Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 178

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 178
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 CT, MRI, and PET scans). Radiation exposure, infrequent scans, pseudo-progression
with immuno-oncology therapy, and inability to precisely quantify changes, highlight some of the limitations of an anatomic-only based approach in treatment monitoring. Our Northstar Response test is complementary to traditional imaging and
introduces real-time, single-molecule quantification to treatment monitoring with a Tumor Methylation Score (TMS). TMS is a quantitative metric that measures the extent of cancer-specific DNA methylation signal that is present in blood and reflects
whether the tumor is growing or shrinking in a cancer patient when measured longitudinally. Using a DNA methylation-based approach in conjunction with our smNGS platform, we bring a new level of precision that can help determine molecular
progression or therapy response at multiple time-points over the course of a patient’s treatment.

Northstar Response is highly accurate at measuring changes in tumor burden across cancer types

Our pan-cancer Northstar Response assay has been analytically validated across more than 10 tumor types and has been evaluated in
several clinical studies. In one study, we demonstrated that our assay could detect minute changes in cfDNA burden as small as 0.02% (e.g., an elevation of tumor fraction from 0.02% to 0.04%) demonstrating high sensitivity for a tissue-free, blood
only test. The assay also achieves a coefficient of variation (CV) of less than 10% for a typical sample with 1% tumor fraction, which is at least two times lower

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than conventional tumor-naive, targeted-panel methods that measure VAF. It has demonstrated a strong correlation with clinical outcomes in patients with lung, colorectal, and pancreatic cancers.

We also collaborated with University of California, San Diego on a study involving immunotherapy and immuno-chemotherapy treated
advanced non-small cell lung cancer patients. In that study, Northstar Response’s changes in TMS measured four to ten weeks after starting treatment significantly predicted real-world progression free
survival (rwPFS, p < 0.0001), compared to standard imaging assessments which did not reach statistical significance (p = 0.55). The p-value is used to determine the probability as to whether the
difference between two data sets is due to chance. The smaller the p-value, the more likely the differences are not due to chance alone. In general, if the p-value is
less than or equal to 0.05, the outcome