UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
x ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the
Fiscal Year Ended September 30, 2008
¨ TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the
transition period from _____ to _____
Commission
File Number 002-90539
APPLIED
DNA SCIENCES, INC.
(Name of
small business issuer in its charter)
Nevada
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59-2262718
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(State
or other jurisdiction of
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(I.R.S.
Employer
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incorporation
or organization)
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Identification
Number)
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25
Health Sciences Drive, Suite 113
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Stony Brook, New
York
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11790
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(631)
444-6862
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(Address
of principal executive office)
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(Postal
Code)
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(Issuer's
telephone number)
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Securities
registered under Section 12(b) of the Exchange Act: None
Securities
registered under Section 12(g) of the Exchange Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes o No
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes o No
x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x
No o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
o
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller
reporting company x
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes o No
x
The
aggregate market value of the Registrant’s common stock held by non-affiliates
of the Registrant, based upon the last sale price of the Common Stock quoted on
the OTC Bulletin Board as of the last business day of the Registrant’s most
recently completed second fiscal quarter (March 31, 2008), was approximately
$21,056,590. Shares of the Registrant’s common stock held by
each executive officer and director and by each entity or person that, to the
Registrant’s knowledge, owned 5% or more of the Registrant’s outstanding common
stock as of March 31, 2008 have been excluded in that such persons may be deemed
to be affiliates of the Registrant. This determination of affiliate
status is not necessarily a conclusive determination for other
purposes.
As of
December 15, 2008, the Registrant had outstanding 231,870,731 shares of Common
Stock, par value $0.001 per share.
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ITEM
1. BUSINESS
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1
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ITEM
1A. RISK FACTORS
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16
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ITEM
1B. UNRESOLVED STAFF COMMENTS
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24
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ITEM
2. PROPERTIES
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24
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ITEM
3. LEGAL PROCEEDINGS
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24
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ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
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25
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PART
II
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ITEM
5. MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
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25
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ITEM
6. SELECTED FINANCIAL DATA
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25
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ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
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25
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ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
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32
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ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
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32
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ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
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32
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ITEM
9A. CONTROLS AND PROCEDURES
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32
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ITEM
9A(T). CONTROLS AND PROCEDURES
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32
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ITEM
9B. OTHER INFORMATION
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33
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PART
III
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ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
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33
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ITEM
11. EXECUTIVE COMPENSATION.
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36
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ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
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38
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ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
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40
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ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
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40
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PART
IV
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ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
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42
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PART
I
Forward-looking
Information
This
Annual Report on Form 10-K (including the section regarding Management's
Discussion and Analysis of Financial Condition and Results of Operations)
contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), including
statements using terminology such as “can”, “may”, “believe”, “designated to”,
“will”, “expect”, “plan”, “anticipate”, “estimate”, “potential” or “continue”,
or the negative thereof or other comparable terminology regarding beliefs,
plans, expectations or intentions regarding the future. You should read
statements that contain these words carefully because they:
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discuss
our future expectations;
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contain
projections of our future results of operations or of our financial
condition; and
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state
other “forward-looking”
information.
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We
believe it is important to communicate our expectations. However, forward
looking statements involve risks and uncertainties and our actual results and
the timing of certain events could differ materially from those discussed in
forward-looking statements as a result of certain factors, including those set
forth under “Risk Factors,” “Business” and elsewhere in this report. All
forward-looking statements and risk factors included in this document are made
as of the date hereof, based on information available to us as of the date
thereof, and we assume no obligations to update any forward-looking statement or
risk factor, unless we are required to do so by law.
ITEM
1. BUSINESS.
Overview
We use
the DNA of plants and innovative technologies to provide anti-counterfeiting and
product authentication solutions and to manufacture ingredients for personal
care products and textiles. SigNature® DNA and BioMaterial™
Genotyping, our principal anti-counterfeiting and product authentication
solutions, allow users to accurately and effectively protect branded products,
artwork and collectibles, fine wine, digital media, financial instruments,
identity cards and other official documents. Our BioActive™
Ingredients, which are being used by our customers in personal care products,
such as skin care products, and in textiles, such as intimate apparel, are
custom-manufactured to address a customer’s specific need.
