Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 186

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 186
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 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 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.

Mother's DNA Test Difficult Conversation & Counseling Father's DNA Test Difficult Conversation & Counseling Amniocentesis 58% not completed or unavailable* * Choates et al. Prenat Diagn. 2020;40(3):311-316. 1 positive case per 4 amniocenteses

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.

We
have two strategic partnerships with Johnson & Johnson. The first is an agreement dated January 6, 2023, which was subsequently amended on July 14, 2023 and August 11, 2023 (collectively, the First J&J Agreement). The First
J&J Agreement provides our UNITY fetal antigen clinical trial assay in Johnson & Johnson’s AZALEA Phase 3 clinical trial of nipocalimab in HDFN. Under the First J&J Agreement, Johnson & Johnson made an initial

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payment to us, with subsequent payments due upon achievement of specific milestones, including receipt of approval of the trial