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RELMADA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
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RELMADA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
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RELMADA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
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RELMADA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
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RELMADA THERAPEUTICS, INC.
Response Received
4 company response(s)
High - file number match
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Company responded
2019-10-11
RELMADA THERAPEUTICS, INC.
References: August 20, 2019
Summary
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Company responded
2019-10-17
RELMADA THERAPEUTICS, INC.
References: October 16, 2019
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Company responded
2019-10-28
RELMADA THERAPEUTICS, INC.
References: October 25, 2019
Summary
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RELMADA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-10-16
RELMADA THERAPEUTICS, INC.
Summary
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RELMADA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-02-08
RELMADA THERAPEUTICS, INC.
Summary
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Company responded
2019-02-28
RELMADA THERAPEUTICS, INC.
Summary
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RELMADA THERAPEUTICS, INC.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2014-07-24
RELMADA THERAPEUTICS, INC.
Summary
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Company responded
2014-09-16
RELMADA THERAPEUTICS, INC.
References: July 24, 2014
Summary
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Company responded
2014-10-16
RELMADA THERAPEUTICS, INC.
References: September 30, 2014
Summary
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Company responded
2014-11-17
RELMADA THERAPEUTICS, INC.
References: November 3, 2014
Summary
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Company responded
2014-12-09
RELMADA THERAPEUTICS, INC.
References: December 2, 2014
Summary
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Company responded
2014-12-23
RELMADA THERAPEUTICS, INC.
Summary
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RELMADA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-12-03
RELMADA THERAPEUTICS, INC.
References: November 3, 2014
Summary
Generating summary...
RELMADA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-11-03
RELMADA THERAPEUTICS, INC.
References: September 30,
2014
Summary
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RELMADA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-10-01
RELMADA THERAPEUTICS, INC.
References: July 24, 2014
Summary
Generating summary...
RELMADA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2012-12-10
RELMADA THERAPEUTICS, INC.
Summary
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Company responded
2013-03-19
RELMADA THERAPEUTICS, INC.
Summary
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RELMADA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-03-01
RELMADA THERAPEUTICS, INC.
References: February 26, 2013 | February 8, 2013
Summary
Generating summary...
RELMADA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-02-08
RELMADA THERAPEUTICS, INC.
References: December 10, 2012
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-07 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2026-04-07 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | 333-294885 | Read Filing View |
| 2024-09-11 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-09-06 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | 333-281877 | Read Filing View |
| 2020-08-19 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2020-08-18 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-30 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-28 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-25 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-21 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-17 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-16 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-11 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-08-20 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-02-28 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-12-23 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-12-09 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-12-03 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-11-17 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-11-03 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-10-16 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-10-01 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-09-16 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-07-24 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-03-19 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-03-01 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-02-08 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2012-12-10 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-07 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | 333-294885 | Read Filing View |
| 2024-09-06 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | 333-281877 | Read Filing View |
| 2020-08-18 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-25 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-16 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-08-20 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-12-03 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-11-03 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-10-01 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-07-24 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-03-01 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-02-08 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2012-12-10 | SEC Comment Letter | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-07 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-09-11 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2020-08-19 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-30 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-28 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-21 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-17 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-10-11 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-02-28 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-12-23 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-12-09 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-11-17 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-10-16 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-09-16 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-03-19 | Company Response | RELMADA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
2026-04-07 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
April 7, 2026
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Relmada Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-294885
Acceleration Request
Requested Date:
April 9, 2026
Requested Time:
4:05 p.m., Eastern Time
Dear Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended, Relmada Therapeutics, Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time as
the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please call Tracy Buffer of Lowenstein Sandler
LLP at (973) 597-2434 to confirm the effectiveness of the Registration Statement or with any questions.
Sincerely,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Name:
Sergio Traversa
Title:
Chief Executive Officer
2026-04-07 - UPLOAD - RELMADA THERAPEUTICS, INC. File: 333-294885
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 7, 2026 Sergio Traversa Chief Executive Officer Relmada Therapeutics, Inc. 2222 Ponce de Leon Blvd., Floor 3 Coral Gables, FL 33134 Re: Relmada Therapeutics, Inc. Registration Statement on Form S-3 Filed April 3, 2026 File No. 333-294885 Dear Sergio Traversa: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Jessica Dickerson at 202-551-8013 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Steven M. Skolnick, Esq. </TEXT> </DOCUMENT>
2024-09-11 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Relmada Therapeutics, Inc.
2222 Ponce de Leon Blvd., Floor 3
Coral Gables, FL 33134
(786) 629-1376
September 11, 2024
VIA EDGAR
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
Re: Relmada Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-281877
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated
under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date for the Registration Statement
referred to above be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time on Thursday, September 12, 2024, or
as soon thereafter as practicable.
Please contact Gregory Sichenzia,
Esq. of Sichenzia Ross Ference Carmel LLP at (212) 398-1207, as soon as the Registration Statement has been declared effective, or if
you have any other questions or concerns regarding this matter.
Very truly yours,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Sergio Traversa
Chief Executive Officer
2024-09-06 - UPLOAD - RELMADA THERAPEUTICS, INC. File: 333-281877
September 6, 2024
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
2222 Ponce de Leon Blvd., Floor 3
Coral Gables, FL 33134
Re:Relmada Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 30, 2024
File No. 333-281877
Dear Sergio Traversa:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gregory Sichenzia, Esq.
2020-08-19 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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RELMADA THERAPEUTICS, INC.
880 Third Avenue, 12th Floor
New York, New York 10022
August 19, 2020
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Attention: Ms. Deanna Virginio
Re:
Relmada Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-245054
Ladies and Gentlemen:
Relmada Therapeutics, Inc. (the
“Company”) hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended,
acceleration of the effectiveness of the above-referenced Registration Statement so that such Registration Statement will
become effective as of 4:00 p.m. Eastern time, Friday, August 21, 2020, or as soon thereafter as practicable, or at such
later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation
Finance of the Securities and Exchange Commission.
Very truly yours,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Name: Sergio Traversa
Title: Chief Executive Officer
2020-08-18 - UPLOAD - RELMADA THERAPEUTICS, INC.
United States securities and exchange commission logo
August 18, 2020
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
Re:Relmada Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 12, 2020
File No. 333-245054
Dear Mr. Traversa:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Barrett DiPaolo, Esq.
2019-10-30 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
RELMADA THERAPEUTICS, INC.
880 Third Avenue, 12th Floor
New York, New York 10022
October 30, 2019
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Attention: Ada D. Sarmento and Celeste Murphy
Re:
Relmada Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-3
File No. 333-234262
Ladies and Gentlemen:
Relmada Therapeutics, Inc.’s (the “Company”)
hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of the effectiveness
of the above-referenced Registration Statement so that such Registration Statement will become effective as of 4:00 p.m. Eastern
time, Thursday, October 31, 2019, or as soon thereafter as practicable, or at such later time as the Company or its counsel may
orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission
(the “Commission”).
In connection with the Company’s request
for acceleration of effectiveness of the above-referenced Registration Statement, the Company acknowledges the following:
(1)
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;
(2) 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
(3)
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.
Very truly yours,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Name: Sergio Traversa
Title: Chief Executive Officer
2019-10-28 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
October 28, 2019
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Attention: Ada D. Sarmento and Celeste Murphy
Re:
Relmada Therapeutics, Inc.
Registration Statement on Form S-3
Filed October 18, 2019
File No. 333-234262
Dear Ms. Sarmento:
We are in receipt of your comment letter
dated October 25, 2019 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:
Forum for Adjudication of Disputes, page 20
1.
Your forum selection provision identifies a Nevada state court as the exclusive forum for certain litigation, including any “derivative action.” We note your disclosure that this provision applies to claims arising under the Securities Act and the Exchange Act. Please 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. In response to the staff's comments on your Registration Statement on Form S-1, File No. 333-233228, you disclosed that you did not intend for the provision to apply to Exchange Act claims. If that is still true, please revise this prospectus to clarify that you do not intend for the exclusive forum provision to apply to Exchange Act claims.
Response:
On page 20 we have revised the prospectus to clarify that the company does not intend for the exclusive forum provision to apply to Exchange Act claims.
Incorporation of Documents by Reference, page 25
2.
We note that you have not incorporated by reference Exchange Act filings made prior to the effective date of the registration statement. In that regard, please revise to incorporate by reference your Current Report on Form 8-K filed on October 21, 2019. Refer to Question 123.05 of the Securities Act Forms Compliance and Disclosure Interpretations.
Response:
On page 25 we have revised the prospectus to incorporate by reference our Current Report on Form 8-K filed on October 21, 2019.
The Company acknowledges
that the Company and its management are responsible for the accuracy and adequacy of the disclosures, notwithstanding any review,
comments, action or absence of action by the staff.
Sincerely,
Relmada Therapeutics, Inc.
By:
/s/ Sergio Traversa
Sergio Traversa
Chief Executive Officer
2019-10-25 - UPLOAD - RELMADA THERAPEUTICS, INC.
October 25, 2019
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
Re:Relmada Therapeutics, Inc.
