CARDIGANT MEDICAL INC
1500 Rosecrans Avenue, Suite 500
Manhattan Beach, CA 90266
November 03, 2011
Jeffrey Riedler
Assistant Director
Securities And Exchange Commission
Washington, DC 20549
Subject: Response to SEC Comment Letter,
File No. 333-176329
Dear Jeffrey,
We have received the SEC's comment letter dated October 11, 2011. We have
reviewed the letter and have the following responses to your questions below.
Please note that we have included your original comments in bold with our
responses below including those filed as part of amendment 3 of our
registration statement in an effort for completeness. Amendment 3 to our
registration statement has been filed with the responses included where
appropriate.
General
1. Please note that where we provide examples to illustrate what we mean by
our comments, they are examples and not complete lists. If our comments are
applicable to portions of the filing that we have not cited as examples,
please make the appropriate changes in accordance with our comments.
Understood.
2. We note on your cover page and throughout your filing that you expect to
receive proceeds of $2,500,000. Since this is a self-underwritten, non-firm
commitment offering, it is not appropriate to expect to receive any amount of
proceeds. Please delete this disclosure and the disclosure about the use of
proceeds on the prospectus cover page. Instead, please revise your disclosure
to add language to the cover page
indicating, if true, that there is no minimum amount of proceeds that must be
raised prior to accepting purchases.
Deleted and added the following disclosure, "This prospectus relates to the
sale of up to 2,500,000 shares of our common stock, $0.001 par value per share
which consists of 300,000 shares offered by our selling security holders and
2,200,000 shares offered by the company. The shares offered by the selling
security holders may be offered for sale from time to time by the selling
security holders identified in this prospectus. We will not receive any
proceeds from stock sold by the selling shareholders. There is currently
no market for our shares, therefore, the selling shareholders will have to
sell their shares at a fixed price of $1.05 per share until such time as a
market develops, if one develops at all. This is being conducted on a best
efforts basis by the company. We have not utilized an underwriter for this
transaction, as such, it is unlikely that we will be able to sell all or any
of the shares we are offering. Our company management will be responsible for
the sale of our shares and will not be compensated for any sales that may
arise."
Prospectus Cover Page
3. Please disclose the price at which the shares will be sold by the company
on the cover
page of the prospectus. Please note that since there is no market for the
shares, the selling shareholders also need to offer their shares at a fixed
price until such time as a market for the shares develops, and such price
should be stated on the prospectus cover page. In addition, please revise the
second paragraph under the section entitled "Selling Shareholder and Plan of
Distribution" to disclose that the shares will be sold at a fixed price,
naming that price and that only after a market develops will the shares be
sold in negotiated transactions, etc.
Changes made in amendment no. 3 and included in language per comment 2.
4. Please state on the cover page of the prospectus which individuals will
sell the shares on behalf of the company and whether they will receive any
compensation for the sale of company shares. Please note that we may have
further comments on your revised disclosure.
Changes made in amendment no. 3 and included in language per comment 2.
5. Please limit your prospectus cover page to one page. Please note that it
should only
include the most important facts about the offering.
Done.
6. We note that your prospectus cover page includes two boldface paragraphs
that contain references to the risk factors. Please revise the prospectus
cover page to
combine these paragraphs into one paragraph that still includes a reference to
the page where the risk factors begin.
Changes made in filed amendment 3.
Prospectus Summary
Description of Business & Overview, page 4
7. Please include disclosure in this section stating that Dr. Kyun-Hyun Cho of
Yeungnam University is the inventor of your lead product CM-121, and that you
currently have one licensing agreement with Yeungnam University covering the
license of CM-121.
Updated in amendment no. 3. The following language was added, "We entered into
an Option and License Agreement with Yeungnam University to acquire the rights
to continue development of our lead compound. This work was conducted by the
inventor Dr. Kyung-hyun Cho from Yeungnam University."
Apoa-1 Overview, page 6
8. We note your disclosure that it has been shown that the Apoa-1 protein has
strong anti-oxidant properties as well. Please disclose when, where and by
whom this effect has been observed. Also, if this effect has been observed in
vitro or in animal testing, please state that there is no guarantee that the
implied therapeutic benefits will be demonstrated after completion of the
necessary and extensive clinical testing of human subjects.
The following language was added, "The potentially superior anti-oxidation
properties of our mutation of Apoa-1 versus the wild type have been
demonstrated in several papers published by Dr. Cho in both in vitro and small
animal models. While these studies showed positive proof of concept data,
there is no guarantee that these results will be realized in larger animal
studies or in human studies. For additional reference, the following two
published papers present some of the proof of concept data: Kyung-Hyun Cho and
Jae-Ryong Kim A reconstituted HDL containing V156K or R173C apoA-I exhibited
anti-inflammatory activity in apo-E deficient mice and showed resistance to
myeloperoxidase-mediated oxidation Exp Mol Med. 2009 June 30; 41(6): 417-428
and K. H. Cho, S. H. Park, J. M. Han, H. C. Kim, Y. K. Choi, I. Choi ApoA-I
mutants V156K and R173C promote anti-inflammatory function and antioxidant
activities, European Journal of Clinical Investigation, Volume 36, Issue 12,
pages 875-882, December 2006."
Secondary Product Candidates, page 7
9. Please revise your disclosure to explain what constitutes a "first-in-man
(FIM) environment."
