Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 340

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 340
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 next 12 months after the financial statements are
available for issuance.

These financial statements were prepared under the assumption that the Company will continue as a going concern, which
contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business, and do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and
classification of liabilities that might result from the outcome of this uncertainty.

Risks and Uncertainties

Certain of the Company’s product candidates are in clinical development or in preclinical development. If the Company is unable to advance its product
candidates through clinical development, obtain regulatory approval and ultimately commercialize its product candidates, or experiences significant delays in doing so, the Company’s business will be materially harmed. Even if the Company
completes the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent the Company from obtaining clinical trial and marketing approvals for the commercialization
of some or all of its product candidates. As a result, the Company cannot predict when, or if, and in which territories, it will obtain marketing approval to commercialize a product candidate.

The Company is subject to certain risks and uncertainties that the Company believes could have a material adverse effect on its future financial position or
results of operations. As of the date of issuance of the financial statements, the Company is not aware of any specific event or circumstance that would require it to update its estimates, judgments, or the carrying value of its assets or
liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the financial statements as soon as they become known. Actual results could differ from those estimates, and any such
differences may be material to the Company’s financial statements.

The Company is subject to regulation and enforcement by the federal government
and by authorities in state and foreign jurisdictions in which the Company conducts business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security laws and regulations. If the
Company’s operations are found to be in violation of any such laws or government regulations that apply to use, the Company may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the
curtailment or restructuring of operations and exclusion from participation in federal and state healthcare programs.

Cash and Cash Equivalents

The Company’s cash and cash equivalents consist of all highly liquid investments deposited with banks, including money