Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 27

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 27
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 us to become a generational healthcare company. Our growth strategy We are driving and leading a paradigm shift within precision diagnostics. Our vision is to leverage our novel smNGS platform to develop ultrasensitive diagnostic tests that enable personalized solutions and enhance patient outcomes. Our growth strategy to achieve this goal includes the following elements:

| • |     | Drive increased adoption of our existing products in the prenatal and oncology markets. |

| • |     | Build beyond our extensive library of clinical evidence to support favorable coverage and reimbursement. |

| • |     | Utilize our smNGS platform and R&D capabilities to efficiently expand and improve our portfolio of category-defining 
 molecular diagnostic tests.                                                                                          |

| • |     | Continue to deploy AI across our entire organization, including laboratory operations, to improve efficiency and 
 productivity.                                                                                                    |

| • |     | Leverage our growing clinical dataset with AI to improve the utility of diagnostics and enable personalized medicine. |

Risk factors summary Our business is subject to a number of risks of which you should be aware before making an investment decision. These risks include the following:

| • |     | Our limited operating history and rapid growth make it difficult to evaluate our future prospects and the risks and 
 challenges we may encounter.                                                                                        |

| • |     | We primarily generate revenue from sales of our molecular diagnostic tests and we are highly dependent on them for our 
 success.                                                                                                               |

| • |     | If the government and other third-party payors fail to provide coverage and adequate payment for our existing and future 
 tests, our revenue and prospects for profitability will be harmed.                                                       |

| • |     | Our revenue may be adversely affected if we are unable to successfully obtain reimbursement from the Medicare program and 
 state Medicaid programs.                                                                                                  |

| • |     | Our billing and claim processing are complex and time-consuming, and any delay in submitting claims or failure to comply 
 with applicable billing requirements could hinder collection and have an adverse effect on our revenue.                  |

| • |     | The inherent variability of the insurance coverage and reimbursement landscape makes it difficult to predict amounts we                                                                                                      
 ultimately collect for our tests, and if our estimates of revenue to be recognized materially differs from the revenue recorded for tests, our revenue or operating results may fall below investor or analyst expectations. |

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| • |     | The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, 
 technicians, clinicians, and sales representatives could adversely affect our business.                                 |

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