November 8, 2018
Glenn Mattes
President and Chief Executive Officer
TFF Pharmaceuticals, Inc.
2801 Via Fortuna, Suite 425
Austin, Texas 78746
Re: TFF Pharmaceuticals, Inc.
Draft Registration Statement on Form S-1
Submitted October 11, 2018
CIK No. 0001733413
Dear Mr. Mattes:
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 October 11, 2018
Prospectus Summary
TFF Triple Combination for COPD/Asthma, page 2
1. We note your disclosure that your triple combination drug contains what
you consider to
be the best-in-class drug in each category. Please provide support for
how you determined
that the three drugs were best-in-class in each category.
2. We note your disclosure that you expect to develop the triple
combination dry powder
drug in partnership with a large pharmaceutical company. Please balance
your disclosure
by also stating, as you do on page 34, that you have no agreements,
understandings or
Glenn Mattes
FirstName LastNameGlenn Mattes
TFF Pharmaceuticals, Inc.
Comapany 8, 2018 Pharmaceuticals, Inc.
November NameTFF
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arrangements concerning a joint development program and there can be
no assurance you
will be able to enter into a joint development agreement on terms
acceptable to you.
Corporate Information, page 3
3. We note your disclosure that you are no longer a subsidiary of LTI.
Please expand your
disclosure to explain your continuing relationship with LTI. For
example, we note that
LTI currently provides you with office space, certain administrative
services and
equipment for no charge and that you share certain officers and
directors with LTI.
Emerging Growth Company, page 3
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.
Risk Factors
Our success is entirely dependent on our ability to obtain the marketing
approval..., page 11
5. We note that you state, "Although we believe our product candidates
are likely to qualify
for the 505(b)(2) pathway, which often times does not require clinical
trials other than a
bioequivalence trial, there can be no assurance that we will not be
required to conduct
clinical trials in order to obtain marketing approval." We also note
your disclosure on
pages 33 and 34 that you expect to be required to conduct additional
clinical trials in order
to obtain marketing approval for each of your product candidates.
Please revise your
disclosure here to clarify whether you expect to conduct additional
clinical trials in order
to obtain marketing approval for your product candidates.
Our Business
Our Thin Film Freezing Platform, page 29
6. Please describe the material terms of your agreement with Patheon and
your Sponsored
Research Agreements with UT and file the agreements as exhibits to the
registration
statement, or tell us why this is not required. See Item 601(b)(10) of
Regulation S-K.
Our Initial Drug Targets, page 32
7. We note your disclosure on page 33 that you have already completed
development
work performance characterization of TFF Vori and TFF Tac-Lac through
early animal
model testing. Please explain what performance characterization is,
and discuss material
observations and results from your early animal model testing.
8. Please expand your disclosure regarding each of the reference drugs in
your product
candidates to provide information regarding any side effects, adverse
events observed in
clinical testing, and the competitive landscape. With respect to
Voriconazole, we note
Glenn Mattes
FirstName LastNameGlenn Mattes
TFF Pharmaceuticals, Inc.
Comapany 8, 2018 Pharmaceuticals, Inc.
November NameTFF
November 8, 2018 Page 3
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FirstName LastName
your disclosure that you believe your drug formulation would reduce or
eliminate
unpleasant and potentially fatal side effects associated with
Voriconazole. Please fully
disclose these side effects and tell us why you believe your
formulation can reduce or
eliminate the side effects.
Licenses and Intellectual Property Rights, page 35
9. Please disclose the expiration dates for the material patents covered
by the license
agreement, as opposed to only the last to expire patent. Please also
disclose the
termination provision in the UT patent license agreement.
Management's Discussion and Analysis of Financial Condition and Results of
Operations, page
42
10. Please substantially expand your disclosure in this section to address
each of the
requirements of Item 303 of Regulation S-K, including a discussion of
your liquidity and
capital resources and explanations for the increases/decreases in your
research and
development and general and administrative expenses.
Related Party Transactions, page 49
11. We note your disclosure that you have not been a party to any related
party transaction
exceeding $120,000 since January 24, 2018. It appears your transaction
with Lung
Therapeutics, Inc. constitutes a related party transaction. Please
provide disclosure
regarding this transaction pursuant to Item 404 of Regulation S-K, or
advise.
Estimated Use of Proceeds, page 52
12. Please revise your disclosure to quantify the amount of proceeds and
your existing cash
and cash equivalents you expect to use to fund each of your product
candidates and
indicate how far it will allow you to proceed with the continued
development of each of
your product candidates. Please also disclose the sources of other
funds needed to reach
regulatory approval and commercialization for each product candidate.
