March 3, 2018
David Moss
Chief Financial Officer
Inmune Bio, Inc.
1224 Prospect Street, Suite 150
La Jolla, CA 92037
Re: INmune Bio Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted February 14, 2018
CIK No. 0001711754
Dear Mr. Moss:
We have reviewed your amended draft offering 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 offering statement or publicly filing your offering 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
any amendment
to your draft offering statement or filed offering statement and the
information you provide in
response to these comments, we may have additional comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 7
1. We note your response to our prior comment 6 and reissue. It appears
that you have not
commenced any clinical trials for any of your product candidates. Please
revise your
product pipeline table on page 8 to better illustrate the current status
of development of
your product candidates and to disclose the indications you are pursuing
as well as your
anticipated development timelines.
2. We note your response to our prior comment 7 and reissue in part. Please
revise the
product pipeline table on page 8 to eliminate any duplication that may
cause confusion. If
you have only two product candidates, there should only be two rows
identifying those
candidates in the table and only one table.
David Moss
FirstName LastNameDavid Moss
Inmune Bio, Inc.
Comapany NameInmune Bio, Inc.
March 3, 2018
June 16, 2017 Page 2
Page 2
FirstName LastName
3. We note your response to our prior comment 9 and reissue. Given the
early stage of
development of your product candidates, please revise to eliminate
disclosure suggesting
that they may be "safer, easier to execute and more effective than
currently available
treatments." We note that this disclosure still appears in Note 1 to
the consolidated
financial statements for the year ended December 31, 2016 and for the
period from
September 25, 2015 (Inception) to December 31, 2015 and Note 1 to the
consolidated
financial statements for the three and nine months ended September 30,
2017 and 2016.
JOBS Act, page 9
4. Please refer to your response to comment 11. The revisions you made on
pages 33 and 59
do not clarify that you have elected to use the transition period for
complying with new or
revised accounting standards. Please add this to the bullet points on
pages 33 and 59 and
clarify that this election allows you to delay the adoption of new or
revise accounting
standards that have different effective dates for public and private
companies until those
standards apply to private companies.
Risk Factors
We are conducting a primary and secondary offering concurrently, page 34
5. We note your response to our prior comment 2 and reissue in part.
Please revise this risk
factor to address the possibility that the secondary offering could
hinder your ability to
raise funds in your best efforts primary offering.
Use of Proceeds, page 34
6. We note your response to our prior comment 15. Please indicate how
much of the
remaining proceeds, based on the minimum and the maximum potential
proceeds, will be
dedicated to each of the uses specified: manufacturing, research and
development
activities, working capital and general corporate purposes. Please
also specify what you
mean by manufacturing, research and development activities.
Business, page 37
7. We note your disclosure on page 40 that the principle of TpNK killing
has been
demonstrated in two Phase I trials in patients with AML. Please
describe in this section
when these two Phase I trials began, where they were being conducted,
the number of
participants, the method by which the products were administered,
serious adverse effects,
and primary and secondary endpoints.
8. We note your response to our prior comment 20 and reissue in part.
Please expand the
disclosure in this section to discuss your manufacturing business and
provide the
disclosure required by Item 101(h)(4) of Regulation S-K.
David Moss
FirstName LastNameDavid Moss
Inmune Bio, Inc.
Comapany NameInmune Bio, Inc.
March 3, 2018
June 16, 2017 Page 3
Page 3
FirstName LastName
INKmune: Our NK cell Directed Product Candidate, page 40
9. We note your response to our prior comment 21 and reissue. We note
your disclosure in
this section about the potential effects of INKmune such as converting
a resting NK cell
into a tumor primed NK cell. As you have not demonstrated the efficacy
of your product
candidate yet, please revise these statements to indicate that they
are your beliefs.
INKmune Product Development Path Proposed Phase I/II Study in patients with
cancer, page 43
10. We note your disclosure that you expect the therapy to well tolerated
in the Phase I to be
performed under a CTA issued by the MHRA at the University College of
London
Hospital in London based on pre-clinical studies and observation of
similar clinical trials
with similar products and delivery strategies. Please identify these
pre-clinical studies and
clinical trials in this section.
