Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 167

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 167
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, clinically actionable, and recommended for universal screening by ACOG, with one in six pregnant individuals in the United States being a carrier for
recessive conditions.

Inherited single gene conditions can be identified through carrier screening of the parents, followed by invasive diagnostic procedures such
as amniocentesis. One of the most significant problems with traditional carrier screening is the requirement for both maternal and paternal blood draws. Obtaining the paternal blood sample is logistically challenging in an
obstetricians-gynecologists (OB-GYN) setting. As reported in studies by

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independent publications, in at least 58% of cases when the mother is identified as a carrier, the father’s carrier test is not performed, resulting in the majority of affected pregnancies
to be undetected.

The significant prevalence of genetic disorders underscores the critical need for safe and effective prenatal screening methods. By
identifying these disorders prenatally, we can significantly improve patient outcomes through earlier therapeutic interventions. For instance, SMA is a progressive and debilitating disorder that causes irreversible damage to affected newborns every
day following birth. Administering therapy within the first six weeks of life can be the difference between lifelong physical disability and meeting age-appropriate physical milestones. Prenatal detection of
SMA is critical when considering the timelines for newborn screening, confirmatory molecular diagnostics and insurance authorization for expensive therapies. Similarly, there are an increasing number of case reports where specialists prescribe
therapeutics to carrier pregnant mothers with affected CF fetuses, which significantly improved newborn outcomes. In addition, novel diagnostics enable the development and use of novel therapies. We have a global exclusive partnership with
Johnson & Johnson in which a therapy for preventing HDFN is administered only to those at-risk pregnancies that we identify through our non-invasive fetal
testing.

The market demand for more sensitive and precise oncology tests

Cancer is the second leading cause of death according to the CDC. There are over 300 commercially available cancer treatments today, with more than 60 new therapies
approved by the FDA in 2024 alone. Despite the breadth of therapeutic options, treatment response rates can be as low as single-digit percentages due to differences in genetic and epigenetic patient profiles. Enabling more personalized cancer
treatments and better outcomes requires more sensitive and precise tests to (i) select the best therapy regimen and (ii) monitor the patient’s response to that treatment.

The gold standard for cancer therapy selection has been a tissue biopsy, which can be sequenced to determine the