þ
|
Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
o
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
Massachusetts
|
04-2652826
|
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S. Employer Identification No.)
|
|
14 Norfolk Avenue South Easton, Massachusetts
|
02375
|
|
(Address of Principal Executive Offices)
|
( Zip Code)
|
|
(508) 230-1828
|
||
(Registrant’s Telephone Number, Including Area Code)
|
Title of Each Class
|
Name of Each Exchange on Which Registered
|
|
Common Stock, par value $.01 per share
Preferred Share Purchase Rights
|
OTC Markets Group Inc
|
Large accelerated filer | o | Accelerated filer | o |
Non-accelerated filer | o | Smaller reporting company | þ |
(Do not check if smaller reporting company)
|
PART I | |||||
ITEM 1. |
BUSINESS.
|
4 | |||
ITEM 1A.
|
RISK FACTORS
|
17 | |||
ITEM 1B. |
UNRESOLVED STAFF COMMENTS.
|
26 | |||
ITEM 2. |
PROPERTIES.
|
26 | |||
ITEM 3. |
LEGAL PROCEEDINGS.
|
26 | |||
ITEM 4. |
MINE SAFETY DISCLOSURES
|
26 | |||
PART II | |||||
ITEM 5. |
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES.
|
27 | |||
ITEM 6. |
SELECTED FINANCIAL DATA.
|
29 | |||
ITEM 7. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION.
|
29 | |||
ITEM 7A. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
38 | |||
ITEM 8. |
FINANCIAL STATEMENTS AND SUPPLIMENTARY DATA.
|
39 | |||
ITEM 9. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
|
77 | |||
ITEM 9A. |
CONTROLS AND PROCEDURES
|
77 | |||
ITEM 9B. |
OTHER INFORMATION.
|
78 | |||
PART III | |||||
ITEM 10. |
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
|
79 | |||
ITEM 11. |
EXECUTIVE COMPENSATION.
|
83 | |||
ITEM 12. |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
|
88 | |||
ITEM 13. |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS; AND DIRECTOR INDEPENDENCE.
|
89 | |||
ITEM 14. |
PRINCIPAL ACCOUNTING FEES AND SERVICES
|
89 | |||
PART IV | |||||
ITEM 15 |
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
|
90 |
●
|
our need for, and our ability to raise, additional equity or debt financing on acceptable terms, if at all;
|
●
|
our need to take additional cost reduction measures, cease operations or sell our operating assets, if we are unable to obtain sufficient additional financing;
|
●
|
our belief that we have sufficient liquidity to finance normal operations until August 2014;
|
●
|
the options we may pursue in light of our financial condition;
|
●
|
the amount of cash necessary to operate our business;
|
●
|
the anticipated uses of grant revenue and the potential for increased grant revenue in future periods;
|
●
|
our plans and expectations with respect to our continued operations;
|
●
|
our belief that PCT has achieved initial market acceptance in the mass spectrometry and other markets;
|
●
|
the expected increase in the number of pressure cycling technology (“PCT”) and constant pressure (“CP”) based units installed and the increase in revenues from the sale of consumable products and extended service contracts;
|
●
|
the expected development and success of new instrument and consumables product offerings;
|
●
|
the potential applications for our instrument and consumables product offerings;
|
●
|
the expected expenses of, and benefits and results from, our research and development efforts;
|
●
|
the expected benefits and results from our collaboration programs, strategic alliances and joint ventures;
|
●
|
our expectation of obtaining additional research grants from the government in the future;
|
●
|
our expectations of the results of our development activities funded by government research grants;
|
●
|
the potential size of the market for biological sample preparation;
|
●
|
general economic conditions;
|
●
|
the anticipated future financial performance and business operations of our company;
|
●
|
our reasons for focusing our resources in the market for genomic, proteomic, lipidomic and small molecule sample preparation;
|
●
|
the importance of mass spectrometry as a laboratory tool;
|
●
|
the advantages of PCT over other current technologies as a method of biological sample preparation in biomarker discovery, forensics, and histology and for other applications;
|
●
|
the capabilities and benefits of our PCT sample preparation system, consumables and other products;
|
●
|
our belief that laboratory scientists will achieve results comparable with those reported to date by certain research scientists who have published or presented publicly on PCT and our other products;
|
●
|
our ability to retain our core group of scientific, administrative and sales personnel; and
|
●
|
our ability to expand our customer base in sample preparation and for other applications of PCT and our other products.
|
A.
|
ITEM 1. BUSINESS.
|
●
|
biological sample preparation in such study areas as genomic, proteomic, lipidomic, metabolomic and small molecule;
|
●
|
pathogen inactivation;
|
●
|
protein purification;
|
●
|
control of chemical reactions, particularly enzymatic; and
|
●
|
immunodiagnostics.
|
●
|
Biomarker Discovery - Mass Spectrometry. A biomarker is any substance (e.g., protein) that can be used as an indicator of the presence or absence of a particular disease-state or condition, to measure disease progression, and to measure the effects of therapy. Biomarkers can help in the diagnosis, prognosis, therapy, prevention, surveillance, control, and cure of diseases and medical conditions.
A mass spectrometer is one of the laboratory instruments used in the analysis of biological samples, primarily proteins, in life sciences research. It is frequently used to help discover biomarkers. According to a recently published market report by Transparency Market Research (www.transparencymarketresearch.com) "Spectrometry Market (Atomic, Molecular and Mass Spectrometry) - Global Scenario, Trends, Industry Analysis, Size, Share & Forecast 2011 – 2017," the global spectrometry market was worth $10.2 billion in 2011 and is expected to reach $15.2 billion in 2017, growing at a compound annual growth rate of 6.9% from 2011 to 2017. In the overall global market, the North American market is expected to maintain its lead position in terms of revenue until 2017 and is expected to have approximately 36.2% of the market revenue share in 2017 followed by Europe. We believe that both PCT and CP based products offer significant advantages in speed and quality compared with current techniques used in the preparation of samples for mass spectrometry analysis.
|
●
|
Forensics. The detection of DNA has become a part of the analysis of forensic samples by laboratories and criminal justice agencies worldwide in their efforts to identify the perpetrators of violent crimes and missing persons. Scientists from the University of North Texas and Florida International University have reported improvements in DNA yield from forensic samples e.g., bone, and hair, using PCT in the sample preparation process. We believe PCT may be capable of differentially extracting DNA from sperm and female epithelial cells in swabs collected from rape victims and stored in rape kits. According to the Joyful Arts Foundation’s website, an organization focused on bringing justice to all victims of rape cases that remain unsolved (http://endthebacklog.org/whatisthebacklog.htm), “Experts in the federal government estimate that there are hundreds of thousands of untested rape kits in police and crime lab storage facilities throughout the United States.” We believe this backlog exists for reasons such as cost, processing time and quality of results. We further believe that the ability to differentially extract DNA from the sperm while not extracting DNA from the female epithelial cells could reduce the cost of such testing, while increasing quality, safety and speed.
|
●
|
Histology. The most commonly used technique worldwide for the preservation of biopsies of cancer and other tissues for subsequent pathology evaluation is formalin-fixation followed by paraffin-embedding (“FFPE”). We believe that the quality and analysis of FFPE tissues is highly problematic. We believe PCT offers significant advantages over current processing methods, which include standardization, speed, biomolecule recovery and safety.
|
●
|
On December 12th, we filed a current report on Form 8K relating to the close of the first tranche ($1 million) of a $1.5 million Convertible Preferred Stock and Common Warrant transaction.
|
●
|
On November 7th, we announced Q3 2013 financial results, including record quarterly total revenue, record quarterly products and services revenue, record quarterly consumable sales, and record quarterly Shredder Systems sales.
|
●
|
On August 1st, we reported that scientists from UCLA presented data at an international scientific symposium on an advanced pressure-based instrument system for biomarker discovery and rational drug design that we believe could offer new insights into protein structure and function.
|
●
|
On June 14th, we announced the close of the third and final tranche of our Series J $2.0 million Private Placement of Preferred Stock and Warrants; we also announced the closing of a $500,000 one-year convertible debenture with an institutional investor.
|
●
|
On June 4th, we announced a core technology breakthrough; that we had succeeded in reaching a pivotal development in our PCT platform that will allow the processing of the high throughput multiwell format found in research (and clinical) laboratories worldwide and that we expected this novel design would have a significant impact on our future growth.
|
●
|
On May 21st, we announced financial results for Q1 2013: total revenue increased 21% over the Q1 2012, consumable sales increased 64% over Q1 2012, and operating loss decreased 24% compared to Q1 2013.
|
●
|
On May 20th we closed the third and final tranche of an over-subscribed $1.5 million Convertible Preferred Stock and Common Warrant transaction, in which the Company received a total of $2,034,700.
|
●
|
On May 16th, we reported the publication of a breakthrough method for lipid analysis in fecal material, developed by a team led by Dr. Bruce Kristal (Harvard Medical School and the Brigham and Women’s Hospital). We believe that this new method can help increase the understanding of diseases and disorders related to gastrointestinal (GI) disorders.
|
●
|
On April 4th, we announced that further advances had been made in the development of an improved method for rape kit sample testing using PBI’s PCT Platform by Dr. Bruce McCord and his team at the International Forensic Research Institute of Florida International University.
|
●
|
On March 19th, we announced that the use and advantages of PBI’s PCT Platform had been highlighted in cancer, stem cell, and heart disease studies at an important protein research conference. We believe that the FDA data indicate that PCT can be used to extract proteins from stem cells with consistency and quality; the Johns Hopkins data indicate that combining PCT with heat might be a way to recover significantly more proteins from FFPE tissues compared to standard (heat) methods, especially membrane proteins (this could be very important with scientists looking for disease biomarkers); and the ETH Zurich data might be significant for extracting proteins from small, needle biopsy samples, something that we believe is vitally needed today yet not well satisfied at the present time, and (we believe) a significant market opportunity.
|
●
|
On February 12th, we announced that Dr. Mickey Urdea had been appointed to the Board of Directors of PBI. Dr. Urdea is one of the most well-known entrepreneurs and leaders in biotechnology today, having founded two successful companies (Halteres Associates and Tethys Bioscience) over the past ten years. Earlier in his career, Dr. Urdea led the infectious diseases R&D groups at Chiron Corporation and Bayer Diagnostics. He has also been on the Scientific Advisory Boards of numerous life sciences companies and has been an advisor and consultant to the Bill and Melinda Gates Foundation Diagnostic Forum.
