Total revenues146,268 127,566 121,085 125,623 135,533 For the three months ended Gross profit June 30, 2023 September 30, 2023 December31, 2023 March 31, 2024 June 30, 2024 (RMB in thousands)Central laboratory channel51,876 41,487 41,886 37,002 38,424 In-hospital channel33,353 35,459 12,910 39,192 44,058 Pharma research and development channel15,193 8,974 23,317 9,500 12,956 Total gross profit100,422 85,920 78,113 85,694 95,438 For the three months endedShare-based compensation expensesJune 30,2023 September 30, 2023 December31, 2023 March 31, 2024 June 30, 2024 (RMB in thousands) Cost of revenues627 680 654 596 464 Research and development expenses15,301 12,161 12,401 12,287 12,008 Selling and marketing expenses3,389 2,848 1,816 508 1,232 General and administrative expenses18,502 57,704 56,472 55,990 54,407 Total share-based compensation expenses 37,819 73,393 71,343 69,381 68,111 Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the three months ended June 30, 2023 September 30, 2023 December 31,2023 March 31, 2024 June 30, 2024 June 30, 2024 RMBRMB RMB RMB RMB US$ Revenues146,268 127,566 121,085 125,623 135,533 18,650 Cost of revenues(45,846) (41,646) (42,972) (39,929) (40,095) (5,517) Gross profit100,422 85,920 78,113 85,694 95,438 13,133 Operating expenses: Research and development expenses(95,779) (83,701) (73,119) (65,985) (64,952) (8,938) Selling and marketing expenses(70,842) (62,310) (49,785) (46,856) (48,907) (6,730) General and administrative expenses(69,525) (118,724) (121,533) (98,681) (92,794) (12,769) Total operating expenses(236,146) (264,735) (244,437) (211,522) (206,653) (28,437) Loss from operations (135,724) (178,815) (166,324) (125,828) (111,215) (15,304) Interest income5,255 4,018 5,539 4,038 3,187 439 Other income (expense), net(118) (157) 160 434 (82) (11) Foreign exchange (loss) gain, net（210) 423 (517) (13) 262 36 Loss before income tax(130,797) (174,531) (161,142) (121,369) (107,848) (14,840) Income tax expenses(445) (450) (1,071) (180) (190) (26) Net loss(131,242) (174,981) (162,213) (121,549) (108,038) (14,866) Net loss attributable to Burning Rock Biotech Limited’s shareholders(131,242) (174,981) (162,213) (121,549) (108,038) (14,866) Net loss attributable to ordinary shareholders(131,242) (174,981) (162,213) (121,549) (108,038) (14,866) Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(1.28) (1.71) (1.58) (1.19) (1.05) (0.14) Class B ordinary shares - basic and diluted(1.28) (1.71) (1.58) (1.19) (1.05) (0.14) Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,151,052 85,000,869 85,071,360 85,219,188 85,271,858 85,271,858 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments14,829 (1,955) (3,026) 590 940 129 Total comprehensive loss(116,413) (176,936 ) (165,239) (120,959 ) (107,098) (14,737) Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(116,413) (176,936) (165,239) (120,959 ) (107,098) (14,737) Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the six months ended June 30, 2023 June 30, 2024 June 30, 2024 RMB RMB US$ Revenues288,784 261,156 35,937 Cost of revenues(89,590) (80,024) (11,012) Gross profit199,194 181,132 24,925 Operating expenses: Research and development expenses(190,196) (130,937) (18,018) Selling and marketing expenses(135,616) (95,763) (13,177) General and administrative expenses(197,564) (191,475) (26,349) Total operating expenses(523,376) (418,175) (57,544) Loss from operations (324,182) (237,043) (32,619) Interest income8,399 7,225 994 Other income, net481 352 48 Foreign exchange loss, net(326) 249 34 Loss before income tax(315,628) (229,217) (31,543) Income tax expenses(867) (370) (51) Net loss(316,495) (229,587) (31,594) Net loss attributable to Burning Rock Biotech Limited’s shareholders(316,495) (229,587) (31,594) Net loss attributable to ordinary shareholders(316,495) (229,587) (31,594) Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(3.09) (2.24) (0.31) Class B ordinary shares - basic and diluted(3.09) (2.24) (0.31) Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,108,555 85,246,969 85,246,969 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments9,170 1,530 211 Total comprehensive loss(307,325) (228,057) (31,383) Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(307,325) (228,057) (31,383) Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets(In thousands) As of December 31, 2023 June 30,2024 June 30,2024 RMB RMB US$ ASSETS Current