SigNature
DNA. We use the DNA of plants to manufacture highly customized
and encrypted botanical DNA markers, or SigNature DNA Markers, which we believe
are virtually impossible to replicate. We have embedded SigNature DNA
Markers into a range of our customers’ products, including various inks, thermal
ribbon, thread, varnishes and adhesives. These items can then be
tested for the presence of SigNature DNA Markers through an instant field
detection or a forensic level authentication. Our SigNature DNA
solution provides a secure, accurate and cost-effective means for users to
incorporate our SigNature DNA Markers in, and then quickly and reliably
authenticate and identify, a broad range of items such as branded products,
artwork and collectibles, cash-in-transit, fine wine, digital media, financial
instruments, identity cards and other official documents. Having the
ability to reliably authenticate and identify counterfeit versions of such items
enables companies and governments to detect, deter, interdict and prosecute
counterfeiting enterprises and individuals.
BioMaterial
GenoTyping. Our BioMaterial GenoTyping solution refers to the
development of genetic assays to distinguish between varieties or strains of
biomaterials, such as cotton, wool, tobacco, fermented beverages, natural drugs
and foods, that contain their own source DNA. We have developed two
proprietary genetic tests (FiberTyping™ and PimaTyping™) to track American Pima
cotton from the field to finished garments. These genetic assays
provide the cotton industry with the first authentication tools that can be
applied throughout the U.S. and worldwide cotton industry from cotton growers,
mills, wholesalers, distributors, manufacturers and retailers through trade
groups and government agencies.
BioActive
Ingredients. Our BioActive Ingredients program began in 2007,
based on the biofermentation expertise developed during the manufacturing of DNA
for our SigNature DNA and BioMaterial Genotyping solutions. Our
BioActive Ingredients have been used by our customers in personal care products,
such as skin care products, and in textiles, such as intimate
apparel.
Corporate
History
We
are a Nevada corporation, which was initially formed under the laws of the
State of Florida as Datalink Systems, Inc. in 1983. In 1998, we
reincorporated in Nevada, and in November of 2002, we changed our name to our
current name, Applied DNA Sciences, Inc. A proposal has been
submitted to the stockholders for consideration at the 2008 Annual Meeting of
Stockholders to be held on December 16, 2008 to change the state of
incorporation from Nevada to Delaware. In November 2005, our corporate
headquarters were relocated from Los Angeles, California to the Long Island High
Technology Incubator at Stony Brook University in Stony Brook, New
York, where we established laboratories for the manufacture of DNA markers and
product prototypes, and DNA authentication. To date, the company has
a very limited operating history, and as a result, the company’s operations have
produced insignificant revenues.
Industry
Background
Counterfeiting,
product diversion, piracy, forgery, identity theft, and unauthorized intrusion
into physical locations and databases create significant and growing problems to
companies in a wide range of industries as well as governments and individuals
worldwide. The U.S. Chamber of Commerce reported in 2007 that
counterfeiting and piracy cost the U.S. economy between $200-$250 billion per
year, or an estimated 750,000 American jobs, and pose a real threat to consumer
health and safety. The World Customs Organization and Interpol
estimate that annual global trade in illegitimate goods was $650 billion in
2007.
Product
counterfeiting and diversion particularly harms manufacturers of consumer
products, especially for prestige and established brands, and the consumers who
purchase them. This total includes:
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$34
billion of software products;
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$12
billion of apparel and footwear;
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$193
million of cigarettes and tobacco products;
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$32
billion of pharmaceuticals;
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$18
million in wine;
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$500
million of sports equipment;
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$35
million of electronic equipment and supplies;
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$3 billion
in cosmetics;
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$12
billion in automobile parts;
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$11
million of food and alcohol products;
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$11
million in jewelry and watches;
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$10
million of computer equipment and supplies; and
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$123
million of other goods.
