As used in this Annual Report on Form 10-K, “we,” “us,” “our,” “QuantRx” and “Company” refer to QuantRx Biomedical Corporation, unless the context otherwise requires.
QuantRx Biomedical Corporation was incorporated on December 5, 1986, in the State of Nevada. The Company’s principal business office is located at 10190 SW 90th Avenue, Tualatin, Oregon 97123. When used in this Quarterly Report on Form 10-K, the terms “Company,” “we,” “our,” “ours,” or “us” mean QuantRx Corporation, a Nevada corporation.
Overview
The Company has developed and ultimately intends to commercialize its innovative PAD based products for the OTC and laboratory markets based on its patented technology platforms, and its genomic diagnostics, based on its patented PadKit® technology for the worldwide healthcare industry. These platforms include: inSync®, Unique™, PadKit®, and OEM branded OTC and laboratory testing products based on the Company’s core intellectual property related to its PAD technology. These products are intended for the treatment of hemorrhoids, minor vaginal infection, urinary incontinence, general catamenial uses and other medical needs.
The Company’s efforts to commercialize its products are currently contingent on the receipt of additional financing required to execute its business and operating plan, which is currently focused on the commercialization of the Company’s PAD technology either directly or through a joint venture or other relationship intended to increase shareholder value. In the interim, the Company has had nominal operations, focused principally on the limited online sale of our Unique® Miniform PAD product and maintaining compliance with the public company reporting requirements. No assurances can be given that the Company will obtain financing, or otherwise successfully develop a business and operating plan or enter into an alternative relationship to commercialize the Company’s PAD technology.
On June 20, 2012, the Company formed a wholly-owned subsidiary, QX Labs, Inc. (“
QX
”), to convey and transfer to QX all intellectual property and assets related to the Company’s diagnostic testing business ("
Diagnostics Business
"). The Diagnostic Business is based principally on the Company’s proprietary PadKit® technology, which the Company believes provides a patented platform technology for genomic diagnostics, including fetal genomics. Following the transfer of the Diagnostics Business to QX, which the Company intends to affect during the current fiscal year, the Company’s other business line will consist of its over-the-counter business, including the InSync feminine hygienic interlabial pad, the Unique® Miniform for hemorrhoid application, and other treated miniforms (the “
OTC Business
”), as well as established and continuing licensing relationships related to the OTC Business. Management believes the creation of QX permits the Company to more efficiently explore different options to maximize the value of the Diagnostics Business and the OTC Business (collectively, the “
Businesses
”), with the objective of maximizing the value of the Businesses for the benefit of the Company and its stakeholders.
The Company’s current focus is to obtain additional working capital necessary to continue as a going concern, and develop a longer term financing and operating plan to: (i) leverage its broad-based intellectual property (“
IP
”) and patent portfolio to develop new and innovative diagnostic products; (ii) commercialize its OTC Business and its Diagnostics Business either directly or through joint ventures, mergers or similar transactions intended to capitalize on commercial opportunities presented by each of the Businesses; (iii) contract manufacturing to third parties while maintaining control over the manufacturing process; and (iv) maximize the value of the Company’s investments in non-core assets. As a result of its current financial condition, however, the Company’s efforts in the short-term will be focused on limited online sale of our Unique® Miniform PAD product, and obtaining financing necessary to maintain the Company as a going concern.
Our Business
Management’s objective is to develop the Company’s innovative PAD based products through genomic testing, although commercialization efforts are conditioned on securing adequate financing. Assuming the availability of adequate working capital, the Company’s objective is to target significant market opportunities for its products through the following platforms:
PAD/Health and Wellness
PAD products are based on the Company’s non-woven disposable absorbent pad technology, with products for aiding the treatment of hemorrhoids, minor vaginal infection, urinary incontinence, the OTC catamenial markets, and other medical needs, including diagnostic sampling products which enable self-collection and worldwide transport for indications such as various cancers, premature delivery, and genomic testing.
Diagnostic Products
Diagnostic products constitute the core of the Company’s historical product development focus. The Company’s healthcare technologies are currently in different stages of development ranging from commercialization to proof of concept. The Company ultimately plans to bring its products to commercialization; however, commercialization of these technologies is currently contingent on the development of a financing and operating plan that permits the Company to successfully capitalize on its development efforts to date. Such plan may include seeking a strategic or other partner to economically commercialize or finance the Company’s technologies. The Company’s objective in the interim is to maintain strict cost control measures, as well as maintain control of its technologies, in order to continue as a going concern. The discussion below assumes the Company continues with the development and commercialization of its technologies, although no assurances can be given.
Product and Product Candidates
The Company has historically operated under a two-fold product development strategy: (i) the maximization of the value of internally developed products that are market-ready for near-term distribution, and (ii) the aggressive development of technology platforms for products that the Company believes will address medical diagnostic and treatment issues into the future.
In introducing its PAD product lines and other products, the Company sought to align itself with experienced marketing partners that have established distribution channels. The Company teamed with a manufacturing partner in Asia, as well as niche United States manufacturers, in order to bring products to market in an efficient manner while controlling product quality. While these relationships are currently in effect, each has been suspended pending the development of a financing and operating plan to commercialize the Company’s products and technology.
PADs for Diagnosis and Treatment
The miniform PAD is a Company patented technology that provides the basis for a line of products that address an array of consumer health issues including: temporary relief of hemorrhoid and minor vaginal infection itch and discomfort, feminine urinary incontinence, catamenial needs, drug delivery, and medical sample collection and transport for diagnostic testing.
The Company’s PAD products for the consumer markets are FDA Class I OTC devices, and are easy to use, non-invasive, fully biodegradable, highly absorbent pads. Additionally, the unique non-woven technology utilized for the PADs allows for a PAD to be used as a sample collection device, providing a sample for diagnostic purposes, or to provide local or systemic therapy.
PADKit®
The PADKit integrates the miniform technology with the Company’s diagnostic expertise. The PADKit contains a miniform used as a collection device to collect a sample for diagnostic evaluation. Vaginally, the miniform collects blood along with numerous cells, vaginal mucous and discharge flushed out by the menstrual flow or during normal daily exfoliation. The PADKit is designed to provide the preferred sample collection system population scale testing for indications such as HPV, Human Immunodeficiency Virus (HIV), and general health screening, where healthcare professionals are not readily accessible.
Although significant improvements have been made in the area of Pap test sample reading and sample preparation, clinical indications support broad testing for HPV that will have a greater impact in lowering the incidence of cervical cancer. The Company believes the PADKit will provide a superior and more consistent sample, as well as a simpler, more comfortable and convenient procedure for HPV testing. The Company further hopes to demonstrate viability of the PADKit as the basis of various other diagnostic and screening tests.
The Company holds several patents for the method and apparatus for collecting vaginal fluid and exfoliated vaginal cells for diagnostic purposes; collection of a sample for general diagnostic screening, and the collection of an anal sample for prostate and other diagnostic purposes. Several clinical studies have been conducted with and on the PADKit, which have provided data needed to show the degree to which the sample collected can be used to replace other accepted samples, ability to provide a genomic testing sample as well as its safety and ease of use.
Unique® Miniforms
Miniform is a safe, convenient, and flushable technology for the underserved OTC hemorrhoid, feminine hygiene and urinary incontinence markets. The disposable miniform pads contain no adhesives and require no insertion, and are small enough to fit in the palm of a hand.
The Unique miniform is available as a treated pad for the temporary relief of the itch and discomfort associated with hemorrhoids and minor vaginal infection, and as an untreated pad, for the daily protection of light urinary, vaginal or anal leakage.
While the Company initiated a limited web-based domestic roll-out of the Unique miniform, it is in search of a strategic partnership(s) to expand the retail availability of the product across the United States and internationally.
The Company has significant experience manufacturing its miniform and a clear understanding of its costs. The miniform technology is protected by numerous patents covering various applications, the manufacturing process, and certain materials. The Company currently has contracted with a firm based in Taiwan to manufacture its pads, although the manufacturing relationship is currently suspended due to the Company’s financial condition, and pending the development of a financing and operations plan that allows the Company to recommence active operations.
Competition
Our industry is highly competitive and characterized by rapid and significant technological change. Significant competitive factors in our industry include, among others, product efficacy and safety; the timing and scope of regulatory approvals; the government reimbursement rates for and the average selling price of products; the availability of raw materials and qualified manufacturing capacity; manufacturing costs; intellectual property and patent rights and their protection; and sales, marketing and distribution capabilities.
We face, and will continue to face, competition from organizations such as pharmaceutical and biotechnology companies, as well as academic and research institutions.
Any product candidates that we successfully develop, which are cleared for sale by the FDA or similar international regulatory authorities in other countries, may compete with competitive products currently being used or that may become available in the future. Most of our competitors have substantially greater capital resources than we have, and greater capabilities and resources for research, conducting preclinical studies and clinical trials, regulatory affairs, manufacturing, marketing and sales. As a result, we may face competitive disadvantages relative to these organizations should they develop or commercialize a competitive product. In addition, given our current lack of working capital, our competitors will have the opportunity to capture market opportunities missed by the Company as it attempts to secure additional financing necessary to commercialize our products.
Raw Materials and Manufacturing
The Company currently does not have manufacturing capacity for any of its products and therefore has historically contracted for the manufacturing of its products to third-party manufacturers in and outside the United States. All manufactured products are produced under FDA mandated Good Manufacturing Practices (GMP) standard operating procedures developed and controlled by the Company’s quality system, which specifies approved raw materials, vendors, and manufacturing methodology. During the quarter ended June 30, 2012, the Company’s operations were inspected by the FDA and found to be in full compliance.