The following language was added, "A FIM study constitutes the first time any
product is used in human subjects in any region of the world. These trials
typically are smaller than 50 patients and focus on safety as a primary study
endpoint versus effectiveness of a therapy. They typically however, will have
secondary endpoints that may provide some glimpse of effectiveness."
10. Please describe the difference between a "systemic delivery route" versus
"local delivery" and clarify which of these your proprietary delivery
catheters utilize. The following language was added, "The systemic route of
delivery is typically given intravenously and is so named as it will travel to
all vascularized tissues in the body." We believe this provides the most
direct regulatory path to establish a safety and efficacy profile of our drug.
However, we have also designed and developed delivery technology and conducted
animal studies on the effectiveness of targeted local delivery of CMI-121 and
other Apoa-1 formulations utilizing two of our proprietary delivery devices.
"Targeted local delivery consists of delivery a therapeutic as close to the
treatment area as is possible with an attempt to administer a lower dose and
realize only local tissue effects."
Our Business Strategy, page 7
11. Please clarify what you mean by the acronyms "GLP" and "GMP."
Acronyms explained in amendment no. 3. The following language was added, "We
currently have a small lab space where we conduct in vitro experiments and
produce products for our pre-clinical studies, however, this lab space is not
sufficient to produce clinical grade CMI-121 or material that can be used for
US FDA toxicology studies. The US FDA requires that material created for the
purpose of conducting animal studies designed to establish the safety of a
therapeutic must be produced under the standards known as Good Laboratory
Practices "GLP". This requires a comprehensive set of documented procedures
and validated test methods. Our laboratory is not considered a GLP facility.
There are several contract labs that are certified as GLP labs that we can
contract with to produce our materials. We do not currently have any
contractual commitments with any lab to perform this work, but are currently
initiating discussions with some labs to establish this relationship. We
currently outsource our in vivo studies to contract research organizations and
plan to continue outsourcing most of our in vivo work. We make decisions on
which contract research organization to contract with on a study by study
basis taking into account factors such as lead time, particular experience
with an animal model and cost among other factors. Additionally we need to
establish production for CMI-121 conducted within FDA regulated facilities
operating under Good Manufacturing Practices "GMP". GMP consists of a set of
documented processes and procedures where products are manufactured under
highly controlled and traceable environments. We plan to contract for this
work. We believe this allows us to better control costs and manage the risk
associated with a changing regulatory environment. We have basic processes
covering the manufacture of CMI-121 in pilot scale quantities and will likely
need to spend considerable efforts scaling up this process and transferring
it to a 3rd party contract manufacturer. We currently procure our material
from a few different non GMP contract manufacturers based on lead times and
cost but will still need to spend time identifying a suitable GMP
manufacturer. GMP material is not required for all animal studies, but is
required for any human studies. We do not currently have any contractual
arrangements with any GMP manufacturer for any of our products."
12. Please specify in this section and in the section entitled "Description
of Our Business" under the appropriate subsections to whom you outsource your
in vivo studies and with which contract manufacturer you work to produce
clinical grade CM-121(we note on page 31 under the section entitled
"Manufacturing" that your biologic supplier is currently located in China).
Also, please clarify whether you currently have a manufacturing agreement
with this manufacturer. If you do, please provide the material terms of this
agreement in your "Business" section, including, but not limited to any
payment provisions, material obligations that must be met to keep the
agreement in place, duration and termination provisions. In addition, please
file the agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S-K.
Discussion and clarification added in amendment no 3 and addressed in language
per comment 11.
Risks Related to Our Business, page 8
13. Please revise your disclosure to separate each risk into its own bullet
point. For example, under your first bullet point, please separate the
statements "We are currently understaffed. While we are recruiting for key
technical positions, we may be unable to fill these positions or retain the
talent and relationships we currently have" into their own bullet point as
they are a separate risk unrelated to your limited operating history. Also,
please move the last sentence under the first bullet point to the second
bullet point as this statement relates to your current lack of capitalization.
Risks updated as advised in amendment no. 3. Additional language added as
follows, "There is no minimum amount of shares that are required to be sold
by the company. This means that while the company may sell some shares, it may
not receive adequate funds to execute its business plan or continue its
operations. This is a self underwritten deal conducted on a best efforts
basis. This means that there has not been and will not be any independent
underwriters due diligence conducted on the company, its management, its
business plan, the market in which it hopes to operate in, the pricing of the
offering or confirmation of the accuracy of disclosures contained herein.
The company's Chief Executive Officer also fills the role of Chief Financial
Officer, Chief Accounting Officer and sole corporate director. This prohibits
any segregation of duties and creates potential conflicts of interests that
normally would be managed by individuals filling those positions uniquely."
Use of Proceeds, page 10
14. Please expand the "Use of Proceeds" section to provide a table with rows
for the various uses of proceeds and columns for various levels of sales (for
example, 25%, 50%, 75% and 100% of the total number of shares offered). Please
also disclose the amount of proceeds you think you will need to use before
you can get to the stage of filing an IND to begin clinical testing.
