Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 11

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 11
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 of care, as evidenced
by two recent ACOG practice advisory changes that cited our publications in support of the change. With UNITY, we have leap-frogged the resolution of cfDNA testing from one million base-pair chromosomal abnormalities to single base-pair recessive
conditions. In this highly competitive market with increasing commoditization, our differentiated UNITY Fetal Risk Screen remains the only cfDNA test for these conditions.

We have more recently entered the oncology market, initially focusing on addressing the highest unmet need areas of therapy selection and response monitoring in
late-stage cancer patients. We intend to expand our oncology test offerings into testing of earlier stage cancer patients, including through MRD testing and potentially for early cancer detection.

To date, we have launched multiple products across these large addressable markets. We performed more than smNGS-based tests in the
last 12 months ended June 30, 2025, with significant room to further grow test volume in both markets.

Prenatal products

Traditional prenatal screening focuses on assessing a fetus’ risk for larger chromosomal changes. However, many common and severe
conditions are the result of much smaller genetic changes, in single base pairs. These recessively inherited conditions, including SCD, alpha thalassemia, beta-thalassemia, CF, and SMA, are collectively more common than aneuploidy conditions like
Down syndrome. Yet these conditions cannot be directly tested with traditional NIPT since each condition requires the precise quantification of fetal cfDNA.

Given
the technical challenges of directly assessing the fetal risk for these conditions, current medical guidelines recommend that every pregnant patient is offered carrier screening, with father screening then required if the mother is found to be a
carrier. However, studies estimate that fewer than half of fathers complete the recommended screening due to barriers related to cost, availability, and willingness. As a result, approximately 58% of pregnancies affected by these recessive
conditions are undetected by traditional screening workflows.

Our UNITY Complete Fetal Risk Screen directly addressed these challenges and is the first test that
uses cfDNA to provide precise fetal risk assessments for recessive conditions without requiring a paternal sample. In addition, it reports fetal aneuploidy and 22q11.2 microdeletion, enabling complete genetic insights from a single maternal blood
draw. We estimate the prenatal market represents an annual opportunity of over $2.5 billion in the United States.

6

Oncology products

Non-invasive liquid