SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2013
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number 333-176329
CARDIGANT MEDICAL, INC.
(Exact name of Registrant as Specified in Its Charter)
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
1500 ROSECRANS AVENUE, ST 500, MANHATTAN BEACH, CALIFORNIA
(Address of principal executive offices)
Registrant’s telephone number, including area code: (310) 421-8654
Securities registered under Section 12(b) of the Act:
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, par value $0.001 per share
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 whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange 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 o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, 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 o
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 definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one).
Large Accelerated Filer o
Accelerated Filer o
Non-Accelerated Filer o
Smaller reporting company X
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes oNo X
The aggregate market value of the voting and non-voting common equity held by non-affiliates as of June 30, 2013, computed by reference to the price at which the common equity was last sold, or as of the last business day of the registrant's most recently completed second fiscal quarter, was approximately $401,142 based upon an estimated per share value of $0.525 at June 30, 2013. For purposes of this computation, it is assumed that the shares beneficially held by directors and officers of the registrant would be deemed to be stock held by affiliates.
As of March 1, 2014, there were 23,235,510 shares of the registrant’s common stock outstanding.
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and 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 and 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. 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 filing, provide examples of these risks and uncertainties. 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.
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.
-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 exploring raising funds through an additional debt or equity offering. There may be no minimum amount of debt or shares that are required to be sold by the company as a part of any offering. This means that while the company may sell some shares or raise debt, it may not receive adequate funds to execute its business plan or continue its operations.
-The company's Chief Executive Officer also has filled the role of Chief Financial Officer and Chief Accounting Officer through September 2012 and since October 2013. This prohibited any segregation of duties during the previous period and currently and creates potential conflicts of interests that normally would be managed by individuals filling those positions uniquely.
CARDIGANT MEDICAL, INC.
ITEM 1. BUSINESS
ITEM 1A. RISK FACTORS
ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 2. PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. MINE SAFETY DISCLOSURES
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
ITEM 6. SELECTED FINANCIAL DATA
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES
ITEM 9B. OTHER INFORMATION
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
ITEM 11. EXECUTIVE COMPENSATION
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
ITEM 1. BUSINESS.
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 filing. Our fiscal year end is December 31. We are focused on the use of biologics and peptide mimetics and combination biologics and devices for the treatment of acute coronary syndromes, carotid stenosis (for the treatment of ischemic stroke) and peripheral artery disease. 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.
Our primary focus is on treating atherosclerosis and plaque stabilization in both the coronary and peripheral vasculature using systemic and local delivery of large molecule therapeutics and peptide mimetics based on high density lipoprotein ("HDL") targets. We are evaluating proteins and peptide mimetics based on the Apolipoprotein A-I ("ApoA-1") alpha helical structure found in HDL to address our primary focus. Our lead drug product which we refer to as CMI-200 is based on the alpha helical structure of the ApoA-1 protein and its ability to bind to lipid rich plaque. 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 experimentation with several short sequence peptide mimetics that have been designed to mimic some of the beneficial properties of the full length ApoA-1 protein, the design and development of various local 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 ischemic stroke patient based on a symptomatic carotid plaque lesion. Our recent and ongoing work is in finalizing the drug formulation, dosing, methods of delivery 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 nine hundred thirty five 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 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.
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 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 an ApoA-1 mutation against the naturally occurring wild type sequence and found it to possess stronger anti-oxidant properties.
The manufacturing, validation and scale up of the production of recombinant proteins is an enormous challenge. We believe there are cost constraints that may limit the ability of a systemically administered drug formulation based on the full length ApoA-1 protein to be fully commercialized. To date our efforts have largely focused on the use of local delivery strategies as we believe these will be necessary to overcome some of the cost limitations as well as
improve the safety profile of the procedure due to less off target exposure. Additional efforts on our part to address the cost and scalability of a suitable drug candidate have also brought us to the use of synthetic peptides whose structure and function mimic many of the same beneficial properties of the full length ApoA-1 protein. These peptides are made synthetically in the lab and are substantially cheaper to manufacture and scale up. We believe this approach combined with our focus on local delivery will create a stronger chance for a viable product in the marketplace once all appropriate regulatory testing is completed.
