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United States securities and exchange commission logo
October 6, 2020
William Ho
Chief Executive Officer
IN8bio, Inc.
79 Madison Avenue
New York, New York 10016
Re: IN8bio, Inc.
Draft Registration
Statement on Form S-1
Submitted September
10, 2020
CIK No. 0001740279
Dear Mr. Ho:
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 on September 10, 2020
Prospectus Summary , page 1
1. Please tell us why you
believe that the final column of your pipeline table "Next
Anticipated Milestones"
is relevant to an investment decision, or eliminate the column
where it appears
throughout the prospectus.
2. Please balance your
disclosure concerning the additional applications of INB-100, INB-
300 and INB-400 to
better explain the status of development to date, and to advise
investors that these
applications are at a very early phase of their development, or
eliminate the products
and applications from the pipeline table.
William Ho
FirstName
IN8bio, Inc.LastNameWilliam Ho
Comapany
October NameIN8bio, Inc.
6, 2020
October
Page 2 6, 2020 Page 2
FirstName LastName
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 5
3. Please provide us with supplemental 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 have presented or expect to present to potential investors in
reliance on Section
5(d) of the Securities Act, whether or not you retained, or intend to
retain, copies of those
communications. Please contact the staff member associated with the
review of this filing
to discuss how to submit the materials, if any, to us for our review.
Please contact
Julia Griffith at 202-551-3267 to discuss how to submit the materials,
if any, to us for our
review.
Risk Factors, page 11
4. We note numerous references to seeking approvals abroad, foreign
regulators and foreign
markets throughout the Risk Factors and other sections of your
prospectus. Please revise
to explain what non-US markets, if any, you plan to enter, and what
steps you have taken
to attain the necessary regulatory and patent approvals. Please tailor
the risk factors
section to more closely reflect the applications you have made or are
planning to make in
the near term.
5. Please refer to the risk factor on page 23 discussing the company's
possible use of
accelerated approval pathways for FDA approval. Please disclose the
specific programs
applicable to products or therapeutic platforms that you are currently
developing.
Use of Proceeds, page 63
6. We note your disclosure that the proceeds of the offer will not be
sufficient to fund any of
your product candidates through regulatory approval. Please revise to
specify how far the
proceeds of the offering will take the company into the clinical
development of INB-200
and INB-100. If any material amounts of other funds are necessary to
accomplish the
specified purposes for which the proceeds are to be obtained, state
the amounts and
sources of such other funds needed for each such specified purpose and
the sources
thereof. Refer to Instruction 3 of Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operation
Results of Operations, page 75
7. We note that you have multiple products in varying stages of
development and clinical
testing. Please expand to provide detail by product candidate for your
research and
development expenses during each period presented. To the extent that
you do not track
expenses by product candidate, please disclose as such.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 80
8. Once you have an estimated offering price or range, please explain to
us how you
William Ho
IN8bio, Inc.
October 6, 2020
Page 3
determined the fair value of the common stock underlying your equity
issuances since
March 2020 and the reasons for any differences between the recent
valuations of your
common stock leading up to the IPO and the estimated offering price.
Provide detail
regarding the extent to which recent sales of preferred stock and/or
common stock in
arms-length transactions represented significant inputs to the fair
value determination.
This information will help facilitate our review of your accounting
for equity issuances,
including stock compensation. Please discuss with the staff how to
submit your response.
Exclusive License Agreement with Emory University, Children s Healthcare of
Atlanta, Inc. and
The UAB Research Foundation, page 105
9. Please disclose the annual minimum royalty you are required to pay,
the share of
sublicensee fees you are required to pay, and the an annual license
maintenance fee.
Exclusive License Agreement with UABRF, page 106
10. Please disclose the share of non-royalty income that you are required
to pay UABRF.
Index to Financial Statements
Note 3. Fair Value Assets and Liabilities, page F-12
11. Please revise to clearly disclose the valuation methodology for your
Series A Preferred
Stock warrants including the significant unobservable inputs
underlying the level 3 fair
value measurements. Refer to ASC 820-10-50-2bbb.
You may contact Tara Harkins at 202-551-3639 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Julia Griffith at 202-551-3267 or Dietrich King at 202-551-8071 with
any other
questions.
FirstName LastNameWilliam Ho Sincerely,
Comapany NameIN8bio, Inc.
Division of
Corporation Finance
October 6, 2020 Page 3 Office of Life
Sciences
FirstName LastName