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October 2, 2019
Steven Gullans, Ph.D.
President & Chief Executive Officer
Gemphire Therapeutics Inc.
P.O. Box 130235
Ann Arbor, MI 48113
Re: Gemphire Therapeutics Inc.
Registration Statement on Form S-4
Filed September 3, 2019
File No. 333-233588
Dear Dr. Gullans:
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.
Registration Statement on Form S-4 filed on September 3, 2019
Questions and Answers About the Merger
What is the Pre-Closing Financing ?, page 7
1. We note your disclosure that shares of NeuroBo Series B preferred stock
that will be
issued in the Pre-Closing Financing will be converted into shares of
NeuroBo common
stock pursuant to the Preferred Stock Conversion and into shares of
Gemphire common
stock in the merger. Please expand your disclosure to indicate that
shares of NeuroBo
preferred stock will convert to NeuroBo common stock on a one-for-one
basis, as
disclosed on page 213, and to provide the purchase price per share in
the Pre-Closing
Financing. Refer to Note A of Schedule 14A.
Steven Gullans, Ph.D.
FirstNameTherapeutics Inc. Gullans, Ph.D.
Gemphire LastNameSteven
Comapany 2019
October 2, NameGemphire Therapeutics Inc.
Page 2
October 2, 2019 Page 2
FirstName LastName
Risk Factors
Risks Related to Gemphire Common Stock
Gemphire's amended and restated bylaws designate the Court of Chancery of the
State of
Delaware as the sole and exclusive forum for certain , page 89
2. We note that your forum selection provision identifies the Court of
Chancery of 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
Securities Act or Exchange Act. 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 ruled and regulations
thereunder, and Section
22 of the Securities Act created concurrent jurisdiction for federal
and state courts over all
suits brought to enforce any duty or liability created by the
Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act
claims, please revise your
prospectus to state that there is uncertainty as to whether a court
would enforce such
provision and that investors cannot waive compliance with the federal
securities laws and
the rules and regulations thereunder. If this provision does not apply
to actions arising
under the Securities Act or Exchange Act, please also ensure that the
exclusive forum
provision in the governing documents states this clearly, or tell us
how you will inform
investors in future filings that the provision does not apply to any
actions arising under the
Securities Act or Exchange Act.
The Merger
Background of the Merger, page 154
3. Please provide us supplementally with copies of all materials prepared
by Ladenburg
Thalmann & Co. Inc. and shared with the Gemphire Board, including
copies of all board
books and all transcripts and summaries, that were material to the
Board's decision to
approve the merger agreement and the transactions contemplated
thereby.
4. Please revise your disclosure to discuss details as to how Gemphire
management
determined the proposed exchange ratio.
Agreements Related to the Merger
Contingent Value Rights Agreement
Receipt of CVRs by Gemphire U.S. Holders, page 209
5. To the extent you intend the disclosure in this section to serve as
the tax opinion and
Exhibit 8 will be filed to confirm this, please revise your disclosure
to state that the
discussion constitutes the opinion of named counsel. If such opinion
is subject to
uncertainty, counsel may provide a "should' or "more likely than not"
opinion and explain
why a "will" opinion cannot be given and describe the degree of
uncertainty. For
guidance, please refer to Sections III.B.2 and III.C.4 of Staff Legal
Bulletin No. 19.
Steven Gullans, Ph.D.
FirstNameTherapeutics Inc. Gullans, Ph.D.
Gemphire LastNameSteven
Comapany 2019
October 2, NameGemphire Therapeutics Inc.
Page 3
October 2, 2019 Page 3
FirstName LastName
Agreements Related to the Merger
Voting Agreements and Written Consents, page 211
6. We note your disclosure that NeuroBo shareholders owning approximately
90% of the
NeuroBo outstanding capital stock on an as converted basis have
entered into a voting
agreement whereby such shareholders have agreed to vote in favor of
the merger and that
such shareholders will execute a written consent providing for such
approval following
effectiveness of the registration statement. Please confirm that, with
respect to NeuroBo
shareholders, the voting agreement was entered into only by executive
officers, directors,
affiliates and holders of 5% or more of NeuroBo's voting equity
securities, and that
NeuroBo is soliciting consents only from shareholders who have not
signed the voting
agreement and would be ineligible to purchase in a private offering.
Refer to Securities
Act Sections Compliance and Disclosure Interpretations 239.13.
Proposal No. 2: Approval of an Amendment to the Gemphire Certificate of
Incorporation
Effecting the Gemphire Reverse Stock Split
Principal Effects of the Gemphire Reverse Stock Split, page 245
7. We note your disclosure that the reverse stock split will effectively
increase the proportion
of authorized shares which are unissued, which could result in the
Gemphire board being
able to issue more shares without further shareholder approval. Please
expand your
disclosure to discuss the potential dilution to Gemphire shareholders
if the reverse stock
split is approved.