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 our drug compound. Our motivation for doing this is to reduce the amount of capital necessary to be raised to reduce potential shareholder dilution and increase the 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 stabilization of symptomatic carotid plaque lesions. We believe this indication provides the best chance of clinical and regulatory 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 signed contractual commitments with any lab to perform this work, but have initiated discussions with labs to establish this relationship. 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 current Good Manufacturing Practices "cGMP". cGMP 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 but will likely need to spend considerable additional efforts scaling up this process and transferring it to a 3rd party contract manufacturer. cGMP 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 cGMP 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 with 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. There are more than 700,000 strokes annually in the United States alone. It is estimated that 30-40% of ischemic strokes are caused by a ruptured carotid plaque. Our lead product is designed to address this ischemic stroke patient population.
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 2014. Based on our current regulatory strategy, we expect this trial to be in Europe. We have been in discussions with Clinical Research Organizations and are drafting protocols for our pre-clinical studies based on the submission requirements necessary for a European first in man trial.
We are currently working on process development and clinical grade standard operating procedures. We regularly purchase non cGMP material from vendors who are also able to provide cGMP material when we need it.
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 distribution upon completion of a successful mid stage trial.
We have filed patent applications with International Priority for both our drug formulation and methods of delivery. Additionally since the change in the US patent law system from a First to Invent to a First to File system occurred in March 2013, we routinely file Provisional Applications to cover modifications or discoveries that we deem to be useful and novel. However, there is no guarantee that any of our current or future filed applications will be converted into a patent application or if filed, that a patent will be granted. As such it is possible that we may advance a product to the clinic with uncertain patent protection.
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 expression, storage, isolation and purification of our biologic products as we have produced small scale batches. Some of this know-how may be relevant for larger scale production.
Our industry is subject to rapid and intense technological change. We will 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 capital 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 the development of our product.
RELATED PARTY TRANSACTIONS
The Company has received some of its working capital from its founder Jerett A. Creed. Mr. Creed has also paid Company expenses with personal funds. These costs have been carried as a shareholder loan accruing interest at the rate of 5% per annum with a balance of $14,938 as of December 31, 2013. In April 2012, an entity of which Mr. Creed is a beneficiary purchased 95,238 shares of the Company’s common stock for $50,000 at $0.525 per share as part of the Form S-1 registered Offering.
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 typically two phase III trials. 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 three hundred fifty 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.
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 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.
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.
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.
As of December 31, 2013 we had three employees, Jerett Creed serving as our Chief Executive and Financial Officer, Ralph Sinibaldi, PhD serving as our Chief Scientific Officer and Emerson Perin, MD, PhD serving as our Chief Medical Officer. We also employ research assistants and scientists on a part-time contract basis.
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 principal balance for any funds advanced to us or unreimbursed by us from the him for recognized business expenses.
Our Chief Science Officer (“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 $0.525 per share. In September 2013, our CSO was compensated with a grant of options to purchase 100,000 shares of the Company common stock at $0.525 per share. The options were valued at $13,613 using the Black-Scholes Option Model, of which 100,000 are vested and their fair value of $13,613 was charged to operations
Our Chief Medical Officer is being compensated solely in equity. A total of 60,000 shares over a 21 month period have been 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.
Our former Chief Financial Officer, who joined the company in September 2012 and resigned in October 2013 , was initially compensated at the rate of $5,000 per month, with a grant of options to purchase 100,000 shares of the Company common stock at $0.525 per share. The options were valued at $13,613 using the Black-Scholes Option Model, of which 100,000 are vested and their fair value of $13,613 was charged to operations.
We estimate that we need to hire an additional 6 full time equivalent staff in the next 12-18 months
Our corporate headquarters are located in Manhattan Beach, CA and we maintain a working laboratory in Pasadena, CA.
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.
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 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.
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
We anticipate that it will cost us $2,500,000 to get us to be in a position to file for an Investigational New Drug (“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 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, Ralph Sinibaldi, PhD our Chief Scientific Officer, and Emerson Perin, MD, PhD our Chief Medical Officer. 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 limited independent board representation and limited independent audit and compensation committees.
We currently have three board members, Jerett A. Creed, William Pinon, and Scott Merz.
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;
- 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 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 three other companies that we are aware of working on HDL based biologics to treat acute coronary syndromes. These include the Medicines Company, Cerenis Therapeutics and CSL Limited.
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.
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:
- 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 may partially depend on our ability to establish and maintain intellectual property protection for our product. While we have filed for patent protection, there is no guarantee which regions if any will issue us a patent for our application, therefore it is possible that we may advance our drug candidate into the clinic in a region where we ultimately may have no patent protection.