Registration Statement on Form S-3
Filed October 18, 2019
File No. 333-234262
Dear Mr. Traversa:
We have limited our review of your registration statement to those issues we have
addressed in our 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-3
Forum for Adjudication of Disputes, page 20
1.Your forum selection provision identifies a Nevada state court as the exclusive forum for
certain litigation, including any “derivative action.” We note your disclosure that this
provision applies to claims arising under the Securities Act and the Exchange Act. Please
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. In response to the staff's comments on your Registration Statement
on Form S-1, File No. 333-233228, you disclosed that you did not intend for the provision
to apply to Exchange Act claims. If that is still true, please revise this prospectus to
clarify that you do not intend for the exclusive forum provision to apply to Exchange Act
claims.
FirstName LastNameSergio Traversa
Comapany NameRelmada Therapeutics, Inc.
October 25, 2019 Page 2
FirstName LastName
Sergio Traversa
Relmada Therapeutics, Inc.
October 25, 2019
Page 2
Incorporation of Documents by Reference, page 25
2.We note that you have not incorporated by reference Exchange Act filings made prior to
the effective date of the registration statement. In that regard, please revise to incorporate
by reference your Current Report on Form 8-K filed on October 21, 2019. Refer to
Question 123.05 of the Securities Act Forms Compliance and Disclosure Interpretations.
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.
Please contact Ada D. Sarmento at 202-551-3798 or Celeste Murphy at 202-551-3257
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Thomas R. Slusarczyk, Esq.
2019-10-21 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
RELMADA THERAPEUTICS, INC.
880 Third Avenue, 12th Floor
New York, New York 10022
October 21, 2019
VIA EDGAR
Ms. Tonya K. Aldave
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
RE:
Relmada Therapeutics, Inc. (the "Company")
Registration Statement on Form S-1
(File No. 333-233228) (the "Registration Statement")
Dear Ms. Aldave:
The Company hereby requests,
pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration
Statement, as amended, so that such Registration Statement will become effective as of 4:00 P.M., Wednesday, October 23, 2019 or
as soon thereafter as practicable, or at such later time as the Company or its counsel may orally request via telephone call to
the staff of the Division of Corporation Finance of the Securities and Exchange Commission.
In connection with the
Company’s request for acceleration of effectiveness of the above-referenced Registration Statement, the Company acknowledges
the following:
(1) 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;
(2) 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
(3) 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.
Very truly yours,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Name: Sergio Traversa
Title: Chief Executive Officer
2019-10-17 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
October 17, 2019
VIA EDGAR
Tonya K. Aldave
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Re:
Relmada Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-l
Filed October 11, 2019
File No. 333-233228
Dear Ms. Aldave:
We are in receipt of your comment letter dated
October 16, 2019 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:
Amendment No. 1 to Form S-1
Description of Securities
Forum of Adjudication of Disputes, page
91
1.
We note your response to our prior comment 1 and reissue in part. Your forum selection provision identifies a Nevada state court as the exclusive forum for certain litigation, including and “derivative action.” We note from your revise disclosure that this provision applies to claims arising under the Exchange Act. Please note that Section 27 of the Exchange Act created 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 revise the prospectus to clarify, it true, that the company does not intend for the exclusive forum provision to apply to Exchange Act claims.
RESPONSE:
On page 91 we have revised the prospectus to clarify that the company does not intend for the exclusive forum provision to apply to Exchange Act claims.
The Company acknowledges that
the Company and its management are responsible for the accuracy and adequacy of the disclosures, notwithstanding any review, comments,
action or absence of action by the staff.
Sincerely,
Relmada Therapeutics, Inc.
By:
/s/ Sergio Traversa
Sergio Traversa
Chief Executive Officer
2019-10-16 - UPLOAD - RELMADA THERAPEUTICS, INC.
October 16, 2019
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
Re:Relmada Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed October 11, 2019
File No. 333-233228
Dear Dr. Traversa:
We have reviewed your amended 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 August 20, 2019 letter.
Amendment No. 1 to Form S-1
Description of Securities
Forum of Adjudication of Disputes, page 91
1.We note your response to our prior comment 1 and reissue in part. Your forum selection
provision identifies a Nevada state court as the exclusive forum for certain litigation,
including any “derivative action.” We note from your revised disclosure that this
provision applies to claims arising under the Exchange Act. Please 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 revise the prospectus to clarify, if true, that the company does not intend for the
exclusive forum provision to apply to Exchange Act claims.
FirstName LastNameSergio Traversa
Comapany NameRelmada Therapeutics, Inc.
October 16, 2019 Page 2
FirstName LastName
Sergio Traversa
Relmada Therapeutics, Inc.
October 16, 2019
Page 2
Please contact Tonya K. Aldave at (202) 551-3601 or Justin Dobbie, Legal Branch
Chief, at (202) 551-3469 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Thomas R. Slusarczyk, Esq.
2019-10-11 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
October 11, 2019
VIA EDGAR
Tonya K. Aldave
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Re:
Relmada Therapeutics, Inc.
Registration Statement on Form S-l
Filed August 12, 2019
File No. 333-233228
Dear Ms. Aldave:
We are in receipt of your comment letter dated
August 20, 2019 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:
Registration
Statement on Form S-1
Description of
Securities, page 93
1. We note your forum selection provision identifies the Eighth Judicial District Court of Clark County, Nevada as the exclusive
forum for certain litigation, including any “derivative action.” Please describe this provision and disclose whether
this provision applies to actions arising under the Securities Act or Exchange Act. In that 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, and 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 the provision applies to Securities Act claims, please also 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 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.
RESPONSE:
On page 97 of the prospectus we have described our forum selection provision that is contained in our bylaws.
We have also disclosed that to the fullest extent permitted by law this provision applies to actions arising under the Securities
Act or Exchange Act. We have also revised the 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 any actions arising under the Securities Act or Exchange Act, we will inform investors in future
filings on Forms 8-K, 10-K or 10-Q, as applicable, that the provision does not apply to any actions arising under the Securities
Act or Exchange Act.
General
2. Please update your financial statements and related disclosures to comply with Rule 8-08 of Regulation S-X.
RESPONSE:
We have updated our financial statements and related disclosures in the prospectus to comply with Rule 8-08 of Regulation S-X. We have included the audited financial statements for the year ended June 30, 2019, our most recent fiscal year end.
The Company
acknowledges that the Company and its management are responsible for the accuracy and adequacy of the disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Relmada Therapeutics, Inc.
By:
/s/ Sergio Traversa
Sergio Traversa
Chief Executive Officer
2019-08-20 - UPLOAD - RELMADA THERAPEUTICS, INC.
August 20, 2019
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
880 Third Avenue, 12th Floor
New York, NY 10022
Re:Relmada Therapeutics, Inc.
Registration Statement on Form S-1
Filed August 12, 2019
File No. 333-233228
Dear Dr. Traversa:
We have limited our review of your registration statement to those issues we have
addressed in our 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-1
Description of Securities, page 93
1.We note that your forum selection provision identifies the Eighth Judicial District Court of
Clark County, Nevada as the exclusive forum for certain litigation, including any
“derivative action.” Please describe this provision and disclose whether this provision
applies to actions arising under the Securities Act or Exchange Act. In that 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, and 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 the provision applies to
Securities Act claims, please also revise your prospectus to state that there is uncertainty
FirstName LastNameSergio Traversa
Comapany NameRelmada Therapeutics, Inc.
August 20, 2019 Page 2
FirstName LastName
Sergio Traversa
Relmada Therapeutics, Inc.
August 20, 2019
Page 2
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 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.
General
2.Please update your financial statements and related disclosures to comply with Rule 8-08
of Regulation S-X.
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.
Please contact Tonya K. Aldave at (202) 551-3601 or Justin Dobbie, Legal Branch Chief,
at (202) 551-3469 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Thomas R. Slusarczyk, Esq.
2019-02-28 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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RELMADA THERAPEUTICS, INC.
880 Third Avenue, 12th Floor
New York, New York 10022
February 28, 2019
VIA EDGAR
Mr. Todd Schiffman
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
RE:
Relmada Therapeutics, Inc. (the "Company")
Registration Statement on Form S-1
(File No. 333-229258) (the "Registration Statement")
Dear Mr. Schiffman:
The Company hereby requests,
pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration
Statement so that such Registration Statement will become effective as of 2:00 P.M., Friday, March 1, 2019 or as soon thereafter
as practicable, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division
of Corporation Finance of the Securities and Exchange Commission.
In connection with the
Company’s request for acceleration of effectiveness of the above-referenced Registration Statement, the Company acknowledges
the following:
(1) 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;
(2) 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
(3) 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.
Very truly yours,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Name: Sergio Traversa
Title: Chief Executive Officer
2019-02-08 - UPLOAD - RELMADA THERAPEUTICS, INC.
February 7, 2019
Sergio Traversa
Chief Executive Officer
RELMADA THERAPEUTICS, INC.
880 Third Avenue
12th Floor
New York, NY 10017
Re:RELMADA THERAPEUTICS, INC.
Registration Statement on Form S-1
Filed January 14, 2019
File No. 333-229258
Dear Mr. Traversa:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Todd Schiffman at 202-551-3491 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2014-12-23 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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RELMADA THERAPEUTICS, INC.
