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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT OF 1934
X For the fiscal year ended December 31, 2011
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _______________ to _______________.
Cardigant Medical Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
26-4731758
(I.R.S. Employer Identification No.)
1500 Rosecrans Ave, St 500
Manhattan Beach, CA 90266
(Address of principal executive offices and zip code)
(310) 421-8654
(Registrant's telephone number, including area code)
Securities registered under Section 12(b) of the Act:
None
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, par value $0.001 per share
None
Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities Act. Yes _ No X
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Act. Yes _ No X
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange
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Act of 1934 during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.Yes X No _
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Website, if any, every
Interactive Data File required to be submitted and posted pursuant to
Rule 405 of Regulation S-T (232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was
required to submit and post such files).Yes X No _
Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of registrant's knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. X
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of large accelerated filer,
accelerated filer? and smaller reporting company? in Rule 12b-2 of the
Exchange Act.
Large accelerated filer _
Accelerated filer _
Non-accelerated filer _
Smaller reporting company X
Indicate by check mark whether the registrant is a shell company (as
defined by Rule 12b-2 of the Exchange Act). Yes_ No X
The aggregate market value of the voting and non-voting common equity
held by non-affiliates computed by reference to the price at which the
common equity was last sold, as of the last business day of the
registrant's most recently completed second fiscal quarter, was
approximately $2,300,000.
As of March 15, 2012 there were 11,337,897 shares of the issuer's common
stock, $0.001 par value per share, outstanding.
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
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Section 21E of the Securities Exchange Act of 1934. The forward-looking
statements are only predictions and provide our current expectations or
forecasts of future events and financial performance and may be
identified by the use of forward-looking statements, including the
terms believes, estimates, anticipates, expects, plans, intends, may,
will or should or, in each case, their negative, plural or other
variations or comparable terminology, though the absence of
these words does not necessarily mean that a statement is not
forward-looking. Forward-looking statements include all matters that
are not historical facts and include, without limitation statements
concerning: our business strategy, outlook, objectives, clinical
success of our technology, future milestones, plans, intentions,
goals, and future financial condition, including the period of time
for which our existing resources will enable us to fund our
operations; plans regarding our efforts to gain regulatory
approval for our HDL based technology for the regression of
stabilization of atherosclerotic plaque buildup; the possibility,
timing and outcome of submitting regulatory filings for our technology
under development; our research and development programs for our HDL
based technology and other possible uses or indications for use of our
technology in reducing and stabilizing lipid based plaques, including
planning for and timing of any clinical trials and potential
development and or commercialization milestones; the development of
financial, clinical, licensing and distribution plans related to the
potential commercialization of our drug products, if approved; and plans
regarding potential strategic alliances and other collaborative
arrangements with pharmaceutical companies or other joint venture
partners to develop, license, manufacture and or market our products.
We intend that all forward-looking statements be subject to the
safe-harbor provisions of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are subject to many risks and
uncertainties that could cause actual results to differ materially from
any future results expressed or implied by the forward-looking
statements. We caution you therefore against relying on any of these
forward-looking statements. They are neither statements of historical
fact nor guarantees or assurances of future performance. Examples of
the risks and uncertainties include, but are not limited to:
RISKS RELATED TO OUR BUSINESS
Our business and our ability to realize the potential advantages of our
technology are subject to a number of risks which should be considered before
making an investment decision. These risks are discussed more fully in the
"Risk Factors" section of this filing. Some of the more substantial risks
that should be taken into account when considering an investment in our
shares include but are not limited to the following:
We have a very limited operating history.
We have incurred losses since our inception in April of 2009 and we expect to
continue to incur substantial losses for the foreseeable future.
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We may never achieve or maintain profitability.
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.
Our current financial position includes a lack of capitalization necessary
to execute on our business plan. This requires that we raise additional funds.
This will result in dilution to shareholders, and we may be unable to raise
any additional capital or raise capital on attractive terms. Our ability to
continue our research and conduct clinical trials also involves a significant
amount of capital of which we may not be able to raise in sufficient quantity
and of which we do not currently possess. The manufacturing of our drug
candidate is expensive and difficult as it is a biologic. We may be unable to
establish a scalable process that is either cost effective and or in sufficient
commercial or clinical quantities. Additionally We may be unable to compete
with better capitalized and or technically managed companies targeting similar
diseases using similar technological approaches.
The nature of our business and technology is highly complex and our lead
product candidate simply may not work for its intended clinical application.
The eventual sale of our drug candidate will be subject to numerous regulatory
challenges imposed by the FDA and regulatory bodies in other countries. We may
be unable to comply with these regulations and gain approval for the sale of
our drug candidate in any region of the world.
There is currently no market for the trading of our shares and there is no
guarantee that one will develop or at what prices and volume.
We are currently raising funds through a registered offering. There is no
minimum amount of shares that are required to be sold by the
company as a part of this offering. 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. Additional risks associated with our offering
can be found in the Risk Factors section of our Prospectus as filed with the
SEC.
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.
Special Note Regarding Forward-Looking Statements
The SEC encourages companies to disclose forward-looking information so that
investors can better understand a company's future prospects and make informed
investment decisions. We make these types of statements directly in this
prospectus. Words such as "anticipates," "estimates," "expects," "projects,"
"intends," "plans," "believes" and words or terms of similar substance used in
connection with any discussion of future operating results or financial
performance identify forward-looking statements.
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All forward-looking statements reflect our present expectation of future events
and are subject to a number of important factors and uncertainties that could
cause actual results to differ materially from those described in the
forward-looking statements. The factors listed in the "Risk Factors" section
below, as well as any cautionary language in this prospectus, provide examples
of these risks and uncertainties. You are cautioned not to place undue reliance
on the forward-looking statements, which speak only as of the date of this
prospectus. We are under no obligation, and expressly disclaim any obligation,
to update or alter any forward-looking statements, whether as a result of new
information, future events or otherwise, subject to our obligations under
federal securities laws.
Cardigant Medical Inc.
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Table of Contents to Annual Report on Form 10-K
For the Fiscal Year Ended December 31, 2011
PART I
ITEM 1. BUSINESS Page 07
ITEM 1A. RISK FACTORS Page 15
ITEM 1B. UNRESOLVED STAFF COMMENTS Page 27
ITEM 2. PROPERTIES Page 27
ITEM 3. LEGAL PROCEEDINGS Page 28
ITEM 4. MINE SAFETY DISCLOSURES Page 28
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED Page 28
STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
ITEM 6. SELECTED FINANCIAL DATA Page 28
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF Page 28
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES Page 39
ABOUT MARKET RISK
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Page 40
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS Page 49
ON ACCOUNTING AND FINANCIAL DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES Page 49
ITEM 9B. OTHER INFORMATION Page 50
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND Page 50
CORPORATE GOVERNANCE
ITEM 11. EXECUTIVE COMPENSATION Page 52
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL Page 53
OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED Page 55
TRANSACTIONS, AND DIRECTOR INDEPENDENCE
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES Page 55
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES Page 55
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PART I
ITEM 1. BUSINESS.
CORPORATE HISTORY
Corporate Information
We were incorporated in Delaware in April 2009. Our principal executive office
is located at 1500 Rosecrans Avenue, Suite 500, Manhattan Beach, CA 90266. We
have laboratory space in Pasadena, CA. Our telephone number is (310) 421-8654.
Our website address is www.cardigant.com. Information contained in, or
accessible through, our website does not constitute a part of, and is not
incorporated into, this prospectus. Our fiscal year end is December 31.
We are focused on the use of biologics and combination biologics and devices
for the treatment of acute coronary syndromes("ACS") and aortic valve
stenosis ("AVS"). We have a very limited operating history, but were formed
to merge certain expertise in drug delivery devices with high density
lipoprotein based compounds. There is currently no active market for our
common stock.
BUSINESS OVERVIEW
Our primary focus is on treating atherosclerosis and plaque stabilization
in both the coronary and peripheral vasculature as well as stenosis of
the aortic valve using systemic delivery of large molecule therapeutics
based on high density lipoprotein ("HDL") targets. Our secondary focus
is on the use of targeted local delivery to reduce systemic exposure
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and drug dosage. We are evaluating proteins based on the Apolipoprotein
A-I ("Apoa-1") structure found in HDL to address our primary focus.
We are looking at both the naturally occurring sequence of apoa-1 as
well as naturally occurring and synthetically modified sequences.
We are utilizing proprietary delivery catheters for targeted local delivery to
achieve our secondary focus. Our lead drug product will be based on the apoa-1
protein. Circulating Apoa-1 is a protein that in humans is encoded by the
Apoa-1 gene. It has a specific role in the metabolism of lipids. Naturally
occurring Apoa-1 is the major protein component of HDL also known as the good
cholesterol. The Apoa-1 protein constitutes roughly 70% of the HDL particle
composition. Circulating plasma levels of HDL have been shown to be inversely
correlated with coronary artery disease.
Our work has focused on the evaluation of various mutations of the genetic
sequence of the Apoa-1 protein versus the naturally occurring sequence, the
design and development of various drug delivery technologies and the
optimization of drug and delivery formulations. We have pre-clinically
evaluated various mutations of the Apoa-1 protein against the naturally
occurring sequence as well as delivery methods to treat simulated stable and
unstable plaque lesions. The output of our work and previous academic work is
an optimized drug formulation designed to address the acute coronary syndrome
patient. Our recent and ongoing work is in finalizing the drug formulation
and the preparation for a regulatory filing to evaluate the safety of our
product candidate in humans.
DISEASE STATE OVERVIEW
Cardiovascular disease consists of a broad group of diseases of the heart and
blood vessels. One of the most common cardiovascular diseases stems from the
progression of atherosclerosis. Atherosclerosis results from the
accumulation of fat and cholesterol in the artery wall, leading to plaque that
can cause narrowing and hardening of the arteries, eventually resulting in a
loss of elasticity and function. The process of atherosclerosis can lead to a
complete blockage or a rupture of the plaque causing a heart attack and or
stroke. Sixty to eighty percent of all heart attacks are caused by a ruptured
plaque lesion with 935 thousand new and recurrent heart attacks in the US each
year (2009 American Heart Association Statistics). Unfortunately most
vulnerable plaque lesions are asymptomatic as the plaque buildup occurs within
the arterial wall and does not always substantially protrude into the vessel
causing any ischemic symptoms. As such intravascular diagnostic techniques such
as angiograms are often unable to detect a vulnerable plaque lesion. Upon
rupture of a plaque lesion, the arterial wall empties its lipid rich pool into
the blood stream where it can either cause a clot further downstream or simply
remain adjacent to the rupture site where it is eventually attacked by the body
causing a clot and complete or partial blockage. It has been established over
the course of scientific research spanning the last few decades that the risk
of cardiovascular disease can be reduced with proper cholesterol management.
Cholesterol is actually required for normal cell function and overall health.
Our bodies obtain cholesterol both through the foods we eat and by
manufacturing cholesterol inside some of our cells and organs. Cholesterol
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either remains within the cell or is transported by the blood to various
organs. The major carriers for cholesterol in the blood are known as
lipoproteins, which are particles composed of fat and protein, including low
density lipoprotein ("LDL") and HDL. LDL delivers cholesterol to organs where
it can be used to produce hormones, maintain healthy cells or be transformed
into natural products that assist in the digestion of other lipids. HDL removes
excess cholesterol from arteries and tissues to transport it back to the liver
for elimination known as reverse cholesterol transport. In a healthy human
body, there is a balance between the delivery and removal of cholesterol from
the blood. Over time, however, an imbalance can occur in which there is too
much cholesterol delivery by LDL and too little cholesterol removal by HDL.
When people have a high level of LDL cholesterol and a low level of HDL
cholesterol, there is more cholesterol being deposited in the arterial walls
than being removed. This imbalance can contribute to cardiovascular disease.
The current treatments for high cholesterol levels primarily focus on the
reduction of LDL. While many widely prescribed LDL treatments such as statins
effectively slow the buildup of dangerous atherosclerotic plaque, they may do
little to reduce existing plaque. Statin drugs can also have a broad spectrum
of potential side effects including liver toxicity. Other treatments have
focused on the management of HDL. The net effect of increasing HDL may be an
increase in the transport of cholesterol that leads to lower total body
cholesterol and a reduced risk of cardiovascular disease. In the acute coronary
syndrome patient, the patient can present with unstable angina or a myocardial
infarction otherwise known as a heart attack. While most heart attacks are
caused by a ruptured plaque lesion caused by an over accumulation of plaque
in the artery wall, this over accumulation can also be problematic in the
aftermath of an acute ischemic event such as a heart attack. When a heart
attack occurs, a region of the heart muscle is deprived of blood flow and
thereby oxygen. Often the treatment is the use of thrombolytics to break up
the clot or angioplasty and or stenting to open the restricted blood vessel.
In response to the transient ischemia and the subsequent reperfusion of oxygen
rich blood, the body responds in a cascade of events. These events include the
activation of the complement system and the up and down regulation of acute
phase proteins. The net result of this ischemia induced response is often
the release of granulocyte neutrophils, macrophages and pro-inflammatory
cytokines. These pro-inflammatory molecules often infiltrate adjacent coronary
sites and can be responsible for the conversion from stable to unstable of
additional blood vessel lesions. As a result, there is a high propensity for
repeat infarcts and elevated mortality within the subsequent six month time
period. Because of this additional risk, we believe there is a strong need for
a drug candidate that can effectively stabilize these plaque lesions in the
aftermath of an acute ischemic event.
APOA-1 OVERVIEW
Wild type Apoa-1 is a protein that in humans is encoded by the Apoa-1 gene.
Its primary sequence is a 243 amino acid protein which has a highly specific
role in the excretion and metabolism of lipids. The Apoa-1 protein tertiary
sequence is largely a repeating alpha helical structure with specific binding
domains. Apoa-1 is the major protein component of HDL in plasma. The protein
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comprises approximately 70% of the total protein content of HDL particles and
promotes cholesterol efflux from peripheral tissues to the liver for excretion
in a process known as reverse cholesterol transport ("RCT"). The exact method
of activation of the RCT process is still being evaluated, but it is known that
Apoa-1 has a specific interaction with the enzyme Lecithin Cholesterol
Acyltransferase ("LCAT"). LCAT is a major enzyme involved in the esterification
of free cholesterol present in circulating plasma lipoproteins and as such is
a major determinant of plasma HDL concentration. It is believed that the enzyme
is responsible for the conversion from a discoidal to spherical HDL particle
which can then take on cholesterol . Apoa-1 is a modulator of this interaction.
