BillionToOne Inc-A 2025年季度报告

FORM 10-Q___________________________________ (Mark One) xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission file number 001-42934 BillionToOne, Inc. (Exact name of registrant as specified in its charter)___________________________________ 81-1082020 (I.R.S. Employer Identification No.) (State or other jurisdiction of incorporation ororganization) 1035 O’Brien DriveMenlo Park, CA94025(Address of Principal Executive Offices)(Zip Code) (650) 460-2551Registrant’s telephone number, including area code Securities registered pursuant to Section 12(b) of the Act: Name of each exchange on which Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant wasrequired to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YesNo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for suchshorter period that the registrant was required to submit such files). Yes x No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, asmaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “acceleratedfiler,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of theExchange Act. Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YesNo As of December5, 2025, the registrant had 41,216,110 shares of Class A common stock, par value $0.00001 per share,and 4,552,650 shares of Class B common stock, par value $0.00001 per share outstanding. TABLE OF CONTENTS PagePART I FINANCIAL INFORMATION4ITEM 1.FINANCIAL STATEMENTS (UNAUDITED)4Balance Sheets4Statements of Operations and Comprehensive Income (Loss)5Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit6Statements of Cash Flows8Notes to Unaudited Interim Financial Statements10ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTSOF OPERATIONS28ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK46ITEM 4.CONTROLS AND PROCEDURES47PART II OTHER INFORMATION49ITEM 1.LEGAL PROCEEDINGS49ITEM 1A.RISK FACTORS49ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS94ITEM 3.DEFAULTS UPON SENIOR SECURITIES95ITEM 4.MINE SAFETY DISCLOSURES95ITEM 5.OTHER INFORMATION95ITEM 6.EXHIBITS95SIGNATURES97 Special Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning ofthe Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statementsof historical facts contained in this Quarterly Report, including statements regarding our future operating results andfinancial position, our business strategy and plans, our market growth, and our objectives for future operations, areforward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “forecast,” “could,” “plan,”“potential,” “predict,” “seek,” “target,” “should,” “would,” or the negative version of these words and similar expressions areintended to identify forward-looking statements. We have based these forward-looking statements on our currentexpectations and projections about future events and trends that we believe may affect our financial condition, results ofoperations, strategy, short- and long-term business operations and objectives, and financial needs. Forward-lookingstatements contained in this Quarterly Report include, but are not limited to, statements about: •the level of demand for any of our products, which may vary significantly;•our ability to increase the adoption of our products in the prenatal and oncology markets and in large healthcaresystems;•our ability to generate persuasive clinical validity and utility evidence;•our ability to expand our portfolio of molecular diagnostic tests;•our ability to use AI effectively and efficiently;•our ability to execute our reimbursement strategy and expand coverage of our tests;•our ability to replicate positive results from tria