Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 153

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 153
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 30, 2025, which has increased percentage points year-over-year, (ii) our
high sales efficiency driven by differentiated products, with our annualized revenue run-rate per sales representative at over $ million for the three months ended June 30,
2025, and (iii) disciplined operational practices supplemented by automation and AI. Going forward, our financial discipline will continue to be integral to our innovation efforts. By prioritizing efficiency, we have been able to consistently
invest in R&D and commercial expansion while reducing losses over time and achieving profitability. In doing so, we believe we have established a differentiated financial profile that positions us for sustainable value creation.

Background on cfDNA and the limitations of traditional NGS technologies

cfDNA represents one of the most promising biomarkers in modern precision medicine. cfDNA is continuously shed from all tissues into the bloodstream and has a short
half-life of approximately one to two hours. This transient nature gives cfDNA a unique capability to provide a real-time snapshot of cellular turnover and can be used to diagnose and monitor disease, as both genetic and epigenetic properties of
cfDNA directly reflect the originating tissue.

Despite its potential, the detection of cfDNA is fundamentally challenging due to its limited quantity in blood and
short half-life. Certain conditions that stem from large scale genetic changes or generate abundant quantities of cfDNA in the bloodstream can be identified by previous testing approaches. However, other serious conditions may have lower DNA
shedding rates which can result in very few relevant DNA fragments in the blood. These conditions are nearly undetectable with previous cfDNA detection techniques. For example, even in a late-stage cancer patient, there may only be one mutated
cell-free tumor DNA molecule found in one tube of blood.

While traditional NGS has revolutionized genomic medicine over the past decade, it faces inherent
limitations when applied to the analysis of cfDNA. Conventional NGS technologies are primarily limited to presence or absence detection. For example, within germline testing, which includes nearly unlimited input DNA material, the clinically
relevant changes are detected at around 50% additional disease burden. However, in cfDNA applications, these clinically relevant changes can be at the level of 0.01% of cfDNA in blood. These applications require ultrasensitive quantification at the
single molecule level that we believe is only possible with our smNGS platform. Further complicating the challenge, cfDNA samples undergo numerous enzymatic, amplification, and other biochemical steps prior to sequencing. Each of these