BNR

Approval of Diagnostic System: Riken Genesis and Burning Rock Biotech announced that their OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare for use as a companion diagnostic for AstraZeneca's capivasertib in breast cancer treatment.

Purpose and Impact: The CDx System is designed to detect specific genetic alterations in breast cancer patients, aiding in treatment decisions and improving access to precision diagnostics in Japan, with plans for insurance coverage to ensure equitable access for eligible patients.

Financial Performance: Burning Rock Biotech Ltd reported a narrowed net loss of RMB 9.70 million ($1.35 million) for Q2, significantly improved from a loss of RMB 108.04 million a year ago, with loss per share decreasing to RMB 0.09 ($0.01).

Revenue Growth: Total revenues increased by 9.6% to RMB 148.55 million ($20.74 million), driven by higher sales from partner hospitals and enhanced development services, although revenue from the central laboratory business fell by 16.2%.

Financial Performance: Burning Rock Biotech reported a revenue of RMB 133.1 million (US$18.3 million) for Q1 2025, marking a 5.9% increase from the previous year, while also achieving a gross profit of RMB 97.4 million (US$13.4 million), up 13.7% year-over-year. The company experienced a significant reduction in operating expenses by 46.8%, leading to a net loss of RMB 13.5 million (US$1.9 million).

Research and Development Updates: The company advanced its Personalized Minimal Residual Disease product, CanCatch® Custom, showing promising results in treating oesophageal squamous cell carcinoma and presented multiple studies at major oncology conferences, highlighting the potential of ctDNA assays in monitoring cancer treatment effectiveness.