Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 221

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 221
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 Ovarian Pancreas Prostate Renal Sarcoma Stomach

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We also collaborated with University of California, San Diego on a study involving immunotherapy and immuno-chemotherapy treated advanced non-smallcell lung cancer patients. 65In 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 free survival (PFS) (HR=0.26) and OS (HR=0.18) than molecular non-responders.This was particularly remarkable given that the separation between responder and non-responderwas made within the first 90 days from baseline and was predictive of durable outcomes years in advance. Molecular responders at day 90 had a significantly improved median overall survival of over two years longer compared to patients who were found to be molecular non-responders. Probability of Survival 100 75 50 25 0 Progression-Free Survival Log-rank P<0.0001 TMS Responder 250 500