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United States securities and exchange commission logo
November 10, 2020
Brian Coe
Chief Executive Officer
Talis Biomedical Corporation
230 Constitution Drive
Menlo Park, CA 94025
Re: Talis Biomedical
Corporation
Draft Registration
Statement on Form S-1
Submitted October
15, 2020
CIK No. 0001584751
Dear Mr. Coe:
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
Prospectus summary
Overview, page 1
1. Please disclose in the
Summary that you are a development stage company and that to
date you have not
generated revenue from product sales.
2. We note your intent to
submit around year end a request for an Emergency Use
Authorization. Please
revise your Summary discussion to explain briefly what the
Emergency Use
Authorization allows and the uncertain nature of its duration.
Brian Coe
FirstName LastNameBrian Coe
Talis Biomedical Corporation
Comapany 10,
November NameTalis
2020 Biomedical Corporation
November
Page 2 10, 2020 Page 2
FirstName LastName
Market opportunity, page 7
3. Please disclose any material assumptions and limitations associated
with your estimate of
the total potential annualized addressable market.
Implications of being an emerging growth company and a smaller reporting
company, page 10
4. 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.
Series 1 convertible preferred stock to be outstanding after this offering,
page 11
5. In an appropriate location in your prospectus, please disclose the
business purposes for the
Series 1 convertible preferred stock that will be outstanding after
your offering.
Risk factors
A significant portion of the funding for the development of our Talis One
platform..., page 51
6. Please file the government contracts described in this section as
exhibits or tell us the
basis for your conclusion that you are not required to file these
agreements.
Some of our intellectual property has been discovered through government funded
programs...,
page 66
7. Please revise to identify intellectual property rights that are or may
be subject to march-in
rights. To the extent that your Talis One platform, including your
COVID-19 diagnostic
test, would be subject to march-in rights, please revise to make this
clear.
Use of proceeds, page 84
8. To the extent that you will allocate proceeds to the development of
Talis One, please
specify how far in the development process you expect to reach with
the proceeds of the
offering. To the extent any material amounts of other funds are
necessary to accomplish
the specified purpose, state the amounts and sources of other funds
needed for each
specified purpose and the sources. Refer to Instruction 3 to Item 504
of Regulation S-K.
Business
Talis One tests, page 120
9. We note your statement that your "initial focus is on the detection of
SARS-CoV-2."
However, on page 121, you state that "[i]mmediately prior to the
current pandemic, we
were beginning the process of verification, validation and conducting
clinical trials of our
Talis One platform for CT/NG." Please reconcile this disclosure and
revise the Overview
Brian Coe
Talis Biomedical Corporation
November 10, 2020
Page 3
section of the Summary to clearly disclose that your initial focus was
on women's health
and sexually transmitted infections and that you postponed development
of that program
to focus on a COVID-19 test.
Performance of the Talis One COVID-19 test, page 121
10. Please disclose any material protocols used during the preclinical
assessment of your
COVID-19 test, including indicating if any portions of the assessments
were blinded.
11. Please revise your textual discussion of the 95% CI statistical
analysis performed to
explain the significance of the ranges provided and how this data
translates into you plan
to submit an Emergency Use Authorization to the FDA.
Intellectual property, page 128
12. To the extent that your agreements with University of Chicago and
Caltech relate to the
Talis One, please disclose the material terms and file the agreements
as an exhibit to the
registration statement or, in the alternative, tell us why you are not
required to file these
agreements.
13. Discuss, as applicable, whether you hold patents that cover the
COVID-19 diagnostic
tests.
14. Please revise your discussion to disclose the material foreign
jurisdictions.
Coverage and reimbursement, page 137
15. Please revise to discuss coverage and reimbursement as it pertains to
the COVID-19
diagnostic test.
Financial Statements
Statements of convertible preferred stock and stockholders' deficit, page F-5
16. As the November and December 2019 stock transactions are complex, with
regard to
the Statements of convertible preferred stock and stockholders' deficit,
revise the
disclosure as necessary to:
explain how you determined the $56.2 million should increase
Additional Paid In
Capital,
quantify how the $0.5 million inducement was computed,
tell us your consideration of disaggregating the single line item
which contains the
FirstName LastNameBrian
$56,241,000 intoCoe
multiple lines, (with perhaps a sub-total), and
Comapany NameTalis
clarify Biomedical
the disclosure in Corporation
the paragraph that begins with "The impact
of the Equity
November 10,Transactions...."
2020 Page 3 on page F-24 so that it reconciles to $53,856,000.
FirstName LastName
Brian Coe
FirstName LastNameBrian Coe
Talis Biomedical Corporation
Comapany 10,
November NameTalis
2020 Biomedical Corporation
November
Page 4 10, 2020 Page 4
FirstName LastName
Notes to Financial Statements
2. Summary of significant accounting policies, page F-8
17. The disclosure here refers to a 10-for-1 reverse split while other
places in the registration
statement refer to a 1-for-10 reverse split. Please revise the
disclosure to remove this
discrepancy.
8. Convertible notes due to related party, page F-22
18. You disclose that then outstanding principal and interest of $19.0
million was converted
and reclassified to Series D-2 Preferred, but your reference on pages
F-5 and F-6 is $15.8
million. Please explain to us how and where you accounted for the
difference between
these two amounts.
13. Net (loss) income per share attributable to Class A Common Stockholders...,
page F-33
19. You disclose that pro forma net loss per share has been computed to
give effect to the
conversion of all outstanding convertible preferred stock into common
stock. Please
revise your disclosure to address the shares that will be converted
into Series 1 convertible
preferred stock and how these shares will be treated under ASC 260.
You may contact Michael Fay at 202-551-3812 or Lisa Vanjoske at
202-551-3614 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Karen E. Deschaine, Esq.