Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 27

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 27
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 presence of the single mutation marker to quantification of disease biology of individuals at the single-molecule level, and (ii) integration of this characterization with multi-modal clinical history, powered by AI. We have already built products for this characterization, and we are starting to integrate our diagnostics with this multi-modal clinical history. Our approach to building AI-enabledprecision medicine will begin with our ability to generate extraordinarily precise molecular data. As we continue to generate unique data via our smNGS platform, we are building a differentiated and clinically actionable genomics dataset. Our advantage stems from two key factors: first, our

| 21 |     | Both MRD and early-detection assays are designed to detect minute amounts of cancer DNA in blood (e.g., at levels of 0.01% or even lower). Given the trade off between specificity and sensitivity (LOD), this higher                             
 specificity can be, in principle, achieved by changing the calling threshold. As a part of our five-year strategic plan, we have included the necessary R&D funding for development of an early detection test that builds upon our earlier work. |

| 22 |     | See “Management’s discussion and analysis of financial condition and results of operations—Key factors affecting our results of operations and performance” for more information regarding how 
 these total addressable markets are calculated, including material assumptions.                                                                                                                |

9

biomarker measurements achieve single-molecule precision and sensitivity, capturing the key disease-causing molecular signatures in cfDNA; and second, our response monitoring assay provides an objective measurement of how a patient is responding to a therapy. AI has recently unlocked widespread access to and analysis of multimodal patient clinical history data. This powerful combination positions us to harness AI for identifying distinct patient subgroups based on their specific biomarker profiles and for predicting how each subgroup will respond to different therapeutic approaches. By mapping these response patterns with extraordinary granularity, we believe we will be able to deliver personalized treatment recommendations based on each person’s unique biology that maximize efficacy while minimizing adverse effects — moving precision medicine from aspiration to clinical reality. While our AI-enabledvision represents the future of our platform, our commercial success today demonstrates the fundamental value of our existing products. Our existing products in prenatal and oncology have already demonstrated strong growth from zero to $266.3 million annualized revenue run-rate(ARR) in five years as of June 30, 2025. As we expand into new and larger markets, we believe that our foundational smNGS platform will position us to become a generational healthcare