April 8, 2019
Sam Backenroth
Chief Financial Officer
Ohr Pharmaceutical Inc.
800 Third Avenue, 11th Floor
New York, NY 10022
Re: Ohr Pharmaceutical Inc.
Registration Statement on Form S-4
Filed March 8, 2019
File No. 333-230168
Dear Mr. Backenroth:
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.
Form S-4 dated March 8, 2019
Questions and Answers about the Ohr Special Meeting and the Merger, page 1
1. Please revise the letter to shareholders; Questions and Answers about
the Ohr Special
Meeting and the merger; and the summary to eliminate the repetitive
detailed
information. Much of the detailed discussion is more appropriate for
discussions
appearing later in the document.
2. The response to the question about the necessity of the reverse stock
split indicates it is
desirable for a number of reasons but only identifies the Nasdaq
requirements. Please
identify the other reasons why a reverse split is desirable and ensure
that you provide a
description of the factors you will consider when determining in reverse
spilt ratio in an
appropriate location in your document.
Sam Backenroth
FirstName LastNameSam Backenroth
Ohr Pharmaceutical Inc.
Comapany NameOhr Pharmaceutical Inc.
April 8, 2019
April 2 2019 Page 2
Page 8,
FirstName LastName
3. Please revise the discussion of the material income tax consequences
to clarify that
shareholders receiving shares in lieu of fractional shares may be
subject to tax.
Summary, page 15
4. You state that NeuBase is a "leader" in the discovery and development
of peptide nucleic
acids, and that its proprietary PATrOL platform allows for "rapid"
drug development.
Please balance your disclosure by disclosing that NeuBase was recently
incorporated in
August 2018, NeuBase has not initiated any clinical trials for any of
its product candidates
or submitted an IND, and it does not currently possess the resources
necessary to
independently develop its product candidates. In addition, disclose
that the PATrOL
technology is licensed from a third party. In light of the early stage
of NeuBase's business
and product development, please also provide the basis for your
statement that NeuBase
is a leader in developing, and that its platform allows for rapid
development of,
gene therapies.
5. Please revise the "Summary of the Merger" and "Overview of the Merger
Agreement" to
include only the most material aspects of the merger agreement.
Additionally, ensure that
the summary presents a balanced discussion. For example, if you decide
to keep the
discussion of the reasons for the merger in the summary, balance the
discussion with an
equally prominent discussion of any risks or potential negative
effects the merger may
have on Ohr shareholders.
Interests of Certain Directors, Officers and Affiliates of Each of Ohr and
NeuBase. . ., page 25
6. Expand your discussion to explain that Mr. Backenroth is expected to
serve as the CFO of
the combined company, and to disclose the payments that are payable to
him and Dr.
Slakter in connection with the merger.
Risk Factors, page 36
7. We note your disclosure on page 235 and in Article VIII of the amended
and restated
certificate of incorporation of the combined company regarding an
exclusive forum
provision. Please add a risk factor disclosing the existence of this
provision and that such
a provision may limit a shareholder's ability to bring a claim in a
judicial forum that it
finds favorable for such disputes and may discourage lawsuits with
respect to such
claims. Please also disclose whether the provision applies to actions
arising under the
Securities Act. In that regard, we note that Section 22 of the
Securities Act creates
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
this provision applies to claims arising under the Securities Act,
then please state that
shareholders will not be deemed to have waived the company's
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, please also ensure
that the exclusive
forum provision in the governing documents states this clearly.
Sam Backenroth
FirstName LastNameSam Backenroth
Ohr Pharmaceutical Inc.
Comapany NameOhr Pharmaceutical Inc.
April 8, 2019
April 3 2019 Page 3
Page 8,
FirstName LastName
The combined company's management will own a significant percentage. . ., page
115
8. Revise your disclosure to also disclose the combined percentage
ownership to be owned
by the directors and executive officers of the combined company. To
that end, we note
that although you state here that Dr. Stephan will be the combined
company's sole officer
and director, you state on page 9 that there will be five directors
and two executive
officers following the merger.