The following table was added:
Estimated Use of Proceeds
Net Cash Received R&D Expenses SG&A Expenses Balance(Deficit)
at 18 months
100% of Proceeds $2,039,500 $700,000 $500,000 $839,500
75% of Proceeds $1,524,300 $700,000 $500,000 $324,300
50% of Proceeds $1,008,000 $425,000 $375,000 $208,000
25% of Proceeds $493,000 $150,000 $375,000 ($32,000)
<FN>
<F1>
SG&A includes some employee related R&D costs
</FN>
Risk Factors, page 11
15. Please provide more extensive disclosure as a separate risk factor
regarding the lack of a minimum amount of shares to be purchased. In doing so,
please explain that a purchaser may purchase shares but the company may not
receive any other substantial amount of proceeds; thus leaving the company
unable to engage in the activities they hope to be able to engage in or the
costs they expect to be able to pay from the offering proceeds.
Additional disclosure and risk factors added in amendment no.3. Language
added per comment 13 above.
16. Please include a risk factor describing the risks related to the fact that
there is no underwriter and therefore no underwriter's due diligence has been
performed. You should explain that the underwriter's due diligence involves
confirming the accuracy of the prospectus disclosure and assisting the
company in pricing the offering. Risk factor added in amendment no. 3. The
following language was added, "This is a self underwritten deal conducted on a
best efforts basis. This means that there has not been and will not be any
independent underwriters due diligence conducted on the company, its
management, its business plan, the market in which it hopes to operate in,
the pricing of the offering or confirmation of the accuracy of disclosures
contained herein."
17. Please include a risk factor discussing the potential conflict of
interests as a result of the majority shareholder being the sole director of
the company as well as the CEO, CFO and CAO.
Risk factor added in amendment no. 3. The following language was added, "The
company's Chief Executive Officer also fills the role of Chief Financial
Officer, Chief Accounting Officer and sole corporate director. This prohibits
any segregation of duties and creates potential conflicts of interests that
normally would be managed by individuals filling those positions uniquely."
We will need substantial additional funding, page 12
18. We note that your future capital requirements will depend on many factors.
To the extent practicable, please estimate the amount of funds you will need
to reach a point where you can file an IND and begin clinical testing.
The following language was added, "We anticipate that it will cost us
$1,335,000 to get us to be in a position to file for an IND with a regulatory
body. While this is subject to change, it is estimated at $625 thousand of
employee and facility related costs, $385 thousand for contract formulation
development and GMP scale biologic production for conducting pre-clinical
safety studies and $325 thousand for conducting pre-clinical efficacy
development studies including dosing concentration and repeat administration
optimization."
19. To the extent that you have experienced problems attracting and retaining
key members of your management team personnel in the recent past, please
revise your disclosure to describe these problems. Additionally, if any member
of your management team has plans to leave your company in the near future,
please revise the discussion to disclose this information.
We have not had any difficulty and we are not are of any intentions to leave,
but have added affirmative statements for both in amendment no. 3.
We face substantial competition from better capitalized, managed and
experience, page 16
20. Please revise your disclosure to include the names of the other companies
from which you face substantial competition.
Companies added that we are aware of based on the following language,
"Currently there are four other companies that we are aware of working on
HDL based biologics to treat acute coronary syndromes. These include the
Medicines Company, Cerenis Therapeutics, CSL Limited and Sembiosys Genetics."
If we are unable to defend our patent position, others could directly compete,
page 18
21. To the extent you have initiated any actions related to possible
infringement of your intellectual property, please discuss the situation and
potential consequences in this risk factor discussion. Similarly revise "If we
infringe or are alleged to infringe intellectual property rights of third
parties" and "We may be brought into a lawsuit to defend our intellectual
property or that of third party collaborators" if you have received notice of
patent infringement, patent challenges or related legal action. We are not
currently a party to any ongoing or pending litigation nor have we
contemplated any action, but have added affirmative disclosures stating such.
If we fail to comply with our obligations in our patent license agreements,
page 18
22. Please revise your disclosure to briefly disclose your financial and
performance obligations in order not to be in breach of the licensing
agreeing with Yeungnam
University. Material financial and performance terms added and agreement
filed. The following language was added, "Our licensing agreement subjects us
to both milestone and royalty obligations that are tied to the
commercialization of CMI-121 in the US only. Within the first 60 days of a
commercial sale in the US, we are required to pay a milestone fee to Yeugnam
University in the sum of $200,000. Upon US commercialization, we are subject
to a 3% royalty payable in quarterly installments to Yeugnam University based
on average selling prices of our product in the US. We are not required to
make any milestone or royalty payments on any sales generated outside of the
US. The royalty obligation continues for the life of the patent in the US
which is expected to continue through 2024 (not including any Hatch-Waxman
extensions). We are not subject to any other performance or monetary
obligations relating to our license and development of CMI-121."
Risks Related to the Purchase of Our Common Stock, page 20
23. Please include a risk factor in this section discussing the risks
associated with your stock being a "penny stock."
Language added as follows, "There are Penny Stock Securities' law
considerations that could affect your ability to sell your shares.
Our common stock is considered a "penny stock" and the sale of our stock will
be subject to the "penny stock rules" of the Securities and Exchange
Commission. The penny stock rules require broker-dealers to take steps before
making any penny stock trades in customer accounts. As a result, the market
for our shares could be illiquid and there could be delays in the trading of
our stock which could negatively affect your ability to sell your shares and
could negatively affect the trading price of your shares."
