Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 210

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 210
---
 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 payment to us, with
subsequent payments due upon achievement of specific milestones, including receipt of approval of the trial, which was achieved in 2023, various patient enrollment milestones, and subsequent full trial completion. Under the First J&J Agreement,
Johnson & Johnson is required to pay us up to $9.4 million in upfront fees and milestone payments, as well as payments related to patient testing activities and other costs. Revenue from this agreement was immaterial to our financial results in
2024.

We also entered into a development and commercialization agreement with Johnson & Johnson on July 11, 202