assets: Cash and cash equivalents615,096 532,542 73,280 Restricted cash120 505 69 Accounts receivable, net126,858 153,641 21,142 Contract assets, net22,748 20,018 2,755 Inventories, net69,020 65,805 9,056 Prepayments and other current assets, net50,254 28,460 3,916 Convertible note receivable- 5,320 732 Total current assets 884,096 806,291 110,950 Non-current assets: Equity method investment337 247 34 Convertible note receivable5,320 - - Property and equipment, net131,912 100,716 13,860 Operating right-of-use assets12,284 105,429 14,508 Intangible assets, net964 724 100 Other non-current assets5,088 9,976 1,372 Total non-current assets 155,905 217,092 29,874 TOTAL ASSETS 1,040,001 1,023,383 140,824 Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets (Continued)(in thousands) As of December 31, 2023 June 30,2024 June 30,2024 RMB RMBUS$LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable18,061 25,870 3,560 Deferred revenue130,537 119,352 16,423 Accrued liabilities and other current liabilities104,935 86,300 11,876 Customer deposits1,197 1,197 165 Current portion of operating lease liabilities8,634 26,922 3,705 Total current liabilities 263,364 259,641 35,729 Non-current liabilities: Non-current portion of operating lease liabilities3,690 80,988 11,144 Other non-current liabilities4,537 4,908 676 Total non-current liabilities 8,227 85,896 11,820 TOTAL LIABILITIES 271,591 345,537 47,549 Shareholders’ equity: Class A ordinary shares116 116 16 Class B ordinary shares21 21 3 Additional paid-in capital4,849,337 4,986,830 686,211 Treasury stock(65,896) (65,896) (9,068) Accumulated deficits(3,853,635) (4,083,222) (561,870) Accumulated other comprehensive loss(161,533) (160,003) (22,017) Total shareholders’ equity768,410 677,846 93,275 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY1,040,001 1,023,383 140,824 Burning Rock Biotech LimitedUnaudited Condensed Statements of Cash Flows(in thousands) For the three months ended June 30, 2023 June 30,2024 June 30,2024 RMBRMBUS$Net cash used in operating activities(79,204) (40,836) (5,619) Net cash used in investing activities(2,928) (227) (31) Net cash used in financing activities(1,003) - - Effect of exchange rate on cash, cash equivalents and restricted cash13,271 1,436 196 Net decrease in cash, cash equivalents and restricted cash (69,864) (39,627) (5,454) Cash, cash equivalents and restricted cash at the beginning of period803,142 572,674 78,803 Cash, cash equivalents and restricted cash at the end of period733,278 533,047 73,349 For the six months ended June 30,2023 June 30,2024 June 30,2024 RMBRMBUS$Net cash used in operating activities(192,347) (81,045) (11,152) Net cash used in investing activities(6,987) (2,613) (360) Net cash used in financing activities(1,035) - - Effect of exchange rate on cash, cash equivalents and restricted cash8,379 1,489 204 Net decrease in cash, cash equivalents and restricted cash (191,990) (82,169) (11,308) Cash, cash equivalents and restricted cash at the beginning of period925,268 615,216 84,657 Cash, cash equivalents and restricted cash at the end of period733,278 533,047 73,349 Burning Rock Biotech LimitedReconciliations of GAAP and Non-GAAP Results For the three months ended June 30,2023 September 30, 2023 December 31, 2023 March 31,2024 June 30,2024 (RMB in thousands)Gross profit: Central laboratory channel51,876 41,487 41,886 37,002 38,424 In-hospital channel33,353 35,459 12,910 39,192 44,058 Pharma research and development channel15,193 8,974 23,317 9,500 12,956 Total gross profit100,422 85,920 78,113 85,694 95,438 Add: depreciation and amortization: Central laboratory channel2,645 2,550 2,414 1,919 1,226 In-hospital channel2,637 2,751 2,728 1,524 824 Pharma research and development channel3,665 3,863 3,808 3,856 4,417 Total depreciation and amortization included in cost of revenues 8,947 9,164 8,950 7,299 6,467 Non-GAAP gross profit： Central laboratory channel54,521 44,037 44,300 38,921 39,650 In-hospital channel35,990 38,210 15,638 40,716 44,882 Pharma research and development channel18,858 12,837 27,125 13,356 17,373 Total non-GAAP gross profit109,369 95,084 87,063 92,993 101,905 Non-GAAP gross margin： Central laboratory channel82.3% 82.3% 86.4% 81.7% 81.3% In-hospital channel66.9% 70.1% 54.3% 70.9% 75.0% Pharma research and development channel72.0% 65.5% 66.2% 64.8% 64.6% Total non-GAAP gross margin74.8% 74.5% 71.9% 74.0% 75.2%