Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 211

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 211
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renatal Diagnosisdemonstrated 100% of “9 in 10” risk pregnancies were confirmed to be affected pregnancies. 55Because UNITY Fetal Risk Screen does not rely on paternal testing, which is often not completed, it detects up to three times as many affected pregnancies for these recessive conditions compared to traditional carrier screening. 55 Fetal risk stratification from UNITY Fetal Risk Screen UNITY Fetal Risk Screen detects up to three times as many affected pregnancies for recessive conditions compared to traditional NIPT approaches 100% 75% 50% 25% 3/8 6/11 2/3 93% Misattributed Paternity 12/12 84% Missing Paternal screening ~3X 35% 93% 0%1/480 1 in 100 1/14 <1 in 4 to >1 in 100 <1 in 2 to >1 in 4 <2 in 3 to >1 in 2 <9 in 10 to >2 in 3 9 in 10 Hypothetical Best-Case Scenario Actual UNITY: Actual Carrier Screening Low Risk High Risk Single-Gene NIPT UNITY Aneuploidy Screen In 2020, we launched our UNITY Aneuploidy Screen, which we believe has become the most performant assay for aneuploidies. Compared to many competing tests, our test overcomes the significant challenge of low fetal cfDNA levels in the mother’s blood, which often produces inconclusive results. This issue can be particularly pronounced for single nucleotide polymorphism-based NIPTs, which tend to have a higher fetal fraction cutoff to provide conclusive results. Our smNGS platform provides a critical signal boost that is especially noticeable at lower fetal fractions, significantly reducing inconclusive results.

| 55 |     | Wynn, J., Hoskovec, J., Carter, R., et al. (2023). “Performance of single-gene noninvasive prenatal testing for autosomal recessive conditions in a general population setting.” Prenatal Diagnosis,                                                      
 43(10), 1344-1354. The study included 42,067 pregnant individuals, with 7,538 carriers undergoing reflex single-gene (sg) NIPT. Fetal or neonatal outcomes were gathered for 528 cases, revealing 25 affected pregnancies. Notably, all pregnancies       
 identified with a 9 in 10 personalized fetal risk were confirmed as affected, showing a