Intellectual Property Rights and Patents
As of December 31, 2013, the Company had seventeen (17) patents issued, three (3) patents pending, and two (2) licensed patents. Our issued patents expire between 2014 and 2024; however, the Company may obtain continuations, which would extend the rights granted under our issued patents, and additional patents to cover technology in development. The Company also holds both United States and foreign trademarks, including QuantRx, PADkit, inSync, and Unique, and has applied for the rights to several others.
Patents and other proprietary rights are an integral part of our business. It is our policy to seek patent protection for our inventions and also to rely upon trade secrets and continuing technological innovations and licensing opportunities to develop and maintain our competitive position.
However, the patent positions of companies like ours involve complex legal and factual questions and, therefore, their enforceability cannot be predicted with any certainty. Our issued patents, those licensed to us, and those that may be issued to us in the future may be challenged, invalidated or circumvented, and the rights granted thereunder may not provide us with proprietary protection or competitive advantages against competitors with similar technology. Furthermore, our competitors may independently develop similar technologies or duplicate any technology developed by us. Because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any of our product candidates can be approved for sale and commercialized, our relevant patent rights may expire or remain in force for only a short period following commercialization. Expiration of patents we own or license could adversely affect our ability to protect future product development and, consequently, our operating results and financial position.
Licensing, Distribution and Development Agreements
On August 14, 2008, the Company entered into a ten-year Technology License Agreement with Church & Dwight Co., Inc. (“
Church & Dwight
”). Under the terms of the Agreement, Church & Dwight acquired exclusive world-wide rights to use certain Company technology related to a jointly developed at-home diagnostic test and began distributing the product in early 2009, resulting in the Company receiving royalties on net sales of the product in 2013 and 2012 of $6,113 and $14,529 respectively.
The Company licenses patent rights and know-how for certain hemorrhoid treatment pads and related coatings from The Procter & Gamble Company. The five-year license agreement was entered into July 2006 and has a five-year automatic renewal option. Although the Company renewed the agreement in 2011, payments have been suspended due to the Company’s current financial condition. The Company has subsequently filed for a patent to address the technology used in its treated miniforms, which was issued during 2013.
Regulatory Requirements
Some of our products and manufacturing activities are, or will be subject to regulation by the FDA, and by other federal, state, local and foreign regulatory authorities. Pursuant to the Food, Drug and Cosmetic Act of 1938, commonly known as the FD&C Act, and the regulations promulgated under it, the FDA regulates the research, development, clinical testing, manufacture, packaging, labeling, storage, distribution, promotion, advertising and sampling of medical devices and medical imaging products. Before a new device or pharmaceutical product can be introduced to the market, the manufacturer must generally obtain marketing clearance through a section 510(k) notification, through a Premarket Approval (“
PMA
”), or New Drug Approval (“
NDA
”).
In the United States, medical devices intended for human use are classified into three categories, Class I, II or III, on the basis of the controls deemed reasonably necessary by the FDA to assure their safety and effectiveness with Class I requiring the fewest controls and Class III the most controls. Class I, unless exempted, and Class II devices are marketed following FDA clearance of a Section 510(k) premarket notification. Since Class III devices (e.g., a device whose failure could cause significant human harm or death) tend to carry the greatest risks, the manufacturer must demonstrate that such a device is safe and effective for its intended use by submitting a PMA application. PMA approval by the FDA is required before a Class III device can be lawfully marketed in the United States. Usually, the PMA process is significantly more time consuming and costly than the 510(k) process.
The U.S. regulatory scheme for the development and commercialization of new pharmaceutical products, which includes the targeted molecular imaging agents, can be divided into three distinct phases: an investigational phase including both preclinical and clinical investigations leading up to the submission of an NDA; a period of FDA review culminating in the approval or refusal to approve the NDA; and the post-marketing period.
All of our OTC products derived from the miniform technology, including Unique, are currently classified as Class I – exempt devices, requiring written notification to the FDA before marketing. RapidSense product candidates generally require validation and notification to the FDA under Section 510(k) prior to commercialization. The Company does not currently market any product that requires full clinical validation as a Class III product under FDA regulations, nor is it involved in RapidSense regulatory issues.
In addition, the FD&C Act requires device manufacturers to obtain a new FDA 510(k) clearance when there is a substantial change or modification in the intended use of a legally marketed device, or a change or modification, including product enhancements, changes to packaging or advertising text and, in some cases, manufacturing changes, to a legally marketed device that could significantly affect its safety or effectiveness. Supplements for approved PMA devices are required for device changes, including some manufacturing changes that affect safety or effectiveness, or disclosure to the consumer, such as labeling. For devices marketed pursuant to 510(k) determinations of substantial equivalence, the manufacturer must obtain FDA clearance of a new 510(k) notification prior to marketing the modified device. For devices marketed with PMA, the manufacturer must obtain FDA approval of a supplement to the PMA prior to marketing the modified device. Such regulatory requirements may require the Company to retain records for up to seven years, and be subject to periodic regulatory review and inspection of all facilities and documents by the FDA.
The FD&C Act requires device manufacturers to comply with Good Manufacturing Practices regulations. The regulations require that medical device manufacturers comply with various quality control requirements pertaining to design controls, purchasing contracts, organization and personnel, including device and manufacturing process design, buildings, environmental control, cleaning and sanitation; equipment and calibration of equipment; medical device components; manufacturing specifications and processes; reprocessing of devices; labeling and packaging; in-process and finished device inspection and acceptance; device failure investigations; and record keeping requirements including complaint files and device tracking. Company personnel and non-affiliated contract auditors periodically inspect the contract manufacturers to assure they remain in compliance.
The Company’s operations are currently in compliance with current FDA requirements. In the quarter ended June 30, 2012, the FDA audited the Company, and its operations were found to be fully compliant.
Additionally, the Centers for Medicare & Medicaid Services (“
CMS
”) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (“
CLIA
”). In total, CLIA covers approximately 225,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Office of Clinical Standards and Quality (“
OCSQ
”) has the responsibility for implementing the CLIA Program.
The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
In the event the Company’s current operating plan includes such a facility, it will fall under CLIA regulatory requirements.
Certain of our product candidates will require significant clinical validation prior to obtaining marketing clearance from the FDA. The Company intends to contract with appropriate and experienced CROs (contract research organizations) to prepare for and review the results from clinical field trials. The Company engages certain scientific advisors, consisting of scientific Ph.D.s and M.D.’s, who contribute to the scientific and medical validity of its clinical trials when appropriate.
Research and Development Activities
The Company spent $27,917 and $24,894 on research and development activities during the years ended December 31, 2013 and 2012, respectively. The increase in research and development fees in the 2013 periods is directly attributable to the costs associated with clinical trial expense in the 2013 period.
Employees
As of December 31, 2013, we had no employees; however, the Company has four part-time consultants providing services to the Company in order to maintain the Company as a going concern and to protect the Company’s intellectual property and other assets. Our employees have never been represented by a labor organization or covered by a collective bargaining agreement.
You should consider carefully the following risks, along with other information contained in this Form 10-K. The risks and uncertainties described below are not the only ones that may affect us. Additional risks and uncertainties may also adversely affect our business and operations, including those discussed in Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operation.
If any of the following risks actually occur, our business, result of operations, and financial condition could be adversely affected.
The Company currently is not generating significant revenue. There can be no assurances that it will generate significant revenue in the future, achieve profitable operations or continue as a going concern.
Currently, the Company is not generating significant revenue from operations. The Company has historically financed its operations primarily through issuances of equity and the proceeds from the issuance of promissory notes. In the past, the Company also provided for its cash needs by issuing Common Stock, options and warrants for certain operating costs, including consulting and professional fees, as well as divesting its minority equity interests and equity-linked investments.
The Company’s history of operating losses, limited cash resources and the absence of an operating plan necessary to capitalize on the Company’s assets raise substantial doubt about our ability to continue as a going concern, absent a strengthening of our cash position. Management is currently pursuing various funding options, including seeking debt or equity financing, licensing opportunities and the sale of certain investment holdings, as well as a strategic, merger or other transaction to obtain additional funding to continue the development of, and to successfully commercialize, its products. There can be no assurance that the Company will be successful in its efforts. Should the Company be unable to obtain adequate financing or generate sufficient revenue in the future, the Company’s business, result of operations, liquidity and financial condition would be materially and adversely harmed, and the Company will be unable to continue as a going concern.
There can be no assurance that, assuming the Company is able to strengthen its cash position, it will achieve adequate revenue or profitable operations sufficient to continue as a going concern.
We have promissory notes in the aggregate principal amount of approximately $268,000 that are due and payable on demand. We have issued additional promissory notes in the aggregate principal amount of approximately $467,000 that are due and payable on demand in the year ended December 31, 2014. In the event that demand for repayment is made, and we are not able to raise sufficient capital to pay such notes or otherwise restructure the same, we will be in default and will not be able to continue as a going concern.
During the years ended December 31, 2013 and 2012, we issued promissory notes with a principal amount aggregating approximately $736,000, of which approximately $268,000 were due and payable at December 31, 2013, bearing interest at 12.0% per annum, and approximately $467,000 were due and payable March 31, 2014, bearing interest at 8.0% per annum. In the event the holders demand repayment and we are unable to pay such notes or restructure the notes, the notes will be in default, and the Company may not be able to continue as a going concern. In the event of a default, among other remedies, the interest rate paid in connection with the notes increases to 12% per annum.