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 at scale, we will determine if our product is better protected through trade secrets or by filing for patent protection. Additionally we may file additional method provisional applications or 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.
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 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
- 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 currently not listed or quoted on any exchange. There has never been and there may never be an active market for our common stock.
In October our 15c-211 application was approved by FINRA granting us the ticker symbol “CARD” to begin trading on the OTCBB. We currently have no trading activity on our stock.
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 options and or warrants to further incentivize some of our key consultants.
A significant concentration of our total issue shares are held by our founder and Chief Executive Officer. Approximately 94% 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 were held by Mr. Jerett A. Creed through September 2012. 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 LIMITED SEGREGATION OF DUTIES AT THE EXECUTIVE LEVEL.
Through September 2012 and since October 2013, the company's Chief Executive Officer has filled the role of Chief Financial Officer and Chief Accounting Officer. This prohibited any segregation of duties and created potential conflicts of interests during the previous period and currently that normally would be managed by individuals filling those positions uniquely.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
ITEM 2. PROPERTIES.
We maintain our principal executive offices at 1500 Rosecrans Ave, St 500, and 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 payments are approximately $15,540 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.
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
There is currently no market for the listing, quotation or trading of our Common Stock.
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
In October 2013, we sold 18,000 shares under a Regulation D exempt offering. The shares were issued for $0.53 per share in exchange for $9,540 in net proceeds.
In November 2013, we sold 38,000 shares under a Regulation D exempt offering. The shares were issued for $0.53 per share in exchange for $20,140 in net proceeds. The offering included Warrants to purchase 38,000 shares of common stock at $0.75 for a period of three years from the date of issuance.
In February 2014 we sold 97,200 shares under a Regulation D exempt offering. The shares were issued for $0.53 per share in exchange for $51,516 in net proceeds. The offering included Warrants to purchase 97,200 shares at $0.65 for a period of four years from the date of issuance.
ITEM 6. SELECTED FINANCIAL DATA.
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 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.
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 acute plaque stabilization using targeted, local delivery of large molecule therapeutics based on high density lipoprotein (“HDL”) targets. Circulating plasma levels of HDL have been shown to be inversely correlated with coronary artery disease. Towards this goal, we are evaluating drug formulations based on the alpha helical structure of the Apolipoprotein A-I (“ApoA-1”) protein that are delivered locally to one or more lesions. Our product candidate consists of a peptide mimetic construct designed to mimic many of the beneficial functions of 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. 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. 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 using a peptide mimetic whose structure and function is designed to mimic the lipid binding affinity of the alpha helical structure of the full length ApoA-1 protein. We have been evaluating this peptide with targeted and local delivery for specifically stabilizing and 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.
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 development efforts.
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 Dr. Sinibaldi, Dr. Perin, Dr. Rodriguez (Chair of our Scientific Advisory Board), and Dr. Merz (director) to R&D expense. We expect to hire additional technical personnel and engage in additional pre-clinical studies. 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 delivery in the treatment of symptomatic carotid plaque lesions for the treatment of ischemic stroke. Assuming we are able to raise sufficient funds, we expect to incur an additional $1.1 million over the next 12 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.
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 $600,000 over the next 12-18 months. Additionally we expect to move into a new office space which will add an additional $22,000 annual expense. In addition to hiring accounting personnel for public company reporting requirements, we also expect to incur an additional $80,000 per year of investor relations expenses for disseminating company information, news releases and public filings.
Results of Operations for the Year ended December 31, 2013 as Compared to the Year ended December 31, 2012
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.
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, 2013 were $178,062 versus $182,398 for the year, ended December 31, 2012. This represents a 2.4% decrease from the prior year. These expenses consisted mainly of allocated salary for our CEO, expense for our CSO, expense for our CMO and pre-clinical in vivo and in vitro studies. We expect our R&D expenses to ramp up to approximately $1,300,000 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, 2013 were $132,922 versus $150,822 for the year ended December 31, 2012. This represents a 13.5% decrease from the prior year. This amount consisted primarily of salary expense, and professional services. The change is due primarily to a decrease in accounting and finance fees associated with the resignation of our Chief Financial Officer in October 2013.
Net Income (Loss)
We had a Net Loss for the period of $314,300 versus a Net Loss of $335,584 for the year ended December 31, 2012. This represents a 6.8% decrease in Net Loss from the prior year. This decrease is also due to the reduced fees associated with our accounting and finance and the resignation of our Chief Financial Officer. On a per share basis, we had a $0.01 loss and $0.01 loss for the years ended December 31, 2013 and 2012, respectively.