|
●
|
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business. The accompanying financial statements do not include adjustments that may be required in the event of the disposal of assets or the discontinuation of the business;
|
●
|
obtain financing with terms that may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products;
|
●
|
or obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.
|
●
|
is a rapidly growing market;
|
●
|
has a large and immediate need for better technology;
|
●
|
is comprised mostly of research laboratories, which are subject to minimal governmental regulation;
|
●
|
is the least technically challenging application for the development of our products;
|
●
|
is compatible with our technical core competency; and
|
●
|
we currently have strong patent protection.
|
●
|
the development of a new application for PCT and CP in sample preparation;
|
●
|
the advancement and validation of our understanding of PCT and CP within an area of life sciences in which we already offer products;
|
●
|
the demonstration of the effectiveness of PCT and CP to specific research scientists who we believe can have a positive impact on market acceptance of PCT; and
|
●
|
the expectation of peer-reviewed publications and/or presentations at scientific meetings by a third party on the merits of PCT and CP.
|
●
|
labor reduction
|
● |
versatility
|
●
|
temperature control
|
● |
efficiency
|
●
|
precision
|
● |
simplicity
|
● |
reproducibility
|
● |
safety
|
1.
|
Applications Research and Development: Our highly educated and trained staff has years of experience in molecular and cellular biology, virology, and proteomics. Our team of scientists focuses on the development of our PCT Sample Preparation System and further commercialization of PCT-dependent genomic, proteomic, and small molecule sample preparation methods. Dr. Alexander Lazarev, our vice president of Research & Development, meets regularly with our sales, marketing, and engineering staff to discuss market needs and trends. Our applications research and development team is responsible for the technical review of all scientific collaborations, for the support of our marketing and sales departments through the generation of internal data in a number of areas of market interest, and in the development of commercially-viable PCT-dependent products.
|
2.
|
Engineering Research and Development: Our engineering research and development team is focused on the design and development of new and improved instrumentation and consumable products to support the commercialization of PCT. Our engineering department is led by Dr. Edmund Ting, our senior vice president of engineering. The primary focus of our engineering group is to ensure seamless production processes, perform installations and field service, and work with our application scientists to complete the development of a high throughput sample processing system for the mass spectrometry market.
|
●
|
Barocycler FFPE Protein Extraction Instrument System - A PCT-based system offering the enhanced extraction of proteins from formalin-fixed, paraffin-embedded (“FFPE”) samples using a modified Barocycler instrument that combines the advantages of pressure cycling, high temperature and certain reagents.
|
●
|
XstreamPCT™ HPLC Digestion Module - For automated, in-line, on-demand PCT-enhanced protein digestion; the first module in PBI's PCT-based HPLC platform.
|
●
|
Barocycler HT Multiwell (24-384) - For high throughput, PCT-enhanced biomolecule extraction/accelerated enzymatic digestion with the capability of processing 48 - 384 samples.
|
●
|
Barocycler HUB880 High Pressure - The next in the line of modular, high pressure generating instruments, the Barocycler HUB880 will be capable of creating and controlling hydrostatic pressure from 35 Bar (500 psi) to approximately 7,000 Bar (100,000 psi). The higher pressure limit of the Barocycler HUB880 will be nearly two times the upper limit of its’ sister instrument, the Barocycler HUB440. This higher limit will allow users to study the effects of pressure on substances (e.g., certain proteins) that do not react to pressures below 58,000 psi. Like the Barocycler HUB440, the Barocycler HUB880 will be computer controlled and run on software specially-written by PBI in LabVIEW. (by National Instruments Corporation). The Barocycler HUB880 will be the first portable, ready to use pressure generator for the laboratory bench that can reach pressures between 60,000 and 100,000 psi. We believe that over the coming years, the Barocycler HUB880 will be one of the main instruments in the Company’s pressure-based instruments line.
|
●
|
the problems, delays, expenses, and complications frequently encountered by early-stage companies;
|
●
|
market acceptance of our pressure cycling technology products and services for sample preparation;
|
●
|
the success of our sales and marketing programs; and
|
●
|
changes in economic, regulatory or competitive conditions in the markets we intend to serve.
|
●
|
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business;
|
●
|
obtain financing with terms that may have the effect of substantially diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or
|
●
|
obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.
|
●
|
availability of adequate financing;
|
●
|
unanticipated problems and costs relating to the development, testing, production, marketing, and sale of our products;
|
●
|
delays and costs associated with our ability to attract and retain key personnel; and
|
●
|
competition.
|
●
|
identify appropriate candidates for alliances, joint ventures or other business relationships;
|
●
|
assure that any candidate for an alliance, joint venture or business relationship will provide us with the support anticipated;
|
●
|
successfully negotiate an alliance, joint venture or business relationship on terms that are advantageous to us; or
|
●
|
successfully manage any alliance or joint venture.
|
●
|
multiple, conflicting and changing governmental laws and regulations, including those that regulate high pressure equipment;
|
●
|
reduced protection for intellectual property rights in some countries;
|
●
|
protectionist laws and business practices that favor local companies;
|
●
|
political and economic changes and disruptions;
|
●
|
export and import controls;
|
●
|
tariff regulations; and
|
●
|
currency fluctuations.
|
●
|
our ability to increase our sales of our pressure cycling technology products for sample preparation on a consistent quarterly or annual basis;
|
●
|
the lengthy sales cycle for our products;
|
●
|
the product mix of the Barocycler instruments we install in a given period, and whether the installations are completed pursuant to sales, rental or lease arrangements, and the average selling prices that we are able to command for our products;
|
●
|
our ability to manage our costs and expenses;
|
●
|
our ability to continue our research and development activities without incurring unexpected costs and expenses; and
|
●
|
our ability to comply with state and federal regulations without incurring unexpected costs and expenses.
|
●
|
a classified board of directors;
|
●
|
advance notice for stockholder nominations to the board of directors;
|
●
|
limitations on the ability of stockholders to remove directors; and
|
●
|
a provision that allows a majority of the directors to fill vacancies on the board of directors.
|
●
|
our inability to raise additional capital to fund our operations, whether through the issuance of equity securities or debt;
|
●
|
our failure to successfully implement our business objectives;
|
●
|
compliance with ongoing regulatory requirements;
|
●
|
market acceptance of our products;
|
●
|
technological innovations and new commercial products by our competitors;
|
●
|
changes in government regulations;
|
●
|
general economic conditions and other external factors;
|
●
|
actual or anticipated fluctuations in our quarterly financial and operating results; and
|
●
|
the degree of trading liquidity in our shares of Common Stock.
|
Year Ended December 31, 2013
|
||||||||
High
|
Low
|
|||||||
First Quarter
|
$ | 0.51 | $ | 0.20 | ||||
Second Quarter
|
$ | 0.42 | $ | 0.23 | ||||
Third Quarter
|
$ | 0.33 | $ | 0.20 | ||||
Fourth Quarter
|
$ | 0.29 | $ | 0.16 |
Year Ended December 31, 2012
|
||||||||
High
|
Low
|
|||||||
First Quarter
|
$ | 0.97 | $ | 0.50 | ||||
Second Quarter
|
$ | 0.75 | $ | 0.20 | ||||
Third Quarter
|
$ | 0.63 | $ | 0.21 | ||||
Fourth Quarter
|
$ | 0.44 | $ | 0.15 |
Common shares issued
|
Common shares to be issued
|
|||||||||
For The Year Ended December 31,
|
For The Year Ended December 31,
|
|||||||||
2013
|
2012
|
2013
|
2012
|
|||||||
Series A
|
-
|
-
|
Series A
|
-
|
-
|
|||||
Series B
|
-
|
96,966
|
Series B
|
-
|
-
|
|||||
Series C
|
-
|
64,621
|
Series C
|
-
|
-
|
|||||
Series D
|
-
|
-
|
Series D
|
-
|
-
|
|||||
Series E
|
-
|
622,837
|
Series E
|
-
|
-
|
|||||
Series G
|
-
|
-
|
Series G
|
-
|
-
|
|||||
Series H
|
-
|
-
|
Series H
|
-
|
-
|
|||||
Series J
|
-
|
-
|
Series J
|
-
|
-
|
|||||
Series K
|
-
|
-
|
Series K
|
-
|
-
|
|||||
-
|
784,424
|
-
|
-
|
Dividends paid in Common Stock or cash |
Dividends payable
|
|||||||||
For The Year Ended December 31,
|
For The Year Ended December 31,
|
|||||||||
2013
|
2012
|
2013
|
2012
|
|||||||
Series A
|
$-
|
$-
|
Series A
|
$-
|
$-
|
|||||
Series B
|
-
|
69,647
|
Series B
|
-
|
-
|
|||||
Series C
|
-
|
10,609
|
Series C
|
-
|
-
|
|||||
Series D
|
-
|
-
|
Series D
|
-
|
-
|
|||||
Series E
|
60,000
|
359,430
|
Series E
|
-
|
60,000
|
|||||
Series G
|
-
|
-
|
Series G
|
89,527
|
-
|
|||||
Series H
|
-
|
-
|
Series H
|
-
|
-
|
|||||
Series J
|
-
|
-
|
Series J
|
95,341
|
-
|
|||||
Series K
|
-
|
-
|
Series K
|
3,131
|
27,584
|
|||||
$60,000
|
$439,686
|
$187,999
|
$87,584
|
●
|
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business. The accompanying financial statements do not include adjustments that may be required in the event of the disposal of assets or the discontinuation of the business;
|
●
|
obtain financing with terms that may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or
|
●
|
obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.
|
●
|
Biomarker Discovery - Mass Spectrometry. A biomarker is any substance (e.g., protein) that can be used as an indicator of the presence or absence of a particular disease-state or condition, and to measure the progression and effects of therapy. Biomarkers can help in the diagnosis, prognosis, therapy, prevention, surveillance, control, and cure of diseases and medical conditions. A number of laboratory instruments are used to help discover biomarkers; a leader among these is the mass spectrometer. The mass spectrometer is one of the laboratory instruments that is frequently used to help discover biomarkers.