NeuroBo Business
Overview, page 297
8. We note your reference here and on page 12 to NeuroBo's pipeline as
having the potential
to deliver efficacy with a superior safety profile. Please revise
these and similar statements
throughout the registration statement that state or imply that
NeuroBo's product
candidates are safe or effective as these determinations are solely
within the authority of
the U.S. Food and Drug Administration and comparable regulatory
bodies. As a non-
exhaustive list of illustrative examples only, we note the following:
NeuroBo expects NB-02 to have a positive safety profile.
NB-01 has generated compelling data on efficacy and safety in a
128-subject Phase 2
clinical trial.
NeuroBo's current pipeline leverages natural drugs that can deliver
requisite efficacy
along with minimal side effects.
The Phase 2 trial provided preliminary evidence of NB-01's efficacy
in the target
population.
In addition to NB-01's safety profile, the data from the Phase 2
study show
preliminary efficacy signals that NB-01 may be equivalent in
effectiveness to that of
other FDA-approved therapeutics for the treatment of diabetic
neuropathic pain
Steven Gullans, Ph.D.
FirstNameTherapeutics Inc. Gullans, Ph.D.
Gemphire LastNameSteven
Comapany 2019
October 2, NameGemphire Therapeutics Inc.
October 2, 2019 Page 4
Page 4
FirstName LastName
(DNP).
We will not object to a discussion of whether NeuroBo's product
candidates were well-
tolerated or discussion of whether trial endpoints were met.
9. We note your disclosure that the Phase 3 clinical program for NB-01 is
expected to launch
in late 2019. We note the disclosure on page 304 stating NeuroBo
expects to screen the
first subject for this trial in the first quarter of 2020. Please
revise or advise. In your
pipeline development chart, please shorten the arrow corresponding to
the development of
NB-01 for the treatment of DNP so that it reflects you have not yet
commenced Phase 3
development. Please also revise your statement on page 13 referencing
current Phase 3
development accordingly.
NeuroBo's Novel Approach to Neurogenerative Diseases
NB-01: Treatment of DNP and Peripheral Neuropathic Conditions, page 300
10. Please cite the source for the graphic in Figure 2 on page 300 and
explain how the graphic
illustrates the referenced efficacy concerns for existing approved
therapies for DNP.
11. We note your comparison to duloxetine and pregabalin in the graphic on
page 304. As this
comparison is not based on head-to-head studies, please tell us why
you believe it is
appropriate to include this comparison. In your response, please tell
us whether you expect
to be able to rely on such comparison to support marketing approval
for NB-01 from the
FDA or other comparable regulators.
NB-01 Development Plan Through NDA , page 305
12. Given the contingencies to NeuroBo successfully completing the two
planned Phase 3
clinical trials, we object to your illustration on page 305 as
speculative and without full
and proper context. In this regard, we note your disclosure that prior
to the initiation of the
second Phase 3 trial of NB-01, NeuroBo plans to request a Type C
meeting with the FDA
and to obtain scientific advice from the European Medicines Agency to
ensure alignment
with these regulators, and further that NeuroBo will continue with its
development
program following a positive recommendation from the Data and Safety
Monitoring
Board. Accordingly, please remove this chart. We will not object to a
narrative discussion
of NeuroBo's clinical development plans in which relevant context is
provided.
Intellectual Property, page 308
13. Please revise your disclosure to specify the number of issued patents
versus patent
applications and the type of patent protection (e.g., composition of
matter, use or
process).
Steven Gullans, Ph.D.
Gemphire Therapeutics Inc.
October 2, 2019
Page 5
Related Party Transactions of Directors and Executive Officers of the Combined
Organization
Agreements with Dong-A ST
Manufacturing Agreement, page 367
14. Please expand your disclosure to include the material terms of your
manufacturing
agreement with Dong-A ST, including the financial terms and termination
provisions.
Unaudited Pro Forma Condensed Combined Financial Information , page 372
15. We acknowledge your disclosure on page 380 regarding pro forma adjustment
J. Please
disclose and provide us with a reconciliation of your historical basic
and diluted earnings
per share to your pro forma basic and diluted earnings per share for all
periods presented.
Please clearly describe how you have computed both the denominator and
numerator in
your pro forma earnings per share calculation.
Principal Stockholders of NeuroBo, page 405
16. Please disclose the natural persons who have beneficial ownership of the
shares held by
Dong-A ST. Refer to Item 403 of Regulation S-K required by Item 6 of
Schedule 14A
required by Item 18(a)(5)(ii) of Form S-4.
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.
You may contact Ibolya Ignat at 202-551-3636 or Sharon Blume at
202-551-3474 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Christine Westbrook at 202-551-5019 or Mary Beth Breslin at
202-551-3625 with any
other questions.
Sincerely,
FirstName LastNameSteven Gullans, Ph.D.
Division of
Corporation Finance
Comapany NameGemphire Therapeutics Inc.
Office of Life
Sciences
October 2, 2019 Page 5
cc: Phillip D. Torrence, Esq.
FirstName LastName