July 13, 2018
David Moss
Chief Financial Officer
INmune Bio Inc.
1224 Prospect Street, Suite 150
La Jolla, CA 92037
Re: INmune Bio Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted June 13, 2018
CIK No. 0001711754
Dear Mr. Moss:
We have reviewed your amended 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. Unless we note otherwise, our references to prior comments are to
comments in our
March 3, 2018 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Use of Proceeds, page 33
1. We note your disclosure that the company anticipates that the existing
cash on hand plus
the expected research and development cash credits from the UK and
Australian trials and
net proceeds from the minimum offering amount will be enough to complete
the
INKmune Phase I/II trial in women with ovarian cancer and the Phase I
trial using INB03
in ovarian cancer patients. Please revise to disclose which clinical
trials you expect to
David Moss
FirstName LastNameDavid Moss
INmune Bio Inc.
Comapany NameINmune Bio Inc.
July 13, 2018
July 13, 2018 Page 2
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FirstName LastName
be able to complete if you are able to sell the maximum number of
shares you intend to
offer.
Dilution, page 35
2. Please revise the net tangible book value as of March 31, 2018 of
$18,633,228 as the
intangible asset should not be included in this amount. Also revise
the net tangible book
value per share of $2.14 as it should agree to the amount disclosed on
page 36 of $0.24.
Business, page 37
3. We note your response to our prior comment 8 and reissue. Please
expand the disclosure
in this section to discuss your human umbilical cord derived
mesenchymal stem/stromal
cells manufacturing business and provide the disclosure required by
Item 101(h)(4) of
Regulation S-K.
INKmune Competition, page 42
4. We note your disclosure in this section that INB03 will be a
"first-in-class" therapy. The
term "first-in-class" suggests that the product candidate is effective
and likely to be
approved. Please delete this reference. If your intention is to convey
your belief that your
product candidate has a novel technology or approach and/or is further
along in the
development process, you may discuss how your technology differs from
technology used
by competitors and that you are not aware of competing products that
are further along in
the development process. Statements such as these should be
accompanied by cautionary
language that the statements are not intended to give any indication
that your product
candidate has been proven effective or that it will receive regulatory
approval. Similarly
revise your disclosure throughout your filing describing your planned
clinical trial as a
"first-in-man" trial since you have not yet submitted an IND, which
then must be
approved before you can initiate your clinical trial.
Intellectual Property, page 44
5. We note your response to our prior comment 11. We note that you list
TBD or N/A for
certain patent applications. If these two terms are intended to have
the same meaning,
please revise for consistency. Otherwise, please explain why you use
TBD for certain
applications and N/A for others. Please also explain in this section
what jurisdictions are
covered by PCT-GLOBAL.
6. We note your response to our prior comment 13. Please revise your
disclosure, if correct,
to clarify that the royalty rate that you have agreed to pay Xencor is
based on net sales of
licensed products. Please also file the license agreement and voting
agreement with
Xencor as exhibits to the registration statement or tell us why you
believe that you are not
required to file such agreements pursuant to Item 601(b)(10) of
Regulation S-K.
David Moss
FirstName LastNameDavid Moss
INmune Bio Inc.
Comapany NameINmune Bio Inc.
July 13, 2018
July 13, 2018 Page 3
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FirstName LastName
Immune Ventures, LLC License Agreement, page 46
7. We note your response to our prior comment 12 and reissue in part.
Please disclose the
duration of this license agreement, the royalty term and the
termination provisions.
INKmune Manufacturing, page 48
8. We note your response to our prior comment 35 and reissue in part.
Please disclose the
royalty term for the agreement with the Anthony Nolan Cord Blood Bank.
Unit Offering, page 64
9. We note your disclosure that you filed the registration statement that
this prospectus forms
a part of to register the shares of common stock issued in the unit
offering. Please revise
this section accordingly since you are no longer pursuing a secondary
offering.
Management, page 66
10. We note your disclosure that Mr. Moss has significant experience
operating public
companies. Please revise his business experience to provide examples
of such experience.
Employment Agreements, page 71
11. We note your disclosure that you have an employment agreement with Mr.
Lowdell for
him to serve as your Chief Scientific Officer. We also note that
Exhibit 10.11 indicates
that the agreement with Mr. Lowdell is a consultancy agreement and
that Mr.
Lowdell was asked to serve as your Chief Scientific Officer as well as
the Chairman of
your Scientific Advisory Board, which you indicated in response to our
prior comment 17
that you do not have. Please tell us whether you amended the
consultancy agreement to
reflect that Mr. Lowdell will no longer serve as the Chairman of your
Scientific Advisory
Board, or alternatively revise the prospectus to provide the
information requested in our
prior comment 17. Please also revise the disclosure in this section to
reflect that the
agreement with Mr. Lowdell is a consultancy agreement.
Certain Relationships and Related Party Transactions, page 75
12. We note your response to our prior comment 20. You have provided your
disclosure in
this section based on the language in Item 404(a) of Regulation S-K.
Item 404(d) of
Regulation S-K states that a registrant that qualifies as a smaller
reporting company must
provide the information required by paragraph (a) of Item 404 for the
period specified
there for a transaction in which the amount involved exceeds the
lesser of $120,000 or one
percent of the average of the smaller reporting company's total assets
at year end for the
last two completed fiscal years. Please revise this section
accordingly.
David Moss
INmune Bio Inc.
July 13, 2018
Page 4
You may contact Vanessa Robertson at 202-551-3649 or Angela Connell at
202-551-
3426 if you have questions regarding comments on the financial statements and
related matters.
Please contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at
202-551-3625 with
any other questions.
FirstName LastNameDavid Moss
Division of
Corporation Finance
Comapany NameINmune Bio Inc.
Office of Healthcare
& Insurance
July 13, 2018 Page 4
cc: David Manno, Esq.
FirstName LastName