|
●
|
Forensics. The detection of DNA has become a part of the analysis of forensic samples by laboratories and criminal justice agencies worldwide in their efforts to identify the perpetrators of violent crimes and missing persons. Scientists from the University of North Texas and Florida International University have reported improvements in DNA yield from forensic samples e.g., bone and hair using PCT in the sample preparation process. We believe that that PCT may be capable of differentially extracting DNA from sperm and (female) epithelial cells in swabs collected from rape victims and stored in rape kits. We believe that there are many completed rape kits that remain untested for reasons such as cost, time, and quality of results. We further believe that the ability to differentially extract DNA from sperm and not epithelial cells could reduce the cost of such testing, while increasing quality, safety, and speed.
|
●
|
Histology. The most commonly used technique worldwide for the preservation of cancer and other tissues for subsequent pathology evaluation is formalin-fixation followed by paraffin-embedding. We believe that the quality and analysis of FFPE tissues is highly problematic, and that PCT offers significant advantages over current processing methods, including standardization, speed, biomolecule recovery, and safety.
|
A.
|
implementing a next-generation upgrade to our product line and offering a superior instrument with greater net margins;
|
B.
|
gaining additional non-dilutive monies from governmental research and development applications, and/or engineering projects; and
|
C.
|
hiring a small team of sales and marketing persons to target research facilities and academic institutions, and cultivate our current customer list of pharmaceutical, military and paramilitary organizations.
|
|
A
|
$2,034,700 in aggregate gross proceeds from our February 6, March 28 and May 20, 2013 Series J private placement, pursuant to which we sold an aggregate of 5,087.5 units for a purchase price of $400 per unit. Each unit consists of one share of Series J Convertible Preferred Stock, convertible into 1,000 shares of our Common Stock and a three-year warrant to purchase 1,000 shares of our Common Stock at a per share exercise price of $0.40. Of the $2,034,700 invested in the Series J Private Placement $921,000 was received in cash and $1,113,700 was from the conversion of outstanding indebtedness and accrued board of directors fees. We incurred fees of $24,405 on this transaction.
|
|
B
|
$1,000,000 in aggregate gross proceeds from our December 12, 2013 Series K private placement, pursuant to which we sold an aggregate of 4,000 units for a purchase price of $250 per unit. Each unit consists of one share of Series K Convertible Preferred Stock, convertible into 1,000 shares of our Common Stock and a three-year warrant to purchase 500 shares of our Common Stock at a per share exercise price of $0.3125. Of the $1,000,000 invested in the Series K Private Placement $572,044 was received in cash and $427,956 was from the conversion of outstanding indebtedness. We incurred fees of $43,334 on this transaction.
|
2014
|
$123,600
|
|
Thereafter
|
-
|
|
$123,600
|
ASSETS
|
2013
|
2012
|
||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$ | 31,417 | $ | 1,461 | ||||
Accounts receivable
|
147,635 | 216,265 | ||||||
Inventories, net of reserves of $50,000 at December 31, 2013 and December 31, 2012
|
736,676 | 923,362 | ||||||
Prepaid income taxes
|
7,381 | 7,381 | ||||||
Prepaid expenses and other current assets
|
85,573 | 83,435 | ||||||
Total current assets
|
1,008,682 | 1,231,904 | ||||||
PROPERTY AND EQUIPMENT, NET
|
58,102 | 30,282 | ||||||
OTHER ASSETS
|
||||||||
Deposits
|
- | 6,472 | ||||||
Intangible assets, net
|
36,498 | 85,130 | ||||||
TOTAL ASSETS
|
$ | 1,103,282 | $ | 1,353,788 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
||||||||
CURRENT LIABILITIES
|
||||||||
Accounts payable
|
1,102,772 | 1,199,846 | ||||||
Accrued employee compensation
|
149,333 | 119,338 | ||||||
Accrued professional fees and other
|
615,244 | 267,936 | ||||||
Deferred revenue
|
28,189 | 46,466 | ||||||
Promissory note
|
75,000 | 75,000 | ||||||
Dividend liability
|
- | 60,000 | ||||||
Related party debt
|
25,182 | 98,675 | ||||||
Convertible debt, net of debt discount of $331,806 at December 31, 2013 and $0 at December 31, 2012
|
281,796 | 863,004 | ||||||
Other debt
|
89,989 | - | ||||||
Warrant derivative liability
|
344,570 | 160,812 | ||||||
Conversion option liability
|
356,197 | - | ||||||
Total current liabilities
|
3,068,272 | 2,891,077 | ||||||
LONG TERM LIABILITIES
|
||||||||
Deferred revenue
|
2,785 | 2,487 | ||||||
TOTAL LIABILITIES
|
3,071,057 | 2,893,564 | ||||||
COMMITMENTS AND CONTINGENCIES (Note 7)
|
||||||||
STOCKHOLDERS' DEFICIT
|
||||||||
Series D convertible preferred stock, $.01 par value; 850 shares authorized; 300 shares issued and outstanding on December 31, 2013 and December 31, 2012 (Liquidation value of $300,000)
|
3 | 3 | ||||||
Series G convertible preferred stock, $.01 par value; 240,000 shares authorized; 145,320 shares issued and outstanding on December 31, 2013 and December 31, 2012
|
1,453 | 1,453 | ||||||
Series H convertible preferred stock $.01 par value 10,000 shares authorized; 10,000 shares issued and outstanding on December 31, 2013 and 0 at December 31, 2012
|
100 | - | ||||||
Series J convertible preferred stock $.01 par value 6,250 shares authorized; 5,087.5 shares issued and outstanding on December 31, 2013 and 0 at December 31, 2012
|
51 | - | ||||||
Series K convertible preferred stock $.01 par value 15,000 shares authorized; 4,000 shares issued and outstanding on December 31, 2013 and 0 at December 31, 2012
|
40 | - | ||||||
Common Stock, $.01 par value; 50,000,000 and 20,000,000 shares authorized; 12,024,267 and 12,149,267 shares issued and outstanding on December 31, 2013 and December 31, 2012, respectively
|
120,243 | 121,493 | ||||||
Warrants to acquire preferred stock and Common Stock
|
4,267,402 | 3,015,996 | ||||||
Additional paid-in capital
|
19,509,921 | 15,940,818 | ||||||
Accumulated deficit
|
(25,866,988 | ) | (20,619,539 | ) | ||||
Total stockholders' deficit
|
(1,967,775 | ) | (1,539,776 | ) | ||||
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$ | 1,103,282 | $ | 1,353,788 |
For the Year Ended
|
||||||||
December 31,
|
||||||||
2013
|
2012
|
|||||||
Revenue:
|
||||||||
Products, services, other
|
$ | 1,046,678 | $ | 809,308 | ||||
Grant revenue
|
456,610 | 428,909 | ||||||
Total revenue
|
1,503,288 | 1,238,217 | ||||||
Costs and expenses:
|
||||||||
Cost of PCT products and services
|
567,828 | 416,415 | ||||||
Research and development
|
1,035,426 | 965,623 | ||||||
Selling and marketing
|
752,288 | 714,635 | ||||||
General and administrative
|
2,474,938 | 2,605,186 | ||||||
Total operating costs and expenses
|
4,830,480 | 4,701,859 | ||||||
Operating loss
|
(3,327,192 | ) | (3,463,642 | ) | ||||
Other income (expense):
|
||||||||
Interest expense, net
|
(339,818 | ) | (133,417 | ) | ||||
Other income (expense), net
|
(531,130 | ) | - | |||||
Change in fair value of derivative liabilities
|
113,713 | 144,840 | ||||||
Total other income (expense)
|
(757,235 | ) | 11,423 | |||||
Loss before income taxes
|
(4,084,427 | ) | (3,452,219 | ) | ||||
Income tax benefit
|
- | 2,014 | ||||||
Net loss
|
(4,084,427 | ) | (3,450,205 | ) | ||||
Accrued and deemed dividends on convertible preferred stock
|
(1,163,022 | ) | (950,010 | ) | ||||
Net loss applicable to common shareholders
|
$ | (5,247,449 | ) | $ | (4,400,215 | ) | ||
Net loss per share attributable to common stockholders - basic and diluted
|
$ | (0.44 | ) | $ | (0.43 | ) | ||
Weighted average common shares outstanding used in basic and diluted net loss per share calculation
|
11,821,870 | 10,154,175 |
Series C Preferred Stock
|
Series D Preferred Stock
|
Series E Preferred Stock
|
Series G Preferred Stock
|
Series H Preferred Stock
|
Series J Preferred Stock
|
|||||||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||||||||||
BALANCE, January 1, 2012
|
88,098 | $ | 881 | 743 | $ | 7 | - | - | - | $ | - | - | $ | - | - | $ | - | |||||||||||||||||||||||||||||||
Stock-based compensation
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of Series E convertible preferred stock
|
- | - | - | - | 500 | 5 | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of Series G convertible preferred stock
|
- | - | - | - | - | - | 120,680 | 1,207 | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Fair value of common stock for services
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Offering costs for issuance of preferred stock
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of warrants in connection short-term loans
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of warrants for services
|
- | - | - | - | - | - | 24,640 | 246 | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of Series G preferred stock in lieu of cash for Board of Director fees
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Warrant modifications
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Conversion of preferred stock to common stock
|
(88,098 | ) | (881 | ) | (443 | ) | (4 | ) | (500 | ) | (5 | ) | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
Common stock paid-in-kind dividends earned
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Series E dividend paid in cash
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of common stock in private placement
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of common stock for dividends paid-in-kind
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
BALANCE, December 31, 2012
|
- | $ | - | 300 | $ | 3 | - | $ | - | 145,320 | $ | 1,453 | - | $ | - | - | $ | - | ||||||||||||||||||||||||||||||
Stock-based compensation
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of Series H convertible preferred stock