It has been shown that the Apoa-1 protein has strong anti-oxidant properties
as well. This is important as the oxidation of HDL particularly in the
pro-inflammatory environment of the acute coronary patient has been shown to
convert HDL from anti-inflammatory to pro-inflammatory. We believe that an
Apoa-1 mutation that exhibits higher anti-oxidant capacity will be a stronger
target than naturally occurring wild type Apoa-1. We have evaluated in animal
models our Apoa-1 mutation against the naturally occurring wild type sequence
and found it to possess stronger anti-oxidant properties.
BUSINESS STRATEGY
Our goal is to establish clinical proof of concept for our drug product and
then selectively pursue strategic collaborations for the commercialization for
our product candidates. We also expect to seek partners in selective regions
to help shoulder some of the financial and development burden for the global
clinical development of drug compound. Our motivation for doing this is to
reduce the amount of capital necessary to be raised, reduce potential
shareholder dilution and increase speed through the clinical trial process.
While we recognize that multiple disease segments can be potentially treated
with our technology, we would like to remain focused on establishing proof of
concept and continuing clinical trials for the acute coronary syndrome patient
and those suffering from moderate aortic valve stenosis. We believe these two
indications provide the best chance of success and adequate return on
investment for our shareholders.
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 of our drug candidate 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. These labs have
included Covance, Synecor LLC, Comparative Biosciences Inc, Aragen Biosciences
and Gateway Medical. We currently do not have any open contracts with any
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contract research organizations. 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 our drug
candidate 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 our drug candidate 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. 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.
Market Opportunity for an HDL based therapeutic
Sixty - eighty percent of new and recurrent heart attacks in the United States
each year are caused by a ruptured plaque lesion (935 thousand new cases in the
US alone (2009 American Heart Association) , 2.2 million in the US, Europe and
Japan combined representing a multibillion US dollar market opportunity. The
risk for the company is whether our eventual lead drug product will achieve
clinically relevant endpoints in a safe and cost effective manner.
Clinical Development of an HDL based therapeutic
It is our goal to initiate a First In Man clinical study before the end of
2012. Based on our current regulatory strategy, we expect this trial to be
in the US. We have been in discussions with Clinical Research Organizations
and are currently conducting our pre-clinical studies based on the submission
requirements necessary for a US first in man trial.
Manufacturing
The method for locally delivering our drug candidate currently requires two
products, a biologic and one FDA approved catheter. The catheter is owned and
supplied by Mercatur Medsystems of San Leandro, CA and does not require any
additional process or product development. They have established GMP
manufacturing for this catheter and we expect that they will continue to be
our supplier. In the future we will be required to negotiate a definitive
supply agreement that will guarantee us a steady supply or provide us the
right to establish 3rd party manufacturing. If we are unable to negotiate a
supply agreement on favorable terms, we have developed local delivery catheters
that can be used as a substitute. We are capable of producing small batches of
material for evaluation in our lab. We are currently working on process
development and clinical grade standard operating procedures. Once we have a
validated process for our protein complex, we will look to find a qualified
vendor. We do not anticipate the purchase of any equipment within the next 12
months in order to execute our business plan. Occasionally we will contract
with a contract manufacturer to produce larger quantities. We do not currently
have any open contracts for any protein purchases with any vendor.
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Sales and Marketing
We currently do not have any sales and marketing infrastructure and do not
plan on establishing any within the next few years. We expect to pursue
strategic marketing and distributing collaboration when that time comes.
Intellectual Property
Our intellectual property is divided into four (4) categories: Compound,
delivery method, transfection, supply agreements.
Compound: We have exclusive US rights to patent US2005287636(A1) - "Proap
olipoproteinA-I mutant and pharmaceutical composition comprising the same for
prevention and treatment of atherosclerosis and hyperlipidemia" and related
filings. This patent has been issues in Korea and the US and covers the gene
sequence, protein product, and ecoli expression system method for manufacture.
It is anticipated that this patent will expire in 2024 not including any
potential extensions based on the Hatch-Waxman Act. We have not determined if
we will advance this compound into the clinic, however, we do have rights to
do so in the US. As stated elsewhere, we have not made a determination as to
whether we will advance this compound into the clinic as we are evaluating
other similar but non patented protein sequences. As such it is possible
that we may not have patent protection for a drug that we decide to advance
into the clinic.
Delivery Method: We expect to file 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 after the provisional filing. 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.
Supply Agreements: We do not plan to initiate any First in Man studies without
all required Material Supply Agreements in place to ensure the required supply.
Additionally we plan to seek exclusive supply agreements for the Field in which
we are operating. How the Field gets defined and what level of exclusivity is
subject to negotiations.
Know-how: We have developed proprietary standard operating procedures and
animal models for producing and evaluating our technology. We consider these
processes and methods confidential to our business. As such we seek to limit
disclosure of this information to those parties that consent to signing
confidentiality agreements limiting their ability to act on such information
and to disclose to others.
Additionally, we have generated know-how related to the manufacturing of our
biologic products as we have produced small scale batches. Some of this
know-how may be relevant for larger scale production.
COMPETITION
Our industry is subject to rapid and intense technological change. We will
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without a doubt face companies with better capitalization and technological
expertise. The vascular space is fiercely competitive and there are numerous
compounds and delivery approaches under study. Specifically related to apoa-1,
there are 4 companies that we are aware of working in this area. Drug
development is a cost intensive project with millions of dollars necessary
to successfully develop, test and market compounds successfully. We expect
to seek multiple financial or strategic financing opportunities in our
development of our IP.
Related Party Transactions
The Company has thus far received most of its working capital from its founder
Jerett A. Creed. These costs have been carried as a shareholder loan accruing
interest at the rate of 5% per annum. On January 4th, 2010, Mr. Creed converted
$50,000 of his outstanding shareholder loan balance in exchange for eleven
million shares of the Company. There was no compensation or interest expense
included in the conversion.
U.S. GOVERNMENT REGULATION
In the United States, our product candidate will be regulated by the FDA as a
biological product. Biological products are subject to regulation under the
Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and
related regulations, and other federal, state and local statutes and
regulations. Failure to comply with the applicable U.S. regulatory requirements
at any time during the product development process, approval process or after
approval, may subject an applicant to administrative or judicial sanctions.
These sanctions could include the imposition by the FDA or an Institutional
Review Board, or IRB, of a clinical hold on trials, the FDA's refusal to
approve pending applications or supplements, withdrawal of an approval,
warning letters, product recalls, product seizures, total or partial
suspension of production or distribution, injunctions, fines, civil penalties
or criminal prosecution. Any agency or judicial enforcement action could have
a material adverse effect on us.
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 of 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.
PRIVACY LAWS
Federal and state laws govern our ability to obtain and, in some cases, to use
and disclose data we need to conduct research activities. Through the Health
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Insurance Portability and Accountability Act of 1996, or HIPAA, Congress
required the Department of Health and Human Services to issue a series of
regulations establishing standards for the electronic transmission of
certain health information. Among these regulations were standards for the
privacy of individually identifiable health information. HIPAA does not
preempt, or override, state privacy laws that provide even more protection
for individuals' health information. These laws' requirements could further
complicate our ability to obtain necessary research data from our
collaborators. In addition, certain state privacy and genetic testing laws
may directly regulate our research activities, affecting the manner in which
we use and disclose individuals' health information, potentially increasing
our cost of doing business, and exposing us to liability claims. In addition,
patients and research collaborators may have contractual rights that further
limit our ability to use and disclose individually identifiable health
information. Claims that we have violated individuals' privacy rights or
breached our contractual obligations, even if we are not found liable,
could be expensive and time-consuming to defend and could result in adverse
publicity that could harm our business.
OTHER REGULATIONS
In addition to privacy law requirements and regulations enforced by the FDA,
we also are subject to various local, state and federal laws and regulations
relating to safe working conditions, laboratory and manufacturing practices,
the experimental use of animals and the use and disposal of hazardous or
potentially hazardous substances, including chemicals, micro-organisms and
various radioactive compounds used in connection with our research and
development activities. These laws include, but are not limited to, the
Occupational Safety and Health Act, the Toxic Test Substances Control Act
and the Resource Conservation and Recovery Act. Although we believe that
our safety procedures for handling and disposing of these materials comply
with the standards prescribed by state and federal regulations, we cannot
assure you that accidental contamination or injury to employees and third
parties from these materials will not occur. We may not have adequate
insurance to cover claims arising from our use and disposal of these
hazardous substances. We do maintain a $2 million general liability policy
for our work that is conducted at our Pasadena laboratory.
FOREIGN REGULATION
In addition to regulations in the United States, we may be subject to a
variety of foreign regulations governing clinical trials and commercial sales
and distribution of biological products. Whether or not we obtain FDA approval
for a product, we must obtain the requisite approvals from regulatory
authorities in foreign countries prior to the commencement of clinical trials
or marketing of the product in those countries. The requirements governing
the conduct of clinical trials and the approval process vary from country to
country and the time may be longer or shorter than that required for FDA
approval.
EMPLOYEES
As of December 31, 2011 we had three employees, Jerett Creed serving as our
Chief Executive Officer and Chief Financial Officer, Ralph Sinibaldi, PhD
--------------------------------- page 14 -------------------------------------
serving as our Chief Scientific Officer and Emerson Perin, MD, PhD serving as
our Chief Medical Officer. Mr. Creed's Employment Agreement extends until he
is no longer able or willing to provide services to us. Mr. Creed is entitled
to annual compensation in the amount of $120,000 per year. Additionally the
agreement provides for 5% accrued annual interest on the outstanding principle
balance for any funds advanced to us or unreimbursed by us from the employee
for recognized business expenses. Dr. Sinibaldi is being compensated on an
hourly basis for time served paid as a mixture of cash and stock. Our CSO is
currently compensated at the rate of $100/ hour plus the equivalent of $100/
hour of compensation paid in equity priced at $0.20 per share. This equity
conversion price will increase to the amount of our offering price once the
price is determined. Dr. Perin 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 approval to conduct a clinical study. 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.
We estimate that we need to hire an additional 6 full
time equivalent staff in the next 12-18 months including two officer
level positions.
FACILITIES
Our corporate headquarters are located in Manhattan Beach, CA and we maintain
a working laboratory in Pasadena, CA.
LEGAL PROCEEDINGS
We are not currently a party to or engaged in any material legal proceedings.
However, we may be subject to various claims and legal actions arising in the
ordinary course of business from time to time.
ITEM 1A. RISK FACTORS.
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should
carefully consider the risks described below, as well as the other information
included in this filing, before you decide to purchase shares of our
common stock. If any of the following risks actually occurs, they may harm our
business, prospects, financial condition and operating results. As a result,
the trading price of our common stock if a market develops could decline and
you could lose part or all of your investment.
RISKS RELATED TO OUR BUSINESS
We have extremely limited operating history.
We have incurred losses since our inception in April 2009 and will continue to
incur losses until we receive a product approval. Even if we are able to
receive product approval, we may be unable to become or maintain profitability.
Most of our activities since our inception have focused on organization,
startup and securing appropriate rights to our product. We have not completed
--------------------------------- page 15 -------------------------------------
development of our product candidate necessary to initiate a phase I study.
Because of the numerous risks associated with drug development, we
are unable to predict whether our development efforts will be successful.
Additionally, we are lacking a strong development infrastructure that will be
required for successfully executing on a complex technology development
program.
We expect to continue to incur significant operating expenses and anticipate
that our expenses and losses will increase in the foreseeable future
as we seek to:
- complete our pre-clinical testing in preparation for a regulatory
submission for a First in Man study;
- initiate our First in Man study;
- hire additional key clinical and scientific personnel;
- complete validation of our product manufacturing;
- scale up our manufacturing for clinical quantities and cGMP production;
- maintain, expand and defend our intellectual property portfolio;
- hire financial and accounting personnel as well as augment our internal
control policies and procedures required for expanding our operations and
our status as a company subject to public reporting requirements.
To become and remain profitable, we must succeed in developing and eventually
commercializing our product with significant market potential. This will
require us to be successful in a range of challenging activities, including
successfully completing preclinical and in vitro testing and clinical trials
of our product candidate, obtaining regulatory approvals, manufacturing
validation and establishing sufficient sales and marketing infrastructure.
Our failure to become and remain profitable would depress the market price
of our common stock and could impair our ability to raise capital, expand
our business or continue our operations. A decline in the market price of
our common stock could also cause a loss of all or part of any investment
in our common stock.
We will need substantial additional funding and may be unable to raise
capital when needed, which would force us to delay, reduce or eliminate our
product development programs or commercialization efforts.
We are a development stage company and have no commercial products. Our
product candidate is still being developed and will require significant
additional pre-clinical, in vitro and clinical development and additional
investment before it can be commercialized. We anticipate that our most
advanced product candidate will not be commercially available
for several years, if it becomes available at all.
--------------------------------- page 16 -------------------------------------
Our research and development expenses will continue to increase in connection
with our ongoing activities. If we are unable to raise additional funding
as needed or on attractive terms, we would be forced to delay, reduce or
abandon our development and commercialization efforts.
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 of which we currently do not have.
Our future capital requirements will depend on many factors, including:
- the progress and results of our research and preclinical development
programs;
- the scale, progress, results, costs, timing and outcomes of any clinical
trials of our product candidate;
- the costs of contracting, operating, expanding and enhancing our contract
manufacturing facilities and capabilities to support our pre-clinical and
clinical activities and, if our product candidates are approved, our
commercialization activities;
- the costs of maintaining, increasing and defending our intellectual
property portfolio, including potential litigation costs and liabilities;
As a result of these factors, we are currently and will need to continue
seeking additional funding. We would likely seek such funding through
public or private financings or some combination of the two. We might
also seek funding through collaborative arrangements if we determine
them to be necessary or mutually beneficial. Additional funding may
not be available to us on acceptable terms, or at all. If we obtain
capital through strategic arrangements, these arrangements could
require us to relinquish rights to our technology or product
candidates and could result in our receiving only a portion of any
revenues associated with the collaborative project. If we raise capital
through the sale of equity, or securities convertible into equity, it would
result in dilution to our then existing stockholders. If we raise additional
capital through the incurrence of indebtedness, we would likely become subject
to loan covenants restricting our business activities, and holders of debt
instruments would have senior rights and privileges to those of our equity
investors. In addition, servicing the interest and principal repayment
obligations under debt facilities could divert funds that would otherwise be
available to support research and development, clinical or commercialization
activities.