Determination of Offering Price, page 21
24. Please expand your disclosure in this section to provide the financial and
market factors you considered. If the price truly bears no relation at all to
the company's prospects, you should state that the offering price is arbitrary
and bears no relation to the company's assets, stage of development or
prospects for profitability.
Explanation for setting of offering price language added as follows, "The
offering price has been estimated solely for the purpose of calculating the
registration fee payable to the Securities and Exchange Commission in
connection with this prospectus. The offering price is not an indication of
value nor has it been established by any recognized methodology for deriving
the value of the Shares. As such it should be considered arbitrary with no
correlation to the company's assets, stage of development or future prospects
for cash flow or profitability."
Selling Shareholders and Plan of Distribution, page 22
25. To the extent that Mr. Creed or any other selling shareholders will also
sell shares on behalf of the company, please revise your disclosure to state
what protocol these individuals will use to determine whether the shares they
sell will be their shares or company shares.
Protocol disclosure added for clarity as follows, "This is a self underwritten
offering conducted on a best efforts basis with no minimum share purchases
required for the sale of our stock. The reader is cautioned that this scenario
means that while some shares may be sold by us or the selling shareholders, it
may constitute a small amount of shares rendering us with insufficient funds
to conduct our operations or fully execute our business plan. Additionally,
since this is a self underwritten offering, our management will be responsible
for any shares sold. This creates a potential conflict of interest as our
management may also be shareholders. It is important to understand the
framework for determining whether shares sold by our management will be
shares owned by the individual responsible for the sale or shares owned by
the company. The protocol that will be followed for this offering is that any
shares sold by any member of our management will be shares owned by us. This
means that all proceeds from shares sold by any member of our management will
be received by us. For purposes of additional disclosure, our management for
this purpose is defined as Jerett Creed, Ralph Sinibaldi and Emerson Perin."
Dilution, page 24
26. Please explain to us why you have not included the information required by
Item 506 of Regulation S-K in the filing. Item 506 requires the following
disclosures, preferably in a tabular form: (a) The net tangible book value per
share before and after the transaction; (b) The amount of the increase in such
net tangible book value per share attributable to the cash payments made by
purchasers of the shares being offered; and (c) The amount of the immediate
dilution from the public offering price which will be absorbed by such
purchasers. Please revise your disclosures accordingly.
Table added along with the following language, "The following table represents
our estimated net tangible book value on a per share basis (basic). The net
tangible book value was estimated after adjustments for accounts receivables;
property, plant and equipment; elimination of any intangible assets and
inclusion of any liabilities not included on the balance sheet. The net
tangible book value per share (post transaction) assumes that all offered
shares are sold. For comparison, the net tangible book value is also shown
reflecting 50% and 25% of shares being sold."
Net Tangible Book Value
Basic Shares Net Tangible Net Tangible Book Value
Book Value per basic share outstanding
BALANCE June 30, 2011 11,185,900 $125,200 $0.011
BALANCE September 30, 2011 (estimated) 11,220,900 $87,900 $0.008
BALANCE Post Closing (estimated - 100%) 13,220,900 $2,120,000 $0.160
BALANCE Post Closing (estimated - 50%) 13,220,900 $1,070,000 $0.081
BALANCE Post Closing (estimated - 25%) 13,220,900 $545,000 $0.041
Management's Discussion and Analysis of Financial Condition and Results of
Operations,
page 24
27. Please remove references to pre-Codification accounting literature
designations such as SFAS No. 148 or SFAS 123R, SFAS 144, SFAS 109 from this
section and from other sections in the filing including the financial
statements.
References removed.
Research and Development Expenses, page 25
28. You disclose that you are focused on the use of biologics and combination
biologics and devices for the treatment of acute coronary syndromes and aortic
valve stenosis. You expect this goal to be supported by substantial research
and development investments; on page F-6 you state that you are engaged in
research and development activities in multiple countries. Please provide
quantitative and qualitative disclosure about the amount of costs, both
internal and external, incurred during each period presented and incurred to
date on each of your major research and development projects. To the extent
that you cannot attribute costs to a project, please explain why management
does not maintain and evaluate those costs by project. The following language
was added, "Our research and development expenses primarily consist of
fees. As our senior management are largely involved with overseeing our
current development programs, we currently allocate 80% of their salary
(accrued or otherwise) to R&D expense. This is a change from 2009 where we
allocated 60% of their salary to R&D. We expect to hire additional technical
personnel, engage in additional pre-clinical studies and incur additional
patent fees. As such we expect our R&D spending to increase in the coming
periods. Although we have multiple potential development programs, we are
currently only working on one program. This program is focused on optimizing
our biologic compound for systemic delivery in the treatment of acute coronary
syndromes. However, since it is likely that we will use the same biologic
compound for both systemic and local delivery, it is expected that a
substantial portion of the work we are incurring for this development program
will translate to other methods of delivery and as well as potentially disease
states. Assuming we are able to raise sufficient funds, we expect to incur an
additional $1.2 million over the next 18 months in execution of our
pre-clinical and clinical development programs. We believe this will take us
through the required approval to begin a phase I trial in the US. This number
is composed of the following estimates: $500 thousand of employee related R&D
costs; $385 thousand of formulation development, protein process development,
and GMP production; and $325 thousand of additional pre-clinical development
studies including standard toxicology studies. Since this is highly dependent
on the availability of funds, it may be important to understand the order and
amount of spending in the event that funds are received piecemeal. In the
event that insufficient funds are available to complete all of the outlined
work, we would initially focus on the formulation development of the final
drug dosage. This is estimated to cost approximately $150 thousand, we would
then expect to begin additional pre-clinical studies using this final drug
dosage conducted as non-GLP studies confirming the efficacy of our final drug
dosage. This is estimated to cost approximately $125 thousand. Next we would
finalize contract based small scale GMP production of our protein required to
conduct our toxicology studies. This is estimated at $175 thousand. Finally we
would perform our GLP toxicology studies estimated at $200 thousand. We expect
the culmination of this work to allow us to submit all required evidence to
initiate a phase I trial in the US or other region of the world."