Commercialization of our products is contingent on the development of a financing and operating plan, and we might not successfully develop a plan to develop our technology or products, or otherwise commercialize the same.
Commercialization of our innovative PAD-based products are conditioned on securing adequate financing, or entering into an alternative relationship necessary to allow the Company to commercialize its products and technology. Although no assurances can be given, in the event the Company is unable to successfully raise additional capital, develop a plan or otherwise enter into an alternative relationship to allow the Company to capitalize on its products and technology, we may not be able to attract or retain the management or personnel necessary to execute such plan and commercialize our technology or products. In the event we are unable to successfully develop a plan, attract or retain necessary and qualified personnel, or otherwise enter into an alternative relationship necessary to allow the Company to commercialize its products and technology, we may be unable to continue as a going concern.
Our ability to operate as a going concern is dependent upon raising adequate financing.
Although we are pursuing various funding and related options to commercialize our innovative PAD-based products, management has been unsuccessful to date in securing financing other than bridge financing. There can be no assurance that we will be successful in our efforts to obtain adequate financing. Should we be unable to raise adequate financing or generate revenue in the future, the Company’s business prospects would be materially and adversely harmed. As a result, management believes that given the current economic environment and the continuing need to strengthen our cash position, there is substantial doubt about our ability to continue as a going concern.
We have a history of incurring net losses and we may never become profitable.
As of the year ended December 31, 2013, the Company had an accumulated deficit of $49,689,862. Our losses resulted principally from costs related to our research programs and the development of our product candidates and general and administrative costs relating to our operations. Since the Company presently has limited sources of revenues, we will incur substantial and increasing losses in 2014. We cannot assure you that we will ever become profitable.
We will need to obtain additional funding to recommence and support our operations, and we may not be able to obtain such capital on a timely basis or under commercially reasonable terms, if at all.
We expect that our need for additional capital to recommence operations will be substantial and the extent of this need will depend on many factors, some of which are beyond our control, including the continued development of our product candidates; the costs associated with maintaining, protecting and expanding our patent and other intellectual property rights; future payments, if any, received or made under existing or possible future collaborative arrangements; the timing of regulatory approvals needed to market our product candidates; and market acceptance of our products.
It is possible that the Company will not generate positive cash flow from operations for several years. We cannot assure you that funds will be available to us in the future on favorable terms, if at all. If adequate funds are not available to us on terms that we find acceptable, or at all, we may be required to delay, reduce the scope of, or eliminate research and development efforts or clinical trials on any or all of our product candidates. We may also be forced to curtail or restructure our operations, obtain funds by entering into arrangements with collaborators on unattractive terms or relinquish rights to certain technologies or product candidates that we would not otherwise relinquish in order to continue independent operations.
Further testing of certain of our product candidates is required and regulatory approval may be delayed or denied, which would limit or prevent us from marketing our product candidates and significantly impair our ability to generate revenues.
Human pharmaceutical products are subject to rigorous preclinical testing and clinical trials and other approval procedures mandated by the FDA and foreign regulatory authorities. Various federal and foreign statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of pharmaceutical products. The process of obtaining these approvals and the subsequent compliance with appropriate U.S. and foreign statutes and regulations is time-consuming and requires the expenditure of substantial resources. In addition, these requirements and processes vary widely from country to country.
To varying degrees based on the regulatory plan for each product candidate, the effect of government regulation and the need for FDA and other regulatory agency approval will delay commercialization of our product candidates, impose costly procedures upon our activities, and put us at a disadvantage relative to larger companies with which we compete. There can be no assurance that FDA or other regulatory approval for any products developed by us will be granted on a timely basis, or at all. If we discontinue the development of one of our product candidates, our business and stock price may suffer.
The Company faces intense competition.
Upon recommencement of operations, the Company will be engaged in a segment of the biomedical industry that is highly competitive. If successfully brought into the marketplace, any of the Company’s products will likely compete with several existing products. The Company anticipates that it will face intense and increasing competition in the future as new products enter the market and advanced technologies become available. We cannot assure that existing products or new products developed by competitors will not be more effective, or more effectively marketed and sold than those by the Company. Competitive products may render the Company’s products obsolete or noncompetitive prior to the Company’s recovery of development and commercialization expenses.
Many of the Company’s competitors also have significantly greater financial, technical and human resources and will likely be better equipped to develop, manufacture and market products. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large biotechnology companies. Furthermore, academic institutions, government agencies and other public and private research organizations are becoming increasingly aware of the commercial value of their inventions and are actively seeking to commercialize the technology they have developed. Accordingly, competitors may succeed in commercializing products more rapidly or effectively than the Company, which would have a material adverse effect on the Company.
Assuming the Company is able to successfully develop a financing and operating plan, and therefore recommence operations, there is no assurance that the Company’s products will gain market acceptance.
Efforts to commercialize our products are conditioned on the development of a financing and operating plan that allows the Company to recommence operations. Assuming the successful development of such a plan, the success of the Company will depend in substantial part on the extent to which our products achieve market acceptance. We cannot predict or guarantee that physicians, patients, healthcare insurers or maintenance organizations, or the medical community in general, will accept or utilize any products of the Company.
If we fail to establish marketing and sales capabilities or fail to enter into effective sales, marketing and distribution arrangements with third parties, we may not be able to successfully commercialize our products.
Upon recommencement of operations, we will be primarily dependent on third parties for the sales, marketing and distribution of our products. We may enter into various agreements providing for the commercialization of our product candidates. We intend to sell our product candidates primarily through third parties and establish relationships with other companies to commercialize them in other countries around the world. We currently have no internal sales and marketing capabilities, and only a limited infrastructure to support such activities. Therefore, our future profitability will depend in part on our ability to enter into effective marketing agreements. To the extent that we enter into sales, marketing and distribution arrangements with other companies to sell our products in the United States or abroad, our product revenues will depend on their efforts, which may not be successful.
The Company’s success will be dependent on licenses and proprietary rights it receives from other parties, and on any patents it may obtain.
Our success will depend in large part on the ability of the Company and its licensors to (i) maintain license and patent protection with respect to our products, (ii) defend patents and licenses once obtained, (iii) maintain trade secrets, (iv) operate without infringing upon the patents and proprietary rights of others, and (v) maintain and obtain appropriate licenses to patents or proprietary rights held by third parties if infringement would otherwise occur, both in the United States and in foreign countries.
The patent positions of biomedical companies, including those of the Company, are uncertain and involve complex legal and factual questions. There is no guarantee that the Company or its licensors have or will develop or obtain the rights to products or processes that are patentable, that patents will issue from any of the pending applications or that claims allowed will be sufficient to protect the technology licensed to the Company. In addition, we cannot be certain that any patents issued to or licensed by the Company will not be challenged, invalidated, infringed or circumvented, or that the rights granted thereunder will provide competitive disadvantages to the Company.
Litigation, which could result in substantial cost, may also be necessary to enforce any patents to which the Company has rights, or to determine the scope, validity and unenforceability of other parties’ proprietary rights, which may affect the rights of the Company. United States patents carry a presumption of validity and generally can be invalidated only through clear and convincing evidence. There can be no assurance that the Company’s patents would be held valid by a court or administrative body or that an alleged infringer would be found to be infringing. The mere uncertainty resulting from the institution and continuation of any technology-related litigation or interference proceeding could have a material adverse effect on the Company pending resolution of the disputed matters.
The Company may also rely on unpatented trade secrets and know-how to maintain its competitive position, which it seeks to protect, in part, by confidentiality agreements with employees, consultants and others. There can be no assurance that these agreements will not be breached or terminated, that the Company will have adequate remedies for any breach, or that trade secrets will not otherwise become known or be independently discovered by competitors.
Protecting our proprietary rights is difficult and costly.
The patent positions of biotechnology companies can be highly uncertain and involve complex legal and factual questions. Accordingly, we cannot predict the breadth of claims allowed in these companies’ patents or whether the Company may infringe or be infringing these claims. Patent disputes are common and could preclude the commercialization of our products. Patent litigation is costly in its own right and could subject us to significant liabilities to third parties. In addition, an adverse decision could force us to either obtain third-party licenses at a material cost or cease using the technology or product in dispute.
We currently do not have any full-time employees, resulting from out objective of substantially reducing expenses. At such time as we recommence operations, we may be unable to attract skilled personnel and maintain key.
The success of our business will depend, in large part, on our ability to attract and retain highly qualified management, scientific and other personnel, and on our ability to develop and maintain important relationships with leading research institutions and consultants and advisors. Competition for these types of personnel and relationships is intense among numerous pharmaceutical and biotechnology companies, universities and other research institutions. As a result of the suspension of the development of our PAD based products, we do not have any full-time employees, and currently rely on consultants and/or contract managers to manage the business and operations of the Company. There can be no assurance that the Company will be able to attract and retain skilled personnel at such time as it recommences operations, and the failure to do so would have a material adverse effect on the Company.
The Company may not be able to efficiently develop manufacturing capabilities or contract for such services from third parties on commercially acceptable terms.
The Company has established relationships with third-party manufacturers for the commercial production of our products, which relationships have been suspended due to the suspension of direct, active operations. There can be no assurance that the Company will be able to reestablish or maintain relationships with third-party manufacturers on commercially acceptable terms or that third-party manufacturers will be able to manufacture our products on a cost-effective basis in commercial quantities under good manufacturing practices mandated by the FDA.