Liquidity and Capital Resources
Sources of Liquidity
During the year ended December 31, 2013, net cash used by operating activities totaled $145,373. Net cash used in investing activities totaled $5,963. Net cash provided by financing activities during the year was $100,466, which included $115,380 proceeds from issuance of common stock plus $31,563 in advances from a related party which were netted against repayments to the related party of $46,477. The resulting change in cash for the period was a decrease of $51,070. The cash balance at the beginning of the year was $54,194. The cash balance at the end of the year was $3,124.
During the year ended December 31, 2012, net cash used by operating activities totaled $167,184. Net cash provided in investing activities totaled $45,886 which included the redemption of a certificate of deposit for $50,381 less the cost of computer software for $4,495. Net cash provided by financing activities during the year was $167,262, which included $164,759 proceeds from issuance of common stock plus $40,402 in advances from a related party which were netted against repayments to the related party of $37,900. The resulting change in cash for the period was an increase of $45,964. The cash balance at the beginning of the year was $8,230. The cash balance at the end of the year was $54,194.
The Company had cash of $3,124 as of December 31, 2013, as compared to $54,194 as of December 31, 2012. As of December 31, 2013, the Company had prepaid assets of $17,378, as compared to $42,789 as of December 31, 2012. The prepaids at December 31, 2013 consisted primarily of a $14,200 prepayment to a laboratory for the processing of proteins and $2,411 of a retainer for legal services. The Company also has $1,195 in security deposits
as of December 31, 2013 and 2012. The Company had no long-term assets at December 31, 2013. At December 31, 2013 the Company had total assets of $28,963. At December 31, 2012, the Company had total assets of $101,549.
On December 31, 2013 the Company had $646,642 in total current liabilities, which was represented by $6,519 in accounts payable, $66,185 in accrued expenses, $559,000 in accrued officer compensation and $14,938 due to a stockholder. The Company had no long-term liabilities at December 31, 2013; therefore the Company had total liabilities of $646,642.
On December 31, 2012 the Company had $544,308 in total current liabilities, which was represented by $8,835 in accounts payable, $57,622 in accrued expenses including a prior period adjustment of $19,503 for receipt of an overpayment of a grant in 2011, $448,000 in accrued officer compensation and $29,852 due to a stockholder. The Company had no long-term liabilities at December 31, 2012; therefore the Company had total liabilities of $544,308.
From inception (April 17, 2009) to December 31, 2013, net cash used in operating activities totaled $358,449. Net cash used in investing activities totaled $10,458 which was for the purchase of computer software and equipment. Net cash provided by financing activities since inception to December 31, 2013 was $372,031 of which $315,992 was from proceeds from issuances of common stock plus $209,483 advances from related parties which was netted against $153,444 of payments to related parties. The resulting change in cash for the period was an increase of $3,124.
The Company is not aware of any known trends, events or uncertainties which may affect its future liquidity. We are development stage and do not have a product commercially available for sale. We do not expect to realize any revenue for several years. As such it is imperative that the reader recognize that our primary source of working capital will generally come from equity sales, or the issuance of debt. We do, however, occasionally apply for non-taxable grant funding to support our research and development efforts. We currently do not have grant applications outstanding, and we can make no guarantees that any grant money will be awarded from any future applications. Our business is subject to risks inherent in the establishment of a new business enterprise, including limited capital resources and possible cost overruns.
During the quarter ended December 31, 2013 the Company issued through private offerings 56,000 shares of its common stock at $0.53 per share. As part consideration for the funds received, the Company granted 38,000 common stock warrants to purchase common shares at $0.75 per share for a period of three years from the November 2013 date of issuance.
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.
On November 11, 2013 we engaged CIM Securities, LLC a FINRA licensed broker-dealer to act as a financial advisor in helping us to raise up to $3,000,000 in a Private Placement Offering. As of the date of this filing, no money has been raised by CIM Securities.
Critical Accounting Policies
We regularly evaluate the accounting policies and estimates that we use. 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.
Cash and Cash Equivalents
We consider all highly liquid debt instruments and other short-term investments with maturities of three months or less, when purchased, to be cash equivalents.
We account for our 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.
We account for our intangible assets in accordance with ASC Topic 350-30 “General intangibles Other than Goodwill.” We capitalize costs we internally incur relating to intangible assets that are specifically identified, have a determinable life, and the intangible is not one that is inherent in a going concern
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.