29. In addition, we believe that including disclosures about estimated future
expenses related to your major research and development projects in the MD&A
would be useful for investors. Please refer to the Division of Corporation
Finance "Current Issues and Rulemaking Projects Quarterly Update" under
section VIII - Industry Specific Issues - Accounting and Disclosure by
Companies Engaged in Research and Development Activities. You can find it at
the following website address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm. Please revise your
disclosures as applicable. To the extent that information requested above is
not estimable, disclose that fact and the reason why it is not estimable.
Estimates added per language above.
Revenue Recognition, page 25
30. Please disclose your accounting policy for recognizing grant revenues.
Please also tell us why you have classified the grant received as revenue as
opposed to other income. Disclose the significant terms of your N.I.H. grant.
Grant terms added per the following language, "This grant was awarded under
the Qualifying Therapeutic Discovery Project Program. There were no specific
performance obligations under the grant as it was awarded based on previous
research and development expenses incurred.". Grant revenue reclassified as
"Other Income"
Liquidity and Capital Resources, page 28
31. Please revise your disclosure to include information as of the end of the
latest fiscal period and cumulative from inception in addition to discussing
the latest six months ended June 30, 2011.
Updated per the following language, "Sources of Liquidity
During the six months ended June 30, 2011, net cash provided by operating
activities totaled $78,473. Net cash used in investing activities totaled
$100,000 which was put into a certificate of deposit with a 4.8 year maturity
date. Net cash used in financing activities during the six months was $8,651
of which $1,500 was from proceeds from issuance of common stock and this was
netted against $3,863 that was advanced by a stockholder. The resulting change
in cash for the period was a decrease of $30,178. The cash balance at the
beginning of the six months was $57,831. The cash balance at the end of the
period ending June 30, 2011 totaled $27,653.
For the six month period ended June 30, 2010, net cash used in operating
activities totaled $38,633. Financing activities provided a total of $27,546
which included $12,000 in proceeds from issuance of common stock, plus $15,546
in advances from a stockholder. The resulting change in cash for the period
was a decrease of $11,087; cash at the beginning of the period totaled $11,308,
the decrease resulted in $221 in cash at the end of the period ending June 30,
2010.
The Company had cash of $27,653 as of June 30, 2011, as compared to $221 as of
June 30, 2010. As of June 30, 2011, the Company had prepaid assets of $8,529
as compared to $1,900 as of June 30, 2010. The Company also has $1,195 in
security deposits as of June 30, 2011 and had $0 of security deposits as of
June 30, 2010. The Company had long-term assets at June 30, 2011 of $100,000
in a certificate of deposit account; therefore the Company had total assets
of $137,377. This is in comparison to June 30, 2010, where the Company had
no long-term assets and total assets of $2,121.
As of June 30, 2011, the Company had $350,910 in total current liabilities,
which was represented by $6,382 in accounts payable, $270,000 in accrued
officer compensation, $20,796 in accrued payroll taxes on the officer
compensation, and $53,732 due to a stockholder. This is in comparison to
June 30, 2010, where the Company had $176,938 in total current liabilities,
which was represented by $23,821 in accounts payable, $93,787 in accrued
officer compensation, $7,960 in accrued payroll taxes on the officer
compensation, and $51,370 due to a stockholder.
The Company had no long-term liabilities at June 30, 2011; therefore the
Company had total liabilities of $350,910. This is in comparison to June 30,
2010, where the Company had no long-term liabilities and total liabilities
of $176,938.
During the year ended December 31, 2010, net cash used in operating activities
totaled $9,189. Net cash provided by financing activities during the year was
$55,712 of which $27,650 was from proceeds from issuance of common stock plus
$42,131 was advances from related parties which were netted against $14,069
that was repayments to related parties. The resulting change in cash for the
period was an increase of $46,523. The cash balance at the beginning of the
year was $11,308. The cash balance at the end of the year totaled $57,831.
For the year ended December 31, 2009, net cash used in operating activities
totaled $74,516. Financing activities provided a total of $85,824, which
included $2 in proceeds from issuance of common stock, plus $91,525 advances
from related parties, less $5,703 in payments to related parties. The resulting
change in cash for the period was an increase of $11,308. There was no cash
at the beginning of the year. The cash balance at the end of the year was
$11,308.
The Company had cash of $57,831 as of December 31, 2010, as compared to
$11,308 as of December 31, 2009. As of December 31, 2010 the Company had
prepaid assets of $1,900, as compared to having no prepaid assets as of
December 31, 2009. The Company had total assets of $59,731 as of December 31,
2010. This is in comparison to $11,308 in total assets as of December 31,
2009.
