Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 129

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 129
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. In order to maintain cost discipline, we will continue to re-designand optimize our processes, integrate AI into our workflows, and increasingly automate both our laboratory and non-laboratoryoperations. We believe that our continued focus in optimization, automation, and AI for higher operational efficiencies will drive further productivity gains.

| • |     | Continued research and development and new product innovation |

We expect to maintain significant levels of investment in research and development as we continue to develop new molecular diagnostic assays, enhance existing tests, and expand our testing capabilities into new clinical applications within our prenatal screening and oncology diagnostics product lines. These investments include costs for new test development, costs to validate new assays or to improve current assays, 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 and $36.6 million in research and development expenses during the years ended December 31, 2023 and 2024, 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 96

example, we recently launched a 14-gene version 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-gene version of UNITY Fetal Risk Screen will expand the serviceable addressable market for UNITY by 70%, as some physicians prefer larger panels. We 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 MR