If we are unable to obtain adequate financing on a timely basis, we may be
required to delay, reduce or eliminate our technology development programs.
This scenario could cause us to accept terms at less than attractive rates
which could increase then shareholders dilution and could possibly decrease
the value of our common stock.
Our operating history may make it difficult for you to evaluate the success of
--------------------------------- page 17 -------------------------------------
our business to date and to assess our future viability.
Our operations to date have been extremely limited and as such will not
provide a reasonable ability for you to gauge management's ability to
successfully manage and execute on a complex technology development program
such as is contemplated herein. We have not yet demonstrated our ability to
complete clinical studies, obtain regulatory approvals and manufacture a
commercial scale product to cGMP standards. This burden will become more
difficult due to the increased requirements for public company reporting.
Our failure to perform on any of these items could hinder our ability to
commercialize our technology or raise additional funds as may be needed.
Additionally as we have an operating history that began during 2009, it
will be more difficult to ascertain through study of the financial statements
any future trends to be understood by comparatively looking at past
performance.
If we are not able to retain and recruit qualified management and technical
personnel, we may fail in developing or commercializing our technologies and
product candidates.
Our future success depends to a significant extent on the skills, experience
and efforts of our scientific and management teams, including Jerett A. Creed
our Chief Executive Officer and our Chief Financial Officer, Ralph
Sinibaldi,PhD our Chief Scientific Officer, and Emerson Perin, MD, PhD our
Chief Medical Officer. Both our Chief Scientific Officer and Chief Medical
Officer are part time and conduct work on an as needed basis. While we have
other scientific consultants currently working for us, our near term efforts
will depend entirely on our current management until we augment our management
team with non-consulting personnel. Additionally, we rely heavily on external
consultants for scientific, regulatory, legal, and financial advice. It is our
intent to recruit for these positions in the near term, however, we may be
unable to find qualified talent at market rates. Additionally our ability to
recruit and retain the required talent may be tied to our ability to pay
market rates for which we may not have sufficient funding. While we have not
had any difficulty to date in identifying consulting personnel with the
required expertise and experience required, we may have difficulty converting
these candidates to full time roles or recruiting full time candidates. We may
have to rely more extensively on our Stock Option plan to recruit and retain
talent. In the event that we need to rely on our Stock Option plan, our then
non-employee shareholders may be subject to additional dilution. A loss of any
of our key personnel including advisors and consultants could compromise our
ability to execute our business plan. None of our current consultants have
indicated any plans to discontinue their services as of the date of this
filing.
We have no independent board representation or independent audit or
compensation committees.
We currently have one board member, Jerett A. Creed with Ralph Sinibaldi, PhD.
serving as advisor. As such we do not have any independent board
--------------------------------- page 18 -------------------------------------
representation of our shareholders. We expect to appoint independent board
members and committee members within the next 6 months coinciding with the
hiring of additional key management, but there is no guarantee that this
will happen in a timely manner or at all.
RISKS RELATED TO THE DEVELOPMENT OF OUR PRODUCT CANDIDATE
If a clinical trial of our product candidate fails to demonstrate safety and
or efficacy to the satisfaction of a regulatory body or does not otherwise
meet primary clinical endpoints, we may incur additional costs or experience
delays in completing, or ultimately be unable to complete, the development
and commercialization of our product candidates.
Before a regulatory approval may be granted for the sale of our product,
we must conduct extensive clinical trials to demonstrate the safety and
efficacy of our product candidates in humans. Clinical testing is expensive,
difficult to design and implement, can take many years to complete and is
uncertain as to the outcome. A failure of one or more of our clinical trials
can occur at any stage of testing. We may experience numerous unforeseen
events during, or as a result of, clinical trials that could delay or prevent
our ability to receive regulatory approval or commercialize our product
candidates, including:
- regulators or institutional review boards may not authorize us or our
investigators to commence a clinical trial or conduct a clinical trial at a
prospective trial site;
- clinical trials of our product candidates may produce negative or
inconclusive results, and we may decide, or regulators may require us, to
conduct additional clinical trials or abandon our product development program
that we think might be promising;
- the number of patients required for clinical trials of our product
candidates may be larger than we anticipate, enrollment in these clinical
trials may be slower than we anticipate, or participants may drop out of
these clinical trials at a higher rate than we anticipate;
- our third party contractors may fail to comply with regulatory requirements
or meet their contractual obligations to us in a timely manner or at all;
- we might have to suspend or terminate clinical trials of our product
candidates for various reasons, including a finding that the participants
are being exposed to unacceptable health risks;
- regulators or institutional review boards may require that we or our
investigators suspend or terminate clinical research for various reasons,
including noncompliance with regulatory requirements;
- the cost of clinical trials of our product may be greater than we
anticipate;
--------------------------------- page 19 -------------------------------------
- the supply or quality of our product or other materials necessary to
conduct clinical trials of our product candidates may be insufficient
or inadequate; and
- our product may have undesirable side effects or other unexpected
characteristics, causing us or our investigators to halt or terminate
the trials.
If any of the above scenarios were to occur, our ability to continue
our development program may be irreparably impaired. We may not be able
to raise additional funding that would be required to conduct additional
pre-clinical testing, our liability insurance may be inadequate for the
potential risks that our patients are exposed to and we may be unable to
convince a regulatory review board to initiate or continue testing of our
product.
The results of preclinical studies may not correlate with the results of human
clinical trials. Additionally early stage clinical trial results do not
ensure success in later stage clinical trials and interim trial results are
not always predictive of final trial results.
We have not conducted any clinical proof of concept studies. If we are
successful in gaining regulatory approval for the initiation of a First in Man
study, we may not realize the same results we have seen pre-clinically.
Additionally, a successful phase I proof of concept study does not in any way
guarantee similar results for larger scale phase I/II trials. In order to
establish statistical significance, the patient sample sizes may have to be
increased based on the data obtained. This would delay our development and
require additional capital which we may not have or be able to raise. As we
progress through our clinical development, we may discover new information
calling into question the safety or efficacy of our product as we examine
larger sets of data. This would require us to examine our overall program and
potentially result in the abandonment of our development efforts.
We may experience delays in enrolling patients in clinical trials of our
product candidates, which could delay or prevent the necessary regulatory
approvals.
We may not be able to initiate or continue clinical trials of our lead compound
if we are unable to locate and enroll a sufficient number of eligible patients
to participate in the clinical trials required by a regulatory authority. We
may also be unable to engage a sufficient number of clinical trial sites to
conduct our trials or convince patients to consent to a new treatment modality.
If our lead compound is not demonstrated in clinical trials to be safe and
effective for our stated indications, the value of our technology, common
stock and our development programs would be significantly reduced if not
reduced to zero.
We have not proven in clinical trials that our compound will be safe and
effective for the indications for which we intend to seek approval. Our drug
--------------------------------- page 20 -------------------------------------
compound is susceptible to various risks, including undesirable and unintended
side effects, inadequate therapeutic efficacy or other characteristics that may
prevent or limit potential regulatory approval or commercial use. The design
of clinical trials is complex and there are often many confounding factors
related to the successful achievement of meeting primary and secondary
endpoints. We may not be able to meet all of the endpoints originally
contemplated in a clinical protocol. Our inability to establish proof of
concept clinical efficacy could render the value of our common stock worthless.
RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCT CANDIDATES
Our product candidate is based on a novel biologic combination that may not be
well understood by or accepted by the market.
We face significant hurdles to executing our development plan through clinical
trials and regulatory approval. We may receive the required regulatory
approval and have limited commercial success because our technology is not well
understood, too complex to administer, too expensive or simply displaced by
better data from another product.
The degree of physician and patient acceptance of our product candidate will
depend on many factors, including:
- the clinical safety and efficacy of our product, the availability of
alternative treatments and the perceived advantages of our product candidates
over any alternative treatments;
- the relative convenience and ease of administration, dosing tolerability and
skill level required to deliver our product;
- the frequency and severity of adverse clinical events or other undesirable
side effects involving our product; and
- the cost of our product, the reimbursement policies of government and
third-party payors and our ability to obtain sufficient third-party coverage
or reimbursement.
We face substantial competition from better capitalized, managed and
experienced companies.
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.
Due to the severity of the disease state we are targeting, there are
significant research and development efforts ongoing from many large
multinational pharmaceutical companies. These companies have proven track
records of development, are better capitalized and often have more established
relationships with academic and government organizations that may give them
substantial advantages over us to commercialize competing or potentially
disruptive technologies.
--------------------------------- page 21 -------------------------------------
Our ability to establish and maintain profitability will be dependent on the
available levels of government and third party reimbursement.
We will have limited ability to establish the reimbursement rates for our
product. We are at risk that even with successful clinical trials and
regulatory approvals, we may not be able to obtain any government or third
party reimbursement, the reimbursement rates may be delayed pending additional
data or the reimbursement rates may be lower than anticipated by us. While we
can potentially influence the reimbursement rates by designing clinical studies
to specifically address quality of life and recurrence rates, the design of
these trials is expensive and may require these trials to be separate from our
primary clinical development pathway. There is no guarantee that even if these
trials were completed, that we would be successful in establishing a timely
and market rate for our product.
We have very limited experience manufacturing our product. We may not be able
to contract or manufacture our product in compliance with evolving regulatory
standards or in quantities sufficient for clinical or commercial sale.
The manufacture of biologic products is complex and expensive. We may be unable
to transition our process from a pilot scale to a commercial scale at all or at
a rate that is commercially feasible. There is no guarantee that our current
contract manufacturer will continue to be able to meet our demand or be willing
to further our process development efforts. If this were to happen, we would be
forced to seek alternative contract manufacturers and incur substantial process
transfer costs. There is no guarantee that our process could be successfully
transferred to a new plant location. We are completely dependent on third
parties for the supply and process development of our product at this time.
We do not currently have any in house lab facilities suitable to produce large
scale biologic products. Additionally our most knowledgeable process experts
for the manufacture of our product are outside advisors including the inventor
of the protein. There is no guarantee that we can keep his involvement in this
project.
The use of our product in humans may expose us to liability, and we may not be
able to obtain adequate insurance for these claims.
The use of our product in humans subjects us to potential liability. Our
product has not been tested in human subjects and therefore does not have an
established safety profile. We face the risk of product liability related to
the testing of our product in human clinical trials and will face an increased
risk if we sell our product commercially.
If we were to face product litigation, there is no guarantee that we would
have sufficient insurance coverage to defend us. We currently maintain a
$2 million general liability policy to cover our lab work, but this policy
would not cover any clinical trial liabilities. We do require our pre-clinical
sites to carry sufficient liability to cover the employees who may come in
contact with our product. Any litigation we would be involved in would likely
consume substantial amounts of our financial and management resources and
could result in:
--------------------------------- page 22 -------------------------------------
- significant monetary awards against us;
- substantial litigation costs and attorneys fees;
- damage to our reputation;
- slower or stopped clinical trial enrollment; and
- a decrease or complete loss in the value of our common shares.
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
If we are unable to create and defend our patent position, others could
directly compete against us.
Our success partially depends on our ability to establish and maintain
intellectual property protection for our product.
Our technology is based on drug formulations which we have developed. These
drug formulations may or may not be patentable. Once we determine our final
protein manufacturing process, we will determine if our product is better
protected through trade secrets or by filing for patent protection.
Additionally we may file method patents covering potential novel ways of
using and delivering our technology, however, there is no guarantee that
any method patents will be granted in the United States or in any other
country we may seek protection or that they will serve as a barrier from
competition from better funded or staffed organizations. Additionally the
protection afforded by international patent laws as well as the enforcement
actions differ from country to country. There is no guarantee that we will
be able to maintain adequate protection or enforcement of our intellectual
property position.
If we infringe or are alleged to infringe intellectual property rights of
third parties, our business could be harmed.
Our research, development and commercialization activities may infringe or be
claimed to infringe patents owned by third parties to whom we do not hold
licenses or other rights. There may be applications that have been filed but
not published that, when issued or placed in the public domain, could be
claimed against us. These third parties could bring claims against us that
would cause us to incur substantial expenses. If these claims against us are
successfully litigated, it could result in substantial monetary damages that
we may be unable to pay or would hinder or ability to further our development
efforts. If a patent infringement suit were brought against us, we could be
forced to stop or delay our development efforts pending the outcome of the
litigation. We are not aware of any infringement of our technology and gave
not received any third party notices indicated otherwise.
We may be brought into a lawsuit to defend our intellectual property or that
of third party collaborators.
--------------------------------- page 23 -------------------------------------
In the event that a competitor infringes our or our collaborator's property,
we may be required to defend the patent right of our collaborators. These types
of cases can be distracting and costly to management. If this were to happen,
our development programs could be reduced or stopped to allow our limited
resources to focus on the case. Additionally as these types of cases often
require substantial discovery, there is risk that some of our confidential
information could be misappropriated through outside disclosure. We have not
initiated any litigation and are unaware of any pending litigation that would
involve us.
RISKS RELATED TO REGULATORY APPROVAL AND OTHER GOVERNMENTAL REGULATIONS
If we are not able to obtain the necessary regulatory approvals for any of
our product candidates, we may not generate sufficient revenues to continue
our business operations.
Obtaining regulatory approval is a complex and timely process. There are
numerous factors that may limit our ability to obtain regulatory approval
in the US or internationally. Failure to achieve approval in any country
where a clinical trial is conducted could have adverse effects on our financial
condition.