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.
Property and Equipment
Property and equipment are stated at cost. Major renewals and improvements are charged to the asset accounts while replacements, maintenance and repairs that do not improve or extend the lives of the respective assets are expensed. At the time property and equipment are retired or otherwise disposed of, the asset and related accumulated depreciation accounts are relieved of the applicable amounts. Gains or losses from retirements or sales are credited or charged to income.
The Company accounts for stock-based compensation under ASC Topic 505-50. This standard defines 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.
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 transactions 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.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Balance Sheets at December 31, 2013 and 2012
Statements of Operations for the years ended December 31, 2013 and 2012 and for the period from
April 17, 2009 (Inception) through December 31, 2013
Statements of Stockholders (Deficit) for the period from April 17, 2009 (Inception) through
December 31, 2013
Statements of Cash Flows for the years ended December 31, 2013 and 2012 and for the period
from April 17, 2009 (Inception) through December 31, 2013
Notes to Financial Statements
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Cardigant Medical, Inc.
Manhattan Beach, California
We have audited the accompanying balance sheets of Cardigant Medical, Inc. as of December 31, 2013 and 2012, and the related statements of operations, stockholders' deficit, and cash flows for the years then ended and for the period from its inception (April 17, 2009) to December 31, 2013. 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 significant estimates 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, 2013 and 2012, 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, 2013 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
March 31, 2014
CARDIGANT MEDICAL INC.
(A DEVELOPMENT STAGE COMPANY)
The accompanying notes are an integral part of these financial statements.
CARDIGANT MEDICAL INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS - (Continued)
Non-cash investing and financing activities:
During the year ended December 31, 2013, the Company received $115,380 through the issuance of 219,238 shares of its common stock through various offering. As part of these offerings, the Company issued warrants to purchase 94,000 shares of its common stock (See Note 6).
During the year ended December 31, 2013, the Company recognized $40,350 of stock based compensation that was charged to operation. Of the $40,350, $16,350 pertained to the value of services rendered in 2013 for prior year issuances, $14,753 was the value assigned to 69,000 common stock options vested in 2013, and $9,247 was the value assigned to 17,568 common shares issued for services.
During the year ended December 31, 2012, the Company received $164,760 through the issuance of 313,826 shares of its common stock through various offering.
During the year ended December 31, 2012, the Company recognized $87,522 of stock based compensation of which $71,172 was charged to operations and $16,351 was classified as a prepaid expense. Of the $87,522, $36,323 was the value assigned to 242,000 common stock options vested in 2012, and $50,449 was the value assigned to 120,378 common shares issued for services.
CARDIGANT MEDICAL, INC.
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2013 and 2012
(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 locations but maintains its corporate office in greater Los Angeles. Effective January 1, 2012, the Company has revoked it S election status, and is a taxable entity going forward. On March 4, 2013, the Company declared a 2-for-1 stock split of its common stock. All references in the accompanying financials to the number of shares outstanding and per-share amounts have been restated to reflect this stock split.
The Company is in the development stage, as defined in Accounting Standards Codification ("ASC") Topic 915-10. From its inception (April 17, 2009) through December 31, 2013, 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.
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 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.
Basis of Presentation
The accompanying financial statements are prepared using the accrual method of accounting in accordance with accounting principles generally accepted in the United States of America.
(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 condensed 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, 2013 and 2012, the Company's cash balances did not exceed the FDIC limits.
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.
Property and Equipment
Property and equipment are stated at cost. Major renewals and improvements are charged to the asset accounts while replacements, maintenance and repairs that do not improve or extend the lives of the respective assets are expensed. At the time property and equipment are retired or otherwise disposed of, the asset and related accumulated depreciation accounts are relieved of the applicable amounts. Gains or losses from retirements or sales are credited or charged to income.
Property and equipment include equipment of $3,600 and computer software totaling $4,095. Equipment is being depreciated on the straight-line method over a five year estimated useful life. The computer software is being depreciated on the straight-line method over a 3 year estimated useful life. Depreciation expense charged to operations for the year ended December 31, 2013 and 2012 amounted to $2,068 and $1,124, respectively.
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.
