Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 180

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 180
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ities.

Additional opportunities in oncology

Beyond our two complementary therapy selection and monitoring tests, we are actively advancing our efforts in developing additional oncology products in MRD testing. Our
Northstar Response test already achieves 0.01% LOD, which is in line with the first-generation tissue-informed MRD assays. We are making further improvements to the Northstar Response assay designed to achieve superior clinical performance than
existing assays using the tumor-naive (blood only) approach. We believe there is a significant market opportunity for tumor-naive MRD assays, especially in certain cancer types such as lung, where the QC failure rates for tissue testing can exceed
40%. Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection. We have leveraged our existing relationship with Allegheny Health Network to collaborate on procuring a
retrospective sample set to begin assessment of our MRD assay across multiple tumor types including CRC and endometrial cancers.

Publications and collaborations

We have extensive publications on our smNGS platform and products. Our UNITY Fetal Risk Screen clinical publication in Genetics in Medicine
was selected for the Top 10 publications in Genomic medicine year in review 2023 by AJHG. Our hallmark publications in the Obstetrics & Gynecology journal (the Green Journal) demonstrated 100% sensitivity and specificity in approximately
860 patients for fetal RhD and other fetal RBC antigen detection, ultimately leading to the ACOG practice guideline changes.

The analytical and clinical validity of
our Northstar products have also been demonstrated in peer-reviewed publications. The analytical validation of Northstar Response was published in January 2025 in Scientific Reports while additional clinical studies of the assay performance in lung
and liver cancer cohorts were published in Clinical Lung Cancer and the Journal of American College of Surgeons,respectively. The analytical and clinical validation of Northstar Select, including the head-to-head comparison against other on-market assays is currently under peer review. Beyond the peer-reviewed journal publications
below, we have published posters and abstracts at various medical conferences including AACR, AACR LBx, ASCO, and the International Society of Liquid Biopsy.

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We leverage our strong clinical studies pipeline and are committed to providing strategic validation data for our
liquid biopsy tests. Leveraging both internally designed prospective studies, as well as partnering with well-known and respected oncology research organizations provides both the efficiency and impact that is needed for validation of novel
precision oncology tools.

UNITY