|
- | - | - | - | - | - | - | - | 10,000 | 100 | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of Series J convertible preferred stock
|
- | - | - | - | - | - | - | - | - | - | 5,088 | 51 | ||||||||||||||||||||||||||||||||||||
Issuance of Series K convertible preferred stock
|
||||||||||||||||||||||||||||||||||||||||||||||||
Fair value of common stock issued for services
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Offering costs for issuance of preferred stock
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of warrants in connection short-term loans
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Issuance of warrants for services
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Conversion of common stock to preferred stock
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Common stock paid-in-kind dividends earned
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Dividends earned on preferred stock
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Beneficial conversion feature on convertible preferred stock
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Reclassification of conversion option liabilities
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
BALANCE, December 31, 2013
|
- | $ | - | 300 | $ | 3 | - | $ | - | 145,320 | $ | 1,453 | 10,000 | $ | 100 | 5,088 | $ | 51 |
Series K Preferred Stock
|
Common Stock
|
Stock
|
Additional Paid-In
|
Accumulated
|
Total Stockholders'
|
||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Warrants | Capital | Deficit | Deficit | ||||||||||||||||||||||||||
BALANCE, January 1, 2012
|
- | - | 6,723,993 | $ | 67,240 | $ | 2,203,101 | $ | 13,823,875 | $ | (16,503,440 | ) | $ | (408,336 | ) | ||||||||||||||||||
Stock-based compensation
|
- | - | - | - | - | 133,193 | - | 133,193 | |||||||||||||||||||||||||
Issuance of Series E convertible preferred stock
|
- | - | - | - | - | 499,995 | - | 500,000 | |||||||||||||||||||||||||
Issuance of Series G convertible preferred stock
|
- | - | - | - | 104,301 | 497,867 | - | 603,375 | |||||||||||||||||||||||||
Fair value of common stock issued for services
|
- | - | 1,125,000 | 11,250 | - | 343,297 | - | 354,547 | |||||||||||||||||||||||||
Offering costs for issuance of preferred stock
|
- | - | - | - | - | (194,367 | ) | - | (194,367 | ) | |||||||||||||||||||||||
Issuance of warrants in connection short-term loans
|
- | - | - | - | 45,156 | - | - | 45,156 | |||||||||||||||||||||||||
Issuance of warrants for services
|
- | - | - | - | 11,883 | - | - | 11,883 | |||||||||||||||||||||||||
Issuance of Series G preferred stock in lieu of cash for Board of Director fees
|
- | - | - | - | 20,596 | 102,358 | - | 123,200 | |||||||||||||||||||||||||
Warrant modifications
|
- | - | - | - | 323,556 | - | (190,891 | ) | 132,665 | ||||||||||||||||||||||||
Conversion of preferred stock to common stock
|
- | - | 2,723,540 | 27,235 | - | (24,549 | ) | - | - | ||||||||||||||||||||||||
Common stock paid-in-kind dividends earned
|
- | - | - | - | - | - | (278,184 | ) | (278,184 | ) | |||||||||||||||||||||||
Series E dividend paid in cash
|
- | - | - | - | - | - | (196,819 | ) | (196,819 | ) | |||||||||||||||||||||||
Issuance of common stock in private placement
|
- | - | 971,867 | 9,719 | 307,403 | 482,878 | - | 800,000 | |||||||||||||||||||||||||
Issuance of common stock for dividends paid-in-kind
|
- | - | 604,867 | 6,049 | - | 276,271 | - | 284,116 | |||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | (3,450,205 | ) | (3,450,205 | ) | |||||||||||||||||||||||
BALANCE, December 31, 2012
|
- | $ | - | 12,149,267 | $ | 121,493 | $ | 3,015,996 | $ | 15,940,818 | $ | (20,619,539 | ) | $ | (1,539,776 | ) | |||||||||||||||||
Stock-based compensation
|
- | - | - | - | - | 136,796 | - | 136,796 | |||||||||||||||||||||||||
Issuance of Series H convertible preferred stock
|
- | - | (1,000,000 | ) | (10,000 | ) | - | 9,900 | - | - | |||||||||||||||||||||||
Issuance of Series J convertible preferred stock
|
- | - | - | - | 885,309 | 1,149,340 | - | 2,034,700 | |||||||||||||||||||||||||
Issuance of Series K convertible preferred stock
|
4,000 | 40 | 271,422 | 728,538 | 1,000,000 | ||||||||||||||||||||||||||||
Fair value of common stock issued for services
|
- | - | 875,000 | 8,750 | - | 467,962 | - | 476,712 | |||||||||||||||||||||||||
Offering costs for issuance of preferred stock
|
- | - | - | - | - | (67,739 | ) | - | (67,739 | ) | |||||||||||||||||||||||
Issuance of warrants in connection short-term loans
|
- | - | - | - | 73,647 | - | - | 73,676 | |||||||||||||||||||||||||
Issuance of warrants for services
|
- | - | - | - | 21,028 | - | - | 21,028 | |||||||||||||||||||||||||
Conversion of common stock to preferred stock
|
- | - | - | - | - | - | - | - | |||||||||||||||||||||||||
Common stock paid-in-kind dividends earned
|
- | - | - | - | - | - | - | - | |||||||||||||||||||||||||
Dividends earned on preferred stock
|
- | - | - | - | - | - | (160,420 | ) | (160,420 | ) | |||||||||||||||||||||||
Beneficial conversion feature on convertible preferred stock
|
- | - | - | - | - | 1,002,602 | (1,002,602 | ) | - | ||||||||||||||||||||||||
Reclassification of conversion option liabilities
|
- | - | - | - | - | 141,704 | - | 141,704 | |||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | (4,084,427 | ) | (4,084,427 | ) | |||||||||||||||||||||||
BALANCE, December 31, 2013
|
4,000 | $ | 40 | 12,024,267 | $ | 120,243 | $ | 4,267,402 | $ | 19,509,921 | $ | (25,866,988 | ) | $ | (1,967,775 | ) |
For the Year Ended
|
||||||||
December 31,
|
||||||||
2013
|
2012
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$ | (4,084,427 | ) | $ | (3,450,205 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
Depreciation and amortization
|
79,563 | 107,519 | ||||||
Accretion of non-cash interest and amortization of debt issue costs
|
708,729 | 91,315 | ||||||
Stock-based compensation expense
|
136,796 | 133,193 | ||||||
Amortization of third party fees paid in restricted common stock
|
480,492 | 489,605 | ||||||
Net change in inventory reserves
|
- | 50,000 | ||||||
Change in fair value of derivative liabilities
|
(113,713 | ) | (144,840 | ) | ||||
Recovery of bad debt expense
|
- | (9,600 | ) | |||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
68,630 | 84,988 | ||||||
Inventories
|
186,686 | 95,651 | ||||||
Accounts payable
|
(97,074 | ) | 309,170 | |||||
Accrued employee compensation
|
29,995 | (61,099 | ) | |||||
Deferred revenue and other accrued expenses
|
257,387 | 119,403 | ||||||
Prepaid expenses and other current assets
|
4,333 | 20,099 | ||||||
Net cash used in operating activities
|
(2,342,603 | ) | (2,164,801 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchases of property and equipment
|
(58,749 | ) | - | |||||
Net cash used in investing activities
|
(58,749 | ) | - | |||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Borrowings on convertible debt, net of issuance costs
|
1,374,297 | 1,394,000 | ||||||
Borrowings on related party and other debt, net of issuance costs
|
222,000 | 98,675 | ||||||
Repayment of related party and other debt
|
(180,304 | ) | - | |||||
Repayment of convertible debt
|
(350,000 | ) | (101,556 | ) | ||||
Payment of dividends
|
(60,000 | ) | (196,818 | ) | ||||
Net proceeds from the issuance of common stock
|
- | 377,453 | ||||||
Net proceeds from the issuance of preferred stock
|
1,425,315 | 371,733 | ||||||
Net cash provided by financing activities
|
2,431,308 | 1,943,487 | ||||||
Change in cash and cash equivalents
|
29,956 | (221,314 | ) | |||||
Cash and cash equivalents, beginning of period
|
1,461 | 222,775 | ||||||
Cash and cash equivalents, end of period
|
$ | 31,417 | $ | 1,461 | ||||
SUPPLEMENTAL INFORMATION:
|
||||||||
Income taxes paid
|
$ | - | $ | 1,900 | ||||
Issuance of common stock dividend on preferred stock
|
- | 284,116 | ||||||
Convertible debt exchanged for common stock
|
0 | 387,547 | ||||||
Debt and accrued interest exchanged for preferred stock
|
1,503,530 | 586,873 | ||||||
Fair value of common stock issued for services
|
467,964 | 354,547 | ||||||
Issuance of preferred stock for board fees
|
38,126 | 123,200 | ||||||
Warrant modifications
|
- | 190,891 | ||||||
Beneficial conversion feature on convertible preferred stock
|
1,002,602 | - | ||||||
Dividends earned on preferred stock | 160,420 | 27,584 | ||||||
(1)
|
Business Overview, Liquidity and Management Plans
|
●
|
severely limit or cease our operations or otherwise reduce planned expenditures and forego other business opportunities, which could harm our business. The accompanying financial statements do not include adjustments that may be required in the event of the disposal of assets or the discontinuation of the business;
|
●
|
obtain financing with terms that may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our capital stock; or
|
●
|
obtain funds through arrangements with future collaboration partners or others that may require us to relinquish rights to some or all of our technologies or products.
|
(2)
|
Summary of Significant Accounting Policies
|
i.
|
Principles of Consolidation
|
ii.
|
Use of Estimates
|
iii.
|
Revenue Recognition
|
iv.
|
Cash and Cash Equivalents
|
v.
|
Research and Development
|
vi.
|
Inventories
|
December 31,
|
||||||||
2013
|
2012
|
|||||||
Raw materials
|
$ | 147,290 | $ | 183,655 | ||||
Finished goods
|
639,386 | 789,707 | ||||||
Inventory reserve
|
(50,000 | ) | (50,000 | ) | ||||
Total
|
$ | 736,676 | $ | 923,362 |
vii.
|
Property and Equipment
|
viii.
|
Intangible Assets
|
ix.
|
Long-Lived Assets and Deferred Costs
|
x.
|
Concentrations
|
For the Year Ended
|
||||||||
December 31,
|
||||||||
2013
|
2012
|
|||||||
Top Five Customers
|
53 | % | 50 | % | ||||
Federal Agencies
|
33 | % | 41 | % |
For the Year Ended
|
||||||||
December 31,
|
||||||||
2013
|
2012
|
|||||||
Top Five Customers
|
86 | % | 34 | % | ||||
Federal Agencies
|
16 | % | 32 | % |
xi.
