# EDGAR Filing Document

**Accession Number:** 0002070849
**File Stem:** 0000000000-25-009093
**Filing Date:** 2025-8
**Character Count:** 9806
**Document Hash:** 8c9170a3ef1c51f551544beb89467677
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-25-009093.hdr.sgml**: 20260508

**ACCESSION NUMBER**: 0000000000-25-009093

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20250826

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BillionToOne, Inc.
- **CENTRAL INDEX KEY:** 0002070849
- **STANDARD INDUSTRIAL CLASSIFICATION:** SERVICES-MEDICAL LABORATORIES [8071]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 811082020
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD
- **SEC FILE NUMBER:** 377-08131

**BUSINESS ADDRESS:**
- **STREET 1:** 1035 O'BRIEN DRIVE
- **CITY:** MENLO PARK
- **STATE:** CA
- **BUSINESS PHONE:** 650-460-2551

**MAIL ADDRESS:**
- **STREET 1:** 1035 O'BRIEN DRIVE
- **CITY:** MENLO PARK
- **STATE:** CA
- **ZIP:** 94025
**PUBLIC REFERENCE ACCESSION NUMBER**: 0000950123-25-006095

## Text-Extract

```

                                                            August 25, 2025

Oguzhan Atay
Chief Executive Officer
BillionToOne, Inc.
1035 O   Brien Drive
Menlo Park, CA 94025

        Re: BillionToOne, Inc.
            Amendment No. 1 to Draft Registration Statement on Form S-1
            Submitted August 11, 2025
            CIK No. 0002070849
Dear Oguzhan Atay:

     We have reviewed your amended draft registration statement and have the
following
comments.

        Please respond to this letter by providing the requested information
and either
submitting an amended draft registration statement or publicly filing your
registration
statement and non-public draft submission(s) on EDGAR. If you do not believe a
comment
applies to your facts and circumstances or do not believe an amendment is
appropriate, please
tell us why in your response.

        After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, any references to prior comments are to
comments in
our July 17, 2025 letter.

Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Our four pillars of differentiation, page 3

1.     We note your response to comment 6, including your revised disclosure in
footnote 5
       that "PCR amplification during library preparation for NGS introduces
significant
       biases, including primer binding bias, mis-priming, non-specific
binding, and
       amplification errors. When this inefficiency is amplified exponentially
over several
       cycles, it leads to notable inaccuracies in sequencing results. [Yo]ur
QCTs act as a
       control when [you] conduct amplification and allow [you] to identify and
remove the
       biases." Please briefly discuss each of these significant biases.
 August 25, 2025
Page 2

Our Superior Efficiency, page 4

2.     We note your response to prior comment 7 and your revised disclosure
identifying
       your competitors. Please revise to balance your disclosure by
clarifying, if true, that
       your competitors consist of different size companies with product
offerings that may
       not be directly comparable to your product offerings.
Management's discussion and analysis of financial condition and results of
operations
Key factors affecting our results of operations and performance, page 93

3.     We note your response to comment 4, including your revised disclosure in
the
       footnotes on page 99. Please revise your disclosures throughout the
registration
       statement to prominently note that half of your total estimated market
includes early
       detection, an area for which you have not yet started any development
and do not have
       any products or product candidates on sale commercially. We also note
your revised
       disclosure on page 98 that your estimate that the 14-gene version of
UNITY Fetal
       Risk Screen will expand the serviceable addressable market for UNITY by
70% is
       based on a survey of OB/GYNs and MFMs conducted in 2023, and your
disclosure on
       page 133 that the oncology market is less than 20% penetrated today by
all molecular
       diagnostics companies based on the most recently reported annual
oncology revenue
       generated by your public company competitors, compared to your estimated
$20
       billion annual United States market opportunity. Please clarify how the
survey
       conducted in 2023 demonstrated that the UNITY panel could be used by 70%
more
       service providers compared to the 5-gene panel, and disclose your public
company
       competitors considered in footnote 42 on page 133.
Liquidity and Capital Resources
Oberland Capital Note Purchase Agreement, page 110

4.     We note your response to prior comment 20 and reissue in part. Please
address the
       following:
