Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 228

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 228
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ctal, and pancreatic cancers.

1000 Tumor Methylation Score 0 750 500 250 Breast Analytical LOD is at 0.01% Colorectal 0% 0.1% 0.2% 0.3% 0.4% 0.5% 900 600 300 0 0% 0.1% 0.2% 0.3% 0.4% 0.5% Contrived Tumor Fraction

157

Northstar Response assay measures changes in tumor burden across 12+ cancer types Brain Breast Colorectal Endometrial Liver Lung Ovarian Pancreas Prostate Renal Sarcoma Stomach We also collaborated with University of California, San Diego on a study involving immunotherapy and immuno-chemotherapy treated advanced non-smallcell lung cancer patients. 70In that study, which involved 60 samples from 51 patients, 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-valueis 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-valueis less than or equal to 0.05, the outcome is considered statistically significant. The study also showed that the test often detected treatment response and progression earlier than standard of care CT scans, with high concordance between TMS and clinical outcomes. 100 RECIST Objective Response Probability of Survival 0 50 75 25 Partial Response Stable Disease Progressive Disease P:0.55 0 100 200 300 Real-World Progression-Free Survival (Days) 400 Probability of Survival 100 Tumor Methylation Score 0 75 50 25 Below Limit of Quantification TMS Decrease No Change TMS Increase P<0.0001 0 100 200 300 Real-World Progression-Free Survival (Days) 400 In collaboration with Allegheny Health Network (AHN), a separate pan-cancervalidation cohort of 54 advanced stage cancer patients (lung, melanoma, and six other solid-tumor cancers) treated with immunotherapy regimens, TMS-basedmolecular responders had significantly better progression