|
Computation of Loss per Share
|
For the Year Ended
|
||||||||
December 31,
|
||||||||
2013
|
2012
|
|||||||
Numerator:
|
||||||||
Net loss
|
$ | (4,084,427 | ) | $ | (3,450,205 | ) | ||
Accrued dividend for Preferred Stock paid in common stock
|
- | (278,184 | ) | |||||
Deemed dividend on warrant modifications
|
- | (190,891 | ) | |||||
Issuance of common stock for dividends paid in kind
|
- | (284,116 | ) | |||||
Beneficial conversion feature for preferred stock
|
(1,002,602 | ) | - | |||||
Preferred dividends accrued
|
(160,420 | ) | - | |||||
Preferred dividends accrued and paid in cash
|
- | (196,819 | ) | |||||
Net loss applicable to common shareholders
|
$ | (5,247,449 | ) | $ | (4,400,215 | ) | ||
Denominator for basic and diluted loss per share:
|
||||||||
Weighted average common shares outstanding
|
11,821,870 | 10,154,175 | ||||||
Loss per common share - basic and diluted
|
$ | (0.44 | ) | $ | (0.43 | ) |
For the Year Ended
|
||||||||
December 31,
|
||||||||
2013
|
2012
|
|||||||
Stock options
|
1,771,708 | 1,605,750 | ||||||
Convertible debt
|
2,242,024 | - | ||||||
Common stock warrants
|
15,012,327 | 6,687,099 | ||||||
Preferred stock warrants
|
- | - | ||||||
Convertible preferred stock:
|
||||||||
Series A Convertible Preferred
|
- | - | ||||||
Series B Convertible Preferred
|
- | - | ||||||
Series C Convertible Preferred
|
- | - | ||||||
Series D Convertible Preferred
|
750,000 | 750,000 | ||||||
Series E Convertible Preferred
|
- | - | ||||||
Series G Convertible Preferred
|
1,453,200 | 1,453,200 | ||||||
Series H Convertible Preferred
|
1,000,000 | - | ||||||
Series J Convertible Preferred
|
5,087,500 | - | ||||||
Series K Convertible Preferred
|
4,000,000 | - | ||||||
31,316,759 | 10,496,049 |
xii.
|
Accounting for Income Taxes
|
xiii.
|
Accounting for Stock-Based Compensation
|
Assumptions
|
Non-Employee Board Members
|
CEO, other Officers and Employees
|
||
Expected life
|
2.0-5.0 (yrs)
|
6.0 (yrs)
|
||
Expected volatility
|
55.66%-134.75% | 55.66%-124.89% | ||
Risk-free interest rate
|
1.00%-4.94% | 0.50%-4.94% | ||
Forfeiture rate
|
0.00%-5.00% | 2.00%-5.00% | ||
Expected dividend yield
|
0.0% | 0.0% |
Assumptions
|
Awards re-priced during the year ended
December 31,
2012
|
|||
Expected life (in years)
|
6 | |||
Weighted average expected volatility
|
124.9 | % | ||
Risk-free interest rate
|
0.7 | % | ||
Weighted average re-priced Black-Scholes calculated fair value
|
0.32 |
For the Year Ended
December 31,
|
||||||||
2013
|
2012
|
|||||||
Research and development
|
$ | 53,509 | $ | 30,034 | ||||
Selling and marketing
|
26,551 | 28,944 | ||||||
General and administrative
|
56,736 | 74,215 | ||||||
Total stock-based compensation expense
|
$ | 136,796 | $ | 133,193 |
xiv.
|
Fair Value of Financial Instruments
|
xv.
|
Advertising
|
xvi.
|
Fair Value Measurements
|
Fair value measurements at December 31, 2013 using:
|
||||||||||||||||
December 31,
2013
|
Quoted prices in active markets (Level 1)
|
Significant other observable inputs (Level 2)
|
Significant unobservable inputs
(Level 3)
|
|||||||||||||
Series D Common Stock Purchase Warrants
|
$ | 344,570 | $ | - | $ | - | $ | 344,570 |
Fair value measurements at December 31, 2012 using:
|
||||||||||||||||
December 31,
2012
|
Quoted prices in active markets (Level 1)
|
Significant other observable inputs (Level 2)
|
Significant unobservable inputs
(Level 3)
|
|||||||||||||
Series D Common Stock Purchase Warrants
|
$ | 160,812 | $ | - | $ | - | $ | 160,812 |
January 1,
2013
|
Change in Fair Value
|
December 31,
2013
|
||||||||||
Series D Common Stock Purchase Warrants
|
$ | 160,812 | $ | 183,758 | $ | 344,570 |
January 1,
2012
|
Change in Fair Value
|
December 31,
2012
|
||||||||||
Series D Common Stock Purchase Warrants
|
$ | 231,200 | $ | (70,388 | ) | $ | 160,812 |
Fair value measurements at December 31, 2013 using:
|
||||||||||||||||
December 31,
2013
|
Quoted prices in active markets (Level 1)
|
Significant other observable inputs (Level 2)
|
Significant unobservable inputs
(Level 3)
|
|||||||||||||
April 11, 2013 note, conversion option
|
$ | 130,734 | - | - | $ | 130,734 | ||||||||||
June 26, 2013 note, conversion option
|
55,307 | - | - | 55,307 | ||||||||||||
December 4, 2013 note, conversion option
|
98,129 | - | - | 98,129 | ||||||||||||
December 23, 2013 note, conversion option
|
72,027 | - | - | 72,027 | ||||||||||||
Embedded conversion options
|
$ | 356,197 | - | - | $ | 356,197 |
January 1,
2013
|
Issuance date fair value |
Change in fair
value
|
Reclassification
into equity
|
December 31,
2013
|
||||||||||||||
April 11, 2013 note, conversion option
|
$ | - | $ | 274,840 | $ | (144,106 | ) | $ | - | $ | 130,734 | |||||||
May 24, 2013 note, conversion option
|
- | 122,223 | (18,702 | ) | (103,521 | ) | - | |||||||||||
June 6, 2013 note, conversion option
|
- | 158,715 | (120,535 | ) | (38,180 | ) | - | |||||||||||
June 26, 2013 note, conversion option
|
- | 84,146 | (28,839 | ) | - | 55,307 | ||||||||||||
December 4, 2013 note, conversion option
|
- | 90,444 | 7,685 | - | 98,129 | |||||||||||||
December 23, 2013 note, conversion option
|
- | 65,033 | 7,024 | - | 72,027 | |||||||||||||
Embedded conversion options
|
$ | - | $ | 795,371 | $ | (297,471 | ) | $ | (141,701 | ) | $ | 356,197 |
Assumptions
|
April 11,
2013
|
Conversion options revalued at
December 31,
2013
|
||||||
Expected life (in months)
|
12 | 4 | ||||||
Expected volatility
|
206.2 | % | 149.9 | % | ||||
Risk-free interest rate
|
0.10 | % | 0.04 | % | ||||
Exercise price
|
$ | 0.14 | $ | 0.14 | ||||
Fair value per conversion option
|
$ | 0.29 | $ | 0.13 |
Assumptions
|
May 24,
2013
|
Conversion options revalued at
November 22,
2013
|
||||||
Expected life (in months)
|
24 | 18 | ||||||
Expected volatility
|
170.0 | % | 181.8 | % | ||||
Risk-free interest rate
|
0.27 | % | 0.35 | % | ||||
Exercise price
|
$ | 0.25 | $ | 0.17 | ||||
Fair value per conversion option
|
$ | 0.31 | $ | 0.17 |
Assumptions
|
June 6,
2013
|
Conversion options revalued at
December 26,
2013
|
||||||
Expected life (in months)
|
12 | 5 | ||||||
Expected volatility
|
209.7 | % | 132.9 | % | ||||
Risk-free interest rate
|
0.13 | % | 0.07 | % | ||||
Exercise price
|
$ | 0.40 | $ | 0.40 | ||||
Fair value per conversion option
|
$ | 0.25 | $ | 0.06 |
Assumptions
|
June 26,
2013
|
Conversion options revalued at
December 31,
2013
|
||||||
Expected life (in months)
|
12 | 6 | ||||||
Expected volatility
|
189.2 | % | 136.5 | % | ||||
Risk-free interest rate
|
0.13 | % | 0.07 | % | ||||
Exercise price
|
$ | 0.17 | $ | 0.14 | ||||
Fair value per conversion option
|
$ | 0.26 | $ | 0.14 |
Assumptions
|
December 4,
2013
|
Conversion options revalued at
December 31,
2013
|
||||||
Expected life (in months)
|
24 | 23 | ||||||
Expected volatility
|
170.3 | % | 170.3 | % | ||||
Risk-free interest rate
|
0.30 | % | 0.38 | % | ||||
Exercise price
|
$ | 0.40 | $ | 0.40 | ||||
Fair value per conversion option
|
$ | 0.16 | $ | 0.18 |
Assumptions
|
December 23,
2013
|
Conversion options revalued at
December 31,
2013
|
||||||
Expected life (in months)
|
36 | 36 | ||||||
Expected volatility
|
151.4 | % | 152.5 | % | ||||
Risk-free interest rate
|
0.77 | % | 0.78 | % | ||||
Exercise price
|
$ | 0.40 | $ | 0.40 | ||||
Fair value per conversion option
|
$ | 0.17 | $ | 0.19 |
(3)
|
Property and Equipment, net
|
December 31,
|
||||||||
2013
|
2012
|
|||||||
Laboratory and manufacturing equipment
|
$ | 226,081 | $ | 172,560 | ||||
Office equipment
|
142,323 | 137,093 | ||||||
Leasehold improvements
|
8,117 | 8,117 | ||||||
PCT collaboration, demonstration and leased systems
|
461,858 | 461,858 | ||||||
Total property and equipment
|
838,379 | 779,628 | ||||||
Less accumulated depreciation
|
(780,277 | ) | (749,346 | ) | ||||
Net book value
|
$ | 58,102 | $ | 30,282 |
(4)
|
Intangible Assets, net
|
December 31,
|
||||||||
2013
|
2012
|
|||||||
PCT Patents
|
$ | 778,156 | $ | 778,156 | ||||
Less accumulated amortization
|
(741,658 | ) | (693,026 | ) | ||||
Net book value
|
$ | 36,498 | $ | 85,130 |
(5)
|
Retirement Plan
|
(6)
|
Income Taxes
|
December 31,
|
||||||||
Current deferred taxes
|
2013
|
2012
|
||||||