The dependence upon third parties for the manufacture of products may adversely affect future costs and the ability to develop and commercialize our products on a timely and competitive basis. Further, there can be no assurance that manufacturing or quality control problems will not arise in connection with the manufacture of our products or that third party manufacturers will be able to maintain the necessary governmental licenses and approvals to continue manufacturing such products. Any failure to establish relationships with third parties for its manufacturing requirements on commercially acceptable terms would have a material adverse effect on the Company. Additionally, the Company may rely upon foreign manufacturers. Any event which negatively impacts these manufacturing facilities, manufacturing systems or equipment, or suppliers, including, among others, wars, terrorist activities, natural disasters and outbreaks of infectious disease, could delay or suspend shipments of products or the release of new products.
In the future, we anticipate that we will need to obtain additional or increased product liability insurance coverage and it is uncertain that such increased or additional insurance coverage can be obtained on commercially reasonable terms.
The business of the Company will expose it to potential product liability risks that are inherent in the testing, manufacturing and marketing of pharmaceutical products. There can be no assurance that product liability claims will not be asserted against the Company. The Company has obtained insurance coverage; however, there can be no assurance that the Company will be able to obtain additional product liability insurance on commercially acceptable terms or that the Company will be able to maintain such insurance at a reasonable cost or in sufficient amounts to protect against potential losses. A successful product liability claim or series of claims brought against the Company could have a material adverse effect on the Company.
Insurance coverage is increasingly more difficult to obtain or maintain.
Obtaining insurance for our business, property and products is increasingly more costly and narrower in scope, and we may be required to assume more risk in the future. If we are subject to third-party claims or suffer a loss or damage in excess of our insurance coverage, we may be required to share that risk in excess of our insurance limits. Furthermore, any first- or third-party claims made on any of our insurance policies may impact our ability to obtain or maintain insurance coverage at reasonable costs or at all in the future.
The market price of our shares, like that of many biotechnology companies, is highly volatile.
Market prices for the Company’s Common Stock and the securities of other medical and biomedical technology companies have been highly volatile and may continue to be highly volatile in the future. Factors such as announcements of technological innovations or new products by the Company or its competitors, government regulatory action, litigation, patent or proprietary rights developments, and market conditions for medical and high technology stocks in general can have a significant impact on any future market for Common Stock of the Company.
Trading of our Common Stock is limited, which may make it difficult for you to sell your shares at times and prices that you feel are appropriate.
Trading of our Common Stock, which is conducted on the OTCQB marketplace (the “
OTCQB
”), has been limited. This adversely affects the liquidity of our Common Stock, not only in terms of the number of shares that can be bought and sold at a given price, but also through delays in the timing of transactions and reduction in security analysts and the media’s coverage of us. This may result in lower prices for our Common Stock than might otherwise be obtained and could also result in a larger spread between the bid and ask prices for our Common Stock.
The issuance of shares of our preferred stock may adversely affect our Common Stock.
The board of directors of the Company is authorized to designate one or more series of preferred stock and to fix the rights, preferences, privileges and restrictions thereof, without any action by the stockholders. The designation and issuance of such shares of our preferred stock may adversely affect the Common Stock, if the rights, preferences and privileges of such preferred stock (i) restrict the declaration or payment of dividends on Common Stock, (ii) dilute the voting power of Common Stock, (iii) impair the liquidation rights of the Common Stock, or (iv) delay or prevent a change in control of the Company from occurring, among other possibilities.
Because we do not expect to pay dividends, you will not realize any income from an investment in our Common Stock unless and until you sell your shares at a profit.
We have never paid dividends on our Common Stock and do not anticipate paying any dividends for the foreseeable future. You should not rely on an investment in our stock if you require dividend income. Further, you will only realize income on an investment in our shares in the event you sell or otherwise dispose of your shares at a price higher than the price you paid for your shares. Such a gain would result only from an increase in the market price of our Common Stock, which is uncertain and unpredictable.
I
TEM
1B. UNRESOLVED STAFF COMMENTS
None.
The Company did not maintain a corporate headquarters during the year ended December 31, 2013. During the year ended December 31, 2012, the Company reduced its operations and ceased to maintain corporate headquarters. The Company has no further obligation under any prior lease agreements, and currently is planning to transfer operations to a new facility pending obtaining financing to recommence operations.
ITEM
3. LEGAL PROCEEDING
S
On April 8, 2013, the Company filed a Motion for Summary Judgment in Lieu of Complaint (the “
Complaint
”) against Genomics USA, Inc. ("
GUSA
") to recover all amounts due the Company under the terms of a promissory note in the principal amount of $200,000. (“
GUSA Note
”). The Complaint was filed in the Supreme Court of the State of New York, and sought repayment of all amounts due under the terms of the GUSA Note, and accrued interest thereon, plus attorney's fees. On May 24, 2013, the Company and GUSA settled the Company’s complaint. The settlement agreement entered into by the parties provides for the payment to the Company of $200,000, of which $20,000 was paid on June 7, 2013, and $10,000 per month has been paid on the 7th day of each consecutive month thereafter. As of the date of this report, a total of $120,000 remains due under the terms of the settlement agreement, which amount will be paid monthly for a total of 12 months.
As of the date hereof, there are no additional material pending legal proceedings to which we are a party to or of which any of our property is the subject.
ITE
M 4. MINE SAFETY DISCLOSURES
None.
1.
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DESCRIPTION OF BUSINESS
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2013 Developments
Settlement of GUSA Note Receivable and Litigation.
On May 24, 2013, the Company and Genomics USA, Inc. ("
GUSA
") settled the Company’s complaint filed against GUSA, wherein the Company sought to recover all amounts due under the terms of a promissory note in the principal amount of $200,000 (the "
GUSA
Note
"). The Complaint was filed in the Supreme Court of the State of New York, and sought repayment of all amounts due under the terms of the GUSA Note, and accrued interest thereon, plus attorney's fees. The settlement agreement entered into by the parties provides for the payment to the Company of $200,000, of which $20,000 was paid on June 7, 2013, and $10,000 per month shall be paid on the 7th day of each consecutive month thereafter for a total of 18 months. During the year ended December 31, 2013, the Company received payments of $80,000 towards the GUSA Note.
Issuance of Additional Promissory Notes.
During the year ended December 31, 2013, the Company issued promissory notes to two investors in the principal amounts of $25,000 (the
“$25K Note
”), $2,000 (the “
$2K Note
”), $20,000 (the “
$20K Note
”) and $17,000 (the
"$17K Note"
) (together, the “
Notes
”). As additional consideration for the purchase of the Notes, the Company issued an aggregate total of 64,000 warrants to purchase shares of FluoroPharma Medical, Inc. (“
FPMI
”) common stock, for $1.00 per share (“
$1.00 FPMI Warrants
”). The $1.00 FPMI Warrants expire on February 15, 2019.
The Notes accrue interest at the rate of 6% annually, and are currently due and payable on demand. The Notes are convertible at the option of each respective holder into shares of the Company’s common stock, par value $0.01 per share (“
Common Stock
”), at a conversion price equal to $0.10 per share. In addition, the holders may exchange the Notes for Common Stock in the event the Company consummates a qualified financing resulting in gross proceeds to the Company of at least $500,000 (“
Qualified Financing
”). While the Company intends to pay the Notes using proceeds from a Qualified Financing, such Qualified Financing may not occur prior to the date the holders of the Notes demand repayment.
On October 29, 2013, the holder of certain outstanding Notes totaling approximately $217,000 in principal and accrued interest agreed to cancel such notes in exchange for a new note with a face amount of $217,000, maturing on June 30, 2014, and 100,000 $1.00 FPMI Warrants.
Separately, our financial advisor, agreed to exchange $216,000 of fees accrued from May 15, 2011 to October 15, 2012 that are payable in cash on December 31, 2013 for a note in the face amount of $250,000 maturing on June 30, 2014 and 100,000 FPMI warrants. These notes accrue 8% interest per annum, and are due and payable on June 30, 2014. Additionally, we entered into a new financial advisory agreement on October 29, 2013, which replaced the previous agreement that expired on October 15, 2012. Pursuant to this Agreement, we agreed to pay a retainer in the amount of $100,000 and $15,000 per month beginning on November 29, 2013. The initial term of the Agreement expires on December 31, 2014. The advisor agreed to defer the cash fees due under the new Agreement until June 30, 2014.
The Company presently intends to issue additional Notes to finance its current working capital needs. However, there can be no assurance that the Company will be able to issue additional Notes.
Exchange Agreement.
On March 1, 2013, the Company entered into an Exchange Agreement with
NuRx Pharmaceuticals, Inc. (“
NuRx
”)
and QN Diagnostics, LLC (“
QND
”), pursuant to which the Company exchanged the shares of NuRx Common Stock received under the terms of the settlement agreement with NuRx in July 2011 for certain patents, trademarks and other intellect property formerly held by NuRx and QND covering point-of-care lateral flow diagnostics (RapidSense™) and related oral fluid collection technologies. The Company recorded the value associates with this exchange at $13,200, and will amortize these costs over the remaining useful lives of the intellectual property exchanged.
Overview
The Company has developed and ultimately intends to commercialize its innovative PAD based products for the OTC and laboratory markets based on its patented technology platforms, and its genomic diagnostics, based on its patented PadKit® technology for the worldwide healthcare industry. These platforms include: inSync®, Unique™, PadKit®, and OEM branded OTC and laboratory testing products based on the Company’s core intellectual property related to its PAD technology. These products are intended for the treatment of hemorrhoids, minor vaginal infection, urinary incontinence, general catamenial uses and other medical needs.