As of December 31, 2010, the Company had $289,726 in total current liabilities,
which was represented by $15,842 in accounts payable, $210,000 in accrued
officer compensation, and $63,884 due to a stockholder. This is in comparison
to December 31, 2009, where the Company had $189,480 in total current
liabilities, which was represented by $14,219 in accounts payable, $90,000 in
accrued officer compensation, and $85,261 due to a stockholder.
The Company had no long-term liabilities as of December 31, 2010; therefore the
Company had total liabilities of $289,726. This is in comparison to December
31, 2009, where the Company had no long-term liabilities and total liabilities
of $189,480.
From inception (April 17, 2009) to June 30, 2011, net cash used in operating
activities totaled $5,232. Net cash used in investing activities totaled
$100,000 which was put into a certificate of deposit with a 4.8 year maturity
date. Net cash provided by financing activities since inception to June 30,
2011 was $132,885 of which $29,152 was from proceeds from issuance of common
stock plus $137,519 advances from related parties which was netted against
$33,786 of payments to related parties. The resulting change in cash for the
period was an increase of $27,653. There was no cash balance at inception. The
cash balance on June 30, 2011 totaled $27,653.
The Company is not aware of any known trends, events or uncertainties which may
affect its future liquidity.
We are development stage and do not have a product commercially available for
sale. We do not expect to realize any revenue for several years. As such it is
imperative that the reader recognize that our primary source of working capital
will generally come from equity sales. We do, however, occasionally apply for
non-taxable grant funding to support our research and development efforts. We
currently have grant applications outstanding, however, we can make no
guarantees that any grant money will be awarded from these applications. Our
business is subject to risks inherent in the establishment of a new business
enterprise, including limited capital resources and possible cost overruns.
Quarterly Events, page 29
32. We note that on April 1, 2011, you entered into a consulting agreement
with your
Chief Medical Officer for the period of approximately 21 months ending
December
2011. It is impossible for a 21 month agreement entered into in April 2011 to
end on December 2011. Please revise your disclosure accordingly or provide an
explanation for this discrepancy.
Should have read through 2012. Updated.
Stock Option Plan, page 32
33. Please file your 2010 Stock Option Plan as an exhibit.
Filed.
Our Business Strategy, page 33
34. We note that you have tested CM-121 and your combined delivery method in
"various pre-clinical experiments." Please clarify and describe what you mean
by "various pre-clinical experiments."
The following language was added, "These pre-clinical experiments have
consisted of both normal and diseased animal models evaluating various safety
and performance criteria of our research studies. To date we have conducted
pre-clinical experiments in mice, rabbits and pigs. In each experiment we
attempted to evaluate various performance characteristics in an effort to
optimize the compound and evaluate its relative safety and effectiveness over
a control or known standard."
Scientific Background of Apoa-1, page 34
35. We note that you have secured exclusive U.S. rights and cooperation from
the inventor of CM-121, Dr. Kyun-Hyun Cho of Yeungnam University. Please
clarify in this section that you have entered in a license agreement with
Yeungnam University to license your lead product CM-121. In addition, please
describe the material terms of the license agreement, including, but not
limited to any payment provisions, royalty rates, aggregate milestones, usage
restrictions, exclusivity provisions, obligations/rights to defend, other
rights obtained and material obligations that must be met to keep the
agreement in place, duration and termination provisions. Also, please file the
agreement as an exhibit pursuant to Item 601(b)(10)(ii)(B) of Regulation S-K.
Material terms provided per comment 22 above and agreement filed.
Market Opportunity for CM-121, page 35
36. Please provide the basis for your statement, "There is no question that
the market(s) that CM-121 is attempting to address represent markets in excess
of a billion dollars," or alternatively, delete this statement from your
disclosure.
Statement removed.
Intellectual Property, page 35
37. Please revise your disclosure to include when patent number
US2005287636(A1)
expires.
The following language was added, "It is anticipated that this patent will
expire in 2024 not including any potential extensions based on the Hatch-Waxman
Act."
38. Please revise your disclosure to include the jurisdictions in which you
have filed patent applications for your delivery method.
The following language was added, "We have filed three provisional applications
related to the delivery method that we have pre-clinically evaluated. There is
no guarantee that we will file a patent application within the required one
year time frame. Additionally there is no guarantee that an actual patent will
be issued. The provisional application process provides a recorded date of file
for the US market. It also allows for priority to be claimed internationally
if a patent application is filed within the US within the one year timeframe."
Related Party Transactions, page 36
39. Please disclose your outstanding balance with Mr. Creed as of the latest
practicable date. Also, please clarify whether these loan agreements are in
writing, and if so, file them as exhibits.
Loan provisions are included in Employment Agreement which has been filed with
the latest amendment and balance added.
U.S. Government Regulation and Combination Products, page 36
40. Please expand your disclosure in both of these sections to discuss in
greater detail the
steps involved in obtaining FDA approval for the commercial sale of biological
and combination products, respectively.
The following language was added, "The process for FDA approval for a drug or
biologic in the US can be a costly and lengthy process. In general it is
divided into four phases of development. These include the pre-clinical phase,
phase I, phase II and phase III. During the pre-clinical phase all studies are
designed in animals to establish the correct dosage level, the frequency and
method of administration and the short and long term survival of the animals.