546 Fifth Avenue, 14th Floor
New York, New York 10036
December 23, 2014
VIA EDGAR
Mr. John Dana Brown
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
RE:
Relmada Therapeutics, Inc. (the "Company")
Registration Statement on Form S-1
(File No. 333-197109) (the "Registration Statement")
Dear Mr. Brown:
The Company hereby
requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration
Statement so that such Registration Statement will become effective as of 4:30 P.M., Monday, December 29, 2014 or as soon thereafter
as practicable, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division
of Corporation Finance of the Securities and Exchange Commission.
In connection with
the Company’s request for acceleration of effectiveness of the above-referenced Registration Statement, the Company acknowledges
the following:
(1) 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;
(2) 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
(3) 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.
Very truly yours,
RELMADA THERAPEUTICS, INC.
By:
/s/ Sergio Traversa
Name: Sergio Traversa
Title: Chief Executive Officer
2014-12-09 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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Relmada Therapeutics, Inc.
546 Fifth Avenue, 14th Floor
New York, NY 10036
December 9, 2014
VIA EDGAR
John Dana Brown
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. 3 to Registration Statement on Form S-l
Filed
November 17, 2014
File
No. 333-197109
Dear
Mr. Brown:
We are in receipt of your comment letter
dated December 2, 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 reissue in part. Please explain to us the extent to which selling this licensed product is a material part of your business plan. In this regard, we note that this is the only patented product in your portfolio. If the agreement is a material part of your business plan, please file the agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S-K or please tell us why you are not required to do so.
RESPONSE:
The selling of the licensed product, d-Methadone, is a material part of our business plan. d-Methadone will compete in the approximately $2.4B neuropathic pain market (Datamonitor, 2010), which is expected to grow to $9.7B by 2018 according to a 2011 report by Decision Resources. Management expects D-Methadone to leverage the established analgesic efficacy and use of methadone but without its safety hazard. We note that the FDA has not concluded that d-methadone is safe. Even though we believe that the selling of d-Methadone is a material part of our overall business plan, we do not believe that at this time the Medeor License Agreement is material to our business. We believe that this license is not material to our business at this time because (i) sales of the product will not occur until at least 2020 and beyond, assuming that the product is approved by the FDA; (ii) royalty payments due to be paid under the agreement, which are only up to 2%, will not commence until the product is approved for sale, which we expect to be not until at least 2020 and beyond; and (iii) any upfront payments ($100,000) that are to be made under the agreement prior to the attainment of marketing allowance for the licensed product and the first commercial sale of the product in the field are extremely immaterial given our cash position.
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
2
2014-12-03 - UPLOAD - RELMADA THERAPEUTICS, INC.
December 2 , 2014 Via E -mail Sergio Traversa Chief Executive Officer Relmada Therapeutics, Inc. 546 Fifth Avenue 14th Floor New York, NY 10036 Re: Relmada Therapeutics, Inc. Amendment No. 3 to Registration Statement on Form S -1 Filed November 17, 2014 File No. 333-197109 Dear Mr. Traversa : We have reviewed your responses to the comments in our letter dated November 3, 2014 and have the following additional comments. Management’s Discussion and Analysis, page 61 1. We note your response to our prior comment 6 and reissue in part. Please explain to us the extent to which selling this licensed product is a material part of your business plan. In this regard, we note that this is the only patented product in your port folio. If the agreement is a material part of your business plan , please file the agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S -K or please tell us why you are not required to do so. Sergio Traversa Relmada Therapeutics, Inc. December 2 , 2014 Page 2 You may contact Aamira Chaudhry (202) 551 -3389 or Amy Geddes at (202) 551 -3304 if you have questions regarding comments on the financial statements and related matters. Please contact Ryan Adams at (202) 551 -3191 or me at (202) 551 -3859 with any other questions. Sincerely, /s/ John Dana Brown John Dana Brown Attorney Advisor cc: Via-Email Thomas R. Slusarczyk The Matt Law Firm, PLLC
2014-11-17 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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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
2014-11-03 - UPLOAD - RELMADA THERAPEUTICS, INC.
November 3 , 2014 Via E -mail Sergio Traversa Chief Executive Officer Relmada Therapeutics, Inc. 546 Fifth Avenue 14th Floor New York, NY 10036 Re: Relmada Therapeutics, Inc. Amendment No. 2 to Registration Statement on Form S -1 Filed October 16, 2014 File No. 333-197109 Dear Mr. Traversa : We have reviewed your responses to the comments in our letter dated September 30, 2014 and have the following additional comments. 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. 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 .” 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 upda te 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. Sergio Traversa Relmada Therapeutics, Inc. November 3 , 2014 Page 2 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. 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. Management’s Discus sion 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. You may contact Aamira Chaudhry (202) 551 -3389 or Amy Geddes at (202) 551 -3304 if you have questions regarding comments on the financial statements and related matters. Please contact Ryan Adams at (202) 551 -3191 or me at (202) 551 -3217 with any other questions. Sincerely, /s/ J. Nolan McWilliams J. Nolan McWilliams Attorney -Advisor cc: Via-Email Thomas R. Slusarczyk The Matt Law Firm, PLLC
2014-10-16 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
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Relmada
Therapeutics, Inc.
546
Fifth Avenue, 14th Floor
New
York, NY 10036
October
16, 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. 1 to Registration Statement on Form S-l
Filed
September 16, 2014
File
No. 333-197109
Dear
Mr. McWilliams:
We
are in receipt of your comment letter dated September 30, 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:
General
1. We
note your response to our prior comment 1. Please provide us with a more detailed analysis
in support of your conclusion that the press release dated July 1, 2014 “substantially
complies” with Rule 134. In your response, please address which of the items of
information enumerated in Rule 134(a) covers the statements you make in the second paragraph,
the second sentence of the third paragraph, and the second, third, and fourth sentences
of the paragraph immediately following the caption “About Relmada Therapeutics
. . . .” In your response please also tell us why it appears you have omitted the
legend pursuant to Rule 134(b)(1).
RESPONSE:
We
agree that the press release does not comply with Rule 134 and have included a risk factor to discuss the associated risks
with such non-compliance.
2. We
note your response to our prior comment 2. The press release on your website dated September
18, 2014 references the PSLRA. Please explain to us why this reference was made, in light
of your confirmation dated September 15, 2014, that you would refrain from such references
for so long as you are an issuer of penny stock.
RESPONSE:
We inadvertently referenced the PSLRA in the September 18, 2014 and October 2, 2014 press releases, and
herby re-confirm that for so long as the Company issues penny stock, the Company will refrain from referencing the PSLRA safe
harbors in its press releases and Exchange Act reports.
3. We
note your response to our prior comment 3. We note that you have provided audited financial
statements for the six month transition period ended June 30, 2014. Please tell us and
revise to disclose whether you have changed your year-end date.
RESPONSE:
We
have changed our fiscal year end from December 31 to June 30. On page 54, under “Our Corporate History and Background”,
we have disclosed that we changed our year end to June 30th.
Prospectus
Summary, page 1
4. We
note your response to our prior comment 6. Please disclose here your accumulated deficit.
RESPONSE:
We
have disclosed our accumulated deficit on page 1 of the prospectus.
5. We
note your response to our prior comment 7. Please clarify which production activities
you intend to engage in compared to those developed or to be undertaken by third parties.
If you have not yet determined this given your stage of development, please discuss the
factors you will consider in determining whether to outsource production and distribution.
RESPONSE:
We
have disclosed that we intend to utilize third parties to manufacture our products and conduct clinical trials on page 1 of
the prospectus.
6. We
note your response to our prior comment 9. We are unable to locate your revised discussion
of your competitive position and the effect of your particular strategy on this position
on page 1. In this regard, please balance the comparison of your product to established
commercial products of your competitors in light of your size and the stage of development
of your product candidates.
RESPONSE:
We
have added disclosure on page 2 of the prospectus to address comment 6.
7. We
note your response to our prior comment 11. It does not appear your prospectus has been
revised to include a discussion of your product pipeline in the business section, or
any other section. Please revise accordingly. Additionally, please clarify why you have
not discussed a Phase II trial for LevoCap. Please also clarify that d-Methadone is preclinical,
and discuss why it appears you will skip Phase I studies. Similarly, please clarify that
that MepiGel is pre-clinical.
RESPONSE:
On
page 53 and 54 of the “Description of Business” section of the prospectus we include a summary of our lead development
projects, as well as a summary of the development status for our products. On page 1, we have clarified why we have not discussed
a Phase II trial for LevoCap. We also have addressed the comments relating to d-Methadone on page 1 and clarified
that Mepige1 is pre-clinical.
2
Selling
Stockholders, page 25
8. We
note your response to our prior comment 22. Please identify in footnote 287 the person
or persons who have voting or investment control over KMR Agency Inc.’s securities.
RESPONSE:
We
have in footnote 287 the person who has voting or investment control over KMR Agency Inc.’s securities
Description
of Business, page 53
9. We
note your response to our prior comment 23. Please describe in greater detail your current
and anticipated manufacturing plans, along with your plans for distribution. If you have
not yet determined this given your stage of development, please discuss the factors you
will consider in determining whether to outsource production and distribution. In this
regard, we note your disclosure on page F-26 that you have a license agreement to distribute
products in Asia. Please also discuss the steps you intend to take, if any, to locate
adequate sources of supply of levorphanol for production and distribution.
