SecProbe.io

Filing text and metadata
Intelligence Terminal Search Probe Scores Topics IPO Watchlist Monthly Activity About API

SEC Company Response from RELMADA THERAPEUTICS, INC. (RLMD) (CIK 0001553643) (RLMD) — Sep 16, 2014

RELMADA THERAPEUTICS, INC. (RLMD) (CIK 0001553643)
Date: Sept. 16, 2014 · CIK: 0001553643 · Accession: 0001213900-14-006672

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

File numbers found in text: 333-197109

Referenced dates: July 24, 2014

Date
September 15, 2014
Author
Not clearly detected
Form
CORRESP
Company
RELMADA THERAPEUTICS, INC. (RLMD) (CIK 0001553643)

Letter

VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 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.

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.

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.

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.

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

Show Raw Text
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