Any or all of the following factors, among others, may cause regulatory
approval for our product to be delayed, limited in marketing scope or denied:
- our product candidate will requires significant clinical testing to
demonstrate safety and efficacy before applications for approval can be filed
with a regulatory body;
- data obtained from pre-clinical and clinical trials can be interpreted
in different ways, and regulatory bodies may require us to conduct additional
testing;
- it may take many years to complete the testing of our product candidates,
and failure can occur at any stage of the clinical trial process;
- Failure to meet clinical endpoints or the occurrence of serious or
unexpected adverse events during a clinical trial could cause the delay or
termination of our development efforts;
- commercialization may be delayed if a regulatory body requires us to expand
the size and scope of the clinical trials.
Any delays or difficulties that we encounter in obtaining regulatory approval
could have a substantial adverse impact on our ability to generate product
sales and cause a decrease in the value of our common stock.
If we are unable to complete our clinical trial program for a cost and time
as contemplated by our business plan, we may be adversely impacted.
Our clinical trial program can be delayed for numerous reasons, many of which
--------------------------------- page 24 -------------------------------------
may be beyond our control. The completion of our clinical trials may be delayed
or terminated for many reasons, including if:
- the FDA or other regulatory authority does not grant permission to proceed
and places the trial on clinical hold;
- subjects do not enroll in our clinical trials at the rate we expect;
- subjects experience an unacceptable rate or severity of adverse side
effects;
- third party clinical investigators do not perform our clinical trials
on our anticipated schedule or consistent with the clinical trial protocol,
good clinical practices required by the FDA and other regulatory requirements,
or other third parties do not perform data collection and analysis in a timely
or accurate manner; or
- inspections of clinical trial sites by the FDA or by institutional review
boards of research institutions participating in our clinical trials, reveal
regulatory violations that require us to undertake corrective action, suspend
or terminate one or more sites, or prohibit us from using some or all of the
data in support of our marketing applications; or
Our expenses will increase if we have material delays in our clinical trials,
or if we are required to modify, terminate or repeat a clinical trial. If we
are unable to conduct our clinical trials on schedule, a regulatory approval
may be delayed or denied by the FDA or other regulatory body. This event could
cause a decrease in the value of our common stock.
Any product for which we obtain marketing approval will be subject to extensive
ongoing regulatory requirements.
Because our technology deals with a biologic, there is potential that the FDA
or any other regulatory body may require us to follow our clinical trial
participants for an extended period of time. This requirement may be
independent from a regulatory approval but could potentially increase our
costs or subject us to additional risk as we may discover additional data
points that were not available previously. Extended monitoring times or
costs could reduce or eliminate our ability to become or maintain
profitability. Additionally adverse events discovered as a result of a post
market approval monitoring could still require us to pull our product from
the market and reduce our ability to generate revenue.
RISKS RELATED TO THE PURCHASE OF OUR COMMON STOCK
Our shares are curently not listed or quoted on any exchange. There has never
been and there may never be an active market for our common stock.
We are currently conducting a registered offering of our common stock. This
risks associated with this offering can be found in the Risk Factors section of
our Prospectus as filed with the SEC.
--------------------------------- page 25 -------------------------------------
If a market develops, the trading of our common stock is likely to be thin and
volatile.
As there is no established track record of share price and performance for
our company, it is likely that it will take some time to develop a market
and a following of our stock if one develops at all. Additionally the market
for biotechnology companies in particular can be volatile. The market can
often react to any news that may or may not directly involve the company
if it is perceived that it effects the environment in which the company
operates. This can include:
- results of clinical trials of our technology or those of our competitors;
- regulatory or legal developments in the United States and foreign countries;
- variations in our financial results or those of companies that are perceived
to be similar to us;
- changes in the structure of healthcare payment systems;
- sales of substantial amounts of our stock by existing stockholders;
- sales of our stock by insiders and large stockholders;
- general economic, industry and market conditions;
- additions or departures of key personnel;
- intellectual property, product liability or other litigation against us;
- expiration or termination of our potential relationships with collaborators;
and
- other factors described in the "Risk Factors" section.
Additionally it is not uncommon for shareholders of biotechnology companies to
initiate class action lawsuits against companies that have experienced periods
of extreme volatility in the share price. If we were to be subject to such a
lawsuit, we would likely incur a substantial cash drain as well as the
distraction of key management personnel.
If you purchase shares of our common stock, you are likely to incur significant
dilution.
We will need to raise additional cash to continue our development efforts.
As there is uncertainty in the market that may develop for our common shares
as well as the established market price, there is no guarantee that a future
fund raising activity will be done at per share prices above what was paid in
this offering or in the open market during this time. Additionally as we will
be recruiting for additional senior executive positions, it is likely that
stock options will be granted. We may also utilize warrants to further
--------------------------------- page 26 -------------------------------------
incentivize some of our key consultants.
A significant concentration of our total issue shares are held by our founder
and Chief Executive Officer. Approximately 96% of our total issued shares are
held directly or through entities controlled by our founder and Chief Executive
Officer. This could make it very difficult for shareholders to exert influence
over the strategic direction of the company.
As a reporting entity, we may be subject to Section 404 of the Sarbanes-Oxley
Act.
Among other things, this act requires our Chief Executive and Chief Financial
Officers to attest to the relevant strength over internal controls and the
quality of financial reporting. Our CEO and CFO positions are currently
held by Mr. Jerett A. Creed. While we expect to hire a CFO in the near term,
there is no guarantee that we will be able to find a suitable candidate.
Additionally Section 404 requires the identification of material weakness in
the internal control over financial reporting process. We are in the early
stages of building an internal control infrastructure that is appropriate for
our size and level of complexity. As such we may have to identify several
material weaknesses that exist which may negatively impact the value of our
common stock.
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.
THERE ARE NO SEGREGATION OF DUTIES AT THE EXECUTIVE LEVEL.
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.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
Not applicable.
ITEM 2. PROPERTIES.
We maintain our principal executive offices at 1500 Rosecrans Ave, St 500,
Manhattan Beach, CA 90266 and have limited research space in Pasadena located
at 2265 East Foothill Blvd, Pasadena, CA 91107. Our rental agreements are
month to month cancellable with thirty days notice, and our total lease
--------------------------------- page 27 -------------------------------------
payments are approximately $14,500 per year for both facilities. We do not
occupy any other facilities or own any real property.
ITEM 3. LEGAL PROCEEDINGS.
We are not aware of any pending or threatened legal actions to which we
are a party or of which our property is the subject that would, if
determined adversely to us, have a material adverse effect on our
business and operations.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY,
RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES.
Market Information
There is currently no market for the listing, quotation or trading
of our Common Stock.
Dividends
We have not paid dividends on our common stock and do not expect to
declare and pay dividends on our common stock in the foreseeable future.
Sales of Unregistered Securities
There have been no sales of unregistered securities which have not
been previosuly disclosed. We are currently engaged in a self
underwritten registered offering of our Common Stock. Additional
information related to this offering can be found in our Prospectus
as filed with the SEC.
ITEM 6. SELECTED FINANCIAL DATA.
Not applicable.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis of our financial condition and results of
operations should be read together with our financial statements and the
related notes to those statements included later in this filing. In
addition to historical financial information, this discussion may contain
forward-looking statements reflecting our current plans, estimates, beliefs
--------------------------------- page 28 -------------------------------------
and expectations that involve risks and uncertainties. As a result of many
important factors, particularly those set forth under "Special Note Regarding
Forward-Looking Statements" and "Risk Factors," our actual results and the
timing of events may differ materially from those anticipated in these
forward-looking statements.
Overview
We are a development stage biotechnology company focused on systemic and local
drug delivery for the treatment of cardiovascular and peripheral vascular
disease. Cardigant was founded to capitalize on the belief that local drug
delivery to the vasculature holds the potential to improve outcomes and
treat previously untreated disease segments most notably vulnerable
atherosclerotic plaque lesions of the coronary, peripheral, and neuro
vasculatures. Our focus is on treating atherosclerosis and plaque
stabilization using systemic and targeted delivery of large molecule
therapeutics based on high density lipoprotein(HDL) targets. Circulating
plasma levels of HDL are inversely correlated with coronary artery disease.
Towards this goal, we are evaluating drug formulations based on the apoa-1
protein that are delivered both systemically via intravenous infusion and
via a catheter to one or more lesions as identified by intravascular
ultrasound (IVUS) and or optical coherence tomography (OCT). Our product
candidate consists of a recombinant protein construct coding for the apoa-1
protein in a phospholipid formulation. The apoa-1 protein's primary
function is the promotion of reverse cholesterol transport (RCT) from the
arterial wall to the liver for catabolism and excretion. Apolipoprotein A-I
is a protein that in humans is encoded by the Apoa-1 gene. It has a specific
role in the metabolism of lipids. Naturally occurring Apoa-1 is the major
protein component of HDL also known as the good cholesterol. Apoa-1 protein
constitutes roughly 70% of the HDL composition. There are both naturally
occurring and synthetically modified mutations of the apoa-1 protein.
Some of these mutations can have positive effects on cholesterol
mobilization. We are currently evaluating various apoa-1 based
protein sequences to determine the optimal drug candidate based on efficacy,
minimum royalty costs and available production methods among other factors.
We have been evaluating the catheter based local delivery of our product for
specifically reducing the plaque content and burden within one or more
adjacent sites.
As we are a development stage company, we have incurred losses since our
inception in April of 2009. As we continue to raise funds and further our
development program, we expect to incur even greater expenses and losses.
We have no revenues and do not expect to incur any revenue for several years
until such time as our lead therapeutic compound may, if at all, be approved
by a regulatory body for sale in a region of the world covered by that
regulatory body.
Revenues
We are a development stage company with our first product candidate several
years away from generating any revenue. We do not expect to generate any
revenue from the sale of our technology for several years. We do however
occasionally apply for non-taxable grant funding to support our research and
--------------------------------- page 29 -------------------------------------
development efforts. We currently have grant applications outstanding, however,
we can make no guarantees that any grant money will be awarded from these
applications. In November of 2010 we were awarded a non-taxable grant in the
amount of $170,750. $60,200 of this was paid in December of 2010 with the
remaining $110,550 paid in February of 2011. This grant was awarded under the
Qualifying Therapeutic Discovery Project Program. There were no specific
future performance obligations under the grant as it was awarded based on
previous research and development expenses incurred.
Cost of Product Sales
We do not currently sell any products and do not expect to for several years.
We are targeting a product cost in the 10-15% of sales as our goal. This is
simply an internal goal that is subject to many uncertainties including the
ability to cost effectively produce the product, establish a supportable market
price in the region of approval and obtain sufficient reimbursement from
governmental and or third party insurance agencies.
Research and Development Expenses ("R&D")
Our research and development expenses primarily consist of personnel-related
costs, technical consulting fees, and contract research fees. As our senior
management are largely involved with overseeing our current development
programs, we currently allocate 80% of Mr. Creed's salary (accrued or
otherwise) and 100% of Drs. Sinibaldi and Perin 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 potential disease states. Assuming we are
able to raise sufficient funds, we expect to incur an additional $1.4 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. This number is composed of the
following estimates of major expenses: $500 thousand of employee related
R&D costs; $385 thousand of formulation development, protein process
development, and cGMP 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
--------------------------------- page 30 -------------------------------------
contract based small scale cGMP 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.
Selling, General and Administrative Expenses ("SG&A")
Our selling, general and administrative expenses consist primarily of non
allocated salaries including benefits. As we expect to hire additional
personnel, we expect this amount to increase to approximately $250 thousand
over the next 12-18 months. Additionally we expect to move into a new office
space which will add an additional $22 thousand annual expense. In addition to
hiring accounting personnel for public company reporting requirements, we also
expect to incur an additional $30 thousand per year of investor relations
expenses for disseminating company information, news releases and public
filings.
Results of Operations for the Year ended December 31, 2011 as Compared to
the Year ended December 31, 2010
Revenues
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. In
November of 2010 we were awarded a non-taxable grant in the amount of $170,750.
$60,200 of this was paid in December of 2010 with the remaining $110,550 paid
in February of 2011.
Cost of Product Sales
We do not currently have any product costs and do not expect to incur any costs
of this type for several years. Any costs associated with producing or
procuring product for pre-clinical or clinical studies is considered R&D
expenses.
Research and Development Expenses
Research and development expenses for the year ended December 31, 2011 were
$164,711 versus $149,881 for the year ended December 31, 2010, This represents
a 10% increase from the prior year. The change from the prior year is mostly
attributed to the insourcing of certain analytical work since we established
our laboratory and a more robust small animal study. These expenses consisted
mainly of allocated salary for our CEO, expense for our CSO and pre-clinical
in vivo and in vitro studies. We expect our R&D expenses to ramp up to
approximately $600 thousand over the next 12-18 months with most of the
expenses back ended.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year ended December
31,2011 were $69,126 versus $38,961 for the year ended December 31, 2010. This
represents a 77% increase from the prior year. This amount consisted primarily
of salary expense, and professional services and the change is due primarily
to an increase in accounting and legal fees in preparation for our Form S-1
filing.
--------------------------------- page 31 -------------------------------------
Net Income (Loss)
We had a Net Loss for the period of $125,188 versus a Net Loss of $131,473 for
the year ended December 31, 2010. This represents a 4% reduction in Net Loss
from the prior year. This reduction is due to the $110,550 grant revenue that
was realized during the first quarter of 2011 versus $60,200 realized in 2010.
Without the additional grant revenue, the net loss would have increased by 24%,
reflecting the increase in professional services fees and research and
development expenses during the current year. On a per share basis, we had a
$0.01 loss for the years ended December 31, 2011 and 2010.
Liquidity and Capital Resources
Sources of Liquidity
During the year ended December 31, 2011, net cash provided by operating
activities totaled $38,013. Net cash used in investing activities totaled
$50,381 which was put into a certificate of deposit that bears interest of
2.3% and matures in 55 months. Net cash used in financing activities during the
year was $37,233 of which included $8,000 proceeds from issuance of common stock
plus $3,862 in advances from a related party which were netted against
repayments to the related party of $49,095. The resulting change in cash for
the period was a decrease of $49,601. The cash balance at the beginning of the
year was $57,831. The cash balance at the end of the year was $8,230.
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 advances from related parties which were netted against $14,069 of
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 was $57,831.