RESPONSE:
We
have added disclosure on page 53 of the prospectus to address Comment 9.
Product
Development, page 56
10. We
note your response to our prior comment 27. Please disclose that Memorial Sloan Kettering
Hospital has filed an IND for d-methadone, and reconcile this with your disclosure under
the “Operations” subheading that you are “preparing to open the U.S.
IND for d-methadone . . . .” Please also briefly describe the significance of and
discuss the material risks associated with parties other than you sponsoring or filing
applications.
RESPONSE:
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 d-methadone. Since we are filing our own IND for this product, we will be the sponsor, so there are no risks associated
with parties other than us sponsoring or filing applications.
Intellectual
Property Portfolio and Market Exclusivity, page 56
11. We
note your response to our prior comment 28. Please provide a basis for your statement
that your technology and products are “protected by an extensive intellectual property
estate of several patents” when it appears that you currently own no patents. Similarly,
revise the statement on page 57 that you have “secured an intellectual property
portfolio comprised of several patents and patent applications.” Please also provide
us your analysis that the license agreement from Cornell University for d-methadone is
not material to your business, or file this agreement as an exhibit.
RESPONSE:
We
have revised the statement that states that our technology and products are “protected by an extensive intellectual
property estate of several patents”. We have also revised the statement on page 57. We believe
that the license agreement from Cornell University for d-methadone is not material to our business because the product is
at a minimum of 5 to 6 years from launch and the royalty payments to be made to Cornell is only up to 2%.
3
Competition
Overview, page 57
12. We
note your response to our prior comment 30 and reissue. Please discuss here your competitive
business conditions and competitive position in the industry. Refer to Item 101(h)(4)(iv)
of Regulation S-K.
RESPONSE:
We
have added disclosure on page 57 regarding our competitive business conditions and our competitive position in the industry.
Government
Regulation, page 57
13. Please
discuss the requirement under the Controlled Substances Act that products containing
Schedule II controlled substances are manufactured in the United States and discuss the
steps you have taken and intend to take to comply with this requirement. We note in this
regard your disclosure in the last risk factor on page 9 and the second risk factor on
page 10.
RESPONSE:
We
have added disclosure in response to this comment on page 57 of the prospectus.
14. We
note your response to our prior comment 31. Please disclose the terms by which you have
obtained “the right to two orphan drug designations for MepiGel from Cinergen,
LLC” and explain your relationship, if any, with Cinergen.
RESPONSE:
We
have added disclosure in response to this comment on page 57 of the prospectus.
Management’s
Discussion and Analysis, page 61
15. We
note your response to our prior comment 33. Please characterize the description of your
portfolio as “diversified” as your belief and briefly disclose the basis
of this belief.
RESPONSE:
We
have characterized the description of your portfolio as “diversified” as our belief, and have briefly disclosed our
basis of this belief.
16. We
note your disclosure on page 62 that in December 2013 you acquired Medeor and “assumed
the obligation to pay a third party for a license agreement.” Please identify this
third party and revise to include a summary of the material terms of this license agreement
and file it as an exhibit to the extent material.
RESPONSE:
We
have identified the third party and included a summary of the material terms of this license agreement on page 62. The
Company does not believe that the agreement is material.
4
Description
of Securities, page 79
17. We
note your response to our prior comment 46. Please quantify how many advisory firm warrants
are currently issued and outstanding.
RESPONSE:
We
have quantified the number of advisory firm warrants on page 79 of the prospectus.
Audited
Financial Statements, page F-1
Report
of Independent Registered Accounting Firm, page F-3
18. The
audit report dated March 25, 2014 contained a going concern paragraph. The new audit
report dated September 3, 2014 does not. Please tell us in further detail why the new
audit report does not have a going concern paragraph.
RESPONSE:
The Company expects to have sufficient cash
to operate for a period of time beyond June 30, 2015. At June 30, 2014, the Company had approximately $25.6 million of cash and
cash equivalents. For the twelve months ending June 30, 2015, the Company expects to use approximately
$12 million of cash to fund its operations.
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
5
2014-10-01 - UPLOAD - RELMADA THERAPEUTICS, INC.
September 30, 2014 Via E -mail Sergio Traversa Chief Executive Officer Relmada Therapeutics, Inc. 546 Fifth Avenue 14th Floor New York, NY 10036 Re: Relmada Therapeutics, Inc. Amendment No. 1 to Registration Statement on Form S -1 Filed September 16 , 2014 File No. 333-197109 Dear Mr. Traversa : We have reviewed your responses to the comments in our letter dated July 24, 2014 and have the following additional comments. General 1. We note your response to our prior comment 1. Please provide us with a more detailed analysis in support of your conclusion that the press release dated July 1, 2014 “substantially complies ” with Rule 134 . In your response, please ad dress which of the items of information enumerated in Rule 134(a) covers the statements you make in the second paragraph, the second sentence of the third paragraph, and the second, third, and fourth sentences of the paragraph immediately following the cap tion “About Relmada Therapeutics . . . .” In your response please also tell us why it appears you have omitted the legend pursuant to Rule 134(b) (1). 2. We note your response to our prior comment 2 . The press release on your website dated September 18, 2014 reference s the PSLRA . Please explain to us why this reference was made, in light of your confirmation dated September 15, 2014, that you would refrain from such references for so long as you are an issuer of penny stock . 3. We note your response to our prior comment 3. We note that you have provided audited financial statements for the six month transition period ended June 30, 2014. Please tell us and revise to disclose whether you have changed your year -end date. Sergio Traversa Relmada Therapeutics, Inc. September 30, 2014 Page 2 Prospectus Su mmary, page 1 4. We note your response to our prior comment 6. Please disclose here your accumulated deficit . 5. We note your response to our prior comment 7. Please clarify which production activities you intend to engage in compared to those developed or t o be undertaken by third parties. If you have not yet determined this given your stage of development, please discuss the factors you will consider in determining whether to outsource production and distribution. 6. We note your response to our prior comment 9. We are unable to locate your revised discuss ion of your competitive position and the effect of your particular strategy on this position on page 1 . In this regard, please balance the compar ison of your produc t to established commercial products of your competitors in light of your size and the stage of development of your product candidates . 7. We note your response to our prior comment 11. It does not appear your prospectus has been revised to include a discussion of your product pipeline in the business section , or any other section . Please revise accordingly . Additionally, please clarify why you have not discussed a Phase II trial for LevoCap . Please also clarify that d-Methadone is preclinical, and discuss why it appears you will skip Phase I studies . Similarly, please clarify that tha t MepiGel is pre -clinical. Selling Stockholders, page 25 8. We note your response to our prior comment 22. Please identify in footnote 287 the person or persons who ha ve voting or investment control over KMR Agency Inc.’s securities . Description of Business, page 5 3 9. We note your response to our prior comment 23. Please describe in greater detail your current and anticipated manufacturing plans, along with your plans for distribution. If you have not yet determined this given your stage of development, please discuss the factors you will consider in determining whether to outsource production and distribution. In this regard, we note your disclosure on page F -26 tha t you have a license agreement to distribute products in Asia. Please also discuss the steps you intend to take, if any, to locate adequate sources of supply of levorphanol for production and distribution . Sergio Traversa Relmada Therapeutics, Inc. September 30, 2014 Page 3 Product Development, page 56 10. We note your response to our prior comment 27. Please disclose that Memorial Sloan Kettering Hospital has filed an IND for d -methadone, and reconcile this with your disclosure under the “Operations” subheading that you are “preparing to open the U.S. IND for d -methado ne . . . .” Please also briefly describe the significance of and discuss the material risks associated with parties other than you sponsoring or filing applications. Intellectual Property Portfolio and Market Exclusivity, page 56 11. We note your response to our prior comment 28. Please provide a basis for your statement that your technology and products are “protected by an extensive intellectual property estate of several patents” when it appears that you currently own no patents. Similarly , revise th e statement on page 57 that you have “secured an intellectual property portfolio comprised of several patents and patent applications.” Please also provide us your analysis that the license agreement from Cornell University for d -methadone i s not material to your business, or file this agreement as an exhibit. Competition Overview, page 5 7 12. We note your response to our prior comment 30 and reissue. Please discuss here your competitive business conditions and competitive position in the industry. Refer to Item 101(h)(4)(iv) of Regulation S -K. Government Regulation, page 57 13. Please discuss the requirement under the Controlled Substances Act that products containing Schedule II controlled substances are manufactured in the United States and discuss the st eps you have taken and int end to take to comply with this requirement. We note in this regard your disclosure in the last risk factor on page 9 and the second risk factor on page 10. 14. We note your response to our prior comment 31. Please disclose the t erms by which you have obtained “the right to two orphan drug designations for MepiGel from Cinergen, LLC” and explain your relationship, if any, with Cinergen. Management’s Discussion and Analysis, page 61 15. We note your response to our prior comment 33 . Please characterize the description of your portfolio as “diversified” as your belief and briefly disclose the basis of this belief. 16. We note your disclosure on page 62 that in December 2013 you acquired Medeor and “assumed the obligation to pay a third party for a license agreement .” Please identify this Sergio Traversa Relmada Therapeutics, Inc. September 30, 2014 Page 4 third party and revise to include a summary of the material terms of this license agreement and file it as an exhibit to the extent material . Description of Securities, page 79 17. We note your resp onse to our prior comment 46 . Please quantify how many advisory firm warrants are currently issued and outstanding. Audited Financial Statements, page F -1 Report of Independent Registered Public Accounting Firm, page F -3 18. The audit report dated March 25, 2014 contained a going concern paragraph. The new audit report dated September 3, 2014 does not. Please tell us in further detail why the new audit report does not have a going concern paragraph. You may contact Aamira C haudhry (202) 551 -3389 or Amy Geddes at (202) 551 -3304 if you have questions regarding comments on the financial statements and related matters. Please contact Ryan Adams at (202) 551 -3191 or me at (202) 551-3217 with any other questions. Sincerely, /s/ J. Nolan McWilliams J. Nolan McWilliams Attorney -Advisor cc: Via-Email Thomas R. Slusarczyk The Matt Law Firm, PLLC
2014-09-16 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Relmada Therapeutics, Inc.