Inventories
|
$ | 19,640 | $ | 19,723 | ||||
Accounts Receivable allowance
|
- | - | ||||||
Other accruals
|
23,050 | 45,053 | ||||||
Less: valuation allowance
|
(42,690 | ) | (64,776 | ) | ||||
Total current deferred tax assets
|
$ | - | $ | - | ||||
Long term deferred taxes:
|
||||||||
Accelerated tax depreciation
|
$ | 29,511 | $ | 32,686 | ||||
Non-cash, stock-based compensation, nonqualified
|
387,708 | 388,506 | ||||||
Goodwill and intangibles
|
(14,337 | ) | (33,580 | ) | ||||
Operating loss carry forwards and tax credits
|
8,938,681 | 7,643,661 | ||||||
Less: valuation allowance
|
(9,341,563 | ) | (8,031,273 | ) | ||||
Total long term deferred tax assets (liabilities), net
|
- | - | ||||||
Total net deferred tax liabilities
|
$ | - | $ | - |
For the Year Ended
|
||||||||
December 31,
|
||||||||
2012
|
2012
|
|||||||
Federal tax (benefit) provision rate
|
34 | % | 34 | % | ||||
Permanent differences
|
(3 | ) % | (1 | ) % | ||||
State tax expense
|
0 | % | 0 | % | ||||
Refundable AMT and R&D tax credit
|
0 | % | 0 | % | ||||
Net operating loss carry back
|
0 | % | 0 | % | ||||
Valuation allowance
|
(31 | ) % | (33 | ) % | ||||
Effective income tax (benefit) provision rate from continuing operations
|
0 | % | 0 | % |
(7)
|
Commitments and Contingencies
|
Year ending
December 31:
|
||||
2014
|
$ | 123,600 | ||
Thereafter
|
- | |||
Total minimum payments required
|
$ | 123,600 |
1)
|
20,000 shares have been designated as Series A Junior Participating Preferred Stock (“Junior A”)
|
2)
|
313,960 shares have been designated as Series A Convertible Preferred Stock (“Series A”)
|
3)
|
279,256 shares have been designated as Series B Convertible Preferred Stock (“Series B”)
|
4)
|
88,098 shares have been designated as Series C Convertible Preferred Stock (“Series C”)
|
5)
|
850 shares have been designated as Series D Convertible Preferred Stock (“Series D”)
|
6)
|
500 shares have been designated as Series E Convertible Preferred Stock (“Series E”)
|
7)
|
240,000 shares have been designated as Series G Convertible Preferred Stock (“Series G”)
|
8)
|
10,000 shares have been designated as Series H Convertible Preferred Stock (“Series H”)
|
9)
|
6,250 shares have been designated as Series J Convertible Preferred Stock (“Series J”)
|
10)
|
15,000 shares have been designated as Series K Convertible Preferred Stock (“Series K”)
|
Assumptions
|
Series A
|
Series A
|
Series B
|
Series C
|
Aug/Sep 2011
|
Feb 2012
|
||||||||||||||||||
(Affiliates)
|
Notes
|
PIPE
|
||||||||||||||||||||||
Contractual life, in years
|
4.1 | 3.1 | 3.1 | 5.1 | 2.1 | 4.6 | ||||||||||||||||||
Expected volatility
|
132.0 | % | 114.1 | % | 114.1 | % | 121.9 | % | 126.6 | % | 126.6 | % | ||||||||||||
Risk-free interest rate
|
0.4 | % | 0.4 | % | 0.4 | % | 0.4 | % | 0.4 | % | 0.4 | % | ||||||||||||
Exercise price
|
$ | 0.60 | $ | 0.60 | $ | 0.60 | $ | 0.60 | $ | 0.60 | $ | 0.60 | ||||||||||||
Fair value per warrant
|
$ | 0.03 | $ | 0.03 | $ | 0.03 | $ | 0.03 | $ | 0.03 | $ | 0.03 |
Assumptions
|
Series J warrants February 6,
2013
|
Series J warrants
March 28,
2013
|
Series J warrants
May 20,
2013
|
|||||||||
Contractual life (in months)
|
36 | 36 | 36 | |||||||||
Expected volatility
|
141.8 | 144.3 | 147.0 | |||||||||
Risk-free interest rate
|
0.39 | % | 0.36 | % | 0.36 | % | ||||||
Exercise price
|
$ | 0.40 | $ | 0.40 | $ | 0.40 | ||||||
Fair value per warrant
|
$ | 0.36 | $ | 0.26 | $ | 0.30 |
Assumptions
|
Series K warrants
December 12,
2013
|
|||
Contractual life (in months)
|
36 | |||
Expected volatility
|
136.1 | |||
Risk-free interest rate
|
0.39 | % | ||
Exercise price
|
$ | 0.3125 | ||
Fair value per warrant
|
$ | 0.2012 |
Stock Options
|
Warrants
|
|||||||||||||||||||||||
Weighted
|
Weighted
|
|||||||||||||||||||||||
Average price
|
Average price
|
Total
|
||||||||||||||||||||||
Shares
|
per share
|
Shares
|
per share
|
Shares
|
Exercisable
|
|||||||||||||||||||
Balance outstanding, January 1, 2012
|
1,508,500 | $ | 2.33 | 4,775,501 | $ | 1.35 | 6,284,001 | 6,112,335 | ||||||||||||||||
Granted
|
1,896,250 | 0.81 | 2,909,068 | 0.62 | 4,805,318 | |||||||||||||||||||
Exercised
|
- | - | - | - | - | |||||||||||||||||||
Expired
|
(130,000 | ) | 2.28 | (116,490 | ) | 2.80 | (246,490 | ) | ||||||||||||||||
Forfeited
|
(1,669,000 | ) | 2.09 | (880,980 | ) | 2.13 | (2,549,980 | ) | ||||||||||||||||
Balance outstanding, December 31, 2012
|
1,605,750 | $ | 0.80 | 6,687,099 | $ | 0.81 | 8,292,849 | 7,989,331 | ||||||||||||||||
Granted
|
363,500 | 0.41 | 8,346,228 | 0.37 | 8,709,728 | |||||||||||||||||||
Exercised
|
- | - | - | - | - | |||||||||||||||||||
Expired
|
(10,000 | ) | 1.00 | (21,000 | ) | 2.38 | (31,000 | ) | ||||||||||||||||
Forfeited
|
(187,542 | ) | .85 | - | - | (187,542 | ) | |||||||||||||||||
Balance outstanding, December 31, 2013
|
1,771,708 | $ | 0.71 | 15,012,327 | $ | 0.57 | 16,784,035 | 16,611,528 |
Options Outstanding
|
Options Exercisable
|
||||||||||||||||||||||||
Weighted Average
|
Weighted Average
|
||||||||||||||||||||||||
Range of Exercise Prices
|
Number of Options
|
Remaining Contractual Life (Years)
|
Exercise Price
|
Number of Options
|
Remaining Contractual Life (Years)
|
Exercise Price
|
|||||||||||||||||||
$0.00 - $0.49 | 321,000 | 9.4 | $ | 0.40 | 255,208 | 9.4 | $ | 0.40 | |||||||||||||||||
0.50 - 0.59 | 251,250 | 8.6 | 0.50 | 251,250 | 8.6 | 0.50 | |||||||||||||||||||
0.60 - 0.99 | 475,250 | 6.0 | 0.60 | 416,658 | 5.7 | 0.60 | |||||||||||||||||||
1.00 - 1.50 | 724,208 | 3.2 | 1.00 | 676,085 | 2.9 | 1.00 | |||||||||||||||||||
$0.50 - $1.00 | 1,771,708 | 5.9 | $ | 0.71 | 1,599,201 | 5.6 | $ | 0.72 |
Assumptions
|
November 10,
2011
|
Warrants revalued at
December 31,
2012
|
Warrants revalued at
December 31,
2013
|
|||||||||
Expected life (in months)
|
60.0 | 43.0 | 34.0 | |||||||||
Expected volatility
|
104.5 | % | 146.4 | % | 154.8 | % | ||||||
Risk-free interest rate
|
0.875 | % | 0.437 | % | 0.78 | % | ||||||
Exercise price
|
$ | 0.81 | $ | 0.40 | $ | 0.25 | ||||||
Fair value per warrant
|
$ | 0.54 | $ | 0.15 | $ | 0.21 |
(8)
|
Subsequent Events
|
●
|
On January 29 and February 28, 2014, the Company entered into a Securities Purchase Agreement with various individuals pursuant to which the Company sold an aggregate of 4,875 units for a purchase price of $250.00 per unit and 1,854 units for a purchase price of $340.00 per unit, respectively, or an aggregate Purchase Price of $1,849,110. This represents the second and third tranches of a $1.5 million private placement which was subsequently increased to $3.5 million and extended to April 4, 2014. Each unit purchased in the second and third tranche (“Unit”) consists of (i) one share of a newly created series of preferred stock, designated Series K Convertible Preferred Stock, par value $0.01 per share convertible into 1,000 shares of the Company’s Common Stock, par value $0.01 per share and (ii) a warrant to purchase 500 shares of Common Stock at an exercise price equal to one hundred and twenty-five percent of the common stock equivalent price per share, with a term expiring three years from the respective closing date.
|
●
|
In February 2014, the Company chose to pay off the April 11, 2013 and June 26, 2013 loan balances, see Note 7. The holder of the note chose to convert $37,500 of the outstanding balance to 150,000 shares of Company common stock, resulting in a cash payment of $203,100.
|
●
|
On February 6, 2014 the Company paid off the $75,000 balance of the promissory note, see Note 7, along with accrued interest on the note.
|
●
|
In March 2014, a Series D warrant holder exercised warrants to purchase 450,000 shares of common stock resulting in net proceeds to the Company of $112,500.
|
●
|
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of our assets;
|
●
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and
|
●
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
|
●
|
We identified a lack of sufficient segregation of duties. Specifically, this material weakness is such that the design over these areas relies primarily on detective controls and could be strengthened by adding preventative controls to properly safeguard company assets.
