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United States securities and exchange commission logo
April 16, 2021
Andrew Spaventa
Chief Executive Officer
Singular Genomics Systems, Inc.
10931 N. Torrey Pines Road
Suite #100
La Jolla, CA 92037
Re: Singular Genomics
Systems, Inc.
Draft Registration
Statement on Form S-1
Submitted March 22,
2021
CIK No. 0001850906
Dear Mr. Spaventa:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply 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 these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1 submitted March 22, 2021
Prospectus Summary
Overview, page 1
1. Please revise your
prospectus summary to include a balanced discussion of your company
and products. For
example:
revise to clarify
that you have no experience manufacturing your products in
commercial
quantities, conducting sales and marketing activities at scale, or
managing customer
support at the commercial level;
Andrew Spaventa
Singular Genomics Systems, Inc.
April 16, 2021
Page 2
discuss whether any third parties tested or evaluated your
products prior to the beta
pilot program for the G4 Integrated Solution;
revise to discuss whether users in the beta pilot program have
achieved the
performance metrics that are referenced throughout this section;
and
disclose that you do not currently intend to seek FDA clearance
for the clinical
diagnostic use of your products and that your products will be
sold for research use
only.
2. We note your disclosures here and throughout your document that your
products are
designed to "empower clinicians", have broad potential application
across "clinical"
markets, that limitations remain in incorporating current sequencing
technologies and
products into "routine clinical practice" and similar statements.
However, your disclosure
on pages 47, 101 and 109 indicates that your products are not designed
as clinical
diagnostic tests or as medical devices, that you do not intend to
pursue clinical diagnostics
applications and that your products are labeled for research use only.
Accordingly, please revise throughout to remove your statements
regarding the potential
clinical use of your products and the limitations of current
sequencing products in clinical
practice or advise.
Applications for the G4 Integrated Solution, page 5
3. Please revise to provide the basis for your statement that HD-Seq
enables higher accuracy
than existing rare variant detection methods and describe the study in
which you
demonstrated 99.99% accuracy for 100 base reads with your current
methodology.
Markets, page 9
4. Please disclose any material assumptions and limitations associated
with your market
estimates. Please also revise this section to reflect your disclosure
elsewhere in the
document that you intend to market your products for research use
only.
Implications of Being an Emerging Growth Company, page 11
5. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Risk Factors
Our ability to use our net operating loss carryforwards and certain other tax
attributes may be
FirstName LastNameAndrew Spaventa
limited, page 31
Comapany NameSingular Genomics Systems, Inc.
6. Please
April 16, 2021quantify
Page 2 your net operating loss carryforwards and research tax
credits.
FirstName LastName
Andrew Spaventa
FirstName LastNameAndrew Spaventa
Singular Genomics Systems, Inc.
Comapany
April NameSingular Genomics Systems, Inc.
16, 2021
April 316, 2021 Page 3
Page
FirstName LastName
Special Note Regarding Forward-Looking Statements, page 61
7. We note the statement that you undertake no obligation to update
forward-looking
statements publicly for any reason following the date of the
prospectus. Please revise to
clarify that you will update this information to the extent required
by law.
Market, Industry and Other Data, page 62
8. We note your statement that third party information regarding market
and industry data
has not been independently verified. We further note your statement
that the content of the
third-party sources, except to the extent set forth in this
prospectus, does not constitute a
portion of the prospectus. These statements may imply an inappropriate
disclaimer of
responsibility with respect to such information that appears in your
prospectus. Please
either delete these statements or specifically state that you are
liable for the information
related to the market and industry data and your internal company
research that appears in
the prospectus.
Business
Capabilities of the G4 Integrated Solution, page 92
9. Please revise your disclosure to describe how the capabilities
referenced in this section
(e.g. Q30 on greater than 70% of base calls, 4.0 minute cycle time,
150 million reads per
flow cell) were assessed or observed.
10. We note your statements that you are "targeting" Q30 for greater than
80% of base calls
for 150 base reads, 2.5 minute cycle times for each base sequenced (as
compared to a
current 4.0 minute cycle time) and 330 million reads per flow cell at
commercial launch
(as compared to demonstrated capability to produce 150 million reads
per flow cell).
Please revise to briefly discuss the anticipated developments that
will permit you to meet
these performance goals.
Applications for the G4 Integrated Solution, page 94
11. Please revise this section to describe the study or trial in which you
generated the data on
page 95. Please also describe the significance of the "Read 1" and
"Read 2" lines in the
chart.
Competitive Strengths, page 102
12. Please revise to provide the basis for your statement that the G4
Integrated Solution and
planned PX Integrated Solution offer differentiated performance as
measured by various
KPIs. To the extent either product has yet to achieve differentiated
performance in these
indicators in comparative analyses, please revise your disclosure
accordingly.
Intellectual Property, page 107
13. Please revise to describe the material terms of your license agreement
with The Trustees
Andrew Spaventa
Singular Genomics Systems, Inc.
April 16, 2021
Page 4
of Columbia University in the City of New York including:
the date of the agreement and the identity of each of the parties
to the agreement;
each parties' rights and obligations under the agreement;
quantify all payment made to date;
disclose separately the aggregate amount of all potential
development, regulatory and
commercial milestone payments;
disclose the amount of option fees for any additional patents or
intellectual property;
quantify the royalty rate, or a range no greater than 10 percentage
points per tier;
disclose when royalty provisions expire, if the expiration is based
on a number of
years following commercialization, disclose the number of years;
disclose the expiration date; and
describe any termination provisions.
Please also file the agreement as an exhibit to your registration
statement.
14. Please revise to disclose for each material patent and patent application
the specific
product(s) to which such patents or patent applications relate and the
type of patent
protection. Please also disclose the jurisdictions of your issued patents
and your European
patent applications.
You may contact Ibolya Ignat at 202-551-3636 or Lynn Dicker at
202-551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at 202-551-4224 or Jeffrey Gabor at 202-551-2544 with any
other
questions.
Sincerely,
FirstName LastNameAndrew Spaventa
Division of
Corporation Finance
Comapany NameSingular Genomics Systems, Inc.
Office of Life
Sciences
April 16, 2021 Page 4
cc: Ryan J. Gunderson, Esq.
FirstName LastName