546 Fifth Avenue, 14th Floor
New York, NY 10036
September 15, 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. (Formerly
Camp Nine, Inc.)
Registration
Statement on Form S-l
Filed June 27, 2014
File No. 333-197109
Dear Mr. McWilliams:
We are in receipt of your comment letter
dated July 24, 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:
General
1. Refer
to the press release dated July 1, 2014 located on the Relmada.com website. Please tell
us whether you intend that this press release does not constitute a “prospectus”
as defined in Section 2(a)(10) of the Securities Act of 1933. To the extent you believe
this press release complies with Rule 134 under the Securities Act, please address this
in your response.
RESPONSE:
We
intend that this press release does not constitute a “prospectus” as defined in Section 2(a)(10) of the Securities
Act of 1933. We believe that the release substantially complies with Rule 134 under the Securities Act because the release
repeats information previously disclosed by the Company in earlier press releases and limits the disclosure to factual information
about the Company and a brief indication of the general type of business of the company. To
the extent that the release does not comply with Rule 134, the Company is willing to include disclosure in the registration
statement regarding such risk.
2. Additionally, forward-looking statements made by issuers of penny stock are excluded from the safe harbors in the Private Securities
Litigation Reform Act. Please confirm that for so long as you issue penny stock, you will refrain from referencing the PSLRA safe
harbors in your press releases and Exchange Act reports.
RESPONSE:
We herby confirm that for so long as the Company issues
penny stock, the Company will refrain from referencing the PSLRA safe harbors in its press releases and Exchange Act reports.
3. The financial statements should be updated, as necessary, to comply with Rule 8-08 of Regulation S-X at the effective date
of the registration statement.
RESPONSE:
We acknowledge that the financial statements will be updated, as necessary, to comply with Rule 8-08 of Regulation S-X at the effective date of the registration statement. We have included the audited financial statements for the six months transition period ended June 30, 2014 in the registration statement.
4. Provide a currently dated consent from the independent public accountant in any amended filing.
RESPONSE:
We have included a currently dated consent from our auditor as Exhibit 23.1 to the Form S-1/A.
Outside
front Cover of Prospectus
5. Please revise the cross-reference to the risk factors section to point to the correct page.
RESPONSE:
We have revised the cross-reference to the risk factors section to point to the correct page in the Form S-1/A.
Prospectus
Summary, page 1
6. Please balance the discussion under Business Overview by disclosing in one of the opening paragraphs
that you have not generated revenues and do not anticipate generating revenues for the foreseeable future, that your auditor has
expressed a substantial doubt as to your ability to continue as a going concern, and disclose your net losses for the most recently
completed fiscal year and interim period.
RESPONSE:
We
have included disclosure that we have not generated revenues and do not anticipate generating revenues for the foreseeable future.
We also have disclosed our net losses for the most recently completed fiscal year. Finally, the auditor did not include a going
concern opinion in the most recent audited financial statements for the transition period ended June 30, 2014.
7. Please revise the discussion to clarify and distinguish what products and processes you have developed
and the activities in which you intend to engage compared to those developed or to be undertaken by third parties. In this regard
we note the statements concerning your development of highly efficient clinical programs to deliver valuable products in areas
of high unmet medical need, and the statements on page 59 concerning your agreements with Malvern Consulting Group Inc. for d-methadone
product development and to Scilucent, Inc. for levorphanol.
RESPONSE:
We have revised the disclosure to include the processes for which the management team will be responsible. We have also revised the disclosure on page 59 to indicate that Scilucent is used by the company as a regulatory consultant. Malvern also was only used as a regulatory consultant but no longer provides services to the Company.
8. Please tell us whether any of the data provided by the listed sources here and in your business
section, such as the data from other third-party sources and industry publications, were commissioned by you for use in connection
with the registration statement. If so, please file consents pursuant to Rule 436 of the Securities Act as exhibits to your registration
statement.
RESPONSE:
None of the data provided by the listed sources in the summary section and in our business section, such as the data from other third-party sources and industry publications, were commissioned by us for use in connection with the registration statement. All information is publically available.
2
9. We note that you include sales data for established products
sold by larger and better-funded competitors as indicative of the potential market for your products. To the extent you reference
sales of competitors’ products, please place this and other market data in context by discussing your competitive position
in light of your size and stage of product development, as well as how your strategy of relying on off-patent drugs and repurposed
drugs influences your competitive position and the comparability of the data you cite.
RESPONSE:
We have added a new paragraph on page 1 to address comment 9.
10. Please define the term “in-license” the first
time it is used and briefly explain how in-licensing will allow you to “accelerate the pathway to become a fully integrated
pain specialty biopharmaceutical company” and expand upon your plans for any in-licensing arrangements here and in the business
section. Please tell us whether you have entered into any such agreements, and if so, please file any material agreements as exhibits.
RESPONSE:
We have defined term “in-license” the first time it is used and briefly explained how in-licensing will allow us to “accelerate the pathway to become a fully integrated pain specialty biopharmaceutical company”. We currently do not have any plans for any in-licensing arrangements and have not entered into any such arrangements to date.
11. Please clarify where in the clinical trial process your product candidates currently stand, as
you have only filed one investigational new drug application (“IND”), and appear to be in preclinical stages for two
of your product candidates. We also note your disclosure here that you have “an early stage pipeline of product candidates
which are briefly described in the business section of this document,” and on page 59 referring to “an early stage
pipeline of an additional three products,” yet it appears that an expanded discussion of these products has been omitted.
Accordingly, please revise this section and your business section to thoroughly discuss your product pipeline.
RESPONSE:
We have expanded our disclosure on our product pipeline status is the summary section and business sections.
12. We note your statement that your “open-label Phase I/IIa study at the Memorial Sloan Kettering
Cancer Center showed that d-methadone was safe and well tolerated with 75% of the patients completing the study finding d-methadone
to be moderately or very effective,” and that your d-methadone can leverage the established analgesic efficacy and use of
methadone “without its safety hazard.” Please qualify these statements by clearly indicating, if true, that the FDA
has not concluded that your specific product candidates are safe.
RESPONSE:
We have qualified the above statements by clearly indicating that the FDA has not concluded that d-methadone is safe.
13. Please explain what you mean by “develop d-methadone
as an innovative NMDA antagonist to platform to treat neuropathic pain or other potential conditions.”
RESPONSE:
We have expanded on what we mean by “develop d-methadone as an innovative NMDA antagonist to platform to treat neuropathic pain or other potential conditions.”
14. Please provide support for the statements on pages 1 and 52 that “levorphanol has also been
shown to partially reverse analgesic tolerance to morphine and may therefore benefit patients who are tolerant to the analgesic
effects of their current opioid,” and that “historically both patients and doctors prefer oral dosing versus sublingual
or patch products [of buprenorphine],” and on page 54 that MepiGel “is anticipated to compete with topical Lidoderm
patch . . . .”
RESPONSE:
We have provided support for the statements above or qualified the statement stating that it is our belief.
3
Risk Factors, page 4
Risks Related to Our Business, page 4
International commercialization of our product
candidates faces significant obstacles, page 4
15. We note your disclosure that you “may plan to commercialize some of
[y]our products internationally through collaborative relationships with foreign partners.” Please tell us whether you have
approached any potential partners, and to the extent you currently have any material agreements with foreign partners, please file
them as exhibits.
RESPONSE:
We have not approached any potential partners to commercialize our products.
Risks Related to Clinical and Regulatory Matters,
page 6
Some of our products for clinical trials are
manufactured outside the United States, page 10
16. We note your disclosure that you manufacture some products outside of the United States. Please
revise your business section to discuss your manufacturing arrangements, and to the extent you have any material agreements file
them as exhibits.
RESPONSE:
Relmada manufactures some products outside the United States for development and to conduct human clinical studies either in the US or outside the US. These products are for development purposes only, and not for commercial manufacturing. There is no material agreement. We have included this disclosure on page 10.