Ohr will pay certain of its executive officers "parachute payments" upon the
compleiton of the
merger..., page 119
9. Please revise the discussion to identify each executive entitled to a
parachute payment and
quantify the amount of the payment.
Ohr's pre-merger net operating loss carryforwards and certain other tax
attributes..., page 119
10. Please quantify the NOLs and other tax attributes that are subject to
limitation and clarify
the factors that will determine the extent of the limitation.
The Merger
Background of the Merger, page 124
11. You state in the second paragraph on page 125 that you had preliminary
discussions in
January and February 2018 with parties that had contacted you
regarding a potential
strategic transction, and you state elsewhere in this section that you
considered various
potential business combinations (such as with Parties A through G).
Please clarify if these
preliminary and more detailed discussions all contemplated reverse
mergers, or if
alternative transactions were discussed. Please also expand your
disclosure in the second
paragraph on page 126 to further explain why the board determined to
pursue a reverse
merger after considering various strategic alternatives.
12. Revise your discussion on page 134 to disclose Ms. Almenoff's
reason(s) for resigning
from the special committee.
13. Please revise the last paragraph on page 138 to clarify the
outstanding and major terms on
which you and Party C were not able to agree.
14. Please revise the third paragraph on page 138 to disclose the material
terms proposed in
the draft term sheet you delivered to NeuBase. Also revise the third
and fourth paragraphs
on page 139 to disclose the material terms and conditions of the
transaction that were
discussed. In addition, expand the discussions in this section of your
merger agreement
negotiations to disclose the material terms and explain how they
changed pursuant to
negotiations, including the non-solicitation provision.
15. Please identify any meetings where Mr. Backenroth's employment by the
combined
company was discussed.
Sam Backenroth
FirstName LastNameSam Backenroth
Ohr Pharmaceutical Inc.
Comapany NameOhr Pharmaceutical Inc.
April 8, 2019
April 4 2019 Page 4
Page 8,
FirstName LastName
Opinion of Ohr's Financial Advisor, page 149
16. Expand the disclosures regarding Roth's IPO comparables, publicly
traded comparable
companies, early stage merger and acquisition transactions, and
licensing transactions
analyses to disclose the underlying data used to calculate the implied
enterprise value
reference ranges. To the extent you considered a transaction with any
companies that had
product candidates that were beyond the preclinical stage, please
disclose this
information. Please also expand the disclosure to explain how Roth
used the reference
ranges. For example, did Roth then apply these ranges to calculate
ranges of estimated
implied enterprise values for NeuBase?
17. Please expand the disclosure to disclose the selection criteria used
to select the companies
and transactions used in the analyses and whether any companies or
transactions meeting
the selection criteria were excluded from the analyses. If any were
excluded, please
explain why.
18. We note the disclosure on page157 that Roth relied on financial
projections when
preparing the discounted cash flow analysis. Please revise to disclose
the financial
projections used and discuss all material assumptions used to develop
the projections,
including which product candidates obtain FDA approval, when they
receive FDA
approval, when these products become commercially available, the
assumed market for
each product candidate and any assumptions about competition.
Additionally, discuss the
possible impact if your assumptions are incorrect.
19. Please expand your disclosure to further explain the Clinical
Development Success Rates
in Phases 1, 2 and 3 and NDA stages of development, quantify these
rates and explain
how this data was used to adjust the projected cash flows. Given your
statement that the
enterprise value range is $56.8 million to $216.6 million, clarify
whether this analysis
considered the possibility that the Neubase Therapeutics product
candidates do not
successfully complete clinical trials. If the analysis did not
consider this possibility,
please explain why.
Material U.S. Federal Income Tax Consequences of the Merger, page 170
20. Please revise to remove language stating that the discussion is a
general discussion and
clarify that it addresses all material tax consequences. We note your
disclosure on page
171 referencing the opinions of Troutman Sanders and Paul Hastings.
