Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 122

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 122
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 |     | our ability to increase the adoption of our products in the prenatal and oncology markets and in large healthcare systems; |

| • |     | our ability to generate persuasive clinical validity and utility evidence; |

| • |     | our ability to expand our portfolio of molecular diagnostic tests; |

| • |     | our ability to use AI effectively and efficiently; |

| • |     | our ability to execute our reimbursement strategy and expand coverage of our tests; |

| • |     | our ability to replicate positive results from trials or studies conducted by us or third parties in current or future 
 trials or studies;                                                                                                     |

| • |     | the potential for our UNITY Fetal Antigen CTA to become the first NIPT to have a companion diagnostics indication pending; |

| • |     | the successful completion of Johnson & Johnson’s AZALEA Phase 3 clinical trial; |

| • |     | the implementation of our business model and strategic plans; |

| • |     | the size and growth potential of the total addressable markets for our current and future products and our ability to serve 
 those markets;                                                                                                              |

| • |     | our ability to realize the benefits of current and future collaborations for the development of our products; |

| • |     | our ability to maintain, expand and protect our intellectual property; |

| • |     | developments relating to our competitors and our industry; |

| • |     | existing regulations and regulatory developments in the United States and other jurisdictions; |

| • |     | general economic, industry, and market conditions, including tariffs and inflation; |

| • |     | our ability to attract, hire, and retain our key personnel and additional qualified personnel; |

| • |     | our ability to remediate our material weaknesses in our internal control over financial reporting; |

| • |     | our anticipated use of our existing cash and cash equivalents and the net proceeds from this offering; |

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| • |     | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and |

| • |     | other risks and uncertainties, including those listed in the section titled “Risk factors.” |

We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described in the section titled “Risk factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time