If the supplier of active pharmaceutical ingredient
(API) or pharmaceutical excipient, page 10
17. We note your disclosure that you have a “single source for [y]our supply of levorphanol”
and that interruption in the supply of levorphanol could have a material adverse effect on your business. Please revise your business
section to identify this source and file any agreement with this provider as an exhibit, or explain to us why you do not believe
it is material.
RESPONSE:
Relmada relies on a single
source of API for levorphanol for the development of the product. Currently this single source supplies the API for research and
development purposes only. There is no material agreement for commercial supply at this time. We have included this statement
in the business section.
4
We
rely on third parties to conduct our clinical trials, page 12
18. We note your disclosure that you have relied on third parties to conduct clinical trials. Please
revise the summary and business section to disclose the terms of your arrangements with any third parties that you utilize in conducting
clinical trials. Please also file any material agreements with these parties as exhibits and disclose the nature of any fees, royalties,
or profit sharing that these agreements contemplate.
RESPONSE:
We have revised the disclosure to indicate that we currently do not have any ongoing trials. We also do not currently have any arrangements with any third parties for trials.
Our patent
position is highly uncertain and involves complex legal and factual questions, page 17
19. We note your disclosure concerning pending patent applications by you and your licensors here,
and your disclosure on page 55 that you have a “substantial” intellectual property portfolio comprised of “several
patents and patent applications.” Please revise this risk factor to include a brief discussion of your most material patents,
the product candidates or technology to which they relate, the jurisdictions in which they were granted, and the expected expiration
date of the patent protection. Additionally, if the patents are subject to a license agreement that may be terminated resulting
in the loss of patent protection, please disclose.
RESPONSE:
We have revised the disclosure in the risk factor per the comment above.
Risks
Related to Ownership of Our Common Stock, page 22
Our Common
Stock may be deemed a “penny stock,” page 23
20. Please reconcile your disclosure here that penny stock rules apply to “companies whose common
stock is not listed on The Nasdaq Stock Market or other national securities exchange and trades at less than $4.00 per share, other
than companies that have had average revenue of at least $6,000,000 for the last three years or that have tangible net worth of
at least $5,000,000” and the disclosure on page 25 that “[p]enny stocks generally are equity securities with a price
of less than $5.00 . . . .”
RESPONSE:
We have revised the disclosure on page 23 to state that penny stock rules apply stock that trades at less than $5.00 per share, and not $4.00 per share.
5
Dilution,
page 25
21. Please discuss the potential dilutive effect to stockholders that may occur if your warrants are
exercised.
RESPONSE:
We
have included a discussion of the potential dilutive effect to stockholders that may occur if our warrants are exercised.
Selling Stockholders, page 25
22. We note that many of the listed selling stockholders are entities, rather than natural persons.
For all selling stockholders that are not natural persons, please identify the person or persons who have voting or investment
control over the company’s securities that the entity owns in the footnotes to the table. In this regard, we note that the
following entities do not have a voting person disclosed: Cornell Research Foundation, Kermit E Reynolds Jr Family LLC, Maurice
Schwartz & Sons Partnership, Octet Investment Ltd, Principle Financial Holdings LLC, Rippee Mineral Management LLC, Rs Draughting
& Engineering Services Ltd., and Standard Sand & Silica Co Inc. Please also fill in all blank spaces in the footnotes to
this table in your next amendment.
RESPONSE:
We updated the footnote table to identify all of the person or persons who have voting or investment control over the Company’s securities that are owned by entities.
Description
of Business, page 52
23. Please significantly revise this section to include the information required by Item 101(h)(4)
of Regulation S-K. For instance, disclose in greater detail your distribution methods, the development status of your lead products
and pipeline products, the sources and availability of raw materials and the names of principal suppliers, the effect of exi
2014-07-24 - UPLOAD - RELMADA THERAPEUTICS, INC.
July 24, 2014 Via E -mail Sergio Traversa Chief Executive Officer Camp Nine, Inc. 546 Fifth Avenue 14th Floor New York, NY 10036 Re: Camp Nine, Inc . Registration Statement on Form S-1 Filed June 27, 2014 File No. 333-197109 Dear Mr. Traversa : 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. General 1. Refer to the press release dated July 1, 2014 l ocated on the Relmada.com website. Please tell us whether you intend that this press release does not constitute a “prospectus” as defined in Section 2(a)(10) of the Securities Act of 1933. To the extent you believe this press release complies with Rule 134 under the Securities Act, please address this in your response. 2. Additionally, forward -looking statements made by issuers of penny stock are excluded from the safe harbors in the Private Securities Litigation Reform Act. Please confirm that for so lo ng as you issue penny stock, you will refrain from referencing the PSLRA safe harbors in your press releases and Exchange Act reports. Sergio Traversa Camp Nine, Inc. July 24, 2014 Page 2 3. The financial statements should be updated, as necessary, to comply with Rule 8 -08 of Regulation S -X at the effective date of the registration statement. 4. Provide a currently dated consent from the independent public accountant in any amend ed filing . Outside Front Cover of Prospectus 5. Please revise the cross -reference to the risk factors section to point to the correct page. Prospectus Summary, page 1 6. Please balance the discussion under Business Overview by disclos ing in one of the opening paragraphs that you have not generated revenues and do not anticipate generating revenues for the foreseeable future, that your auditor has expressed a substantial doubt as to your ability to continue as a going concern , and disclose your net losses for the most recently completed fiscal year and interim period. 7. Please revise the discussion to clarify and distinguish what pro ducts and processes you have developed and the activities in which you intend to engage compared to those developed or to be undertaken by third parties. In this regard we note the statements concerning your development of highly efficient clinical progra ms to deliver valuable products in areas of high unmet medical need , and the statements on page 59 concerning your agreements with Malvern Consulting Group Inc. for d -methadone product development and to Scilucent, Inc. for levorphanol . 8. Please tell us whether any of the data provided by the listed sources here and in your business section , such as the data from other third -party sources and industry publication s, were commissioned by you for use in connection with the registration statement . If so, plea se file consents pursuant to Rule 436 of the Securities Act as exhibits to your registration statement. 9. We note that you include sales data for established products sold by larger and better - funded competitors as indicative of the potential market for y our products. To the extent you reference sales of competitors’ products, please place this and other market data in context by discussing your competitive position in light of your size and stage of product development, as well as how your strategy of re lying on off -patent drugs and repurposed drugs influences your competitive position and the comparability of the data you cite . 10. Please define the term “in -license” the first time it is used and briefly explain how in - licensing will allow you to “ accelerate the pathway to become a fully integrated pain specialty biopharmaceutical company ” and expand upon your plans for any in -licensing arrangements here and in the business section. Please tell us whether you have entered into any such agreements, and if so, please file any material agreements as exhibits . Sergio Traversa Camp Nine, Inc. July 24, 2014 Page 3 11. Please clarify where in the clinical trial process your product candidates currently stand, as you have only filed one investigational new drug application (“IND”), and appear to be in preclinical stages for two of your product candidates. We also note your disclosure here that you have “ an early stage pipeline of product candidates which are briefly described in the business section of this document ,” and on page 59 referring to “an early stage p ipeline of an additional three products, ” yet it appears that an expanded discussion of these products has been omitted. Accordingly, please revise this section and your business section to thoroughly discuss your product pipeline. 12. We note your stateme nt that your “ open -label Phase I/IIa study at the Memorial Sloan Kettering Cancer Center showed that d -methadone was safe and well tolerated with 75% of the patients completing the study finding d -methadone to be moderately or very effective ,” and that you r d-methadone can leverage the established analgesic efficacy and use of methadone “without its safety hazard. ” Please qualify these statements by clearly indicating , if true, that the FDA has not concluded that your specific product candidates are safe. 13. Please explain what you mean by “develop d -methadone as an innovative NMDA antagonist to platform to treat neuropathic pain or other poten tial conditions. ” 14. Please provide support for the statements on pages 1 and 52 that “ levorphanol has also been shown to partially reverse analgesic tolerance to morphine and may therefore benefit patients who are tolerant to the analgesic effects of their current opioid ,” and that “historically both patients and doctors prefer oral dosing versus sublingual or patch products [of b uprenorphine ],” and on page 54 that MepiGel “is anticipated to compete with topical Lidoderm patch . . . .” Risk Factors, page 4 Risks Related to Our Business, page 4 International commercialization of our product candidates faces significant obstacles, page 4 15. We note your disclosure that you “may plan to commercialize some of [y]our products internationally through collaborative relationships with foreign partners.” Please tell us whether you have approached any potential partners, and to the extent you currently have any material agreements with foreign partners, please file them as exhibits . Sergio Traversa Camp Nine, Inc. July 24, 2014 Page 4 Risks Related to Clinical and Regulatory Matters, page 6 Some of our produ cts for clinical trials are manufactured outside the United States, page 10 16. We note your disclosure that you manufacture some products outside of the United States. Please revise your business section to disc uss your manufacturing arrangements, and to th e extent you have any material agreements file them as exhibits. If the supplier of active pharmaceutical ingredient (API) or pharmaceutical excipient, page 10 17. We note your disclosure that you have a “single source for [y]our supply of levorphanol” and that interruption in the