Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 14

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 14
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 develop and launch competing NIPTs for recessive conditions, we believe the differentiation of our smNGS technology and five years of accumulated data and publications will allow us to maintain our competitive advantage as this type of testing becomes the standard of care and significantly improves patient outcomes. In the oncology setting, ultrasensitive tests 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 test is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid

| 1 |     | Our smNGS platform overcomes the technical noise that restrains the traditional NGS testing methods used by other diagnostic companies. Please see “Business—Our Technology” for more details. |

| 2 |     | For further information on the impact of our products on how diseases are diagnosed and treated, please see “Business—Patient Case Studies”. |

| 3 |     | This is based on (i) our 2024 prenatal testing revenue as compared to the publicly disclosed prenatal testing revenue of Myriad Genetics, one of the largest laboratories for prenatal diagnostic testing, and (ii) recent 
 ACOG practice advisory changes for RhD and fetal antigen NIPT have specifically cited our publications, resulting in changes to the standard of care.                                                                      |

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biopsies. 4Based 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. Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. To date, we have processed more than one million smNGS-based tests, including tests in the 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. While we have incurred losses since