Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 147

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 147
---
, clinical studies to demonstrate utility and support reimbursement efforts, and development costs for new testing methodologies and platforms. Our ability to develop new products, obtain regulatory approvals for such products when required, successfully launch new products into the market, and drive adoption by healthcare providers will continue to play a key role in our competitive position and financial results. We believe these investments are critical to maintaining our technological leadership, supporting physician adoption, and driving favorable coverage decisions by payors across both our prenatal and oncology product lines. We incurred $22.4 million, $36.6 million, $16.1 million and $22.2 million in research and development expenses during the years ended December 31, 2023 and 2024 and the six months ended June 30, 2024 and 2025, respectively. Some of our earlier prenatal product innovations include our UNITY Complete Portfolio, which encompasses our original five gene UNITY Fetal Risk Screen, UNITY Aneuploidy Screen, UNITY Fetal RhD NIPT, and UNITY Fetal Antigen NIPT. We continue to innovate within our prenatal product portfolio. For example, we recently launched a 14-geneversion of our UNITY Fetal Risk Screen panel, which screens for more conditions than our existing five-gene guideline-focused screening panel. We estimate the 14-geneversion of UNITY Fetal Risk Screen will expand the serviceable addressable market for UNITY by 70%, as some physicians prefer larger panels. 26We plan to continue innovating novel screening and diagnostic products for the prenatal market. We are innovating within our oncology portfolio of products as well. For example, earlier this year, we launched a new version of our Northstar Response test, called Response V2, which provides significant improvements in precision and sensitivity over our original Response product. Importantly, Response V2’s limit of detection at 0.01% tumor allele fraction already matches that of the leading tumor informed MRD assay. This level of sensitivity suggests our potential ability to develop a highly competitive tumor-naïveMRD assay using our smNGS platform. Longer-term we believe we may be able to develop products for even larger segments of the oncology diagnostic market, which we estimate represents an annual market opportunity of over $100 billion in the United States alone. Half of this addressable market includes early detection, an area in which we have not yet begun specific product development or commercial sales, but we believe will be strongly enabled by our existing technology platform.

| 26 |     | This estimate