Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 138

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 138
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 with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complementary pan-cancerliquid biopsy tests – Northstar Select and Northstar Response. Our Northstar Select is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid biopsies. 23Based on our knowledge of all widely available tests, Northstar Response is the only methylation-based assay that quantifies the amount of cancer (tumor burden) at the single molecule level without requiring a tissue biopsy, enabling real-time monitoring of patient response to therapy with unprecedented precision. Our Northstar tests give physicians extraordinary visibility into cancer profile and treatment response, enabling more informed and earlier treatment decisions that can fundamentally alter patient outcomes.

| 23 |     | Bower, X., Wignall, J., Varga, M. G., Zhu, J., O’Sullivan, M., Searle, N. E., Hong, L. K., Dogruluk, T., Li, Z., Farmer, T. E., Rosas-Linhard, E., Luong, J., Lin, E., Simon, M. E., Tsao, D. S., Bosch, J. R. T., 
 Palmer, G., Gajra, A., Huynh, C., & Zhou, W. (2025). Validation of a liquid biopsy assay with increased sensitivity for clinical comprehensive genomic profiling. The Journal of Liquid Biopsy, 100322.            |

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Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of
approximately one million smNGS-based tests that we have processed since our initial launch, over 50% of them, or approximately 508,000 tests, were processed within the last 12 months ended June 30, 2025. For the year ended December 31, 2024, we
generated revenue of $152.6 million, representing 113% year-over-year growth, with a gross margin of 53% and net loss of $41.6 million. We have incurred losses since inception, including a net loss of $41.6 million and $4.2 million for the year
ended December 31, 2024 and six months ended June 30, 2025, respectively, and we had an