supply of levorphanol could have a material adverse effect on your business. Please revise your business section to identify this source and file any agreement with this provider as an exhibit, or explain to us why you do not believe it is material. We rely on third parties to conduct our clinical trials, page 12 18. We note your disclosure that you have relied on third parties to conduct clinical trials. Please revise the summary and business section to disclose the terms of your arrangements with any third parties that you utilize in conducting clinical trials. Please also file any material agreements with these parties as exhibits and disclose the nature of any fees, royalties, or profit sharing that these agreements contemplate . Our patent position is highly uncertain and involves complex legal and factual questions, page 17 19. We note your disclosure concerning pending patent applica tions by you and your licensors here, and your disclosure on page 55 that you have a “substantial” intellectual property portfolio comprised of “several patents and patent applications.” Please revise this risk factor to include a brief discussion of your most material patents, the product candidates or technology to which they relate, th e jurisdictions in which they were granted, and the expected expiration date of the patent protection. Additionally, if the patents are subject to a license agreement that may be terminated resulting in the loss of patent protection, please disclose. Risks Related to Ownership of Our Common Stock, page 22 Our Common Stock may be deemed a “penny stock,” page 23 20. Please reconcile your disclosure here that penny stock rules apply to “ companies whose common stock is not listed on The Nasdaq Stock Market o r other national securities exchange and trades at less than $4.00 per share, other than companies that have had average revenue of at least $6,000,000 for the last three years or that have tangible net Sergio Traversa Camp Nine, Inc. July 24, 2014 Page 5 worth of at least $5,000,000 ” and the disclosure on p age 25 that “[p] enny stocks generally are equity securities with a price of less than $5.00 . . . .” Dilution, page 25 21. Please discuss the potential dilutive effect to stockholders that may occur if your warrants are exercised. Selling Stockholders, page 25 22. We note that many of the listed selling stockholders are entities, rather than natural persons. For all selling stockholders that are not natural persons, please identify the person or persons who have voting or investment control over the company’s securities that the entity owns in the footnotes to the table. In this regard, we note that the following entities do not have a voting person disclosed: Cornell Research Foundation, Kermit E Reynolds Jr Family LLC, Maurice Schwartz & Sons Partnership, O ctet Investment Ltd, Principle Financial Holdings LLC, Rippee Mineral Management LLC, Rs Draughting & Engineering Services Ltd., and Standard Sand & Silica Co Inc. Please also fill in all blank spaces in the footnotes to this table in your next amendment. Description of Business, page 52 23. Please significantly revise this section to include the information required by Item 101(h)(4) of Regulation S -K. For instance, disclose in greater detail your distribution methods, the development status of your lead p roducts and pipeline products, the sources and availability of raw materials and the names of princip al suppliers , the effect of existin g or probable governmental regulations on your business, the costs and effects of compliance with environmental laws, and an estimate of the amount spent during each of the last two fiscal years on research and development activities. Please also clarify your role in the design, manufacturing and production of these products versus your suppliers’ and other third parties ’ roles. 24. Please include the information required by Item 102 of Regulation S -K. 25. Please revise this section to include a section discussing the status and results of your clinical trials, including recent results and planned future development . Company Overview, page 52 26. We note your references to proprietary systems in your LevoCap ER , BuTab ER, and MepiGel products. Please clarify the elements of these products that are proprietary, and to what extent you have patent protection for these systems. Sergio Traversa Camp Nine, Inc. July 24, 2014 Page 6 Product Development, page 55 27. It appears that you have filed an investigational new drug (IND) application for LevoCap ER, but not d -methadone, BuTab ER, or MepiGel. Please disclose the identity of the filers and dates the application was filed for LevoCa p, and explain to us why INDs have not been filed for your other product candidates. Intellectual Property Portfolio and Market Exclusivity, page 55 28. We note your disclosure that you believe “ Relmada’s technology and products are protected by an extensive intellectual property estate of several patents or patent applications” and that you “have secured an intellectual property portfolio comprised of several patents and patent applications. ” Please disclose in this section the number of issued material pat ents, if any, covering your products . As to each material patent related to your products , please disclose the following information: the expiration date of the patent; the jurisdiction covered by the patent; the type of protection afforded by each such p atent; and whether the patent is owned by or licensed to the company. As to any licensed material patent related to your products , please indicate from whom the patent was licensed and describe all material terms of the license agreement, including its du ration and any conditions that must be satisfied in order to maintain the license. Please file all material license agreements as exhibits . Key Strengths, page 55 29. Please explain the reference to “Exhibit 1” in the second bullet point of this subsection. We are unable to locate this exhibit in the prospectus. Competition Overview, page 56 30. Please disclose the names and products of any other companies that are developing or have developed similar products. Government Regulation, page 56 31. Please expand this section to describe the status of your products within the FDA approval process, e.g., what type of applications have been submitted, when, the nature o f designations assigned by the FDA to your products, the basis for your belief that y our products will be eligible for 505(b)(2) registration with the FDA, and why you believe your “two tiered” approach will reduce ov erall clinical development risks. We note that you have received two 7 -year FDA Orphan Drug market exclusivities for MepiGe l. Please tell us when you received these exclusivities, and disclose all material details of Sergio Traversa Camp Nine, Inc. July 24, 2014 Page 7 any communications with the FDA here. Please also clarify that although you may pursue a 505(b)(2) pathway, that approval is not guaranteed by the FDA. Additio nally, please clarify what you mean by the phrase on page 54 that you will “pursue the development of d -methadone via the traditional NDA route.” Market Price of an d Dividends on Our Common Stock and Related Stockholder Matters, page 57 32. Please revise to include the high and low bid information for your common stock for each full quarterly period within the two most recent fiscal years and any subsequent interim period for which financial statements are included. Refer to Item 201(a)(1)(iii) of Regulation S-K. Management’s Discussion and Analysis, page 59 33. Please briefly explain why it is appropriate to characterize your product portfolio as “diversified” given that no products are currently approved for sale and you have not generated revenues and do not expect to generate revenues for the foreseeable future from these products. 34. Please characterize as a belief the statement that your “efforts are guided by the internationally recognized scientific expertise of [your] research team with inputs from a world-class scientific advisory board .” 35. We note your statement that “ [a]s of now none of [y]our drugs have been approved for sale in the United States or elsewhere” and that you have no “sales or marketing infrastructure .” Please revise to disclose this in you
2013-03-19 - CORRESP - RELMADA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Camp NINE, INC. March 18, 2013 THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION Attn: Susan Block Division of Corporation Finance Mail Stop 7010 100 F. Street NE Washington, D.C. 20549-7010 Re: Camp Nine, Inc. Registration Statement on Form S-1 File No. 333-184881 Dear Mrs. Block: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Camp Nine, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 to 4:00 PM Eastern Standard Time on March 22, 2013, or as soon thereafter as is practicable. The Company acknowledges the following: 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. Thank you for your assistance. Please call with any questions. CAMP NINE, INC. By: /s/ Michael Garcia Michael Garcia Chief Executive Officer 1065 Kawaiahao St Ste 2207, Honolulu, Hawaii 96814 Phone: (803) 226-7944
2013-03-01 - UPLOAD - RELMADA THERAPEUTICS, INC.
March 1 , 2013
Via E -mail
Michael Garcia
President and Chief Executive Officer
Camp Nine, Inc.
1065 Kawaiahao St. Ste 2207
Honolulu, Hawaii 96814
Re: Camp Nine, Inc .
Amendment No s. 2 and 3 to Registration Statement on Form S-1
Filed February 15 , 2013 and February 26, 2013
File No. 333-184881
Dear Mr. Garcia :
We have reviewed your responses to the comments in our letter dated February 8, 2013
and have the following additional comments.
While we believe that our three surfboard models to date perform well, page 7
1. Please revise to remove the first part of the heading or provide support for your belief.
Also, please provide support for your st atement that you have not received any negative
feedback from your buyers on existing models or revise to remove. Please also indicate
in the revised risk factor that you have only manufactured a limited number of surfboards
so far to date.
Because we ar e currently considered a “shell company”, page 12
2. We note that the revised language of this risk factor as indicated by your letter dated
February 26, 2013 does not reconcile with the revised language on page 12. Please
reinstate the first two sentences of the risk factor as included in the prior amendment, and
as shown in your letter dated February 26, 2013, which attempts to show the risk factor as
it should now read after the most recent changes were made to the disclosure.
Products and Pricing, page 20
3. We note your disclosure that you are currently designing another surfboard called the
Classic. Please expand to discuss any material steps necessary in order for you to begin
offering this surfboard for sale, if applicable. If any additional financin g will be need to
continue to develop this surfboard for sale, also disclose that, if applicable. If any needed
financing for this endeavor is not currently available, please make that clear as well.
Michael Garcia
Camp Nine, Inc.
March 1 , 2013
Page 2
We urge all persons who are responsible for the accur acy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relatin g to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
You may contact Effie Simpson at (202) 551 -3346 or Linda Cvrkel at (202) 551 -3313 if
you have questions regarding comments on the financia l statements and related matters. Please
contact John Stickel at (202) 551 -3324 or me at (202) 551 -3210 with any other questions.