The Company’s efforts to commercialize its products are currently contingent on the receipt of additional financing required to execute its business and operating plan, which is currently focused on the commercialization of the Company’s PAD technology either directly or through a joint venture or other relationship intended to increase shareholder value. In the interim, the Company has had nominal operations, focused principally on the limited online sale of our Unique® Miniform PAD product and maintaining compliance with the public company reporting requirements. No assurances can be given that the Company will obtain financing, or otherwise successfully develop a business and operating plan or enter into an alternative relationship to commercialize the Company’s PAD technology.
On June 20, 2012, the Company formed a wholly-owned subsidiary, QX Labs, Inc. (“
QX
”), to convey and transfer to QX all intellectual property and assets related to the Company’s diagnostic testing business ("
Diagnostics Business
"). The Diagnostic Business is based principally on the Company’s proprietary PadKit® technology, which the Company believes provides a patented platform technology for genomic diagnostics, including fetal genomics. Following the transfer of the Diagnostics Business to QX, which the Company intends to affect during the current fiscal year, the Company’s other business line will consist of its over-the-counter business, including the InSync feminine hygienic interlabial pad, the Unique® Miniform for hemorrhoid application, and other treated miniforms (the “
OTC Business
”), as well as established and continuing licensing relationships related to the OTC Business. Management believes the creation of QX permits the Company to more efficiently explore different options to maximize the value of the Diagnostics Business and the OTC Business (collectively, the “
Businesses
”), with the objective of maximizing the value of the Businesses for the benefit of the Company and its stakeholders.
The Company’s current focus is to obtain additional working capital necessary to continue as a going concern, and develop a longer term financing and operating plan to: (i) leverage its broad-based intellectual property (“
IP
”) and patent portfolio to develop new and innovative diagnostic products; (ii) commercialize its OTC Business and its Diagnostics Business either directly or through joint ventures, mergers or similar transactions intended to capitalize on commercial opportunities presented by each of the Businesses; (iii) contract manufacturing to third parties while maintaining control over the manufacturing process; and (iv) maximize the value of the Company’s investments in non-core assets. As a result of its current financial condition, however, the Company’s efforts in the short-term will be focused on limited online sale of our Unique® Miniform PAD product, and obtaining financing necessary to maintain the Company as a going concern.
2.
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MANAGEMENT STATEMENT REGARDING GOING CONCERN
|
The Company currently is generating only nominal revenue from operations. The Company has historically financed its operations primarily through issuances of equity and the proceeds from the issuance of promissory notes. In the past, the Company also provided for its cash needs by issuing Common Stock, options and warrants for certain operating costs, including consulting and professional fees, as well as divesting its minority equity interests and equity-linked investments.
The Company’s history of operating losses, limited cash resources and the absence of an operating plan necessary to capitalize on the Company’s assets raise substantial doubt about our ability to continue as a going concern absent a strengthening of our cash position. Management is currently pursuing various funding options, including seeking debt or equity financing, licensing opportunities and the sale of certain investment holdings, as well as a strategic, merger or other transaction to obtain additional funding to continue the development of, and to successfully commercialize, its products. There can be no assurance that the Company will be successful in its efforts. Should the Company be unable to obtain adequate financing or generate sufficient revenue in the future, the Company’s business, result of operations, liquidity and financial condition would be materially and adversely harmed, and the Company will be unable to continue as a going concern.
There can be no assurance that, assuming the Company is able to strengthen its cash position, it will achieve sufficient revenue or profitable operations to continue as a going concern.
3.
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CONSOLIDATED SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
This summary of significant accounting policies of the Company is presented to assist in understanding the Company’s consolidated financial statements. The consolidated financial statements and notes are representations of the Company’s management, which is responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted in the United States of America (GAAP) and have been consistently applied in the preparation of the consolidated financial statements.
Accounting for Share-Based Payments
The Company follows the provisions of ASC Topic 718, which establishes the accounting for transactions in which an entity exchanges equity securities for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company uses the Black-Scholes option pricing model in determining fair value. Accordingly, compensation cost has been recognized using the fair value method and expected term accrual requirements as prescribed, which resulted in employee stock-based compensation expense for the years ended December 31, 2013 and 2012 of $39,000 and $27,000, respectively.
The Company accounts for share-based payments granted to non-employees in accordance with ASC Topic 505, “Equity Based Payments to Non-Employees.” The Company determines the fair value of the stock-based payment as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. If the fair value of the equity instruments issued is used, it is measured using the stock price and other measurement assumptions as of the earlier of either (i) the date at which a commitment for performance by the counterparty to earn the equity instruments is reached, or (ii) the date at which the counterparty’s performance is complete.
In the case of modifications, the Black-Scholes model is used to value the warrant on the modification date by applying the revised assumptions. The difference between the fair value of the warrants prior to the modification and after the modification determines the incremental value. The Company has modified warrants in connection with the issuance of certain notes and note extensions. These modified warrants were originally issued in connection with previous private placement investments. In the case of debt issuances, the warrants were accounted for as original issuance discount based on their relative fair values. When modified in connection with a note issuance, the Company recognizes the incremental value as a part of the debt discount calculation, using its relative fair value in accordance with ASC Topic 470-20, “Debt with Conversion and Other Options.” When modified in connection with note extensions, the Company recognized the incremental value as prepaid interest, which is expensed over the term of the extension.
The fair value of each share based payment is estimated on the measurement date using the Black-Scholes model with the following assumptions, which are determined at the beginning of each year and utilized in all calculations for that year:
During 2013, the fair value of each share based payment is estimated on the measurement date using the Black-Scholes model using an average risk free interest rate of 2.6%, expected volatility of 331%, and a dividend yield of zero. During 2012, the fair value of each share based payment is estimated on the measurement date using the Black-Scholes model using a risk free interest rate of 3.08%, expected volatility of 261%, and a dividend yield of zero.
Risk-Free Interest Rate.
The interest rate used is based on the yield of a U.S. Treasury security as of the beginning of the year.
Expected Volatility.
The Company calculates the expected volatility based on historical volatility of monthly stock prices over a three year period.
Dividend Yield.
The Company has never paid cash dividends, and does not currently intend to pay cash dividends, and thus has assumed a 0% dividend yield.
Expected Term.
For options, the Company has no history of employee exercise patterns; therefore, uses the option term as the expected term. For warrants, the Company uses the actual term of the warrant.
Pre-Vesting Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience. The Company will adjust its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and will also impact the amount of compensation expense to be recognized in future periods.
Accounts, Notes and Interest Receivable and Allowance for Bad Debts
The Company carries its receivables at net realizable value. Interest on notes receivable is accrued based upon the terms of the note agreement. The Company provides reserves against receivables and related accrued interest for estimated losses that may result from a debtor’s inability to pay. The amount is determined by analyzing known uncollectible accounts, economic conditions, historical losses and customer credit-worthiness. Additionally, all accounts with aged balances greater than one year are fully reserved. Amounts later determined and specifically identified to be uncollectible are charged or written off against the reserve. At December 31, 2013, the Company has determined that its Accounts, Notes and Interest Receivable outstanding are deemed to be collectible, and accordingly has not recorded a reserve for the year ended December 31, 2013.
Cash and Cash Equivalents
The Company considers all highly liquid investments and short-term debt instruments with maturities of three months or less from date of purchase to be cash equivalents. Cash equivalents consisted of money market funds at December 31, 2013 and 2012.
Concentration of Risks
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company primarily maintains its cash balances with financial institutions in federally insured accounts. At times, such balances may exceed federally insured limits. The Company has not experienced any losses to date resulting from this practice. At December 31, 2013 and 2012, our cash was not in excess of these limits.
Earnings per Share
The Company computes net income (loss) per common share in accordance with ASC Topic 260. Net income (loss) per share is based upon the weighted average number of outstanding common shares and the dilutive effect of common share equivalents, such as options and warrants to purchase Common Stock, convertible preferred stock and convertible notes, if applicable, that are outstanding each year. Basic and diluted earnings per share were the same at the reporting dates of the accompanying financial statements, as including Common Stock equivalents in the calculation of diluted earnings per share would have been antidilutive.
As of December 31, 2013, the Company had outstanding options exercisable for 304,500 shares of its Common Stock, warrants exercisable for 1,556,000 shares of its Common Stock, and preferred shares convertible into 20,416,228 shares of its Common Stock. The above options, warrants, and preferred shares were deemed to be antidilutive for the year ended December 31, 2013.
As of December 31, 2012, the Company had outstanding options exercisable for 304,500 shares of its Common Stock, warrants exercisable for 2,771,000 shares of its Common Stock, and preferred shares convertible into 20,416,228 shares of its Common Stock. The above options, warrants, and preferred shares were deemed to be antidilutive for the year ended December 31, 2012.
Fair Value of Financial Instruments
Current U.S. generally accepted accounting principles establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
The three levels of the fair value hierarchy are as follows:
Level 1 – Quoted prices are available in active markets for identical assets or liabilities. Active markets are those in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reporting date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.
Level 3 – Pricing inputs include significant inputs that are generally unobservable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value. Level 3 instruments include those that may be more structured or otherwise tailored to the Company’s needs.
The Company has adopted ASC Topic 820, “Fair Value Measurements and Disclosures” for both financial and nonfinancial assets and liabilities. The Company has not elected the fair value option for any of its assets or liabilities.
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At December 31, 2013
Fair Measurements Using
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Description
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Year
Ended
12/31/2012
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Significant Other
Observable Inputs
(Level 2)
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Significant
Unobservable
Inputs (Level 3)
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Total Gains
(Losses)
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In determining fair value of our investment from GUSA, the Company estimated fair value based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of this investment that are not readily apparent from other sources.