The Company had cash of $8,230 as of December 31, 2011, as compared to $57,831
as of December 31, 2010. As of December 31, 2011, the Company had prepaid
assets of $429, as compared to $1,900 as of December 31, 2010. The Company also
has $1,195 in security deposits as of December 31, 2011 and had $0 of security
deposits as of December 31, 2010. The Company had long-term assets at December
31, 2011 of $50,381 in a certificate of
deposit account; therefore the Company had total assets of $60,235. This is in
comparison to December 31, 2010, where the Company had no long-term assets and
total assets of $59,731.
--------------------------------- page 32 -------------------------------------
As of December 31, 2011, the Company had $399,638 in total current
liabilities, which was represented by $26,350 in accounts payable, $24,637 in
accrued expenses, $330,000 in accrued officer compensation and $18,651 due to a
stockholder. This is in comparison to December 31, 2010, where the Company had
$289,726 in total current liabilities, which was represented by $15,842 in
accounts payable and accrued expenses, $210,000 in accrued officer compensation
and $63,884 due to a stockholder.
The Company had no long-term liabilities at December 31, 2011; therefore the
Company had total liabilities of $399,638. This is in comparison to December
31, 2010, where the Company had no long-term liabilities and total liabilities
of $289,726.
From inception (April 17, 2009) to December 31, 2011, net cash used in
operating activities totaled $45,692. Net cash used in investing activities
totaled $50,381 which was put into a certificate of deposit that bears
interest of 2.3% and matures in 55 months. Net cash provided by financing
activities since inception to December 31, 2011 was $104,303 of which $35,652
was from proceeds from issuances of common stock plus $137,518 advances from
related parties which was netted against $68,867 of payments to related
parties. The resulting change in cash for the period was an increase of
$8,230. There was no cash balance at inception. The cash balance on December
31, 2011 totaled $8,230.
The Company is not aware of any known trends, events or uncertainties which
may affect its future liquidity.
--------------------------------- page 33 -------------------------------------
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
During the year ended December 31, 2011 the Company issued 23,500
shares of its common stock for services provided by its Chief Scientific
officer valued at $4,700. Our agreement with our CSO provides for compensation
in the form of $200 per hour for work performed. The expense is paid 50% in
equity valued at $0.20 per share and 50% in cash. The fair market value of our
shares used for compensation is $0.20 and is based on the pricing of our last
private place offering. As of January 19, 2012, the fair market value for
services will be $1.05 based on the per share pricing of our most recent
offering.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are
reasonably likely to have a current or future effect on our financial
condition, changes in financial condition, revenues or expenses, results of
operations, liquidity, capital expenditures or capital resources that are
material to stockholders.
Future Financings
On January 19, 2012, the United States Securities and Exchange Commission
granted our registration statement as filed on Form S-1 (File No. 333-176329)
effective. This registered offering is still ongoing as of this filing.
We will continue to rely on equity sales of our common shares in order to
continue to fund our business operations. Issuances of additional shares will
result in dilution to existing stockholders. There is no assurance that we
will achieve any additional sales of the equity securities or arrange for
debt or other financing to fund our operations and other activities.
Critical Accounting Policies
We regularly evaluate the accounting policies and estimates that we use to
A complete summary of these policies is included in the notes to our financial
statements. In general, management's estimates are based on historical
experience, on information from third party professionals, and on various other
assumptions that are believed to be reasonable under the facts and
circumstances. Actual results could differ from those estimates made by
management.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
consolidated financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those
estimates.
--------------------------------- page 34 -------------------------------------
Cash and Cash Equivalents
The Company considers all highly liquid debt instruments and other short-term
investments with maturities of three months or less, when purchased, to be cash
equivalents. The Company maintains cash balances at one financial institution
that is insured by the Federal Deposit Insurance Corporation ("FDIC") up to
$250,000. As of December 31, 2011, the Company's cash balances did not exceed
the FDIC limits.
Certificates of Deposit
Certificates of deposit totaling $51,054 are included as a certificate of
deposit classified under long-term assets in the accompanying financial
statements. The certificate bears interest of 2.3% and matures in 55 months,
with penalties for early withdrawal. Any penalties for early withdrawal would
not have a material effect on the financial statements.
S Corporation-Income Tax Status
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.
The Company has filed to revoke it S election status effective as of
01/01/2012. Any income tax asset or liability will be recognized during
the first quarter of 2012.
--------------------------------- page 35 -------------------------------------
Revenue Recognition
The Company will recognize revenue when evidence of an arrangement exists,
title has passed or services have been rendered, the selling price is fixed
or determinable and collectability is reasonably assured. Revenue from
product sales to new customers will be recognized when all elements of the
sale have been delivered. All costs related to product shipment will be
recognized at time of shipment. The Company does not expect to provide for
rights of return to customers on product sales and therefore will not
record a provision for returns.
Revenue from grant awards is recorded as income when the funds from the
respective grant are received and all conditions under the grant have been met.
Research and development
The Company accounts for research and development costs in accordance with the
Accounting Standards Codification subtopic 730-10, Research and Development
("ASC 730-10"). Under ASC 730-10, all research and development costs must be
charged to expense as incurred. Accordingly, internal research and development
costs are expensed as incurred. Third-party research and development costs are
expensed when the contracted work has been performed or as milestone results
have been achieved. Company-sponsored research and development costs related
to both present and future products are expensed in the period incurred. For
the years ended December 31, 2011 and 2010, the Company incurred research and
development expenses of $164,711 and $149,881, respectively.
--------------------------------- page 36 -------------------------------------
Fair Value of Financial Instruments
Pursuant to ASC No. 820, Fair Value Measurements and Disclosures, the Company
is required to estimate the fair value of all financial instruments included on
its balance sheet as of September 30, 2011 and 2010. The Company's financial
instruments consist of payables and due to related party. The Company considers
the carrying value of such amounts in the financial statements to approximate
their fair value due to the short-term nature of these financial instruments.
Loss Per Share of Common Stock
The Company follows ASC No. 260, Earnings Per Share (ASC No. 260) that
requires the reporting of both basic and diluted earnings (loss) per share.
Basic earnings (loss) per share is computed by dividing net income (loss)
available to common stockholders by the weighted average number of common
shares outstanding for the period. The calculation of diluted earnings (loss)
per share reflects the potential dilution that could occur if securities or
other contracts to issue common stock were exercised or converted into common
stock. In accordance with ASC No. 260, any anti-dilutive effects on net
earnings (loss) per share are excluded. There were no potential dilutive
common shares at DEcember 31, 2011 or December 31, 2010.
Stock-Based Compensation
The Company accounts for stock-based compensation under ASC Topic 505-50,
This standard define a fair value-based method of accounting for stock-based
compensation. The cost of stock-based compensation is measured at the grant
date based on the value of the award and is recognized over the period in
which the Company expects to receive the benefit, which is generally the
vesting period. The Company adopted its 2010 Stock Option Plan in May of
2010 allowing for a maximum of five million shares to be issued. At
December 31, 2011, no options have been granted.
The following table highlights all of our equity based transactions from
inception through December 31, 2011.
--------------------------------- page 37 -------------------------------------
Equity Schedule
1/3/2010 Change of authorized capital to 15,000,000 shares / restated par value of $0.001
Common Shares
---------------- Paid-in Related
Shares Amount Capital Party (Y/N)
------- -------- ---------- -------------
4/9/2009 Shares issued to president/founder at inception 1,500 $ 2 $ -- Yes
---------- -------- ---------- -------------
Balance at December 31, 2009, retroactively restated 1,500 2 --
1/4/2010 Cancellation of $50k in shareholder loan bal converted
to equity 11,000,000 11,000 39,000 Yes
3/1/2010 Equity per subscription agreement $0.20/share 70,000 70 13,930 No
6/30/2010 R. Sinbaldi payment of svc's with stock per agreement 5,000 5 995 Yes
7/29/2010 Equity per subscription agreement $0.20/share 25,000 25 4,975 No
7/31/2010 R. Sinbaldi payment of svc's with stock per agreement 2,500 2 498 Yes
9/9/2010 Equity per subscription agreement $0.20/share 43,250 43 8,607 No
12/31/2010 R. Sinbaldi payment of svc's with stock per agreement 2,500 3 497 Yes
---------- --------- ----------
BALANCE December 31, 2010, as restated 11,149,750 11,150 68,502
---------- --------- ----------
1/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 1,500 2 298 Yes
2/28/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,000 2 398 Yes
3/27/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,000 2 398 Yes
4/1/2011 Dr. Perin MD 15,000 shares for consulting 15,000 15 2,985 Yes
4/11/2011 Shares issued for cash at $0.20/share 7,500 8 1,492 No
4/30/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500 2 498 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 3 597 Yes
6/30/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500 2 498 Yes
6/30/2011 Payment for financial services- invoice for $880
to stock @ $0.20/sh 4,400 4 876 No
7/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500 2 498 Yes
8/12/2011 Equity per subscription agreement $0.20/share 32,500 32 6,468 No
8/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500 3 497 Yes
9/30/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500 3 497 Yes
10/31/2011 R. Sinbaldi payment of svc's with stock per
agreement ($0.20 /share) 2,500 3 497 Yes
----------- ---------- ----------
BALANCE December 31, 2011, as restated 11,232,650 $ 11,233 $ 84,999
----------- ---------- ----------
----------- ---------- ----------
--------------------------------- page 38 -------------------------------------
As stated elsewhere, we have previously placed a value for our private
share placements at $0.20 per share. On January 19, 2012, the United
States Securities and Exchange Commission granted our registration
statement as filed on Form S-1 effective. The pricing in this
offering is $1.05. Any equity based trasnactions will be priced at
$1.05 until such time as a market develops for our shares if one
develops at all.
Recently Issued Accounting Pronouncements
In May 2011, FASB issued Accounting Standards Update 2011-04 Fair Value
Measurement (ASU 2011-04). The amendments in ASU 2011-04 change the wording
used to describe the requirements in U.S. GAAP for measuring fair value and
for disclosing information about fair value measurements. The amendments
include (1) those that clarify the Board's intent about the application of
existing fair value measurement and disclosure requirements and (2) those that
change a particular principle or requirement for measuring fair value or for
disclosing information about fair value measurements. In addition, to improve
consistency in application across jurisdictions some changes in wording are
necessary to ensure that U.S. GAAP and IFRS fair value measurement and
disclosure requirements are described in the same way (for example, using the
word shall rather than should to describe the requirements in U.S. GAAP). The
amendments that clarify the Board's intent about the application of existing
fair value measurement and disclosure requirements include (a) the application
of the highest and best use and valuation premise concepts, (b) measuring the
fair value of an instrument classified in a reporting entity's shareholders'
equity, and (c) disclosures about fair value measurements that clarify that a
reporting entity should disclose quantitative information about the
unobservable inputs usedin a fair value measurement that is categorized within
Level 3 of the fair value hierarchy. The amendments in this Update that change
a particular principle or requirement for measuring fair value or disclosing
information about fair value measurements include (a) measuring the fair value
of financial instruments that are managed within a portfolio, (b) application of
premiums and discounts in a fair value measurement, and (c) additional
disclosures about fair value measurements that expand the disclosures about
fair value measurements. The amendments in ASU 2011-04 are to be applied
prospectively. For public entities, the amendments are effective during
interim and annual periods beginning after December 15, 2011. Early
application by public entities is not permitted. Management does not expect
the adoption of ASU 2011-04 to have a material effect on the Company's financial
position, results of operations or cash flows.
ITEM 7A. QUANTITATIVE AND QUALITITATIVE DISCLOSURES
ABOUT MARKET RISK.
Our exposure to market risk is confined to our cash and cash equivalents, all
of which are held in US dollar denominated cash. The goal of our investment
policy is to preserve capital and maintain liquidity as needed to allow for
the fastest completion of our development program. We do have operations in
foreign countries including Korea and China. While the China currency is
currently pegged to the US dollar, there is risk that this policy will shift
in the future. We attempt to mitigate the risk posed by currency fluctuations
by negotiating our contracts to be payable in US dollars. All of our current
contracts have been negotiated in this manner. We currently have not entered
into any hedging or derivative contracts.
--------------------------------- page 39 -------------------------------------
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
INDEX TO COSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm Page 41
Balance Sheets at December 31, 2011 and 2010 Page 42
Statements of Operations for the years ended Page 43
December 31, 2011 and 2010 and for the period from
April 17, 2009 (Inception) through December 31, 2011
Statements of Stockholders Equity (Deficit) Page 44
for the period from April 17, 2009 (Inception) through
December 31, 2011
Statements of Cash Flows for the years
ended December 31, 2011 and 2010 and for the period
from April 17, 2009 (Inception) through December 31, 2011 Page 45
Notes to Financial Statements Page 46
--------------------------------- page 40 -------------------------------------
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of Cardigant Medical, Inc.
Manhattan Beach, California
We have audited the accompanying balance sheets of Cardigant Medical, Inc. as
of December 31, 2011 and 2010, and the related statements of operations,
stockholders' equity, and cash flows for the years then ended and for the
period from its inception (April 17, 2009) to December 31, 2011. Cardigant
Medical, Inc.'s management is responsible for these financial statements.
Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public
Company Accounting Oversight Board (United States). Those standards require
that we plan and perform the audits to obtain reasonable assurance about
whether the financial statements are free of material misstatement. The
company is not required to have, nor were we engaged to perform, an audit of
its internal control over financial reporting. Our audit included
consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of the company's
internal control over financial reporting. Accordingly, we express no such
opinion. An audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing
the accounting principles used and significanestimates made by management, as
well as evaluating the overall financial statement presentation. We believe
that our audits provide a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Cardigant Medical, Inc. as of
December 31, 2011 and 2010, and the results of its operations and its cash flows
for the years then ended and for the period from its inception (April 17, 2009)
to December 31, 2011 in conformity with accounting principles generally accepted
in the United States of America.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in the Note 1 to the
financial statements, the Company is in the development stage with a limited
operating history, has generated losses from operations to date, does not
expect to generate operating revenue for several years, and its viability is
dependent upon its ability to obtain financing and the success of its future
operations. These factors raise substantial doubt about its ability to continue
as a going concern. Management's plan in regards to these matters is also
discussed in Note 1. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
/s/ Jonathon P. Reuben CPA
Jonathon P. Reuben CPA,
An Accountancy Corporation
Torrance, California
March 30, 2012
--------------------------------- page 41 -------------------------------------
CARDIGANT MEDICAL INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
December 31,
2011 2010
--------------------------
ASSETS
CURRENT ASSETS
Cash $8,230 $57,831
Prepaid expense 429 1,900
Deposits 1,195 -
-------- --------
Total current assets 9,854 59,731
-------- --------
OTHER ASSETS
Certificate of Deposit 50,381 -
-------- --------
TOTAL ASSETS $60,235 $59,731
-------- --------
-------- --------
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
CURRENT LIABILITIES
Accounts payable $26,350 -
Accrued expenses 24,637 15,842
Accrued officer compensation 330,000 210,000
Due to stockholder 18,651 63,884
-------- --------
Total current liabilities 399,638 289,726
-------- --------
TOTAL LIABILITIES 399,638 289,726
-------- --------
STOCKHOLDERS' (DEFICIT)
Common stock, 25,000,000 shares authorized,
$0.001" par value, 11,232,650 issued and
outstanding at December 31, 2011, 11,149,750
shares issued and outstanding at December
31, 2010 11,233 11,150
Additional paid-in capital 84,999 68,502
Deficit accumulated during the development stage (435,635) (309,647)
-------- --------
Total stockholders' (deficit) (339,403) (229,995)
-------- --------
TOTAL LIABILITIES AND STOCKHOLDERS'(DEFICIT) $60,235 $59,731
-------- --------
-------- --------
(The accompanying notes are an integral part of these financial statements)
--------------------------------- page 42 -------------------------------------
CARDIGANT MEDICAL INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
From Inception
(April 17, 2009)
For Year Ended For Year Ended to
December 31 December 31, December 31,
2011 2010 2011
--------------- --------------- ---------------
REVENUE $ - $ - $ -
--------------- --------------- ---------------
OPERATING EXPENSES
Research and development 164,711 149,881 434,978
Selling, general, and administrative 69,126 38,961 165,314
--------------- --------------- ---------------
Total operating expenses 233,837 188,842 600,292
--------------- --------------- ---------------
(LOSS) FROM OPERATIONS (233,837) (188,842) (600,292)
--------------- --------------- ---------------
OTHER INCOME/(EXPENSES)
Grant from National Institute of Health 110,550 60,200 170,750
Interest income 381 - 381
Interest expense (2,282) (2,031) (4,874)
--------------- --------------- ---------------
Net Loss before income taxes $(125,188) $(130,673) $(434,035)
Provision for taxes (800) (800) (1,600)
--------------- --------------- ---------------
NET (LOSS) $(125,988) $(131,473) $(435,635)
--------------- --------------- ---------------
--------------- --------------- ---------------
(LOSS) PER COMMON SHARE -
BASIC AND DILUTED $(0.01) $(0.01)
--------------- ---------------
--------------- ---------------
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 11,192,876 11,087,021
--------------- ---------------
--------------- ---------------
(The accompanying notes are an integral part of these financial statements)
--------------------------------- page 43 -------------------------------------
CARDIGANT MEDICAL INC
(A DEVELOPMENT STAGE COMPANY)
STATEMENT OF CHANGES IN STOCKHOLDERS' (DEFICIT)
FOR THE PERIOD FROM INCEPTION (APRIL 17, 2009) THORUGH DECEMBER 31, 2011
Additional
Transaction Common Stock Paid-In Accumulated
Unit Price Date Shares Amount Capital Deficit Total
----------- ---------- ------- -------- ------- -------- -------
Shares issued to founder $0.001 4/9/2009 1,500 $2 $- $- $2
Net loss from April 17, 2009 through December 31, 2009 - - - (178,174) (178,174)
-------- -------- ------- -------- --------
Balance - December 31, 2009 1,500 2 - (178,174) (178,172)
Shares issued in exchange for the cancellation of
$50,000 of debt due its founder $0.005 1/4/2010 11,000,000 11,000 39,000 - 50,000
Issuance of shares for cash $0.200 3/1/2010 70,000 70 13,930 - 14,000
Shares issued to Chief Scientific Officer for services $0.200 6/30/2010 5,000 5 995 - 1,000
Issuance of shares for cash $0.200 7/29/2010 25,000 25 4,975 - 5,000
Shares issued to Chief Scientific Officer for services $0.200 7/31/2010 2,500 2 498 - 500
Issuance of shares for cash $0.200 9/9/2010 43,250 43 8,607 - 8,650
Shares issued to Chief Scientific Officer for services $0.200 12/31/2010 2,500 3 497 - 500
Net loss for the year - - - (131,473) (131,473)
--------- ---------- ------- -------- ---------
Balance - December 31, 2010 11,149,750 $11,150 $68,502 $(309,647) $(229,995)
Shares issued to Chief Scientific Officer for services $0.200 1/31/2011 1,500 2 298 - 300
Shares issued to Chief Scientific Officer for services $0.200 2/28/2011 2,000 2 398 - 400
Shares issued to Chief Medical Officer for services $0.200 4/01/2011 15,000 15 2985 - 3,000
Issuance of shares for cash $0.200 4/11/2010 7,500 8 1,492 - 1,500
Shares issued to Chief Scientific Officer for services $0.200 4/30/2011 4,500 5 895 - 900
5/20/2011 Change of authorized capital to 25,000,000 shares
Shares issued to Chief Scientific Officer for services $0.200 5/31/2011 3,000 3 597 - 600
Shares issued to Chief Scientific Officer for services $0.200 6/30/2011 2,500 2 498 - 500
Payment for financial services- invoice for $880 $0.200 6/30/2011 4,400 5 875 - 880
Shares issued to Chief Scientific Officer for services $0.200 7/31/2011 2,500 2 498 - 500
Issuance of shares for cash $0.200 8/12/2011 32,500 33 6,467 - 6,500
Shares issued to Chief Scientific Officer for services $0.200 8/31/2011 2,500 2 498 - 500
Shares issued to Chief Scientific Officer for services $0.200 9/30/2011 2,500 2 498 - 500
Shares issued to Chief Scientific Officer for services $0.200 10/31/2011 2,500 2 498 - 500
Net loss for the year - - - (125,988) (125,988)
--------- ---------- ------- -------- ---------
Balance - December 31, 2011 11,232,650 $11,233 $84,999 $(435,635) $(339,403)
--------- ---------- ------- -------- ---------
--------- ---------- ------- -------- ---------
(The accompanying notes are an integral part of these financial statements)
--------------------------------- page 44 -------------------------------------
CARDIGANT MEDICAL INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
From date of
For year ended For Year Ended inception
(April17, 2009)
to
December 31, December 31, December 31,
2011 2010 2011
------------- ------------- ------------
CASH FLOWS FROM OPERATING ACTIVITIES
Net (loss) $(125,988) $(131,473) $(435,635)
Adjustments to reconcile net income (loss) to net cash provided by
(used in) operating activities:
Stock Based Compensation 8,580 2,000 10,580
Net changes in operating assets and liabilities:
Decrease in prepaid expenses 1,471 (1,900) (429)
(Increase) in deposits (1,195) - (1,195)
Increase (decrease) in accounts payable 26,350 - 26,350
Increase (decrease) in accrued expenses 8,795 2,184 24,637
Increase in accrued officer compensation 120,000 120,000 330,000
-------- -------- --------
Net cash provided by (used in) operating activities 38,013 (9,189) (45,692)
-------- -------- --------
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in long-term certificate of deposit (100,381) - (100,381)
Redemption of certificate of deposit 50,000 - 50,000
-------- -------- --------
Net cash provided by (used in) investing activities (50,381) - (50,381)
-------- -------- --------
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common stock 8,000 27,650 35,652
Advancements from related party 3,862 42,131 137,518
Repayments to related party (49,095) (14,069) (68,867)
-------- -------- --------
Net cash provided by (used in) financing activities (37,233) 55,712 104,303
-------- -------- --------
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (49,601) 46,523 8,230
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD 57,831 11,308 -
-------- -------- --------
CASH AND CASH EQUIVALENTS - END OF PERIOD $8,230 $57,831 $8,230
-------- -------- ---------
-------- -------- ---------
SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITY
Cash paid during the year for income taxes $800 $- $800
-------- -------- --------
-------- -------- --------
Cash paid during the year for interest expense $2,282 $2,031 $4,874
-------- -------- --------
-------- -------- --------
Noncash investing and financing activities:
During the year ended December 31, 2011 the Company issued 23,500 shares of its common stock for services provided
by its Chief Scientific Officer valued at $4,700.
In April 2011 the Company issued 15,000 shares of its common stock to its Chief Medical Officer in connection with its
research and development efforts. The 15,000 shares were valued at $3,000 and are being charged to operations over 2011
as per the underlying consulting agreement.
In June 2011, the Company cancelled $880 of accounts payable for bookkeeping services in exchange for the issuance of 4,400
shares of its common stock.
In January 2010, the Company's founder converted $50,000 of his shareholder loan balance in exchange for 11,000,000 shares
of the Company's common stock. There was no compensation or interest expense included in the conversion.
During the year ended December 31, 2010 the Company issued 10,000 shares of its common stock for services provided by its Chief
Scientific Officer valued at $2,000.
(The accompanying notes are an integral part of these financial statements)
--------------------------------- page 45 -------------------------------------
(1) Nature and Continuance of Operations
Description of the Business
Cardigant Medical Inc. ("Cardigant" or "Company") is a development stage
biotechnology company focused on the development of novel biologic compounds
and enhanced methods for local delivery for the treatment of cardiovascular
disease. Cardigant was founded on April 17, 2009 and is incorporated within
the state of Delaware. The Company is engaged in research and development
in multiple countries but maintains its corporate office in greater Los
Angeles. The Corporation has elected to be taxed under the provisions of
Subchapter "S" for income tax purposes. Effective January 1, 2012, the Company
has elected to revoke it S election status, and will be a taxable entity going
forward.
The Company is in the development stage, as defined in Accounting Codification
Standard ("ACS") Topic 915-10. From its inception (April 17, 2009) through
December 31, 2011, the Company has not had any revenue from its principal
planned operations. The Company will continue to report as a development
stage company until significant revenues are produced.
On January 3, 2010, the Company filed an amendment to its articles of
incorporation changing its authorized capital to 15,000,000 shares of common
stock at a restated par value of $0.001. The accompanying financial statements
have been restated to reflect the change in capital and stock split as if they
occurred at the Company's inception. In May of 2011, the Company further
amended its articles of incorporation increasing its authorized capital to
25,000,000 with a par value of $0.001.
Going Concern
The Company's financial statements are prepared using the accrual method of
accounting in accordance with accounting principles generally accepted in
the United States of America and have been prepared on a going concern basis,
which contemplates the realization of assets and the settlement of liabilities
in the normal course of business. The Company has generated losses from
operations to date, does not expect to generate operating revenue for several
years, and its viability is dependent upon its ability to obtain financing and
the success of its future operations. These factors raise substantial doubt
about the Company's ability to continue as a going concern. Management's plan
in regards to these matters is to raise funds through the sale of common stock.
These financial statements do not include any adjustments relating to the
recoverability and classification of recorded assets or liabilities that might
be necessary should the Company be unable to continue as a going concern.
(2) Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid debt instruments and other short-term
investments with maturities of three months or less, when purchased, to be cash
equivalents. The Company maintains cash balances at one financial institution
that is insured by the Federal Deposit Insurance Corporation ("FDIC") up to
$250,000. As of December 31, 2011, the Company's cash balances did not exceed
the FDIC limits.
Certificates of Deposit
A certificate of deposit totaling $50,381 has been classified as a long-term
asset in the accompanying financial statements. The certificate bears interest
of 2.3% and matures in 55 months, with penalties for early withdrawal. Any
penalties for early withdrawal would not have a material effect on the
financial statements.
Revenue Recognition
The Company recognizes revenue when evidence of an arrangement exists, title
has passed (generally upon shipment) or services have been rendered, the
selling price is fixed or determinable and collectability is reasonably
assured. Revenue from product sales to new customers is recognized when all
elements of the sale have been delivered. All costs related to product shipment
are recognized at time of shipment. The Company does not provide for rights
of return to customers on product sales and therefore does not record a
provision for returns.
Revenue from grant awards is recorded as income when the funds from the
respective grant are received and all conditions under the grant have been met.
--------------------------------- page 46 -------------------------------------
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and
amortization. Depreciation and amortization are calculated using the
straight-line method and with useful lives used in computing depreciation
ranging from 3 to 5 years. When property and equipment are retired or otherwise
disposed of, the related cost and accumulated depreciation are removed from the
respective accounts, and any gain or loss is included in operations.
Expenditures for maintenance and repairs are charged to operations
as incurred; additions, renewals and betterments are capitalized.
Long-Lived Assets
The Company accounts for its long-lived assets in accordance with ASC Topic
360-10 "Accounting for the Impairment or Disposal of Long-Lived Assets." ASC
Topic 360-10 requires that long-lived assets be reviewed for impairment
whenever events or changes in circumstances indicate that the historical cost
carrying value of an asset may no longer be appropriate. The Company assesses
recoverability of the carrying value of an asset by estimating the future net
cash flows expected to result from the asset, including eventual disposition.
If the future net cash flows are less than the carrying value of the asset, an
impairment loss is recorded equal to the difference between the asset's
carrying value and fair value or disposable value. As of December 31, 2011 and
2010, the Company had no long-lived assets.
Research and Development
The Company accounts for research and development costs in accordance with
ASC Topic 730-10 "Research and Development." Under ASC Topic 730-10, all
research and development costs must be charged to expense as incurred.
Third-party research and development costs are expensed when the contracted
work has been performed or as milestone results have been achieved. Company
sponsored research and development costs related to both present and future
products are expensed in the period incurred. For the years ended December 31,
2011 and 2010, the Company incurred research and development expenses of
$164,711 and $149,881, respectively.