Sincerely,
/s/ Susan Block
Susan Block
Attorney -Advisor
cc: Puoy Premsrirut , Esq.
2013-02-08 - UPLOAD - RELMADA THERAPEUTICS, INC.
February 8, 2013
Via E -mail
Michael Garcia
President and Chief Executive Officer
Camp Nine, Inc.
1065 Kawaiahao St. Ste 2207
Honolulu, Hawaii 96814
Re: Camp Nine, Inc .
Amendment No. 1 to Registration Statement on Form S-1
Filed January 25, 2013
File No. 333-184881
Dear Mr. Garcia :
We have reviewed your responses to the comments in our letter dated December 10, 2012
and have the following additional comments.
Cover Page
1. Please remove the third paragraph, discussing your shell company status, from the cover
page, as this is not responsive to Item 501 of Regulation S -K.
The Company, page 5
2. We note your response to our prior comment 7 and reissue in part. Please rev ise to also
include your revenue and net loss for the most recent audited period in that first
paragraph.
Because we do not have written contracts, page 8
3. Please indicate briefly in this risk factor what services your independent contractors do
for you.
Because we are currently considered a “shell company”, page 12
4. Please also indicate here that you are considered a “shell company” under the meaning of
Rule 405 under the Securities Act of 1933 as well. Similarly revise the last paragraph
under “Rule 14 4 Shares,” at page 23.
Michael Garcia
Camp Nine, Inc.
February 8, 2013
Page 2
5. Please also revise this risk factor to clarify that it is restricted securities that may not be
resold in reliance on Rule 144 until certain requirements are met, similar to the disclosure
you have provided in the last paragraph u nder “Rule 144 Shares,” at page 23.
Products and Pricing, page 20
6. In some of your statements regarding your products, please revise to state them as beliefs,
as the statements appear subjective. Please revise the following statements:
“The Ace I is considered a high performance shortboard. This surfboard is for the
more advanced surfer that excels at catching waves in all conditions.
Performance is the design emphasis for this model. It is a good surfboard for
waves up to 8 -10 feet . . . .”
“The Bandito is considered a medium performance shortboard . . . it is a still a
good surfboard for waves up to 8 -10 feet.”
“The Hot Pocket is considered a fun shortboard. As such this surfboard was
designed with an emphasis on making it easy to catch waves and ride them
without worrying about maneuverability on the wave. It is a good surfboard for
waves up to 6 feet . . . .”
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing i ncludes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
You may contact Effie Simpson at (202) 551 -3346 or Linda Cvrkel at (202) 551 -3313 if
you have questions regarding comments on the financial statements and related matters. Please
contact John Stickel at (202) 551 -3324 or me at (202) 551 -3210 with any other questions.
Sincerely,
/s/ Susan Block
Susan Block
Attorney -Advisor
cc: Puoy Premsrirut , Esq.
2012-12-10 - UPLOAD - RELMADA THERAPEUTICS, INC.
December 10, 201 2
Via E -mail
Michael Garcia
President and Chief Executive Officer
Camp Nine, Inc.
1065 Kawaiahao St. Ste 2207
Honolulu, Hawaii 96814
Re: Camp Nine, Inc .
Registration Statement on Form S-1
Filed November 13, 2012
File No. 333-184881
Dear Mr. Garcia :
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.
General
1. Please supplementally provide u s 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 reta in copies of the communications. Similarly, please
supplementally provide us with any research reports about you that are published or
distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by
Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is
participating or will participate in your offering.
2. It appears from your disclosure that you may be a shell company pursuant to Rule 405 of
the Securities Act. Please revise to disclose your status a s a shell company or explain
why you believe you are not a shell company.
Michael Garcia
Camp Nine, Inc.
December 10 , 201 2
Page 2
3. Please revise throughout to clarify that Mr. Garcia is the sole officer and director. We
note references throughout your filing to y our “officers” and “directors.”
Registration Fee Table, page 1
4. It appears that you are registering a number of shares of your common stock. As such,
please revise to indicate that you are registering under Rule 457(a), rather than Rule
457(o) or advise.
Cover Page of the Prospectus, page 2
5. Since you appear to qualify as an "emerging growth company," as defined in the
Jumpstart Our Business Startups Act, please disclose on your prospectus cover page that
you are an emerging growth company.
6. Please indicate that there currently is no a public market fo r your common stock. Please
also disclose here that you intend to apply through FINRA to the over -the-counter
bulletin board, but that there is no guarantee that your common stock will be accepted for
quotation.
Summary, page 5
7. Please revise to include your revenues and net losses as of the most recent audited period and
interim period, as applicable . In addition, d isclose your monthly "burn rate " and how long
your present capital wil l last at that rate . Please also disclose your current cash balance o n
hand as of the most recent practicable date and update that with any subsequent amendment.
8. We note your disclosure in the last sentence of the first paragraph, indicating that you will
require additional financing. Please quantify the additional fundin g you anticipate you will
need to develop your business plan. To the extent you discuss future business plans in your
filing, please revise to provide timeframes and the material steps needed to accomplish your
goals. To the extent you will need addition al funding, please make that clear, as well. If the
needed financing is currently not available to you, please also make that clear.
Risk Factors, page 6
9. Please revise to add risk factors that discuss the risk that it may not be possible for you to
have adequate internal controls because one person occupies all of the corporate
positions, and the risk that there may not be funds available for net income because the
sole director and officer will determine his salary and perquisites or explain why these
risk factors are not necessary
If we do not obtain additional financing, our business may fail, page 7
10. Please revise the heading to quantify the amount of additional funds you require to
develop your business.
Michael Garcia
Camp Nine, Inc.
December 10 , 201 2
Page 3
If a market for our common stock does not develop, page 10
11. Please revise to clarify that there is no guarantee that your common stock will ever be
quoted on the OTC Bulletin Board.
Use of Proceeds, page 12
12. Accompanying the disclosure regarding use of proceeds, if less than all the shares are
sold, please revise to indicate how many surfboards you anticipate being able to ma ke if
75%, 50% or 25% of the proceeds are raised. Also, provide a timeframe for producing
the surfboards to accompany the different levels of funding raised and timeframes for any
material steps involved in order to produce the surfboards or otherwise develop your
business.
Description of Business, page 19
13. Please revise to state as your belief that you are able to limit your liability by designing,
manufacturing, marketing a nd selling of surfboards in your wholly owned LLC
subsidiary.
14. Please provide support for your beliefs that most surfboards have limited graphics and are
generally blank except for some small decals, or revise to remove these statements.
15. We note your refe rence to data about the surfer population from 2007. If available,
please revise to update your disclosure with more recent and relevant data.
16. We note that you will rely on independent contractors for the production of your
surfboards . Please expand you r disclosure here to discuss the existence or non -existence
of any production or distribution arrangements and file any agr eements with the next
amendment.
17. Please provide support for your belief that local manufacturers of surfboards possess a
high degree of brand loyalty or revise to remove this statement.
Products and Pricing, page 20
18. Please expand upon your description of your various surfboard models. You indicate that
the current description is taken from your website. These descriptions appear to be for
people already familiar with different types of surfboards. As such, please expand upon
your descriptions.
19. We note the prices that are listed here. From your website, it appears that you are
offering some at prices discounted from the original p rices. Please update your
Michael Garcia
Camp Nine, Inc.
December 10 , 201 2
Page 4
disclosure or add disclosure to indicate that you may sell at prices discounted from the se
disclosed prices from time to time or advise.
Employees, page 22
20. Consistent with your disclosure on page 9, please expand your disclosur e here to clarify
that Mr. Garcia devotes 5 to 15 hours per week to your business.
Description of Property, page 22
21. Please briefly describe the property you maintain in Honolulu, Hawaii, and describe the
existence and nature of any lease arrangements.
Plan of Operation, page 25
22. Absent a written guarantee, please revise your disclosure at the bottom of page 27 to
clarify that there is no guarantee that Mr. Garcia will fund your legal and operating
compliances expenses through additional capital infusions . If you have a written
agreement with Mr. Garcia, please file it. If it is a verbal commitment, please indicate
that.
Michael Garcia, page 28
23. Please revise to include a five -year busines s description for Mr. Garcia , including
companies, positions, and stop and start months. Please also disclose the date upon
which Mr. Garcia began to serve you is his respective officer and director positions.
24. Please clarify if Mr. Garcia is employed on a full -time basis with the real estate
development firm, and also clarify that Mr. Garcia devotes 5 to 15 hours per week to your
business.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they ar e responsible for the accuracy
and adequacy of the disclosures they have made.
Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the co mpany
acknowledging 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;
Michael Garcia
Camp Nine, Inc.
December 10 , 201 2
Page 5
the action of the Commission or t he 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 an d 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.
Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement. Please allow
adequate time for us to review any amendment prior to the requested effective date of the
registration statement.
You may contact Effie Simpson at (202) 551 -3346 or Linda Cvrkel at (202) 551 -3313 if
you have questions regarding comments on the financial statements and related matters. Please
contact John Stickel at (202) 551 -3324 or me at (202) 551 -3210 with any o ther questions.
Sincerely,
/s/ Susan Block
Susan Block
Attorney -Advisor
cc: Puoy Premsrirut , Esq.