Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 164

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 164
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 remediation efforts or testing their effectiveness may extend into 2026. Material weaknesses may still exist when we report on the effectiveness of our internal control over financial reporting as required under Section 404 of the Sarbanes-Oxley Act, beginning with our second annual report after the completion of this offering. If we are unable to remediate the material weaknesses or if we identify additional material weaknesses in the future or otherwise fail to develop and maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business. 117

Business

Business Overview BillionToOne is transforming healthcare by redefining molecular diagnostics. Our revolutionary single molecule NGS (smNGS) platform achieves what was once thought impossible—detecting and precisely quantifying genetic targets with single-molecule sensitivity. At the heart of this technological breakthrough lies our patented QCTs, enabling measurements at the physical limit of detection—the single DNA molecule. This leap forward addresses a fundamental limitation in healthcare—the inability to detect sparse but clinically crucial disease signals in cfDNA. Our superior technology platform 22has enabled us to build category-defining prenatal and oncology products. Our products reveal actionable insights from a simple blood draw that are fundamentally changing how diseases are diagnosed and treated, leading to a paradigm shift in personalized medicine. We believe our novel smNGS platform technologies combined with our AI-enhancedintegrated workflow, allows us to push the technology frontier forward and deliver on the full promise of non-invasiveliquid biopsy, which we estimate has an annual market opportunity of over $100 billion in the United States alone. Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from an R&D-focusedcompany to a proven commercial organization. In 2019, we launched our first prenatal product, UNITY. UNITY is the first non-invasiveprenatal test (NIPT) that uses cfDNA to provide fetal risk assessment for recessive conditions such as sickle cell disease and cystic fibrosis without requiring a paternal sample or invasive procedures such as amniocentesis. Since then, we have established ourselves as a leader in the prenatal testing market 23and expanded our UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw. While we know of competitors working to develop and launch competing NIPTs for recessive conditions, we believe the differentiation of our smNGS technology and five years of accumulated data and publications will