SecProbe.io

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