|
●
|
Management has identified a lack of sufficient personnel in the accounting function due to our limited resources with appropriate skills, training and experience to perform the review processes to ensure the complete and proper application of generally accepted accounting principles, particularly as it relates to valuation of warrants and other complex debt /equity transactions. Specifically, this material weakness led to segregation of duties issues and resulted in audit adjustments to the annual consolidated financial statements and revisions to related disclosures, valuation of warrants and other equity transactions.
|
●
|
Improve the effectiveness of the accounting group by continuing to augment our existing resources with additional consultants or employees to improve segregation procedures and to assist in the analysis and recording of complex accounting transactions. We plan to mitigate the segregation of duties issues by hiring an independent consultant once we generate significantly more revenue or raise significant additional working capital.
|
●
|
Improve segregation procedures by strengthening cross approval of various functions including quarterly internal audit procedures where appropriate.
|
Name
|
Age
|
Position
|
Board Committees
|
Term of office
|
||||||
Richard T. Schumacher
|
63 |
President, Chief Executive Officer, Treasurer, Clerk and Director
|
2014 | |||||||
Jeffrey N. Peterson
|
58 |
Chairman of the Board
|
Audit, Compensation, Nominating
|
2015 | ||||||
Dr. Mickey Urdea
|
62 |
Director
|
2014 | |||||||
Vito J. Mangiardi
|
65 |
Director
|
Audit, Compensation, Nominating
|
2016 | ||||||
Kevin A. Pollack
|
43 |
Director
|
Audit, Compensation, Nominating
|
2016 |
●
|
Mr. Richard T. Schumacher, the Company’s founder, provides valuable operational, sales and marketing, financial, and management expertise and experience and has significant knowledge of the Company’s technology and products. Prior to founding the company, Mr. Schumacher spent over 16 years working in the clinical research setting. In the more than 30 years since the Company’s formation, Mr. Schumacher has served the Company in various roles, including President, Chief Executive Officer and Chairman.
|
●
|
Mr. Jeffrey N. Peterson, the Chairman of our Board, is the CEO of Target Discovery, Inc., a personalized medicine diagnostics company, and has broad executive, general management, multi-functional, multi-business, and international experience.
|
●
|
Mr. Vito J. Mangiardi has broad executive, general management, multi-functional, multi-business, and international experience, specifically in the life sciences field.
|
●
|
Mr. Kevin A. Pollack provides a wealth of knowledge and experience in financial and administrative matters. Mr. Pollack recently served as managing director of Paragon Capital LP, a private investment firm, and serves as Chief Financial Officer of Lightlake Therapeutics Inc.
|
●
|
Dr. Michael S. “Mickey” Urdea offers significant scientific and technical experience from leading research and development programs in both small and large life sciences companies, and entrepreneurial experience from founding and leading successful personalized medicine and consulting companies in the biotechnology field.
|
●
|
been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
|
●
|
had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;
|
●
|
been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;
|
●
|
been found by a court of competent jurisdiction in a civil action or by the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
|
●
|
been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
|
●
|
been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
|
Name and Principal Position
|
Fiscal
Year
|
Salary(1)
|
Bonus
|
Stock Awards
|
Option
Awards(2)
|
Non-Qualified Deferred Compensation Earning
|
All other
Compensation(3)
|
Total
|
|||||||||||||||||||||
Richard T. Schumacher
|
2013
|
$ | 294,250 | $ | - | $ | - | $ | 26,497 | $ | - | $ | 11,524 | $ | 332,271 | ||||||||||||||
President, CEO |
2012
|
286,190 | - | - | 4,800 | - | 100,692 | 391,682 | |||||||||||||||||||||
Edmund Ting, Ph.D
|
2013
|
197,600 | - | - | 19,078 | - | 1,670 | 218,348 | |||||||||||||||||||||
Senior Vice President of |
2012
|
202,160 | - | - | 4,800 | - | 1,304 | 208,264 | |||||||||||||||||||||
Engineering | |||||||||||||||||||||||||||||
Alexander
|
2013
|
165,600 | - | - | 15,898 | - | 7,655 | 189,153 | |||||||||||||||||||||
Lazarev, Ph.D |
2012
|
175,103 | - | - | 4,800 | - | 7,501 | 187,404 | |||||||||||||||||||||
Vice President of | |||||||||||||||||||||||||||||
Research and | |||||||||||||||||||||||||||||
Development |
Option Awards
|
|||||||||||||
Name
|
Number of Securities Underlying Unexercised Options
Exercisable
|
Number of Securities Underlying Unexercised Options
Unexercisable (1)
|
Option Exercise Price
($)
|
Option Expiration Date
|
|||||||||
Richard T. Schumacher
|
75,000 | - | $ | 1.00 |
6/17/2015
|
||||||||
President, CEO
|
30,000 | - | $ | 1.00 |
3/30/2016
|
||||||||
70,000 | - | $ | 1.00 |
2/12/2017
|
|||||||||
75,000 | - | $ | 0.60 |
3/12/2019
|
|||||||||
8,438 | 6,562 | $ | 1.00 |
9/09/2021
|
|||||||||
13,125 | 16,875 | $ | 0.60 |
3/13/2022
|
|||||||||
59,375 | 15,625 | (2) | $ | 0.40 | 5/14/2023 | ||||||||
Edmund Y. Ting, Ph.D
|
60,000 | - | $ | 1.00 |
4/24/2016
|
||||||||
Senior Vice President of Engineering
|
12,000 | - | $ | 1.00 |
3/30/2016
|
||||||||
42,000 | - | $ | 1.00 |
2/12/2017
|
|||||||||
8,438 | 6,562 | $ | 1.00 |
9/09/2021
|
|||||||||
7,656 | 9,844 | $ | 0.60 |
3/13/2022
|
|||||||||
42,750 | 11,250 | (2) | $ | 0.40 | 5/14/2023 | ||||||||
Alexander V. Lazarev, Ph.D
|
50,000 | - | $ | 1.00 |
6/17/2015
|
||||||||
Vice President of Research & Development
|
10,000 | - | $ | 1.00 |
3/30/2016
|
||||||||
35,000 | - | $ | 0.60 |
2/12/2017
|
|||||||||
8,438 | 6,562 | $ | 1.00 |
9/09/2021
|
|||||||||
6,563 | 8,437 | $ | 0.60 |
3/13/2022
|
|||||||||
35,625 | 9,375 | (2) | $ | 0.40 |
5/14/2023
|
Name
|
Fees Paid in Cash (1)
|
Fees Paid in Stock (1)
|
Option Awards (2)(3)
|
Total
|
||||||||||||
Jeffrey N. Peterson (a,b)
|
$ | 17,250 | $ | 7,292 | - | $ | 25,542 | |||||||||
Vito J. Mangiardi (b)
|
15,000 | 4,167 | - | 19,167 | ||||||||||||
Kevin A. Pollack (b)
|
15,000 | 4,167 | - | 19,167 | ||||||||||||
Dr. Mickey Urdea (a)
|
25,000 | 22,500 | 12,137 | 59,637 |
Name
|
Aggregate Number of Stock Options Outstanding
|
|||
Jeffrey N. Peterson
|
63,750 | |||
Michael S. Urdea
|
37,500 | |||
Vito J. Mangiardi
|
50,000 | |||
Kevin A. Pollack
|
50,000 |
Name
|
Number of Shares of Common Stock Beneficially Owned
|
Percent of Class
|
||||||
Richard T. Schumacher (1)
|
1,551,104 | 12.0 | % | |||||
Jeffrey N. Peterson, MS (2)
|
385,726 | 3.1 | % | |||||
Kevin A. Pollack, Esq. MBA (3)
|
499,500 | 4.0 | % | |||||
Vito J. Mangiardi, MBA (4)
|
346,000 | 2.8 | % | |||||
Michael S. Urdea, Ph D (5)
|
311,500 | 2.5 | % | |||||
Edmund Y. Ting, Ph.D (6)
|
205,773 | 1.7 | % | |||||
Alexander V. Lazarev, Ph.D (7)
|
170,891 | 1.4 | % | |||||
All other officers
|
305,743 | 2.7 | % | |||||
All Executive Officers and Directors as a Group (nine persons)
|
3,776,237 | 25.1 | % |
1)
|
Includes (i) 343,125 shares of Common Stock issuable upon exercise of options; (ii) 428,675 shares of Common Stock issuable upon the exercise of warrants. Amount does not include 20,162 shares of Common Stock held by Mr. Schumacher’s minor son as his wife exercises all voting and investment control over such shares.
|
2)
|
Includes (i) 63,750 shares of Common Stock issuable upon exercise of options, and (ii) 191,000 shares of Common Stock issuable upon exercise of warrants.
|
3)
|
Includes (i) 50,000 shares of Common Stock issuable upon exercise of options, and (ii) 241,000 shares of Common Stock issuable upon the exercise of warrants
|
4)
|
Includes (i) 50,000 shares of Common Stock issuable upon exercise of options, and (ii) 183,000 shares of Common Stock issuable upon the exercise of warrants.
|
5)
|
Includes (i) 37,500 shares of Common Stock issuable upon exercise of options, and (ii) 167,000 shares of Common Stock issuable upon the exercise of warrants.
|
6)
|
Includes (i) 181,625 shares of Common Stock issuable upon exercise of options, and (ii) 8,290 shares of Common Stock issuable upon the exercise of warrants.
|
7)
|
Includes (i) 153,125 shares of Common Stock issuable upon exercise of options, and (ii) 6,705 shares of Common Stock issuable upon the exercise of warrants.
|
Plan Category
|
Number of securities to be issued upon exercise of outstanding options
|
Weighted-average exercise price of outstanding options
|
Number of securities remaining available for future issuance under equity compensation plans
|
|||||||||
Equity compensation plans approved by security holders(1)
|
1,771,708 | $ | 0.71 | 61,292 |
Fiscal 2013 Fees
|
Fiscal 2012 Fees
|
|||||||
Audit Fees
|
$ | 120,000 | $ | 143,250 | ||||
Audit-Related Fees
|
23,661 | 51,500 | ||||||
Tax and Other Fees
|
- | - | ||||||
$ | 143,661 | $ | 203,750 |
Exhibit No.
