Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 158

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 158
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 This sobering reality underscores a fundamental challenge:
many current approaches to precision medicine often rely on single biomarkers that fail to capture the full complexity of disease biology and individual patient variation. We believe that these important problems can be addressed in the future with
the combination of AI and smNGS technology.

We believe AI-enabled personalized medicine can revolutionize healthcare
delivery across all specialties. Truly personalized medicine requires the (i) characterization of the disease specific to each patient beyond the presence of the single mutation marker to quantification of disease biology of individuals at the
single-molecule level, and (ii) integration of this characterization with multi-modal clinical history, powered by AI. We have already built products for this characterization, and we are starting to integrate our diagnostics with this
multi-modal clinical history.

Our approach to building AI-enabled precision medicine will begin with our ability to generate
extraordinarily precise molecular data. As we continue to generate unique data via our smNGS platform, we are building a differentiated and clinically actionable genomics dataset. Our advantage stems from two key factors: first, our biomarker
measurements achieve single-molecule precision and sensitivity, capturing the key disease-causing molecular signatures in cfDNA; and second, our response monitoring assay provides an objective measurement of how a patient is responding to a therapy.
AI has recently unlocked widespread access to and analysis of multimodal patient clinical history data. This powerful combination positions us to harness AI for identifying distinct patient subgroups based on their specific biomarker profiles and
for predicting how each subgroup will respond to different therapeutic approaches. By mapping these response patterns with extraordinary granularity, we believe we will be able to deliver personalized treatment recommendations based on each
person’s unique biology that maximize efficacy while minimizing adverse effects — moving precision medicine from aspiration to clinical reality.

While our
AI-enabled vision represents the future of our platform, our commercial success today demonstrates the fundamental value of our existing products. Our existing products in prenatal and oncology have already
demonstrated strong growth from zero to $ million annualized revenue run-rate (ARR) in six years. As we expand into new and larger markets, we believe that our foundational smNGS platform will
position us to become a generational healthcare company.

The BillionToOne smNGS platform leverages proprietary and patent-protected technologies that allow us to detect previously
undetectable diseases and support physicians developing and managing treatment plans for patients. Our platform integrates our patented QCTs, proprietary machine learning algorithms embedded in sophisticated bioinformatics systems, and a