During phase I, a small scale human study is initiated usually in healthy
human subjects looking at how well the drug is tolerated, how it is processed
by the human body, and the correct dosing. During phase II, it is then tested
for effectiveness for its intended disease treatment in a small number of
patients, usually between 100-300. During phase III, a large scale study is
performed on the effectiveness and side effects of the drug in a larger
population. This can be between 350 up to several thousand patients. The FDA
will look at the Phase III data to determine if the drug is safe and effective
for its intended treatment. "
"As described above, the process for FDA approval of a drug or biologic can be
lengthy and expensive. The general process for approval of a combination
product is fairly similar to that of a stand alone drug. All of the required
phases for a stand alone drug are also required for a combination device. The
main difference is that the safety and effectiveness os typically measured
locally which requires studies and outcomes measurements that emphasize the
local effects. For example in establishing the safety profile of a systemically
administered drug, you would be concerned with exposure in all major organs,
whereas a locally delivered drug administered via a combination product would
focus more on local tissue effects."
Employees, page 37
41. We note that as of June 30, 2011, you had one employee. Please specify the
name of that employee. If you have entered into an employment agreement with
the employee, please disclose the material terms of that agreement and file it
as an exhibit.
Added and filed.
42. We note under the section entitled "Quarterly Events" on page 26 that on
April 1, 2011, you entered into a consulting agreement with your Chief Medical
Officer for the period of approximately 21 months. Please include this
information in this section and specify that your Chief Medical Officer's name
is Emerson C. Perin and file the consulting agreement as an exhibit. Also, if
you have entered into a consulting agreement with you Chief Scientific Officer,
Ralph Sinibaldi, please include the material terms of that agreement in this
section as well and the file the agreement as an exhibit.
Disclosure added and both agreements filed. The following language was also
added, "Our CMO is being compensated solely in equity. A total of 30,000 shares
over a 21 month period will be paid representing compensation in the amount of
$6,000. This arrangement may be augmented with an hourly fee as we move closer
to filing for an IND. If this happens, we anticipate offering a similar
compensation structure as our CSO which would include a $200 per hour rate paid
50% in equity based on the fair market value of the shares at the time and 50%
in cash."
Directors and Executive Officers, page 38
43. Please revise your disclosure to state the ages of your directors and
executive officers
and the period of time which they have served in those capacities.
Added.
Executive Compensation, page 39
44. We note that your CEO and CFO (currently served by Jerett A. Creed) is
accruing a cash salary of $120,000 per year and your CSO and CMO are
compensated on an hourly basis for time served paid as a mixture of cash and
stock. We also note that your CSO is currently compensated at the rate of
$100/hr plus the equivalent of $100/hr of compensation paid in equity priced
at $0.20 per share. Please revise your disclosure to include the compensation
amount of your CMO.
Updated and language added per comment 40 above.
45. Please revise your disclosure to include the required summary compensation
table
pursuant to Item 402(n) of Regulation S-K.
Table added as below.
Summary Compensation Table
Name & Principle Position Fiscal Year Base Compensation Total Annual
Structure Bonus Stock Options Compensation
Jerett A. Creed; CEO, CFO, CAO, Director 2011 $120,000 $0 $0 $120,000
Ralph M. Sinibaldi, PhD; CSO 2011 $200/ hour $0 $0 Hourly
Emerson C. Perin, MD, PhD; CMO 2011 15,000 shares $0 $0 $3,000
(valued at $0.20 /sh)
Disclosure Controls and Procedures, page 40
46. We note your disclosure that your disclosure controls and procedures are
effective. However, we also note your disclosure that given that the company
has a limited accounting department, segregation of duties cannot be
completely accomplished at this stage of the business cycle. Given this
disclosure and the fact that your CEO, CFO and CAO are the same person, an
inability to segregate duties would render your disclosure controls and
procedures ineffective. Please explain this apparent discrepancy or how you
determined that your disclosure controls and procedures are effective.
Otherwise, please revise your disclosure to state that your disclosure
controls and procedures are not effective.
Disclosures revised per the following language, "As stated previously, our
Chief Financial Officer is also serving in the capacity of Chief Executive
Officer, Chief Accounting Officer and the company's sole director. Because of
these multiple roles, it is impossible to fully segregate duties. As such he
has concluded that our disclosure controls and procedures are ineffective."
Audited Financial Statements
Report of Independent registered Accounting Firm, page F-1
47. Please ask your auditor to revise the wording of its report to state, if
true that it has audited your financial statements as of December 31, 2010 and
2009 and for the period from inception (April 17, 2009) to December 31, 2010.
Language changed.
Statements of Cash Flows, page F-5
48. We note that you included the advancements from related net of repayments
within the financing activities. Please revise the presentation to present
these amounts on a gross basis or explain the basis for your presentation.
Presentation changed.
Notes to Financial Statements
(2) Summary of Significant Accounting Policies
Revenue recognition, page F-6
49. Please disclose your accounting policy for recognizing grant revenues.
As noted elsewhere, it has also been reclassed as "Other Income". The following
language has been added, "Revenue from grant awards are recorded as income
when the funds from the respective grant is received and all conditions under
the grant have been met."
