Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 184

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 184
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 sickle-cell disease could only be detected by invasive methods such as amniocentesis following carrier testing of the parents. By first focusing our smNGS platform on directly assessing fetal risk for these conditions, we expanded the indication of NIPT from more than one million base pair aneuploidies to single base pair conditions. Currently, we are the second largest prenatal genetics laboratory in the United States by revenue, achieving a % revenue growth rate to $ million in the 12-monthperiod ended June 30, 2025 from the preceding 12-monthperiod. We estimate the market opportunity for our prenatal products to be over $2.5 billion annually in the United States. 41 Building on our success in the prenatal market, we have applied our smNGS platform to solve similar technical challenges in the oncology market – specifically focusing on late-stage cancer. In 2023, we launched offerings in oncology specifically related to therapy selection (Northstar Select) and response monitoring (Northstar Response). We estimate the annual market opportunity for these two products to be more than $20 billion, and critically, we estimate that the market is less than 20% penetrated today by all molecular diagnostics companies. 42We also plan to expand our product portfolio and are developing a tissue-free, pan-cancerMRD test, which we expect to be commercially available in 2026. We estimate the annual United States market opportunity for MRD to be over $30 billion. 42Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection; however, we have not yet started development in this area. 43We estimate the annual United States market opportunity for early detection to be over $50 billion. Collectively, we estimate these addressable oncology markets represent over $100 billion annually. 42

| 41 |     | 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.                                                                                                                            |

| 42 |     | This estimate includes the most recently reported annual oncology revenue generated by our public company competitors, compared to our estimated $20 billion annual United States market opportunity. For competitors that 
 do not disaggregate oncology revenue, this estimate is over-inclusive.                                                                                                                                                     |

| 42 |     | See “Management’s discussion and analysis of financial condition and results of operations—Key factors affecting