Intellectual Property, page 45
11. We note your response to our prior comment 23 and reissue. Please
revise the tables on
page 45 to disclose the specific products, product groups and
technologies to which each
patent in the table relates, whether the patents are owned or licensed
from third parties, the
type of patent protection, such as composition of matter, use or
process, and the patent
expiration dates. Please also explain what jurisdictions are covered
by PCT in the last
column in the table and how you file a global patent.
INKmune License Agreement, page 46
12. We note your response to our prior comment 26 and reissue. Please
disclose the nature
and scope of the intellectual property transferred in the license
agreement with INmune
Ventures, LLC, what you mean by Patent Rights in the Field, the
duration of the
agreement, the royalty term and the termination provisions.
13. We note your response to our prior comment 27 and that you removed the
royalty rate that
the company has agreed to pay Xencor and the details of the
sublicensing terms. Please
restore this disclosure in the next amendment.
Government Regulation, page 50
14. We note your response to our prior comment 31 and reissue in part.
Please briefly
describe how the drug approval process works in Australia and Europe.
INB03 Product Development Path: Proposed Phase I and Phase II Studies in
patients with
cancer, page 51
15. Please remove the statements that you do not expect significant safety
issues based on pre-
clinical studies in rodents and non-human primates and that the safety
profile of
combination therapy with INB03 and CPI is expected to be better than
CPI alone.
David Moss
FirstName LastNameDavid Moss
Inmune Bio, Inc.
Comapany NameInmune Bio, Inc.
March 3, 2018
June 16, 2017 Page 4
Page 4
FirstName LastName
Management's Discussion and Analysis
Licensing and Collaboration Agreements, page 62
16. We note your response to our prior comment 35 and reissue. Please
disclose the duration
of your agreement with the Anthony Nolan Cord Blood Bank, the royalty
term, and any
termination provisions. Please file this agreement as an exhibit to
the registration
statement or tell us why you believe that you are not required to file
this agreement
pursuant to Item 601(b)(10) of Regulation S-K.
Management, page 66
17. We note your disclosure that you have a Scientific Advisory Board.
Please describe the
role or function of the Scientific Advisory Board and whether there
are any rules or
procedures governing such board.
18. We note your response to our prior comment 37 and reissue in part.
Please describe Mr.
Moss's role in taking Tonix Pharmaceuticals public.
Executive Compensation, page 71
19. Please update your executive and director compensation disclosure to
provide the
information required by Item 402 of Regulation S-K as of December 31,
2017, the date of
your most recently completed fiscal year. For guidance, refer to
Question 117.05 of our
Regulation S-K Compliance and Disclosure Interpretations, available at
http://www.sec.gov/divisions/corpfin/guidance/regs-kinterp.htm.
Certain Relationships and Related Transactions, page 75
20. We note your response to our prior comment 41. Please revise the lead
in paragraph to
this section to reflect the language from Item 404(d) of Regulation
S-K.
Plan of Distribution, page 77
21. We note your response to our prior comment 13 and reissue. We note
your disclosure in
this section concerning the purchase of common stock and warrants by
investors. As you
are only offering investors common stock, please revise accordingly.
Consolidated Financial Statements for the Year Ended December 31, 2016 and from
September
25, 2015 (Inception) to December 31, 2015
Note 8 - Commitments and Contingencies, page 91
22. We refer to your response to comment 43. Based on your response, it
appears that you
classified the stock payable as a liability due to the fact that the
shares were not yet issued
as of the balance sheet date. Please tell us how you determined that
the stock payable met
the definition of a liability in Concept Statement 6 given that you
have an obligation to
transfer shares rather than assets. Please also tell us what
consideration you gave to the
David Moss
Inmune Bio, Inc.
March 3, 2018
Page 5
fact that since you are obligated to issue a fixed number of shares at a
fixed price, the
recipients of such shares are economically exposed to changes in your
share price.
Finally, tell us what consideration you gave to the guidance in ASC
815-40-25-4.
Selling Stockholders, page 108
23. We note your response to our prior comment 46 and reissue in part. Please
confirm
whether Kenneth M. Sutin has voting and investment control of the shares
held by the
M.D. Revoc Trust. We also note that Lawrence A. Pabst appears in the
table twice.
Please revise or advise.
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
June 16, 2017 Page 5
cc: David Manno
FirstName LastName