As of December 31, 2013, the Company had 109,917 warrants to purchase Common Stock of FPMI. The Company has estimated the fair value of the warrants at $30,908, in accordance with ASC Topic 820, Level 3. At December 31, 2013, the Company deems the options and warrants to be fully impaired.
Impairments
We assess the impairment of long-lived assets, including our other intangible assets, at least annually or whenever events or changes in circumstances indicate that their carrying value may not be recoverable. The determination of related estimated useful lives and whether or not these assets are impaired involves significant judgments, related primarily to the future profitability and/or future value of the assets. Changes in our strategic plan and/or market conditions could significantly impact these judgments and could require adjustments to recorded asset balances. We hold investments in companies having operations or technologies in areas which are within or adjacent to our strategic focus when acquired, all of which are privately held and whose values are difficult to determine. We record an investment impairment charge if we believe an investment has experienced a decline in value that is other than temporary. Future changes in our strategic direction, adverse changes in market conditions or poor operating results of underlying investments could result in losses or an inability to recover the carrying value of the investments that may not be reflected in an investment’s current carrying value, thereby possibly requiring an impairment charge in the future.
In determining fair value of assets, the Company bases estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets that are not readily apparent from other sources. Actual fair value may differ from management estimates resulting in potential impairments causing material changes to certain assets and results of operations.
At December 31, 2013 and 2012, the Company has determined that its interest receivable from a related party in the amount of $59,395 and $95,689 is fully impaired.
Income Taxes
The Company accounts for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and the income tax bases of assets and liabilities. A valuation allowance is applied against any net deferred tax asset if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense. We had no accrual for interest or penalties on our balance sheets at December 31, 2013 or 2012, and have not recognized interest and/or penalties in the statement of operations for the years ended December 31, 2013 or 2012. See Note 12, Income Taxes.
Intangible Assets
The Company’s intangible assets consist of patents, licensed patents and patent rights, and website development costs, and are carried at the legal cost to obtain them. Costs to renew or extend the term of intangible assets are expensed when incurred. In 2008, through our formerly majority owned subsidiary, the Company also held technology licenses and other acquired intangibles. Intangible assets are amortized using the straight-line method over the estimated useful life. Useful lives are as follows: patents, 17 years; patents under licensing, 10 years; website development costs, three years, and in 2008, acquired intangibles had a weighted average life of 15 years. Amortization expense for the years ended December 31, 2013 and 2012, totaled $8,089.
The estimated total aggregate amortization expense for 2013 through 2016 is $7,825 for each year, or $31,300.
Inventories
Inventories, consisting solely of products available for sale, are accounted for using the first-in, first-out (FIFO) method, and are valued at the lower of cost of market value. This valuation requires us to make judgments, based on current market conditions, about the likely method of dispositions and expected recoverable value inventories.
Non-Controlling Interest
In January 2009, we adopted an amendment to ASC Topic 810 “Consolidation”, which required us to make certain changes to the presentation of our financial statements. This amendment required noncontrolling interests to be treated as a separate component of equity, not as a liability or other item outside of permanent equity. Upon a loss of control, the interest sold, as well as any interest retained, is required to be measured at fair value, with any gain or loss recognized in earnings. The statement required that the noncontrolling interest continue to be attributed its share of losses even if that attribution results in a deficit noncontrolling interest balance; if this would result in a material change to net income, pro forma financial information is required. As of January 1, 2009, the Company presented its financial statements in accordance with this statement.
On May 5, 2009, the Company and FPMI reorganized their relationship by terminating their investment and related agreements. The termination of these agreements, which were originally executed on March 10, 2006, allowed FPMI to close an equity financing with third party investors. In conjunction with the termination of these agreements and the additional investment in FPMI by third parties, the Company agreed to convert all outstanding receivables from FPMI into Common Stock of FPMI. As a result of these transactions and the third party investment, the Company’s ownership interest in FPMI’s issued and outstanding capital stock was reduced to a noncontrolling interest, which resulted in deconsolidation and a loss at deconsolidation in accordance with ASC 810. See Note 8 for additional details.
Property and Equipment
Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. The Company’s property and equipment at December 31, 2013 and 2012 consisted of computer and office equipment, machinery and equipment and leasehold improvements with estimated useful lives of three to seven years. Estimated useful lives of leasehold improvements do not exceed the remaining lease term. Depreciation expense was $1,095 and $2,926 for the years ended December 31, 2013 and 2012. Expenditures for repairs and maintenance are expensed as incurred. See Note 6.
Recent Accounting Pronouncements
Management does not believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the accompanying financial statements.
In February 2013, the FASB issued additional guidance related to the reclassification of items out of Accumulated Other Comprehensive Income, effective for period beginning after December 15, 2012. While we do not expect this pronouncement to have a current, material effect on our financial statements, we will continue to evaluate it going forward.
In November 2013, the FASB issued guidance related to the presentation of an unrecognized tax benefit in entities with a Net Operating Loss (NOL) carryforward, or a similar tax loss or tax credit carryforward, effective for periods beginning after December 15, 2013. We are currently assessing the impact of the guidance, but do not expect it to have a material effect on our financial statements.
Research and Development Costs
Research and development costs are expensed as incurred. The cost of intellectual property purchased from others that is immediately marketable or that has an alternative future use is capitalized and amortized as intangible assets. Capitalized costs are amortized using the straight-line method over the estimated economic life of the related asset.
Revenue Recognition
The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin Topic 13 when persuasive evidence of an arrangement exists and delivery or performance has occurred, provided the fee is fixed or determinable and collection is probable. The Company assesses whether the fee is fixed and determinable based on the payment terms associated with the transaction. If a fee is based upon a variable such as acceptance by the customer, the Company accounts for the fee as not being fixed and determinable. In these cases, the Company defers revenue and recognizes it when it becomes due and payable. Up-front engagement fees are recorded as deferred revenue and amortized to income on a straight-line basis over the term of the agreement, although the fee is due and payable at the time the agreement is signed or upon annual renewal. Payments related to substantive, performance-based milestones in an agreement are recognized as revenue upon the achievement of the milestones as specified in the underlying agreement when they represent the culmination of the earnings process. The Company assesses the probability of collection based on a number of factors, including past transaction history with the customer and the current financial condition of the customer. If the Company determines that collection of a fee is not reasonably assured, revenue is deferred until the time collection becomes reasonably assured.
The Company recognizes revenue from nonrefundable minimum royalty agreements from distributors or resellers upon delivery of product to the distributor or reseller, provided no significant obligations remain outstanding, the fee is fixed and determinable, and collection is probable. Once minimum royalties have been received, additional royalties are recognized as revenue when earned based on the distributor’s or reseller’s contractual reporting obligations.
The Company’s strategy includes entering into collaborative agreements with strategic partners for the development, commercialization and distribution of its product candidates. Such collaborative agreements may have multiple deliverables. The Company evaluates multiple deliverable arrangements pursuant to ASC Topic 605-25, “Revenue Recognition: Multiple-Element Arrangements.” Pursuant to this Topic, in arrangements with multiple deliverables where the Company has continuing performance obligations, contract, milestone and license fees are recognized together with any up-front payments over the term of the arrangement as performance obligations are completed, unless the deliverable has standalone value and there is objective, reliable evidence of fair value of the undelivered element in the arrangement. In the case of an arrangement where it is determined there is a single unit of accounting, all cash flows from the arrangement are considered in the determination of all revenue to be recognized. Cash received in advance of revenue recognition is recorded as deferred revenue.
Development Agreements and Royalties
In 2007, the Company entered into a development agreement for an at-home diagnostic test with Church & Dwight Co., Inc. (“
C&D
”). The C&D agreement included milestone based payments, which were recognized in 2007 and 2008. On August 14, 2008, the Company entered into a Technology License Agreement with C&D. Under the terms of the agreement, C&D acquired exclusive worldwide rights to use certain Company technology related to the jointly developed test. Under the ten-year agreement, the Company received royalties on net sales of the product of $6,113 and $14,529 in 2013 and 2012, respectively.
Use of Estimates
The accompanying financial statements are prepared in conformity with accounting principles generally accepted in the United States of America, and include certain estimates and assumptions which affect the reported amounts of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Accordingly, actual results may differ from those estimates.
4.
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INVESTMENT IN JOINT VENTURE - QN DIAGNOSTICS, LLC
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On July 30, 2009, the Company and NuRx entered into agreements to form QND. Pursuant to the agreements, the Company contributed certain intellectual property and other assets related to its lateral flow strip technology and related lateral flow strip reader technology with a fair value of $5,450,000, and NuRx contributed $5,000,000 in cash to QND. Following the respective contributions by NuRx and the Company to the joint venture, NuRx and the Company each owned a 50% interest in QND. The purpose of the joint venture was to develop and commercialize products incorporating the lateral flow strip technology and related lateral flow strip readers.
Under the terms of the agreements, QND made a $2,000,000 cash distribution to the Company. The Company was committed to further capital contributions aggregating $1.55 million, comprised of: payment of milestone payments with PRIA Diagnostics (see Note 5) in Company Common Stock (fair value of $750,000); transfer of fixed assets with a fair value of $100,000 at QND’s discretion; and a $700,000 sustaining capital contribution as required by QND. Subsequent sustaining capital contributions were required to be made by the Company and NuRx on an equal basis.
The Company and QND also entered into the Development Agreement, pursuant to which QND was required to pay a monthly fee to the Company in exchange for the Company providing all services related to the development, regulatory approval and commercialization of lateral flow products.
