September 14, 2018
David J. Moss
Chief Financial Officer
INmune Bio Inc.
1224 Prospect Street, Suite 150
La Jolla, CA 92037
Re: INmune Bio Inc.
Registration Statement on Form S-1
Filed August 30, 2018
File No. 333-227122
Dear Mr. Moss:
We have reviewed your 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 amending your registration statement
and providing the
requested information. 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 registration statement and the
information you
provide in response to these comments, we may have additional comments. Unless
we note
otherwise, our references to prior comments are to comments in our July 13,
2018 letter.
Registration Statement on Form S-1
Risk Factors
We rely on key personnel, page 26
1. We note your disclosure in this risk factor that you do not have
employment agreements in
place with your President or other executives yet you disclose on page
71 that you have
employment agreements with Dr. Tesi and Mr. Moss. Please revise this
risk factor
accordingly.
David J. Moss
FirstName LastNameDavid J. Moss
INmune Bio Inc.
Comapany 14, 2018
September NameINmune Bio Inc.
September 14, 2018 Page 2
Page 2
FirstName LastName
Use of Proceeds, page 33
2. We note your response to our prior comment 1. Please revise to clarify
whether the Phase
1 trials for INKmune that you state that you will complete if the
maximum offering
amount is raised are the same as the Phase I/II trials for INKmune
that you list in the
bullet points underneath that disclosure.
Business, page 36
3. We note your revisions in response to our prior comment 3. Please
expand the disclosure
in this section to describe in greater detail the status of your human
umbilical cord derived
mesenchymal stem/stromal cells manufacturing business. Please clarify
why you need to
identify a contract manufacturer when you state you will be acting as
a contract
manufacturer, what program must be identified before you will "seek
partners," and what
you mean by the term partner. Also describe any intellectual property
rights related to this
business, the effect of existing or probable governmental regulations,
the amount spent on
research and development during each of the past two fiscal years, and
other applicable
items of Regulation S-K Item 101(h)(4).
Immune Ventures, LLC License Agreement, page 46
4. We note your disclosure in this section that the agreement will
terminate, unless
terminated sooner, on a country by country basis on the date of the
expiration of the last to
expire patent rights where patent rights exists. Please revise this
section to disclose when
the latest to expire patent is scheduled to expire.
Unit Offering, page 64
5. We note that your prior disclosure in this section and Section B of
the subscription
agreement filed as Exhibit 10.1 indicate that you would be required to
pay a penalty to the
investors in your unit offering if you did not have a registration
statement declared
effective to register the resale of the shares of common stock
underlying the units within
six months of filing. As it appears that you have failed to meet that
deadline, please revise
your disclosure in this section to indicate whether you paid such
penalties, how much was
paid or how much you will be required to pay, and when or whether you
renegotiated the
terms to avoid such penalties.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
David J. Moss
INmune Bio Inc.
September 14, 2018
Page 3
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.
Sincerely,
FirstName LastNameDavid J. Moss
Division of
Corporation Finance
Comapany NameINmune Bio Inc.
Office of Healthcare
& Insurance
September 14, 2018 Page 3
cc: David Manno, Esq.
FirstName LastName