Refer to
Instruction 3 to Item 504 of Regulation S-K.
Description of Securities, page 56
13. We note that Section 12.1 of your Bylaws identifies a state court
located within the State
of Delaware as the exclusive forum for certain litigation, including
any "derivative
action." Please disclose whether this provision applies to actions
arising under the federal
securities laws. Also ensure that the exclusive forum provision in
your proposed
organizational documents states this clearly. In this regard, we note
that Section 27 of the
Exchange Act creates exclusive federal jurisdiction over all suits
brought to enforce any
duty or liability created by the Exchange Act or the rules and
regulations thereunder.
Please also include disclosure in this section about the exclusive
forum provision
generally, its scope, its enforceability and its potential impact on
the rights of investors.
Glenn Mattes
FirstName LastNameGlenn Mattes
TFF Pharmaceuticals, Inc.
Comapany 8, 2018 Pharmaceuticals, Inc.
November NameTFF
November 8, 2018 Page 4
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FirstName LastName
Please also include a risk factor to discuss the effects of the
provision, including the
possibility that the exclusive forum provision may discourage
stockholder lawsuits, or
limit stockholders' ability to bring a claim in a judicial forum that
it finds favorable for
disputes with the company and its officers and directors.
Underwriting
Underwriter Warrants, page 63
14. We note that you issued to Liquid Patent Advisors, LLC warrants to
purchase up to
400,000 shares of your common stock in consideration of the provision
of consulting
services. Please explain the consulting services received and file
this agreement as an
exhibit to the registration statement, or tell us why this is not
required.
Notes to the Financial Statements for the Years Ended December 31, 2017 and
2016
Note 1 - Background and Basis for Presentation, page F-6
15. Please revise disclosures for the inconsistency regarding when Lung
Therapeutics, Inc.
(LTI) was issued 4,000,000 shares of common stock and the reason for
the issuance. See,
for example:
Note 1 at page F-6 where you indicate that the shares were issued on
January 24, 2018
in exchange for LTI's non-core intellectual property rights and
other assets;
Corporate Information disclosure on page 3 where you indicate that
the shares were
issued in March 2018 for LTI's non-core intellectual property
rights and other assets;
The 2018 Private Placement section under Note 5 at page F-16 where
you indicate that
the shares were issued in March 2018 for LTI's assignment of
certain patent license
rights and other valuable consideration; and
The issuance of capital stock disclosure on page II-2 where you
indicate that the shares
were issued on January 24, 2018 in consideration for certain of
LTI's licensed patent
rights.
In your revised disclosure clarify whether the "non-core" intellectual
property rights were
non-core to LTI or to you and/or whether they relate to your Thin Film
Freezing
technology platform.
Note 4 - License and Agreement, page F-8
16. Please revise your disclosure to reconcile inconsistencies regarding
when the rights and
interest to the TFF platform, including the patent license agreement
with the University of
Texas at Austin, was assigned to you. For example, pages 8, 35 and F-8
state that the
assignment was in March 2018 and page 31 states January 2018.
Glenn Mattes
TFF Pharmaceuticals, Inc.
November 8, 2018
Page 5
Notes to the Condensed Financial Statements for the Period From January 24,
2018 to June 30,
2018,
January 1, 2018 to January 23, 2018 (Predecessor), and Six Months Ended June
30, 2017
Note 7 - Stock Based Compensation, page F-17
17. Once you have an estimated offering price or range, please explain to us
how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your common
stock leading
up to this offering and the estimated offering price. This information
will help facilitate
our review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Exhibits
18. Please file the consent of each director nominee as an exhibit to your
registration
statement. See Rule 438 of Regulation C under the Securities Act. To the
extent that any
of the nominees have become directors of the company by the time that
you amend your
registration statement, please update your disclosure accordingly.
General
19. Please provide us proofs of all graphics, visual, or photographic
information you
will provide in the printed prospectus prior to its use, for example in
a preliminary
prospectus.
You may contact Christine Torney at 202-551-3652 or Mark Brunhofer at
202-551-3638
if you have questions regarding comments on the financial statements and
related
matters. Please contact Irene Paik at 202-551-6553 or Erin Jaskot at
202-551-3442 with any
other questions.
Sincerely,
FirstName LastNameGlenn Mattes
Division of
Corporation Finance
Comapany NameTFF Pharmaceuticals, Inc.
Office of
Healthcare & Insurance
November 8, 2018 Page 5
cc: Daniel K. Donahue - Greenberg Traurig, LLP
FirstName LastName