On July 20, 2010, the Company notified NuRx that NuRx was in material breach of the Development Agreement, and on August 24, 2010, NuRx filed suit against the Company and one of its directors. On July 7, 2011, the Company and NuRx settled all disputes between the parties relating to a complaint brought against the Company by NuRx relating to QND. Under the terms of the settlement with NuRx, the Company transferred its entire membership interest in QND to NuRx, including all assets held by the Company relating to QND, for and in consideration for the issuance to the Company of 12.0 million shares of Common Stock of NuRx (the "Settlement Shares"). As a result of the issuance of the Settlement Shares, the Company held an approximate 25% equity interest in NuRx at December 31, 2012, and the Company had no further contractual obligations or liabilities associated with its former interest in QND.
On March 1, 2013, the Company entered into an Exchange Agreement with NuRx and QND, pursuant to which the Company exchanged its Settlement Shares for certain patents, trademarks and other intellectual property formerly held by NuRx and QND covering point-of-care lateral flow diagnostics (RapidSenseTM) and related oral fluid collection technologies.
5.
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OTHER BALANCE SHEET INFORMATION
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Components of selected captions in the accompanying balance sheets as of December 31, 2013 and 2012 consist of:
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2013
|
|
|
2012
|
|
Prepaid expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
Computers and office furniture, fixtures and equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: accumulated depreciation
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
|
|
Genomics USA, Inc.
In January 2007, the Company advanced $200,000 to GUSA through an 8% promissory note due April 8, 2007 (the “
GUSA Note
”).
On September 24, 2012, the Company sent a final notice to GUSA, demanding immediate payment in full of all amounts due under the terms of the GUSA Note.
On April 8, 2013, the Company filed a Motion for Summary Judgment in Lieu of Complaint (the “
Complaint
”) against GUSA to recover all amounts due the Company under the terms of GUSA Note. On May 24, 2013, the Company and GUSA settled the Company’s complaint. The settlement agreement entered into by the parties provides for the payment to the Company of $200,000, of which $20,000 was paid on June 7, 2013, and $10,000 per month shall be paid on the 7th day of each consecutive month thereafter for a total of 18 months (collectively, the “
Settlement Payments
”). As of December 31, 2103, the Company had received a total of $80,000 in Settlement Payments.
|
|
Warrants
Held
|
|
|
Options
Held
|
|
|
Recognized
Gain/(Loss)
|
|
Balance as of December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued for consideration of debt extension
|
|
|
|
)
|
|
|
-
|
|
|
|
|
|
Balance as of December 31, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
In May 2011, FluoroPharma, Inc. ("
FPI
") entered into a reverse merger with FPMI. In connection with this transaction, the Company's warrants and options in FPI were exchanged for warrants and options in FPMI. During the year ended December 31, 2012, all options held by the Company in FPMI were exchanged for substantially identical warrants in FPMI. During 2012, the Company issued 277,500 warrants, exercisable at $.50 and set to expire April 19, 2014, in consideration for the extension on the terms of notes set to mature during the year. The Company recognized a gain in the amount of $115,752 as a result of the warrants issued in consideration of debt extension. During 2013, the company issued $264,000 warrants exercisable at $1.00 in consideration for promissory notes issued during 2013. The Company recognized a gain of $86,944, as a result of the warrants issued in consideration of debt.
As
of December 31, 2013, the Company retained control over 109,917 warrants exercisable at $1.00 that are set to expire on February 15, 2019. The Company continues to deem the value of the $1.00 FPMI warrants to be fully impaired at December 31, 2013.
In
May 2006, the Company purchased 144,024 shares of GUSA common stock for $200,000. The Company uses the cost method to account for this investment since the Company does not control nor have the ability to exercise significant influence over operating and financial policies. In accordance with the cost method, the investment is recorded at cost and impairment is considered in accordance with the Company’s impairment policy. No impairment was recognized for the years ended December 31, 2013 and December 31, 2012.
Intangible assets as of December 31, 2013 and 2012 consisted of the following:
|
|
2013
|
|
|
2012
|
|
Licensed patents and patent rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: accumulated amortization
|
|
|
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent under Licensing
The Company licenses patent rights and know-how for certain hemorrhoid treatment pads and related coatings from The Procter & Gamble Company. The five-year license agreement was entered into July 2006 and has a five-year automatic renewal option. Although the Company renewed the agreement in 2011, payments have been suspended due to the Company’s current financial condition. The Company has subsequently filed for a patent to address the technology used in its treated miniforms, which was issued during 2013.
9.
|
CONVERTIBLE NOTES PAYABLE
|
In May 2012, in consideration for the extension of certain promissory notes (the “
2012 Notes
”) due and payable on March 31, 2012 to June 30, 2012, the Company agreed to assign to the holders of the 2012 Notes warrants to purchase a total of 113,127 shares of FPMI common stock for $0.50 per share (the
“$0.50 FPMI Warrants
”). In August 2012, in consideration for the extension of the maturity date of the 2012 Notes maturing on June 30, 2012 to November 15, 2012, the Company agreed to assign a total of 155,877 $0.50 FPMI Warrants to the holders of the 2012 Notes. As a result, a total of 260,508 $0.50 FPMI Warrants have been assigned to holders of 2012 Notes.
Between August 2012 and May 2013, the Company issued promissory notes to two investors in the principal amounts of $10,000 (the
“$10K Note
”), $25,000 (the “
2012
$25K Note
”), $15,000 (the “
$15K Note
”), $20,000 (the “
$20K Note
”), $17,000 (the
"$17K Note"
), $2,000 (the
“$2K Note
”) and $25,000 (the “
2013 $25K Note
”) (together, the “
Notes
”). As additional consideration for the purchase of the Notes, the Company issued: (i) 200,000 shares of its Common Stock, par value $0.001 per share, to the purchaser of the $25K Note and the $15K Note, (ii) 8,496 $0.50 FPMI Warrants to the purchaser of the $10K Note, and (iii) 64,000 warrants to purchase shares of FluoroPharma Medical, Inc. (“
FPMI
”) Common Stock, for $1.00 per share (“
$1.00 FPMI Warrants
”), to the purchasers of the $20K Note, $17K Note, $2K Note and the 2013 $25K Note. The $1.00 FPMI Warrants expire on February 15, 2019.
The Notes accrue interest at the rate of 6% annually, and are currently due and payable on demand. The Notes are convertible at the option of each respective holder into shares of Common Stock at a conversion price equal to $0.10 per share. In addition, the holders may exchange the Notes for Common Stock in the event the Company consummates a qualified financing (the “
Qualified Financing
”), which is defined in the Notes as a financing resulting in gross proceeds to the Company of at least $500,000. While the Company intends to pay the Notes using proceeds from a Qualified Financing, such Qualified Financing may not occur prior to the date the holders of the Notes demand repayment.
On October 29, 2013, the holder of certain outstanding Notes totaling approximately $
217
,000 in principal and accrued interest agreed to cancel such notes in exchange for a new note with a face amount of $
217
,000, maturing on June 30, 2014, and 100,000 $1.00 FPMI Warrants.
Separately, our financial advisor, agreed to exchange $216,000 of fees accrued from May 15, 2011 to October 15, 2012 that are payable in cash on December 31, 2013 for a note in the face amount of $250,000 maturing on June 30, 2014 and 100,000 FPMI warrants. These notes accrue 8% interest per annum, and are due and payable on June 30, 2014. Additionally, we entered into a new financial advisory agreement on October 29, 2013, which replaced the previous agreement that expired on October 15, 2012. Pursuant to this Agreement, we agreed to pay a retainer in the amount of $100,000 and $15,000 per month beginning on November 29, 2013. The initial term of the Agreement expires on December 31, 2014. The advisor agreed to defer the cash fees due under the new Agreement until June 30, 2014.
In connection with the issuance of all Notes and Exchange Notes, the Company has recorded debt discount and expenses of the beneficial conversion feature of $193,206 and $28,999, respectively. The Company will amortize these expenses over the life of the Notes and Exchange Notes. During the year ended December 31, 2013, the Company recorded interest expense related to the amortization of debt discount of $41,433 and no amounts related to the beneficial conversion feature. During the year ended December 31, 2012, the Company recorded interest expense related to the debt discount of $81,945 and $25,722 related to the beneficial conversion feature.
10.
|
LONG-TERM NOTES PAYABLE
|
The Company received a $44,000 loan from the Portland Development Commission in 2007. The loan matures in 20 years and was interest free through February 2010. The terms of the note stipulate monthly interest only payments from April 2010 through December 2014, at a 5% annual rate. The Company recorded interest expense on this loan of $2,246 for the year ended December 31, 2013.
Pursuant to ASC 740, income taxes are provided for based upon the liability method of accounting. Under this approach, deferred income taxes are recorded to reflect the tax consequences on future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end.
We are subject to taxation in the U.S. and the state of Oregon. The Company is not current on its tax filings and is subject to examination until the filings take place.
At December 31, 2013 and 2012, the Company had gross deferred tax assets calculated at an expected blended rate of 38% of approximately $10,251,000 and $10,115,000, respectively, principally arising from net operating loss carryforwards for income tax purposes. As management of the Company cannot determine that it is more likely than not that the Company will realize the benefit of the deferred tax asset, a valuation allowance of $10,251,000 and $10,115,000 has been established at December 31, 2013 and 2012, respectively.
Topic 740 in the Accounting Standards Codification (ASC 740) prescribes recognition threshold and measurement attributes for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. At December 30, 2013, the Company had taken no tax positions that would require disclosure under ASC 740.