Please revise your
exhibit index to include Paul Hastings tax opinion and clarify that
the tax opinion includes
the discussion of consequences of the merger qualifying as a
"reorganization."
OHR Executive Compensation, page 208
21. Please also separately provide executive compensation information for
Dr. Stephan, and
biographical information for both him and Mr. Backenroth, as required
by Item 19(a)(7)
of the Form S-4.
Sam Backenroth
FirstName LastNameSam Backenroth
Ohr Pharmaceutical Inc.
Comapany NameOhr Pharmaceutical Inc.
April 8, 2019
April 5 2019 Page 5
Page 8,
FirstName LastName
Ohr's Business
Assets and Technologies, page 246
22. You state that you are a passive joint venturer in DepYmed, and on
page 248 that you are
party to a license agreement with Akina. Please clarify whether you
have any ongoing
monetary or other obligations under these agreements.
NeuBase's Business
Business Strategy, page 253
23. You state that NeuBase believes its scientists can optimize the
properties of its PATrOL-
enabled drugs. You also state here that NeuBase has "distinct
partnering strategies" and
on page 70 that NeuBase does not currently possess the necessary
resources to
independently develop and commercialize its product candidates. Please
revise to clarify
the product development that can be conducted by the combined company
on its own
following the transaction.
NeuBase's PATrOLTM Technology Platform, page 255
24. You reference early preclinical studies on page 256, as well as
beliefs about the
technology's advantages. Please substantially revise your disclosure
in this section to
describe the early preclinical studies and disclose the specific
results disclose who
conducted such studies, and your rights to the data. Also show how
these results support
your statements on pages 252 and 256 regarding the various advantages
of the PATrOL
platform.
25. Please revise your disclosure beginning on page 257 to more clearly
and fully explain how
the platform works, including the significance of the non-polar single
chiral center
backbone, and why you believe it can be utilized for DNA therapeutics.
Intellectual Property, page 259
26. You disclose that you have licensed patent applications covering
various patents and
patent applications. Please revise to clarify whether they are
licensed pursuant to the
Carnegie Mellon license agreement, and to the extent any are not,
please revise to disclose
the terms of such other license agreement(s) or advise. In addition,
for each type of patent
family that you have described on pages 259-260, please revise to
disclose
the jurisdictions covered by the issued patents or pending patent
applications, and the
corresponding expiration (or expected expiration) dates.
27. Please revise to clarify the extent your patent protection (from the
Carnegie Mellon
license or otherwise) covers the 16 Janus bases referenced on page
257.
License Agreement with Carnegie Mellon University, page 260
28. Please revise to disclose other material terms of your agreement,
including all payments
Sam Backenroth
Ohr Pharmaceutical Inc.
April 8, 2019
Page 6
made to date, the aggregate potential milestone payments under the
agreement and term
and termination provisions. To the extent not otherwise disclosed,
please also disclose the
expiration dates and jurisdictions of the underlying patents and patent
applications.
29. Please revise to clarify, if true, that following the transaction, the
warrant will have been
exercised and the preemptive rights will be terminated. Please also
disclose this
agreement in the Related Party Transactions section, and to the extent
accurate, state that
Carnegie Mellon will continue to have piggyback rights.
General
30. Please provide us with copies of the materials that your financial
advisor prepared
and shared with your board in connection with this transaction,
including any board
books, transcripts and summaries of oral presentations made to the
board. We may have
additional comments after we review those materials.
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 Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Dorrie Yale at 202-551-8776 or Suzanne Hayes at 202-551-3675 with any
other
questions.
Sincerely,
FirstName LastNameSam Backenroth
Division of
Corporation Finance
Comapany NameOhr Pharmaceutical Inc.
Office of
Healthcare & Insurance
April 8, 2019 Page 6
cc: Joseph Walsh, Esq. - Troutman Sanders LLP
FirstName LastName