Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 62

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 62
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 including validation studies; |

| • |     | find appropriate third party collaborators to conduct clinical studies; |

| • |     | further develop and scale our laboratory processes to accommodate different products; and |

| • |     | further develop and scale our infrastructure to be able to analyze increasingly large amounts of data. |

Our product development process involves a high degree of risk, and product development efforts may fail for many reasons, including:

| • |     | failure of the product to perform as expected, including defects and errors; |

| • |     | inability to pass validation required by regulatory requirements; |

| • |     | inability to find appropriate samples for clinical validity and utility studies; |

| • |     | failure to demonstrate the clinical validity or utility of the product; |

| • |     | inability to obtain necessary reimbursement by commercial or government payors; |

| • |     | unattractive economics due to unexpected higher costs of the final version of the product; or |

| • |     | high cost of commercialization. |

Our development plan involves using data and analytical insights generated from our current products to foster research and development investment in our future products. However, if we are unable to generate additional or compatible data and insights, then we may not be able to advance our products under development as quickly, or at all, or without significant additional investment. As we develop products, we have made and will have to make significant investments in product development, marketing and selling resources, including investing heavily in clinical studies, which could adversely affect our 36

future cash flows. In addition, in our development and commercialization plans, we may forego other opportunities that may provide greater revenue or be more profitable. As a result, even if
our development efforts result in commercially viable products, our business and results of operations could underperform in comparison to our customers and competitors.

The molecular diagnostics industry is subject to rapid change, which could make our current products, and any future products we may develop, obsolete.

Our industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new product introductions and enhancements
and evolving industry standards, all of which could make our current and future products obsolete. Our future success will depend on our ability to keep pace with the evolving needs of our customers on a timely and cost-effective basis and to pursue
new market opportunities that develop as a result of scientific and technological advances. In recent years, there have been numerous advances in technologies in the prenatal and oncology fields, as well as advances