During 2013, the Company recorded $2,236 in costs it incurred in the preparation of a patent application. Of the $2,236, $1,736 pertains to the allocated portion of compensation and related expenses for time the Company’s president spent in preparation of patent application and $500 in legal fees for a patent application review. At the time the patent is issued, the Company will either commence amortizing the cumulative balance of the patent application costs over the estimated useful life of the patent or expense the cumulative balance at the time the application is abandoned.
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 expenses 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 years ended December 31, 2013 and 2012, the Company incurred research and development expenses of $178,062 and $182,398, respectively.
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 carry forwards. 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 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.
See Note (7) Stockholder’s (Deficit) for detail stock-based compensation activity.
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. Diluted earnings (loss) per share has not been presented since the effect of the assumed conversion of warrants and debt to purchase common shares would have an anti-dilutive effect. Potential common shares as of December 31, 2013 that have been excluded from the computation of diluted net loss per share amounted to 427,000 shares and include 94,000 common stock warrants and 333,000 common stock options. Of the 427,000 potential common shares at December 31, 2013, 22,000 shares were not vested. Potential common shares as of December 31, 2012 that have been excluded from the computation of diluted net loss per share amounted to 328,000 shares all of which include common stock options, Of the 328,000 potential common shares at December 31, 2012, 86,000 shares were not vested.
Recent Accounting Pronouncements
The Company continually assesses any new accounting pronouncements to determine their applicability to the Company. Where it is determined that a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a study to determine the consequence of the change to its financial statements and assures that there are proper controls in place to ascertain that the Company’s financials properly reflect the change.
(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 Company’s financial instruments for 2013 and 2012 consist of accounts payables, accrued expenses and a short-term loan payable. The Company considers the carrying value of such amounts in the financial statements to approximate their fair value due their respective short maturity dates.
(4) Related Party Transactions
The Company has received some of its working capital from its founder, Jerett A. Creed. Mr. Creed has also paid Company expenses with personal funds. These costs have been carried as a shareholder loan accruing interest at the rate of 5% per annum. The amounts due at December 31, 2013 and 2012 including accrued interest, amounted to $14,938 and $29,852, respectively. Accrued interest charged to operations for 2013 and 2012 was $977 and $1,564, respectively. In April 2012, an entity in which Mr. Creed is a beneficiary purchased 95,238 shares of the Company’s common stock for $50,000 at $0.525 per share per the S-1 registration. During 2013, no shares were sold to affiliates or family members of the Company’s management.
(5) 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, 2013 and 2012 were $559,000 and $448,000, respectively. Salary is allocated between research and development and general and administrative based upon time spent.
(6) Stockholder's (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.
During the year ended December 31, 2013, the Company issued 8,568 shares of its common stock for services provided by its Chief Scientific Officer valued at $4,500 and charged to expense.
During the year ended December 31, 2013, the Company issued 9,000 shares of its common stock for services provided by its former Chief Financial officer valued at $4,747 and charged to expense.
On June 1, 2013, the Company granted options to a consultant to purchase 5,000 shares of the Company common stock at a purchase price of $0.53 per share expiring ten years from date of grant. The 5,000 options were valued at $932 under the Black-Scholes Option Model using a trading price of $0.525 per share, a risk free interest rate of 2.13%, and volatility of 22.61%. The options immediately vest and the $932 was fully charged to operations on the date of grant.
During 2013, the Company, through private offerings, issued a total of 219,238 of common shares for $115,380 in cash. In connection with these private offerings, the Company granted common stock warrants to purchase 38,000 common shares for a three-year period at an exercise price of $0.75 per share and to purchase 56.000 common shares for a four year period at an exercise price of $ 0.65 per share. The warrants to acquire 38,000 shares
During the year ended December, 2012, the Company issued 11,424 shares of its common stock for services provided by its Chief Scientific Officer valued at $6,000 and charged to expense.
In September 2012, the Company granted its Chief Scientific Officer and Chief financial officer options to purchase a total of 200,000 shares of the Company common stock at an exercise price of $0.525 per share expiring five years from date of grants. The options were valued at $27,226 under the Black-Scholes Option Model using a trading price of $0.525, risk free interest rate of 0.72%, and volatility of approximately 28%. The options immediately vest and the $27,226 was fully charged to operations on the date of grant.
In August 2012, the Company issued a new member of its Board of Directors 24,000 shares of its common stock pursuant to the terms of the director’s agreement. The 24,000 shares were valued at $12,600, which is being charged to operations over the one-year term of the director’s agreement. For the year ended December 31, 2012, $5,250 was charged to operations. The unamortized balance at December 31, 2012 of $7,350 was charged to operations in 2013.