The Company has analyzed its filing positions in all jurisdictions where it is required to file income tax returns and found no positions that would require a liability for unrecognized income tax benefits to be recognized. We are subject to examinations for all unfiled tax years. We deduct interest and penalties as interest expense on the financial statements.
Additionally, the future utilization of our net operating loss and R&D credit carryforwards to offset future taxable income may be subject to an annual limitation, pursuant to IRC Sections 382 and 383, as a result of ownership changes that may have occurred previously or that could occur in the future.
There is no unrecognized tax benefit included in the balance sheet that would, if recognized, affect the effective tax rate.
The significant components of the Company’s net deferred tax assets (liabilities) at December 31, 2013 and 2012 are as follows:
|
|
2013
|
|
2012
|
|
Gross deferred tax assets:
|
|
|
|
|
|
Net operating loss carryforwards
|
|
|
9,275,000
|
|
|
$
|
|
|
Difference between book and tax basis of former subsidiary stock held
|
|
|
-
|
|
|
|
|
|
|
|
|
202,000
|
|
|
|
|
|
|
|
|
211,000
|
|
|
|
|
|
|
|
|
563,000
|
|
|
|
|
|
|
|
|
10,251,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax asset valuation allowance
|
|
|
(10,251,000
|
|
|
|
|
|
Net deferred tax asset (liability)
|
|
|
|
|
|
|
|
|
At December 31, 2013, the Company has net operating loss carryforwards of approximately $9,275,000, which expire in the years 2013 through 2032. The net change in the allowance account was an increase of $136,000 for the year ended December 31, 2013.
Preferred Stock
The Company has authorized 25,000,000 shares of preferred stock, of which 20,500,000 is designated as Series B Convertible Preferred Stock, $0.01 par value, with a stated value of approximately $204,000 (“
Series B Preferred
”). The remaining 4,500,000 authorized preferred shares have not been designated by the Company as of December 31, 2013.
On November 19, 2010, the Company filed a Certificate of Withdrawal of the Certificates of Designations of the Series A Preferred Stock (“
Series A Preferred
”) with the Nevada Secretary of State, as there were no shares of Series A Preferred issued and outstanding after the exchange transaction discussed below.
Series B Convertible Preferred Stock
The Company has authorized 20,500,000 shares of Series B Preferred, $0.01 par value. The Series B Preferred ranks prior to the Common Stock for purposes of liquidation preference, and to all other classes and series of equity securities of the Company that by their terms did not rank senior to the Series B Preferred (“
Junior Stock
”). Holders of the Series B Preferred are entitled to receive cash dividends, when, as and if declared by the Board of Directors, and they shall be entitled to receive an amount equal to the cash dividend declared on one share of Common Stock multiplied by the number of shares of Common Stock equal to the outstanding shares of Series B Preferred, on an as converted basis. The holders of Series B Preferred have voting rights to vote as a class on matters a) amending, altering or repealing the provisions of the Series B Preferred so as to adversely affect any right, preference, privilege or voting power of the Series B Preferred; or b) to effect any distribution with respect to Junior Stock. At any time, the holders of Series B Preferred may, subject to limitations, elect to convert all or any portion of their Series B Preferred into fully paid nonassessable shares of Common Stock at a 1:1 conversion rate.
At December 31, 2013, the Company had 20,416,228 shares of Series B Preferred issued and outstanding with a liquidation preference of $204,162, and convertible into 20,416,228 shares of Common Stock.
Common Stock
The Company has authorized 150,000,000 shares of its Common Stock, $0.01 par value. The Company had issued and outstanding 52,728,644 and 52,528,644 shares of its Common Stock at December 31, 2013 and 2012.
During the year ended December 31, 2013, the Company reserved for issuance 300,000 shares Common Stock as settlement of accounts payable, and 1,900,000 shares of Common Stock as compensation to its three board members. During 2013, 200,000 shares of to-be-issued stock were issued and outstanding as of December 31.
During the year ended December 31, 2012, the Company issued 900,000 shares of Common Stock related to settlement agreements, 1,732,015 shares of Common Stock in connection with debt financing, 2,018,999 shares of Common Stock in connection with a financial services agreement, 450,000 shares of Common Stock as compensation to each of its two board members and 50,000 shares of Common Stock in exchange for warrants. At December 31, 2012, the Company had reserved for issuance a total of 2,000,000 shares of Common Stock valued at $82,500, including 200,000 shares to be issued in connection with debt financing, and 1,800,000 shares of Common Stock to be issued in exchange for warrants related to a financial services agreement.
13.
|
STOCK PURCHASE WARRANTS
|
Common Stock Warrants
The following is a summary of all Common Stock warrant activity during the years ended December 31, 2013 and 2012:
|
|
Number of Shares Under Warrants
|
|
Exercise Price Per Share
|
|
Weighted Average
Exercise Price
|
|
Warrants issued and exercisable at December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued and exercisable at December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued and exercisable at December 31, 2013
|
|
|
|
|
|
|
|
|
|
The following represents additional information related to Common Stock warrants outstanding and exercisable at December 31, 2013:
Exercise Price
|
|
Number of Shares
Under Warrants
|
|
Weighted Average Remaining
Contract Life in Years
|
|
Weighted Average
Exercise Price
|
|
|
|
|
210,000
|
|
0.04
|
|
|
|
|
|
|
|
25,000
|
|
0.88
|
|
|
|
|
|
|
|
350,000
|
|
0.52
|
|
|
|
|
|
|
|
676,750
|
|
0.24
|
|
|
|
|
|
|
|
194,250
|
|
0.16
|
|
|
|
|
|
|
|
100,000
|
|
0.75
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,556,000
|
|
0.30
|
|
|
|
|
The Company used the Black-Scholes option price calculation to value the warrants granted in 2013 and 2012 using the following assumptions: an average risk-free rate of 2.6% and 3.08%; volatility of 331% and 260%; actual term and exercise price of warrants granted. See Note 3, Summary of Significant Accounting Policies, “
Accounting for Share-Based Payments
.”
In 2007, the Company adopted the 2007 Incentive and Non-Qualified Stock Option Plan (hereinafter the “
Plan
”), which replaced the 1997 Incentive and Non-Qualified Stock Option Plan, as amended in 2001, and under which 8,000,000 shares of Common Stock are reserved for issuance under qualified options, nonqualified options, stock appreciation rights and other awards as set forth in the Plan.
Under the Plan, qualified options are available for issuance to employees of the Company and non-qualified options are available for issuance to consultants and advisors. The Plan provides that the exercise price of a qualified option cannot be less than the fair market value on the date of grant and the exercise price of a nonqualified option must be determined on the date of grant. Options granted under the Plan generally vest three to five years from the date of grant and generally expire ten years from the date of grant.
During the year ended December 31, 2013, no stock options were granted by the Company.
The following is a summary of all Common Stock option activity during the year ended December 31, 2013 and 2012:
|
Shares Under
Options Outstanding
|
|
Weighted Average
Exercise Price
|
|
Outstanding at December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2013
|
|
|
|
|
|
|
|
Options
Exercisable
|
|
|
Weighted Average Exercise Price Per Share
|
|
Exercisable at December 31, 2012
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2013
|
|
|
|
|
|
|
|
|
The following represents additional information related to Common Stock options outstanding and exercisable at December 31, 2013:
|
|
Outstanding
|
|
Exercisable
|
|
Exercise
Price
|
|
Number of
Shares
|
|
Weighted Average
Remaining
Contract Life in Years
|
|
Weighted
Average
Exercise Price
|
|
Number of
Shares
|
|
Weighted Average
Exercise Price
|
|
|
|
|
|
|
|
0.04
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.58
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.77
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.67
|
|
|
|
|
|
|
|
|
|
|
The weighted average remaining contractual term for both fully vested share options (exercisable, above) and options expected to vest (outstanding, above) is 2.0 years.
A summary of the status of the Company’s nonvested stock options as of December 31, 2013 and changes during the year ended December 31, 2013 is presented below:
Nonvested Stock Options
|
|
Shares
|
|
|
Weighted Average Grant Date Fair Value
|
|
Nonvested at December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2013
|
|
|
|
|
|
|
|
|
The Company used the Black-Scholes option price calculation to value the warrants granted in 2013 and 2012 using the following assumptions: an average risk-free rate of 2.6% and 3.08%; volatility of 331% and 260%; actual term and exercise price of warrants granted. See Note 3, Summary of Significant Accounting Policies, “
Accounting for Share-Based Payments
.”
On March 24 and 25, 2014, the Company issued promissory notes in the principal amounts of $100,000 and $36,000, respectively (“
March Notes
”), which March Notes were issued to certain accredited investors. As additional consideration for the issuance of the March Notes, the holders thereof were issued 20,000 shares of our Common Stock for each $10,000 principal amount of the March Notes purchased, for an aggregate of 272,000 shares of Common Stock. Each of the March Notes accrues interest at the rate of 8% annually, and is due and payable on June 30, 2014. In addition, each of the March Notes voluntarily converts into our Common Stock at $0.08 per share in the event of the consummation of a qualified financing totaling at least $500,000 or, alternatively, in the event of the consumation of a qualified financing, holders may convert into the securities issued in connection with the qualified financing at 110% of the outstanding balance of the March Notes.
Management has reviewed and evaluated subsequent events and transactions occurring after the balance sheet date through the filing of this Annual Report on Form 10-K on April 15, 2014 and determined that no additional subsequent events occurred.
F-22