SEC Company Response from RELMADA THERAPEUTICS, INC. (RLMD) (CIK 0001553643) (RLMD) — Nov 17, 2014
RELMADA THERAPEUTICS, INC. (RLMD) (CIK 0001553643)
Date: Nov. 17, 2014 · CIK: 0001553643 · Accession: 0001213900-14-008345
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-197109
Referenced dates: November 3, 2014
Letter
VIA EDGAR Division of Corporation Finance Securities and Exchange Commission Re: Relmada Therapeutics, Inc. Amendment No. 2 to Registration Statement on Form S-l Filed October 16, 2014 File No. 333-197109
Dear Mr. McWilliams:
We are in receipt of your comment letter dated November 3, 2014 regarding the above referenced filing. As requested in your letter, we have provided responses to the questions raised by the staff. For your convenience, the matters are listed below, followed by Relmada Therapeutics, Inc.’s (the “Company”) responses:
Prospectus Summary, page 1
1. We note your response to our prior comment 6 and your revised disclosure that you plan to “out-license” sales, promotion and marketing to third parties. Please define the term “out-license” when it is first used, and reconcile this aspect of your strategy with your plan to “in-license” competitor companies’ products.
RESPONSE:
We have defined the term “out-license” when it is first used on page 1. We also have reconciled this aspect of our strategy with our plan to “in-license” competitor companies’ products on page 1.
2. We note your response to our prior comment 7. Please explain the statement in note 1 to your financial statements on page F-10 that you have an “early stage pipeline of an additional three products.”
RESPONSE:
Please We have removed the phrase “early stage pipeline of an additional three products” from note 1.
The Offering, page 3
3. We note your disclosure that the common stock outstanding before the offering and after the offering has been calculated based upon the total number of issued and outstanding shares as of September 8, 2014. Please update this to account for the October 10, 2014 issuance of 10.1 million shares pursuant to the exercise of Series A Warrants. Please similarly revise Description of Securities on page 79 and Item 15 on page II-2 to reflect the issuance of common stock upon exercise of the Series A Warrants.
RESPONSE:
We have updated the Offering section to take into account the issuance of shares pursuant to the exercise of our Series A Warrants. We have also removed the description of the Series A Warrants from Description of Securities on page 79 (since they have expired), and in Item 15 on page II-2 we have reflected the issuance of common stock upon exercise of the Series A Warrants.
Selling Stockholders, page 26
4. We note that the beneficial ownership information has been provided as of September 12, 2014. Please provide the beneficial ownership information as of the most recent practicable date.
RESPONSE:
We have updated the beneficial ownership information as of November 12, 2014.
Description of Business, page 53
Product Development, page 56
5. We note your response to our prior comment 10. It does not appear your disclosure has been revised in the manner indicated. Please revise accordingly.
RESPONSE:
On page 56 we have disclosed that Memorial Sloan Kettering Hospital has filed an IND for d-methadone and that we are preparing to open the U.S. IND for the product.
Management’s discussion and Analysis, page 61
6. We note your response to our prior comment 16. Please provide us your analysis why the license agreement is not material to your business or why you are otherwise not substantially dependent on this agreement. In this regard, we note that it appears this agreement represents your only patented product.
RESPONSE:
We do not believe that the Medeor license agreement is material because the royalty payments due to be paid are only up to 2% and these payments do not start until the product is on the market, which we expect to be beyond 2020. In addition any payments that are required to be paid under the license are immaterial until the product is approved, which will be after 2020.
The Company acknowledges that:
• should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
• the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
• the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Sincerely,
Relmada
Therapeutics, Inc.
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CORRESP
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filename1.htm
Relmada
Therapeutics, Inc.
546
Fifth Avenue, 14th Floor
New
York, NY 10036
November
17, 2014
VIA
EDGAR
J.
Nolan McWilliams
Attorney-Advisor
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street N.E.
Washington,
D.C. 20549
Re:
Relmada Therapeutics, Inc.
Amendment
No. 2 to Registration Statement on Form S-l
Filed
October 16, 2014
File
No. 333-197109
Dear
Mr. McWilliams:
We
are in receipt of your comment letter dated November 3, 2014 regarding the above referenced filing. As requested in your letter,
we have provided responses to the questions raised by the staff. For your convenience, the matters are listed below, followed
by Relmada Therapeutics, Inc.’s (the “Company”) responses:
Prospectus
Summary, page 1
1. We
note your response to our prior comment 6 and your revised disclosure that you plan to
“out-license” sales, promotion and marketing to third parties. Please define
the term “out-license” when it is first used, and reconcile this aspect of
your strategy with your plan to “in-license” competitor companies’
products.
RESPONSE:
We have defined the term “out-license”
when it is first used on page 1. We also have reconciled this aspect of our strategy with our plan to “in-license”
competitor companies’ products on page 1.
2. We
note your response to our prior comment 7. Please explain the statement in note 1 to
your financial statements on page F-10 that you have an “early stage pipeline of
an additional three products.”
RESPONSE:
Please We have removed the
phrase “early stage pipeline of an additional three products” from note 1.
The
Offering, page 3
3. We
note your disclosure that the common stock outstanding before the offering and after
the offering has been calculated based upon the total number of issued and outstanding
shares as of September 8, 2014. Please update this to account for the October 10, 2014
issuance of 10.1 million shares pursuant to the exercise of Series A Warrants. Please
similarly revise Description of Securities on page 79 and Item 15 on page II-2 to reflect
the issuance of common stock upon exercise of the Series A Warrants.
RESPONSE:
We have updated the Offering section to take
into account the issuance of shares pursuant to the exercise of our Series A Warrants. We have also removed the description
of the Series A Warrants from Description of Securities on page 79 (since they have expired), and in Item 15 on page II-2
we have reflected the issuance of common stock upon exercise of the Series A Warrants.
Selling
Stockholders, page 26
4. We
note that the beneficial ownership information has been provided as of September 12,
2014. Please provide the beneficial ownership information as of the most recent practicable
date.
RESPONSE:
We have updated the beneficial ownership information
as of November 12, 2014.
Description
of Business, page 53
Product
Development, page 56
5. We
note your response to our prior comment 10. It does not appear your disclosure has been
revised in the manner indicated. Please revise accordingly.
RESPONSE:
On page 56 we have disclosed that Memorial Sloan
Kettering Hospital has filed an IND for d-methadone and that we are preparing to open the U.S. IND for the product.
Management’s
discussion and Analysis, page 61
6. We
note your response to our prior comment 16. Please provide us your analysis why the license
agreement is not material to your business or why you are otherwise not substantially
dependent on this agreement. In this regard, we note that it appears this agreement represents
your only patented product.
RESPONSE:
We do not believe that the Medeor license agreement
is material because the royalty payments due to be paid are only up to 2% and these payments do not start until the product
is on the market, which we expect to be beyond 2020. In addition any payments that are required to be paid under the license
are immaterial until the product is approved, which will be after 2020.
2
The
Company acknowledges that:
• should
the Commission or the staff, acting pursuant to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to
the filing;
• the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not relieve the company from its full responsibility for the
adequacy and accuracy of the disclosure in the filing; and
• the
company may not assert staff comments and the declaration of effectiveness as a defense
in any proceeding initiated by the Commission or any person under the federal securities
laws of the United States.
Sincerely,
Relmada
Therapeutics, Inc.
By:
/s/
Sergio Traversa
Sergio
Traversa
Chief
Executive Officer
3