In connection with the director’s agreement, the Company granted its new board member options to purchase 48,000 shares of the Company common stock at $0.2625 per share and expires ten years from date of grant. The options were valued at $10,150 using the Black-Scholes Option Model using a trading price $0.525, a risk-free interest rate of approximately 1.83%, and volatility of approximately 28%. The options vest over a two year period and 12,000 options vested 2012 and their fair value of $2,538 was charged to operations. In 2013, 24,000 options vested and their fair value of $5,075 was charged to operations. The fair value of the unvested stock options at December 31, 2013 amounted to $2,537.
In August 2012, the Company issued a consultant 668 shares of its common stock pursuant in exchange for consulting services per the terms of the consulting agreement. The 668 shares were valued at $0.525 per share totaling $349, which was charged to operations for the year ended December 31, 2012.
In July 2012, the Company issued the new Chairman of its Scientific Advisory Board, 14,286 shares of its common stock pursuant to the terms of the consulting agreement. The 14,286 shares were valued at $0.525 each, totaling $7,500, which is being charged to operations over the one-year term of the consulting agreement. For the year ended December 31, 2012, $3,750 was charged to operations. The unamortized balance at December 31, 2012 of $3,750 was charged to operations in 2013.
In April 2012, the Company issued its new Chairman of its Board of Directors 40,000 shares of its common stock pursuant to the terms of the consulting agreement. The 40,000 shares were valued at $21,000, which is being charged to operations over the one-year term of the consulting agreement. For the year ended December 31, 2012, $15,750 was charged to operations. The unamortized balance at December 31, 2012 of $5,250 was charged to operations in 2013.
In connection with the consulting agreement, the Company granted its new Chairman options to purchase 80,000 shares of the Company common stock at $0.525 per share and expires ten years from date of grant. The options were valued at $17,492 under the Black-Scholes Option Model using a trading price of $0.525, a risk-free interest rate of 2.23%, and volatility of approximately 28%. The options vest over a two year period and 30,000 options vested in 2012 and their fair value of $6,559 was charged to operations. In 2013, 40,000 options vested and their fair value of $8,746 was charged to operations.
In January 2012, the Company issued 30,000 shares of its common stock to its Chief Medical Officer in connection with its research and development efforts. The 30,000 shares were valued at $3,000, which is being charged to operations over the remaining one-year term of the underlying agreement. For the year ended December 31, 2012, $3,000 was charged to operations.
During 2012 the Company issued a total of 313,826 of shares of its common stock for cash and received $164,759.
A summary of outstanding common stock options is as follows:
Outstanding – December 31, 2011
Outstanding – December 31, 2012
Outstanding – December 31, 2013
Of the 333,000 options outstanding, 306,000 are fully vested and currently available for exercise.
A summary of outstanding common stock warrant is as follows:
Outstanding – December 31, 2011
Outstanding – December 31, 2012
Outstanding – December 31, 2013
Of the 333,000 options outstanding, 306,000 are fully vested and currently available for exercise
(7) Income Taxes
Deferred income tax assets and liabilities are computed annually for differences between financial statement and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable or refundable for the period plus or minus the change during the period in deferred tax assets and liabilities.
The effective tax rate on the net loss before income taxes differs from the U.S. statutory rate as follows:
U.S statutory rate
Less valuation allowance
Effective tax rate
The significant components of deferred tax assets and liabilities are as follows:
Deferred tax assets
Stock based compensation
Net operating losses
Less valuation allowance
Deferred tax asset - net valuation allowance
The net increase in the valuation allowance for the year ended December 31, 2013 was $(98,160).
The Company has a net operating loss carryover of approximately $382,000 available to offset future income for income tax reporting purposes that expire in various years through 2033, if not previously utilized.
The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company is no longer subject to U.S. federal income tax examinations by tax authorities for years beginning on January 1, 2009. or California state income tax examination by tax authorities for years beginning on January 1, 2008. We are not currently involved in any income tax examinations.
(8) Commitments and Contingencies
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 in 2012 and effective January 1, 2013 $1,200. 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, 2013 and 2012 totaled $15,540 and $14,350, respectively.