           Clarify whether the revenue participation payments reduce the amount
of the
           principal loan balance or if they are additional financing costs of
the loan.
           If the revenue participation payments are additional financing
costs, address the
           need to include them in the internal rate of return disclosures.
           In your updated interim financial information, ensure you quantify
your
           obligations associated with the revenue participation payments.
Business
Industry Background & Market Opportunity, page 132

5.     We note your response to comment 24, including your disclosure on page
134 that
       "[u]nder the First J&J Agreement, Johnson & Johnson made an initial
payment to
       [you], with subsequent payments due upon achievement of specific
milestones,
       including receipt of approval of the trial, which was achieved in 2023,
various patient
       enrollment milestones, and subsequent full trial completion." We also
note your
       disclosure that "[u]nder the Commercialization Agreement, Johnson &
Johnson is
       required to make an initial payment to [you], with subsequent payments
due upon
       achievement of specific milestones, including submission of the
companion diagnostic
 August 25, 2025
Page 3

       product to the FDA for marketing approval by January 2028, and FDA
approval of the
       companion diagnostic product, by the later of (i) December 2029 and (ii)
one year
       after Johnson & Johnson obtains regulatory approval for nipocalimab."
Please revise
       to disclose the commercial terms, including any payments received and/or
due from
       Johnson & Johnson pursuant to these agreements.
Our Product Portfolio, page 137

6.     We note your response to comment 21, including your response that "the
clinical
       studies referenced in the Company   s Amended Draft Registration
Statement were
       retrospective analyses involving previously collected blood samples
obtained from
       patient cohorts as reflected in medical records. No new patient
enrollment,
       randomization, or interventional procedures were undertaken. The Company
  s
       methodology involved processing these pre-existing samples using its
LDTs and
       comparing the resulting test outputs to patient outcomes as documented
in existing
       clinical data. As a result, information typically requested for clinical
trials, including,
       but not limited to, the dates and locations of trial conduct, the
identity of trial
       sponsors, the occurrence of serious adverse events, and statistical
measures such as p-
       values, is not applicable or available in the context of these
retrospective clinical
       studies." Please revise page 150 to include these disclosures.
7.     We note your response to comment 22, including your response that "[t]o
be offered
       as high-complexity laboratory tests, LDTs must comply with the
requirements of the
       Clinical Laboratory Improvement Amendments of 1988...which mandate that
       laboratories demonstrate analytical validity. While CLIA does not
explicitly require
       demonstration of clinical validity or clinical utility, these elements
are typically
       prerequisites for coverage and reimbursement by third-party payors,
including private
       insurers, Medicare, and entities such as MolDX," and that your "tests
have received
       broad third-party payor coverage, including approval by MolDX." Please
revise your
       disclosures on page 135 to note that your LDTs are not regulated by the
FDA, clarify
       whether all of your LDTs are subject to CLIA requirements, and include a
cross
       reference to your disclosures elsewhere, including on page 150,
discussing the results
       of studies demonstrating clinical validity and/or utility. Please also
note, as you do in
       the response letter, that any references to clinical validity and/or
utility are distinct
       from claims of safety and/or efficacy relating to each of your products.
General

8.     We note your response to comment 30. Please ensure that your filing,
including the
       graphics with text and letter from your co-founder and CEO, are
text-searchable.
       Please contact Tayyaba Shafique at 202-551-2110 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Juan Grana at 202-551-6034 or Lauren Nguyen at
202-551-3642 with
any other questions.

                                                              Sincerely,
 August 25, 2025
Page 4

                               Division of Corporation Finance
                               Office of Industrial Applications and
                               Services
cc:   Elena M. Vespoli, Esq.

```

### Attached PDF Documents

**Attachment 1:** `filename1`

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