|
Reference
|
|
3.1
|
Restated Articles of Organization of the Company
|
A-3.1**
|
3.2
|
Articles of Amendment to Restated Articles of Organization of the Company
|
B-3.1**
|
3.3
|
Articles of Amendment to Restated Articles of Organization of the Company, as amended
|
O-3.1**
|
3.4
|
Articles of Amendment to Restated Articles of Organization of the Company, as amended
|
L-3.1**
|
3.5
|
Articles of Amendment to Restated Articles of Organization of the Company, as amended
|
P-3.1**
|
3.6
|
Articles of Amendment to Restated Articles of Organization of the Company, as amended
|
U-3.1**
|
3.7
|
Amended and Restated By-Laws of the Company
|
A-3.2**
|
3.8 | Amendment to Amended and Restated By-Laws of the Company | C-3.3** |
3.9 | Articles of Amendment to Restated Articles of Organization of the Company, as amended | W-3.1 |
3.10 | Articles of Amendment to Restated Articles of Organization of the Company, as amended | X-3.1 |
3.11 | Articles of Amendment to Restated Articles of Organization of the Company, as amended | Z-3.1 |
4.1
|
Specimen Certificate for Shares of the Company’s Common Stock
|
D-4.1**
|
4.2
|
Description of Capital Stock (contained in the Amended and Restated Articles of Organization, as amended, of the Company filed as Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7)
|
A-3.1 & 3.2, B-31, O-31, L-31, P-31 and U.31**
|
4.3
|
Rights Agreement dated as of February 27, 2003 between the Company and Computershare Trust Company, Inc.
|
E-4**
|
4.4
|
Amendment No. 1 to Rights Agreement dated April 16, 2004 between the Company and Computershare Trust Company, Inc.
|
F-4**
|
4.5
|
Amendment No. 2 to Rights Agreement dated November 8, 2011 between the Company and Computershare Trust N.A.
|
U-4.2**
|
4.6 | Securities Purchase Agreement dated November 21, 2007 between the Company and the purchasers named therein | G-4.9** |
4.7
|
Registration Rights Agreement dated November 21, 2007 between the Company and the purchasers named therein
|
G-4.10**
|
4.8
|
Securities Purchase Agreement dated February 12, 2009 between the Company and the purchasers named therein
|
L-4.1**
|
4.9
|
Form of 15-Month Preferred Stock Warrant
|
L-4.3**
|
4.10
|
Form of 30-Month Common Stock Purchase Warrant
|
L-4.4**
|
4.11
|
Amendment No. 1 to 30-Month Common Stock Purchase Warrant
|
Q-4.2**
|
4.12 | Amendment No. 2 to 30-Month Common Stock Purchase Warrant | S-4.1** |
4.13 | Registration Rights Agreement dated February 12, 2009 between the Company and the purchasers named therein | L-4.5** |
4.14
|
Securities Purchase Agreement dated November 18, 2009 between the company and the purchasers named therein
|
O-4.1**
|
4.15
|
Registration Rights Agreement dated November 18, 2009 between the Company and the purchasers named therein
|
O-4.3**
|
4.16
|
Series B Preferred Stock Warrant
|
O-4.2**
|
Exhibit No.
|
Reference
|
|
4.17
|
Amendment No. 1 to Series B Convertible Preferred Stock Purchase Warrant
|
Q-4.1**
|
4.18
|
Amendment No. 2 to Series B Convertible Preferred Stock Purchase Warrant
|
S-4.2**
|
4.19
|
Securities Purchase Agreement dated April 8, 2011 between the Company and the Purchasers Named Therein
|
P-4.1**
|
Registration Rights Agreement dated April 8, 2011 between the Company and the Purchasers Named Therein
|
||
4.2
|
Amendment No. 1 to Securities Purchase Agreement dated June 21, 2011, amending Securities Purchase Agreement dated April 8, 2011 between the Company and the Purchasers Named Therein
|
P-4.3**
|
Form of Common Stock Purchase Warrant
|
||
4.21
|
Form of Warrant Issued to Lenders
|
R-4.1**
|
Form of Promissory Note Issued to Lenders
|
||
Form of Common Stock Purchase Warrant
|
||
4.22
|
Form of Warrant
|
P-4.2**
|
4.23
|
Securities Purchase and Exchange Agreement, dated December 28, 2012
|
T-4.1**
|
4.24
|
Securities Purchase and Exchange Agreement, dated December 28, 2012
|
T-4.2**
|
4.25
|
Form of Warrant
|
U-4.1**
|
4.26
|
Registration Rights Agreement, dated February 6, 2013 between the Company and Purchasers named therein
|
V-4.1**
|
4.27
|
10% Convertible Debenture, issued on June 7, 2013 for a Purchase price of $250.00
|
W-4.2
|
4.28
|
Securities Purchase and Exchange Agreement, dated December 12, 2013
|
X-4.1
|
4.29
|
Form of Warrant, initial exercise date December 12, 2013
|
X-4.2
|
4.3
|
Registration Rights Agreement, dated December 12, 2013
|
X-4.3
|
1999 Non-Qualified Stock Option Plan*
|
Y-4.1
|
|
4.31
|
Z-4.1
|
|
4.32
|
Z-4.2
|
|
4.33
|
Z-4.3
|
|
4.34
|
H**
|
|
10.1
|
||
10.2
|
1999 Employee Stock Purchase Plan*
|
H**
|
10.3
|
2005 Equity Incentive Plan.*
|
I-99.1**
|
10.4
|
Amendment No. 1 to 2005 Equity Incentive Plan*
|
M-10.1**
|
10.5
|
Description of Compensation for Certain Directors*
|
N-10.7**
|
10.6
|
Severance Agreement between the registrant and Richard T. Schumacher*
|
N-10.6**
|
10.7
|
Form of Severance Agreement including list of officers to whom provided*
|
N-10.7**
|
10.8
|
Consent Agreement, dated May 29, 2007, by and among the registrant, PBI Source Scientific, Inc., Source Scientific, LLC, BIT Analytical Instruments, Inc., Richard W. Henson and Bruce A. Sargeant.
|
J-10.1**
|
10.9
|
Asset Purchase Agreement dated April 16, 2004 between the Company, BBI Biotech Research Laboratories, Inc. and SeraCare Life Sciences, Inc.
|
F-1**
|
10.1
|
Technology Transfer and Patent Assignment Agreement dated October 7, 1996, between Bioseq, Inc. and BioMolecular Assays, Inc.
|
N-10.11**
|
10.11
|
Amendment to Technology Transfer and Patent Assignment Agreement dated October 8, 1998 between Bioseq, Inc. and BioMolecular Assays, Inc.
|
N-10.12**
|
10.12
|
Nonexclusive License Agreement dated September 30, 1998 between Bioseq, Inc. and BioMolecular Assays, Inc.
|
N-10.13**
|
10.13
|
Agreement for Research Services dated February 1, 2006 by and between the registrant and the University of New Hampshire
|
K-10.1**
|
10.14
|
Placement Agency Agreement between the Placement agent and the Company, dated November 8, 2011
|
U-10.1**
|
Form of Securities Purchase Agreement
|
||
10.15
|
Form of Escrow Agreement, as amended
|
U-10.2**
|
10.16
|
Form of Securities Purchase Agreement
|
U-10.3**
|
10.17
|
Securities Purchase Agreement, dated June 7, 2013
|
V-3.1**
|
10.18
|
Consent of Independent Registered Public Accounting Firm (Marcum LLP)
|
Y-10.1
|
23.1
|
Filed herewith
|
|
31.1
|
Principal Executive Officer and Principal Financial Officer Certification Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
32.1
|
Principal Executive Officer and Principal Financial Officer Certification Pursuant to Item 601(b)(32) of Regulation S-K, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
101
|
Interactive Data File
|
Filed herewith
|
A
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Registration Statement on Form S-1 (Registration No. 333-10759) filed with the Commission on August 23, 1996.
|
B
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2004.
|
C
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002.
|
D
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Annual Report on Form 10-KSB for the fiscal year ended December 31, 2004.
|
E
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission March 12, 2003.
|
F
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission April 16, 2004.
|
G
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Registration Statement on Form S-3 (Registration No. 333-148227) filed with the Commission on December 20, 2007.
|
H
|
We previously filed this exhibit as an appendix to the registrant’s proxy statement filed June 14, 1999.
|
I
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Registration Statement on Form S-8 (Reg. No. 333-128594) filed with the Commission on September 26, 2005.
|
J
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on June 1, 2007.
|
K
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 7, 2006.
|
L
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 18, 2009.
|
M
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on September 29, 2008.
|
N
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Annual Report on Form 10-K filed with the Commission on March 27, 2008.
|
O
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on November 19, 2009.
|
P
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on April 12, 2011.
|
Q
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on August 11, 2011.
|
R
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on June 21, 2011.
|
S
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on October 6, 2011.
|
T
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2011.
|
U
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on November 10, 2011.
|
V
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 9, 2012.
|
W
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on January 4, 2013.
|
X
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on February 13, 2013.
|
Y
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on June 13, 2013.
|
Z
|
We previously filed this exhibit with the referenced exhibit number as an exhibit to the registrant’s Current Report on Form 8-K filed with the Commission on December 12, 2013.
|
Date: March 31, 2014
|
Pressure BioSciences, Inc.
|
|
By:
|
/s/ Richard T. Schumacher
|
|
Richard T. Schumacher
|
||
President and Chief Executive Officer
|
Name
|
Capacity
|
Date
|
||
/s/ Richard T. Schumacher
Richard T. Schumacher
|
President, Chief Executive Officer, Treasurer, Clerk and Director (Principal Executive Officer)
|
March 31, 2014
|
||
/s/ Richard P. Thomley
Richard P. Thomley
|
Chief Financial Officer
(Principal Financial Officer)
|
March 31, 2014
|
||
/s/ Jeffrey N. Peterson
Jeffrey N. Peterson
|
Chairman of the Board of Directors
|
March 31, 2014
|
||
/s/ Mickey Urdea
Michael S.Urdea, Ph.D.
|
Director
|
March 31, 2014
|
||
/s/ Vito Mangiardi
Vito J. Mangiardi
|
Director
|
March 31, 2014
|
||
/s/ Kevin Pollack
Kevin A. Pollack
|
Director
|
March 31, 2014
|