Income Taxes
Income taxes are accounted for under the asset and liability method in
accordance with ASC Topic 740-10. Deferred tax assets and liabilities are
recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities
and their respective tax bases and operating loss carryforwards. Deferred tax
assets and liabilities are measured using enacted tax rates expected to apply
to taxable income in the years in which those temporary differences are
expected to be recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period
that includes the enactment date. When it is considered to be more likely than
not that a deferred tax asset will not be realized, a valuation allowance is
provided for the excess.
The Company, with the consent of its shareholders, has elected under the
Internal Revenue Code to be an S corporation. In lieu of corporate 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.
Effective January 1, 2012, the Company has elected to revoke it S election
status, and will be a taxable entity going forward.
--------------------------------- page 47 -------------------------------------
Stock-Based Compensation
The Company accounts for its stock-based compensation under ASC Topic 505-50.
This standard defines a fair value-based method of accounting for stock-based
compensation. In accordance with ASC Topic 505-50, the cost of stock-based
compensation is measured at the grant date based on the value of the award and
is recognized over the period in which the Company expects to receive the
benefit, which is generally the vesting period. Stock-based compensation for
the year ended December 31, 2011 was comprised of the issuance of 42,900 shares
of common stock for services rendered. The 42,900 common shares were valued at
$8,580. Stock-based compensation for the year ended December 31, 2010 was
comprised of the issuance of 10,000 shares of common stock for services
rendered. The 10,000 common shares were valued at $2,000.
The Company adopted its 2010 Stock Option Plan in May of 2010 allowing for a
maximum of five million shares to be issued. At December 31, 2011, no options
have been granted.
Per Share Amounts
The Company reports earnings (loss) per share in accordance with ASC Topic
260-10 "Earnings per Share." Basic earnings (loss) per share is computed by
dividing income (loss) available to common shareholders by the weighted average
number of common shares available. Diluted earnings (loss) per share is
computed similar to basic earnings (loss) per share except that the denominator
is increased to include the number of additional common shares that would have
been outstanding if the potential common shares had been issued and if the
additional common shares were dilutive. For the years ended December 31, 2011
and 2010, the Company did not have equity or debt instruments issued or granted
which would be anti-dilutive. Earnings (loss) per share calculations reflect
the effects of the restated par value that occurred with the January 2010
amendment to its articles of incorporation, as discussed in Note 1.
Recent Accounting Pronouncements
In May 2011, FASB issued Accounting Standards Update 2011-04 "Fair Value
Measurement"(ASU 2011-04). The amendments in ASU 2011-04 change the wording
used to describe the requirements in U.S. GAAP for measuring fair value and for
disclosing information about fair value measurements. The amendments include
(1) those that clarify the Board's intent about the application of existing
fair value measurement and disclosure requirements and (2) those that change
a particular principle or requirement for measuring fair value or for
disclosing information about fair value measurements. In addition, to improve
consistency in application across jurisdictions some changes in wording are
necessary to ensure that U.S. GAAP and IFRS fair value measurement and
disclosure requirements are described in the same way (for example, using
the word shall rather than should to describe the requirements in U.S. GAAP).
The amendments that clarify the Board's intent about the application of
existing fair value measurement and disclosure requirements include (a) the
application of the highest and best use and valuation premise concepts, (b)
measuring the fair value of an instrument classified in a reporting entity's
shareholders' equity, and (c) disclosures about fair value measurements that
clarify that a reporting entity should disclose quantitative information about
the unobservable inputs used in a fair value measurement that is categorized
within Level 3 of the fair value hierarchy. The amendments in this Update that
change a particular principle or requirement for measuring fair value or
disclosing information about fair value measurements include (a) measuring the
fair value of financial instruments that are managed within a portfolio, (b)
application of premiums and discounts in a fair value measurement, and (c)
additional disclosures about fair value measurements that expand the
disclosures about fair value measurements. The amendments in ASU 2011-04 are
to be applied prospectively. For public entities, the amendments are effective
during interim and annual periods beginning after December 15, 2011. Early
application by public entities is not permitted. Management does not expect
the adoption of ASU 2011-04 to have a material effect on the Company's
financial position, results of operations or cash flows.
(3) Fair Value Measurements
The Company follows the provisions of ASC No. 820-10 "Fair Value Measurements."
ASC 820-10 relates to financial assets and financial liabilities. ASC 820-10
defines fair value, establishes a framework for measuring fair value in
accounting principles generally accepted in the United States of America
(GAAP), and expands disclosures about fair value measurements. The provisions
of this standard apply to other accounting pronouncements that require or
permit fair value measurements and are to be applied prospectively with limited
exceptions.
ASC 820-10 defines fair value as the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market
participants at the measurement date. ASC 820-10 establishes a fair value
hierarchy that distinguishes between (1) market participant assumptions
developed based on market data obtained from independent sources (observable
inputs) and (2) an entity's own assumptions, about market participant
assumptions, that are developed based on the best information available in the
circumstances (unobservable inputs). The fair value hierarchy consists of three
broad levels, which gives the highest priority to unadjusted quoted prices in
active markets for identical assets or liabilities (Level 1) and the lowest
priority to unobservable inputs (Level 3). The three levels of the fair value
hierarchy under ASC 820-10 are described below:
Level 1 - Unadjusted quoted prices in active markets that are accessible at the
measurement date for identical, unrestricted assets or liabilities.
Level 2 - Inputs other than quoted prices included within Level 1 that are
observable for the asset or liability, either directly or indirectly,
including quoted prices for similar assets or liabilities in active markets;
quoted prices for identical or similar assets or liabilities in markets that
are not active; inputs other than quoted prices that are observable for the
asset or liability (e.g., interest rates); and inputs that are derived
principally from or corroborated by observable market data by correlation or
other means.
Level 3 - Inputs that are both significant to the fair value measurement and
unobservable. These inputs rely on management's own assumptions about the
assumptions that market participants would use in pricing the asset or
liability. (The unobservable inputs are developed based on the best
information available in the circumstances and may include the Company's own
data.)
The following table presents the Company's fair value hierarchy for those
assets and liabilities measured at fair value on a recurring basis as of
December 31, 2011 and 2010:
December 31, 2011
Carrying
Level Fair Value Amount
Liabilities
Due to stockholder 2 $ 18,651 $ 18,651
December 31, 2010
Carrying
Level Fair Value Amount
Liabilities
Due to stockholder 2 $ 63,884 $ 63,884
Recorded values for the due to stockholder liability approximate their fair
values due to the short maturities of such instruments.
(4) Grant Award and Concentration
In November 2010 the Company was awarded a non-taxable grant in the amount of
$170,750. Of this total, $60,200 was paid in December 2010 with the remaining
$110,500 paid in February 2011. This grant was awarded under the Qualifying
Therapeutic Discovery Project Program. There were no specific
future performance obligations under the grant as it was awarded based on
previous research and development expenses incurred. Funds from this grant
award represented 100% of the Company's income for the years ended December
31, 2011 and 2010.
(5) Related Party Transactions
The Company has thus far received much of its working capital from its founder
Jerett A. Creed. These costs have been carried as a shareholder loan accruing
interest at the rate of 5% per annum. On January 4, 2010, Mr. Creed converted
$50,000 of his outstanding shareholder loan balance in exchange for 11,000,000
shares of the Company's common stock. There was no compensation or interest
expense included in the conversion. The amounts due at December 31, 2011 and
2010, including accrued interest, amounted to $18,651 and $63,884,
respectively. Interest expense charged to operations for the years ended
December 31, 2011 and 2010 amounted to $2,282 and $2,031, respectively.
--------------------------------- page 48 -------------------------------------
(6) Accrued Officer's Compensation
The Company has been accruing a salary in the amount of $120,000 per annum for
its founder Jerett A. Creed since January 3, 2010. The balances accrued at
December 31, 2011 and 2010 were $330,000 and $210,000, respectively. Salary is
allocated between research and development and general and administrative based
upon time spent.
(7) Stockholder's Equity (Deficit)
There is no public market for the Company's common shares. Since its inception,
the Company has negotiated the value of its common stock in arm's length
transactions with all unrelated parties.
Year Ended December 31, 2011
On April 1, 2011 the Company entered into a consulting agreement with its Chief
Medical Officer for the period of approximately 21 months ending December 2012.
Compensation provided to the Chief Medical Officer consists of 30,000 shares of
the Company's restricted common stock, which will be earned by the consultant
in two equal installments of 15,000 shares on April 1, 2011 and January 1,
2012. Each installment of 15,000 shares of common stock was valued at $3,000
and is being amortized over the subsequent ten month period after issuance.
Amortization for the year ended December 31, 2011 totaled $2,571, which has
been charged to operations and included in research and development costs.
In April 2011, the Company issued 7,500 shares of its common stock in exchange
for receiving $1,500 in cash.
In June 2011, the Company issued 4,400 shares of its common stock in
cancellation of $880 due for past accounting services.
In August 2011 the Company issued a total of 32,500 shares of its common stock
in exchange for receiving $6,500 in cash.
During the year ended December 31, 2011 the Company issued 23,500 shares of its
common stock for services provided by its Chief Scientific officer valued at
$4,700 that has been charged to operations and included in research and
development costs.
Year Ended December 31, 2010
In January 2010, Jerett Creed, the Company's founder, cancelled $50,000 of
debt due him by the Company in exchange for receiving 11,000,000 shares of
its common stock.
In March 2010, the Company issued 70,000 shares of its common stock in
exchange for receiving $14,000 in cash.
In July 2010 the Company issued 25,000 shares of its common stock in exchange
for receiving $5,000 in cash.
In September 2010, the Company issued 43,250 shares of its common stock in
exchange for receiving $8,650 in cash.
During the year ended December 31, 2010 the Company issued 10,000 shares of its
common stock for services provided by its Chief Scientific officer valued at
$2,000, which has been charged to operations and included in research and
development costs.
A discounted cash flow model ("DCF") was developed internally to establish the
estimated value of the Company in determining the share price for equity
conversions and raises solely as a tool for management in negotiating
transactions. The Company believes that the discounted cash flow model
is the most appropriate model for valuing a non revenue generating enterprise
with no comparable publicly traded peers. This model was generated in part as
a function of the Company's strategic planning and budgeting process. It was
developed as an internal tool to help management make strategic business
decisions but also to help determine a reasonable value to management of the
Company's value on a per share basis. While the discounted cash flow model is
limited in that it is largely assumption driven, the Company believes it is the
best tool for valuing its common shares. The DCF took into account among other
factors the size of the markets, the technology it is attempting to address,
estimated market share, the anticipated research and development costs
associated with developing a product to address the market, the administrative
costs and resources that would be required, the estimated time to reach an
approval in Europe and the US, the estimated technology development risks,
the regulatory risks with delayed or denied approvals, and estimated future
revenue streams. In certain scenarios, the model extended 10 years with a 2%
perpetuity growth rate and used treasury pricing for risk free rates and a
28% weighted average cost of capital. However all equity transactions with
unrelated parties were conducted as arm's length transactions.
(8) Income Taxes
Deferred tax assets and liabilities are recognized for the future tax
consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective
tax bases and operating loss carryforwards. Deferred tax assets and liabilities
are measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment date.
When it is considered to be more likely than not that a deferred tax asset will
not be realized, a valuation allowance is provided for the excess.
The Company, with the consent of its shareholders, has elected under the
Internal Revenue Code to be an S corporation. In lieu of corporate 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.
Effective January 1, 2012, the Company has elected to revoke it S election
status, and will be a taxable entity going forward.
The Company had no material unrecognized income tax assets or liabilities as
of December 31, 2011 and 2010.
The Company's policy regarding income tax interest and penalties is to expense
those items as general and administrative expense and to identify them for tax
purposes. During the years ended December 31, 2011 and 2010, income tax
interest and penalties in the statement of operations totaled $624 and $0,
respectively. The Company files income tax returns in the U.S. federal
jurisdiction and the state of California. The Company is subject to income
tax examination by tax authorities for 2009, 2010 and 2011. The Company is
not currently involved in any income tax examinations.
(9) Commitments and Contingencies
Rental Agreement
On May 3, 2011 the Company entered into a rental agreement for laboratory space
at a bioscience collective in Pasadena, California. The rental agreement calls
for a security deposit of $1,100 and monthly rent payments of $1,100. The lease
is month to month and can be terminated by either party with thirty days'
notice.
Rent expense for the years ended December 31, 2011 and 2010 totaled $8,485 and
$155, respectively.
Option and License Agreement
Effective June 14, 2010, the Company entered into an option and license
agreement with Yeungnam University in South Korea covering the license of a
potential product candidate (CMI-121), but it has not determined if it will
advance this compound to the clinic or not. This agreement provides for
exclusive United States rights to use the patented gene sequence for the
treatment of vascular disease and disorders with respect to restenosis and
atherosclerosis arising from the buildup of plaque. The agreement subjects
the Company to both milestone and royalty obligations that are tied to the
commercialization of CMI-121 in the United States only.
Within 60 days of the first commercial sale of this product in the United
States, the Company will be required to pay a milestone fee to Yeugnam
University in the sum of $200,000. Upon United States commercialization,
the Company would also be subject to a 3% royalty payable in quarterly
installments based on average selling prices of this product in the United
States. The Company would not be required to make any milestone or royalty
payments on any sales generated outside of the United States. The royalty
obligation would continue for the life of the patent in the United States,
which is expected to continue through 2024.
As described above, the Company has not decided if we will pursue this
compound clinically and is still evaluating other similar non-patented
sequences that do not have a royalty burden or other performance
obligations associated with them. The Company is conducting research and
analyzing its existing data to determine which compound sequence and
formulation it will attempt to advance to the clinic. The monetary
obligations will form part of the decision criteria. Additional factors
will include pre-clinical efficacy data and ability to scale up
manufacturing of the compound.
(10) Subsequent Events
In January 2012, the Company issued 15,000 common shares to its Chief Medical
Officer for consulting services valued at $3,000, as described in Note 7. In
February 2012, the Company issued 476 common shares to its Chief Scientific
Officer for consulting services valued at $500.
On January 19, 2012, the United States Securities and Exchange Commission
recognized the Company's registration statement as filed on Form S-1 as
effective (File No. 333-176329). This self underwritten registered
offering provides for the sale of up to 2.2 million shares of Common
Stock priced at $1.05 per share. This offering is still open. Additional
information can be found in the Prospectus as filed with the SEC.