Shareholder's Equity, page F-8
50. In order for us to fully understand the equity fair market valuations
reflected in your financial statements please provide an itemized chronological
schedule here and in the MD&A covering all equity instruments issued since
inception through the date of your response. Please provide the following
information separately for each equity issuance:
The date of the transaction, The number of equity instruments granted or
shares issued, The exercise price of equity instruments granted if any,
Management's estimated fair market value per share and how the estimate was
Developed
The identity of the recipient, indicating if the recipient was a related party,
The nature and terms of concurrent transactions; and,
The amount of any compensation or interest expense element.
The following table has been added in the MD&A:
Equity Schedule
1/3/2010 Change of authorized capital to 15,000,000 shares / restated par value of $0.001
Common Shares Paid-in
---------------- Capital
Shares Amount (Deficit) Related Party (Y/N)
------- -------- ---------- -------------
4/9/2009 Shares issued to president/founder at inception 1,500 1.50 298.50 Yes
------- -------- ---------- -------------
Balance at December 31, 2009, retroactively restated 1,500 1.50 298.50
1/4/2010 Cancellation of $50k in shareholder loan bal converted
to equity 11,000,000 11,000.00 39,000.00 Yes
3/1/2010 Equity per subscription agreement $0.20/share 70,000 70.00 13,930.00 No
6/30/2010 R. Sinbaldi payment of svc's with stock per agreement 5,000 5.00 995.00 Yes
7/29/2010 Equity per subscription agreement $0.20/share 25,000 25.00 4,975.00 No
7/31/2010 R. Sinbaldi payment of svc's with stock per agreement 2,500 2.50 497.50 Yes
9/9/2010 Equity per subscription agreement $0.20/share 43,250 43.25 8,606.75 No
12/31/2010 R. Sinbaldi payment of svc's with stock per agreement 2,500 2.50 497.50 Yes
Adjustment (298.50)
---------- --------- ----------
BALANCE December 31, 2010, as restated 11,149,750 11,149.75 68,501.75
---------- --------- ----------
1/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 1,500.00 1.5 298.50 Yes
2/28/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,000.00 2 398.00 Yes
---------- --------- ----------
BALANCE March 31, 2011, as restated 11,153,250 11,153.25 69,198.25
---------- --------- ----------
4/1/2011 Dr. Perin MD 15,000 shares for consulting 15,000.00 15.00 2,985.00 Yes
4/11/2011 Shares issued for cash at $0.20/share 7,500.00 7.50 1,492.50 No
4/30/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500.00 2.50 497.50 Yes
5/20/2011 Change of authorized capital to 25,000,000 shares
5/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 3,000.00 3.00 597.00 Yes
6/30/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 250.00 0.25 49.75 Yes
6/30/2011 Payment for financial services- invoice for $880
to stock @ $0.20/sh 4,400.00 4.40 875.60 No
---------- --------- ----------
BALANCE June 30, 2011, as restated 11,185,900 11,185.90 75,695.60
---------- --------- ----------
7/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500.00 2.50 497.50 Yes
8/12/2011 Equity per subscription agreement $0.20/share 27,500.00 27.50 5,472.50 No
8/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500.00 2.50 497.50 Yes
9/30/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500.00 2.50 497.50 Yes
---------- --------- ----------
BALANCE October 12, 2011, as restated 11,220,900 11,220.90 82,660.60
---------- --------- ----------
51. Please tell us how you plan to account for your undistributed losses in
your accumulated deficit line item upon conversion from an S corporation to a C
Corporation. Please refer to SAB Topic 4:B.
Financial Statements at June 30, 2011, Unaudited
The following language has been added, "The Company, with the consent of its
shareholders, has elected under the Internal Revenue Code to be an S
corporation. In lieu of corporation income taxes, the shareholders of an S
corporation are taxed on their proportionate share of the Company's taxable
income. Therefore, no provision or liability for federal income taxes has been
included in the financial statements. It is not likely that the Company will
continue to elect for tax treatment as an S Corporation after the registration
statement is effective. As such the change from a taxable to a nontaxable
entity will require some additional disclosure. Any undistributed earnings and
losses will be reclassified to additional paid-in capital rather than included
in in retained earnings (SAB Topic 4:B). A deferred income tax asset or
liability will be recognized for any temporary differences at the date the
nontaxable entity becomes taxable. The effect of recognizing the deferred tax
asset or liability will be included in income from continuing operations.
Additionally as the date of change from a nontaxable entity to a taxable
entity is recognized on the date of approval, this date may not coincide with
the financial statements. If this is the case, the impact of the change will
be disclosed as a subsequent event."
52. Please update the unaudited financial statements and related disclosures
based on the comments related to the audited financial statements as at
December 31, 2010 as applicable.
Updated throughout.
Exhibits
53. Please refer to Item 601 of Regulation S-K which provides a listing of the
required exhibits and file your remaining exhibits, including the articles of
incorporation, bylaws, accountant's consent, legal opinion, material contracts
and consents of experts and counsel. These exhibits should be filed with your
next amendment or as soon as practicable. We will need time to review the
exhibits prior to granting effectiveness of the registration statement. Please
also note that the list of exhibits should be a cumulative record which
includes all of the exhibits that have been filed in the initial filing and
each amendment.
Additional exhibits filed.
Please do not hesitate to contact us, if you have any additional questions or
require clarification to our responses.
Most Sincerely,
/s/ Jerett Creed
Jerett A. Creed
CEO, CFO, CAO, Director