(9) Subsequent Events
In the first quarter of 2014, the Company issued 97,200 shares of Common Stock and 97,200 stock warrants through a private offering in exchange for $51,516 in cash. The 97,200 warrants are exercisable at $0.65 per share for a period of four years from the date of issuance.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
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 and Chief Executive Officer the role of which is currently being filled by the same person, has evaluated our disclosure controls and procedures on December 31, 2013. In September 2012 we hired a Chief Financial Officer. In October 2013 our Chief Financial Officer resigned without any issues. Subsequent to the resignation of our Chief Financial Officer, the role of Chief Financial Officer is being filled by our Company’s Chief Executive Officer. Because of these multiple roles being filled by the same individual, it is impossible to fully segregate duties. As such our Chief Executive Officer acting also as Chief Financial officer has concluded that our disclosure controls and procedures are ineffective. 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, our 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 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 has been no change in our internal control over financial reporting during the year ended December 31, 2013 except that which is disclosed above that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The following 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, Member Board of Directors, Chief Financial Officer, (through September 2012), Chief Accounting Officer (through September 2012)
(Age: 40 has served in the capacities since our founding except as noted above)
Mr. Creed has more than 18 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 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. 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: 65, has served in this 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: 54, has served in this 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.
Chairman, Board of Directors (Age 50, has served in this capacity since April 2012)
Mr. Pinon has extensive experience in all aspects of the biotech and medical device industry over the last 25 years. Mr. Pinon is currently President and CEO of Terumo Heart Inc. a company pioneering treatments for congestive heart failure. Prior to Terumo, Mr. Pinon was President and CEO of Bioheart Inc., an adult stem cell company treating ischemic heart disease which he led through its initial public offering and NASDAQ listing. Prior to Bioheart, Mr. Pinon held a variety of positions with Johnson & Johnson including Worldwide Vice President of Sales and Marketing at Cordis Corporation where he oversaw the cardiovascular business including the CYPHER drug eluting stent which was the fastest billion dollar device product in healthcare. He was also Executive Director of Centocor, a pioneer in the large molecule cardiovascular drug space. Mr. Pinon received a bachelor's degree in biology from the University of Oregon.
Scott Merz, Ph.D.
Member Board of Directors (Age 49, has served in this capacity since August 2012
Dr. Merz has extensive experience in all aspects of the medtech industry over the last 25 years including technology startup, research and development, regulatory, fundraising and partnering. Dr. Merz is currently the President of Michigan Critical Care Consultants (MC3) of which he is also a co-founder. MC3 was founded in 1991 to commercialize blood pump technology developed by Dr. Merz. The technology was sold to Medtronic and eventually transferred to Edwards Life Sciences. MC3 currently incubates new technology and spins it out. MC3 has spun out six companies based on internally developed technologies. Dr. Merz earned his Bachelor’s Degree in Electrical/Biomedical Engineering from Duke University and his Ph.D. in Biomedical Engineering from the University of Michigan.
Upon the completion of additional debt or equity financing, we will begin the process for nominating additional board members. We anticipate having a board composition of five (5). We anticipate compensation in the range of $3,000 per year plus the addition of 40,000 stock options priced at fair market value at the time of granting and the annual renewal thereof.
Each member of our board of directors serves with our Chief Financial Officer on the 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, 2013, all of our executive officers, directors and greater-than-ten percent stockholders complied with all Section 16(a) filing requirements.
ITEM 11. EXECUTIVE COMPENSATION.
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 our CEO (who also served as CFO through September 2012 and currently fills this role) is compensated at the rate of $120,000 annually. For the year ended December 31, 2013, compensation of $559,000 has not been paid and was accrued pending sufficient funding.
Our Chief Science Officer (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 $0.525 per share for the year ended December 31, 2013.
Our Chief Medical Officer (CMO) is being compensated solely in equity. A total of 60,000 shares over a 21 month period will be paid representing compensation in the amount of $6,000. This arrangement may be augmented with an hourly fee as we move closer to filing for an IND. If this happens, we anticipate offering a similar compensation structure as our CSO which would include a $200 per hour rate paid 50% in equity based on the fair market value of the shares at the time and 50% in cash.
Our Chief Financial Officer, who joined the company from September 2012 – October 16, 2013, was initially compensated at the rate of $5,000 per month, with a grant of options to purchase 100,000 shares of the Company common stock at $0.525 per share. The options were valued at $13,613 using the Black-Scholes Option Model, of which 100,000 are vested and their fair value of $13,613 was charged to operations. For the year ended December 31, 2013 our former Chief Financial Officer was compensated in the amount of $18,000 in cash plus the issuance of 9,000 shares value at $4,748.
Summary Compensation Table