Pursuant to the offering described above, the Company issued 89,771 shares
in exchange for cash totaling $94,260 in January through March 2012.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
In connection with our compliance with securities laws and rules, our Chief
Financial Officer has evaluated our disclosure controls and procedures on
December 31, 2011. 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 at this time. There have
been no significant changes in our internal controls or in other factors
that could significantly affect these controls subsequent to the date of
their evaluation, including any corrective actions with regard to
significant deficiencies and material weaknesses.
In making this assessment, management, used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission in the
Internal Control-Integrated Framework. Inherent in a development stage entity
--------------------------------- page 49 -------------------------------------
is the problem of segregation of duties. Given that the Company has a limited
accounting department, segregation of duties cannot be completely accomplished
at this stage in the business lifecycle.
Based on its assessment, management has concluded that the Company's disclosure
controls and procedures and internal control over financial reporting are not
effective based on those criteria.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting
that occurred during the fourth quarter of the year ended December 31,
2011 that have materially affected, or that are reasonably likely to
materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE.
The following table sets forth the names, ages and positions of our
current executive officers and directors. All directors serve until the
next annual meeting of stockholders or until their successors are
elected and qualified. Officers are appointed by our board of directors
and their terms of office are, except to the extent governed by an
employment contract, at the discretion of our board of directors.
Jerett A. Creed
Chief Executive Officer, Chief Financial Officer, Chief Accounting Officer
(Age: 38, has served in the above capacities since our founding.)
Mr. Creed has more than 15 years of medtech experience including 11 years with
Johnson & Johnson in roles ranging from manufacturing, quality, product
development, and M&A/ licensing transactions focused on cardiology assets and
technologies including drug delivery devices, cell and gene based therapeutics,
and mechanical implants. His primary focus was on optimized delivery strategies
for large molecule therapeutics for treating ischemia related congestive heart
failure and vascular disease. Mr. Creed was the Director of Business
Development and R&D for Biologics Delivery Systems, a division of Cordis
Corporation (a Johnson & Johnson Company). Upon leaving Biologics Delivery
Systems he was a co-founder of Silverpoint Therapeutics, LLC. Silverpoint
designed and developed a percutaneous transendocardial injection catheter
for the delivery of cell and gene based therapeutics to the myocardium. The
company is currently in negotiations to be sold. Mr. Creed then went on to form
Cardigant Medical Inc. with a belief that local drug delivery to the
vasculature could improve clinical outcomes and reduce healthcare costs.
Cardigant is currently focused on the use of specially designed delivery
catheters for the targeted delivery of apoa-1 based therapeutics for treating
--------------------------------- page 50 -------------------------------------
vascular disease and aortic valve stenosis. Mr. Creed has designed and
executed various pre-clinical studies in large and small animal models as part
of numerous product development programs and has been involved with the
commercialization in both the US and Europe of several cardiovascular related
technologies including some of the first drug coated stent concepts. He has
completed several licensing and technology development contracts, and has been
involved in a leadership role with over $600 million in M&A transactions. Mr.
Creed serves as the sole board member of Cardigant until additional
appointments are made. He holds a bachelor of science degree in engineering and
a master of science degree in accounting, both from the University of Miami.
Ralph Sinibaldi, PhD
Vice President & Chief Scientific Officer
(Age: 63, has served in the above capacity since 2009)
Dr. Sinibaldi's career has spanned more than 30 years of senior level
biotechnology management and research including positions as VP of Product
development at GenoSpectra, VP of Scientific Affairs at Operon technologies,
VP of Product Development at Iris Biotechnologies and Senior Staff Scientist
at Sandoz. His particular expertise and research have focused in the areas of
gene expression, protein production optimization, and nucleic acid
hybridizations. Dr. Sinibaldi serves as the Chief Scientific Officer for
Cardigant Medical and is largely responsible for its assay development work,
apoa-1 protein production scale up and vector optimization. He has extensive
experience is designing, conducting and supervising complex in vitro and in
vivo experimental programs. Dr. Sinibaldi holds both a BS and MS in biological
sciences and a PhD in experimental biology all from the University of Illinois
at Chicago. Additionally Dr. Sinibaldi completed post docs in biochemistry from
the University of Illinois College of Medicine and developmental biology from
the University of Chicago.
Emerson C. Perin, MD, PhD, FACC
Chief Medical Officer
(Age: 52, has served in the above capacity since April 2011)
Dr. Perin is the Director of Clinical Research for Cardiovascular Medicine and
the Medical Director of the Stem Cell Center at the Texas Heart Institute at
St. Luke's Episcopal Hospital. He is a Clinical Assistant Professor of Internal
Medicine both at Baylor College of Medicine and The University of Texas Health
Science Center at Houston and a staff interventional cardiologist at St. Luke's
Episcopal Hospital. Dr. Perin has provided innovative cardiovascular care for
18 years, focusing on minimally invasive interventional approaches to therapy.
For the past 10 years, his major research interest has been the study of adult
stem cells and biologics for the treatment of acute myocardial infarction,
chronic heart failure, and peripheral vascular disease. Dr. Perin is an expert
in stem cell therapy and delivery. He was the first investigator in the United
States to receive approval from the Food and Drug Administration to inject stem
cells directly into the hearts of patients suffering from heart failure. Dr.
Perin serves as the Chief Medical Officer for Cardigant Medical and is largely
responsible for ensuring the designs of its pre-clinical programs translate
into innovative clinical products.
--------------------------------- page 51 -------------------------------------
Board Committees
Upon the completion of this offering, we will begin the process for nominating
additional board members. We anticipate having an initial board composition of
five (5) with at least two (2) external members. We anticipate compensation in
the range of $3,000 per year plus the addition of 20,000 stock options priced
at fair market value at the time of granting and the annual renewal thereof.
Audit Committee
Upon the appointment of our additional board members, we anticipate that two
(2) will be independent per the applicable listing standards. It is our goal
that one of these members serve with our Chief Financial Officer to make up
the initial audit committee.
Section 16(a) Beneficial Ownership Reporting Compliance.
Section 16(a) of the Securities Exchange Act of 1934 requires that our
executive officers and directors, and persons who own more than ten
percent of a registered class of our equity securities, file reports of
ownership and changes in ownership with the SEC. Executive officers,
directors and greater-than-ten percent stockholders are required by SEC
regulations to furnish us with all Section 16(a) forms they file. Based
solely on our review of the copies of the forms received by us and
written representations from certain reporting persons that they have
complied with the relevant filing requirements, we believe that, during
the year ended December 31, 2011, all of our executive officers,
directors and greater-than-ten percent stockholders complied with all
Section 16(a) filing requirements.
ITEM 11. EXECUTIVE COMPENSATION.
Summary Compensation Table
Our executive compensation program is designed to help us attract talented
individuals to manage and operate all aspects of our business, to reward those
individuals fairly over time and to retain those individuals who continue to
meet our high expectations. As a development stage company, we are limited in
the amount of cash compensation we can offer to accomplish this goal. As such
a large part of our executive compensation going forward will be based on our
Stock Option Plan. Currently only or CEO and CFO (currently served by the same
person) is compensated at the rate of $120,000 annually. This compensation has
not been paid and is simply being accrued pending sufficient funding. Our CSO
is being compensated on an hourly basis for time served paid as a mixture of
cash and stock. Our CSO is currently compensated at the rate of $100/ hour
plus the equivalent of $100/ hour of compensation paid in equity priced at
$0.20 per share. This equity conversion price will increase to the amount of
our offering price once the price is determined. 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
--------------------------------- page 52 -------------------------------------
market value of the shares at the time and 50% in cash.
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
2010 $120,000 $0 $0 $120,000
Ralph M. Sinibaldi, PhD; CSO 2011 $ 7,500 $0 $0 $ 7,500
2010 $13,632 $0 $0 $13,632
Emerson C. Perin, MD, PhD; CMO 2011 15,000 shares $0 $0 $3,000
(valued at $0.20 /sh)
2010 None $0 $0 None
Employment Contracts
As of December 31, 2011 we had three employees, Jerett Creed serving as our
Chief Executive Officer and Chief Financial Officer, Ralph Sinibaldi, PhD
serving as our Chief Scientific Officer and Emerson Perin, MD, PhD serving as
our Chief Medical Officer. Mr. Creed's Employment Agreement extends until he
is no longer able or willing to provide services to us. Mr. Creed is entitled
to annual compensation in the amount of $120,000 per year. Additionally the
agreement provides for 5% accrued annual interest on the outstanding principle
balance for any funds advanced to us or unreimbursed by us from the employee
for recognized business expenses. Dr. Sinibaldi is being compensated on an
hourly basis for time served paid as a mixture of cash and stock. Our CSO is
currently compensated at the rate of $100/ hour plus the equivalent of $100/
hour of compensation paid in equity priced at $0.20 per share. Effective
January 19, 2012 this equity conversion price increased to our current offering
price of $1.05. Dr. Perin 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 approval to conduct a clinical study. 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.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The following table presents information regarding the beneficial
ownership of our common stock by the following persons as of March 15,
2012: (i) each executive officer and director, (ii) all executive
officers and directors as a group and (iii) each stockholder known to be
--------------------------------- page 53 -------------------------------------
the beneficial owner of more than 5% of our outstanding common stock
(not taking into account contractual restrictions on beneficial ownership.
Beneficial ownership is determined in accordance with the rules of the
SEC and generally includes voting or investment power with respect to
securities. Unless otherwise indicated below, to our knowledge, the
persons and entities named in the table have sole voting and sole
investment power with respect to all shares beneficially owned, subject
to community property laws where applicable.
The information presented in this table is based on 11,337,897 shares of
our common stock outstanding on March 15, 2012. Unless otherwise
indicated, the address of each of the executive officers and directors
and 5% or more stockholders named below is c/o Cardigant Medical Inc.,
1500 Rosecrans Ave, St 500, Manhattan Beach, CA 90266.
Name & Address of Beneficial Owner
Shares
Percentage of Class
Outstanding
Executive Officers and Directors:
Jerett A. Creed 11,001,500 97.9%
Ralph Sinibaldi, PhD 33,976 < 1%
Emerson Perin, MD, PhD 30,000 < 1%
Directors and
Executive Officers as a
Group 11,065,476 98.5%
5% Stockholders:
None
Changes in Control Arrangements
To our knowledge there are no arrangements which may result in a change
in control of our company at a subsequent date.
Equity Compensation Plan Information
The Company approved its Stock Option Plan in May 2010 allowing for the
issue of up to 5,000,000 shares of Common Stock. As of March 15, 2012,
no options have been issued.
--------------------------------- page 54 -------------------------------------
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS,
AND DIRECTOR INDEPENDENCE.
Transactions with Officers and Directors
Our current CEO, Mr. Jerett Creed has entered into a loan arrangement
with the Company whereby advances to the Company may be made by Mr.
Creed from time to time for general working capital purposes. Interest is
acrrued at 5% annual. The note can be called by Mr. Creed at any time as
well it can be converted to equity at the current fair market value at
Mr. Creed's sole option.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
In October, 2010, we retained Jonathan P. Reuben, CPA An Accountancy
Corporation to serve as our principal independent accountant. All
audit work was performed by the full time employees of Reuben.
Audit Fees
The aggregate fees billed by our principal independent accountant for
professional services rendered for the audit of our annual financial
statements and review of financial statements included in our quarterly
reports and services that are normally provided in connection with statutory
and regulatory filings were $22,514 for the fiscal year ended December 31, 2011.
Audit-Related Fees
None.
Tax Fees
During fiscal year 2011, we recorded accounting and professional fees
totaling approximately $1,200 that were billed to us for the preparation
of our 2010 and 2009 annual tax returns.
All Other Fees
None.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
The financial statements filed as part of this Annual Report on Form
10-K are listed on page 42.
The exhibits filed with this Annual Report on Form 10-K are listed in
the attached Exhibit Index.
--------------------------------- page 55 -------------------------------------
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
Cardigant Medical Inc.
(Registrant)
Date: March 30, 2012
By:
/s/ Jerett A. Creed
Jerett A. Creed
Chairman, Chief Executive Officer &
Chief Financial Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1933,
this report has been signed below by the following persons on behalf of
the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ Jerett A. Creed Chairman, Chief Executive Officer
Jerett A. Creed and Chief Financial Officer March 30, 2012
(Principal Executive Officer)
Exhibit Index
Exhibit Number Description of Exhibit
3.1 Amended and Restated Certificate of Incorporation. Incorporated
by reference to Exhibit 3.1 to the Current Form S-1 Registration Statement
(File No. 333-176329) filed with the Securities and Exchange Commission
on January 04, 2012.
3.2 Corporate Bylaws. Incorporated by reference to
Exhibit 3.2 to the Current Form S-1 Registration Statement
(File No. 333-176329) filed with the Securities and Exchange Commission
on January 04, 2012.
4.3 2010 Stock Option Plan. Incorporated by reference to the Current
Form S-1 Registration Statement (File No. 333-176329) filed with
the Securities and Exchange Commission on January 04, 2012.
10.1 R. Sinibaldi Consulting Agreement. Incorporated by reference to the
Current Form S-1 Registration Statement (File No. 333-176329) filed with
the Securities and Exchange Commission on January 04, 2012.
10.2 E. Perin Consulting Agreement. Incorporated by reference to the Current
Form S-1 Registration Statement (File No. 333-176329) filed with
the Securities and Exchange Commission on January 04, 2012.
10.3 J. Creed Employment Agreement. Incorporated by reference to the Current
Form S-1 Registration Statement (File No. 333-176329) filed with
the Securities and Exchange Commission on January 04, 2012.
23.1 Consent of Registered Audit Firm
31.1 Certification of Principal Executive Officer pursuant to Securities
Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to
section 302 of the Sarbanes-Oxley Act of 2002.
31.2 Certification of Principal Financial Officer pursuant to Securities
Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to
section 302 of the Sarbanes-Oxley Act of 2002.
32.1 Certification of Principal Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to section 906 of the
Sarbanes-Oxley Act of 2002.
32.2 Certification of Principal Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley
Act of 2002.