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The
artworks and collectibles markets are also particularly vulnerable to
counterfeiting, forgery and fraud. New works are produced and then
passed off as originating from a particular artistic period or source, authentic
fragments are pieced together to simulate an original work, and existing works
are modified in order to increase their purported value. Such phony
artwork and collectibles are then often sold with fake or questionable
signatures and “provenance,” or documented ownership histories that confirm
authenticity.
Cash-in-transit
businesses transport and store cash and ATM cassettes. In the U.K. alone, there
is an estimated £500 billion being transported each year, or £1.4 billion per
day. The nature of this business makes cash-in-transit an attractive
target for criminals, and as a result the industry invests in excess of £100
million per year in security equipment and devices. Currently, a
system of cash degradation, using a smoke or liquid dye to permanently mark and
essentially destroy stolen cash, is used. The incidence of
cash-in-transit based crime has increased over 170% in London since 2006,
according to the Metropolitan Police.
Governments
are increasingly vulnerable to counterfeiting, terrorism and other security
threats at least in part because currencies, identity and security cards and
other official documents can be counterfeited with relative ease. For
instance, the DOPIP valued 2005 seizures and losses associated with counterfeit
currency at around $609 billion, and counterfeit identification at $124
million. Governments must also enforce the various
anti-counterfeiting and anti-piracy regimes of their respective jurisdictions
which becomes increasingly difficult with the continued expansion of global
trade.
The
digital and recording media industry, including the segment that records
computer software on compact discs, has long been a victim of piracy, or the
production of illegal copies of genuine media or software, and the
counterfeiting and distribution of imitation media or
software. Compact discs, DVDs, videotapes, computer software and
other digital and recording media that appears identical to genuine products are
sold at substantial discounts by vendors at street and night markets, via mail
order catalogs and on the internet at direct retail websites or at auction
sites. In 2008 the Business Software Alliance ("BSA") reported that
in 2007, the United States lost $8.0 billion as a result of software
piracy. The BSA also estimated that 33 percent of software programs
in the U.S. are unlicensed and that since January 1, 2000, the BSA has settled
with 1,668 companies for a total of $81,821,895. In a white paper
published in December 2005, the BSA and the IDC also reported that they found in
a 2007 study that for every two dollars worth of software purchased
legitimately, one dollar was obtained illegally.
The
pharmaceutical industry also faces major problems relative to counterfeit,
diluted, or falsely labeled drugs that make their way through healthcare systems
worldwide, posing a health threat to patients and a financial threat to
drugmakers and distributors. In 2006 the Center for Medicine in the
Public Interest predicted that counterfeit drug sales will reach $75 billion
globally in 2010, an increase of more than 90% from 2005. In February
2006, the World Health Organization ("WHO") estimated that counterfeits account
for more than 10% of the global pharmaceuticals market, and 25% of
pharmaceuticals consumed in developing countries and that as much as 50% in some
countries, are counterfeit. According to the WHO, counterfeiting can
apply to both branded and generic products and counterfeit pharmaceuticals may
include products with the correct ingredients but fake packaging, with the wrong
ingredients, without active ingredients or with insufficient active
ingredients. The challenges presented by traditional counterfeiters
have recently been supplemented by the many websites, from direct retailers to
auction sites, that offer counterfeit prescription drugs online. As a
result, the pharmaceutical industry and regulators are examining emerging
anti-counterfeit technologies, including radio-frequency identification tags and
electronic product codes, known as EPCs, to help stem the wave of counterfeit
drugs and better track legitimate drugs from manufacturing through the supply
chain.
As more
and more companies in each of these markets begin to address the problem of
counterfeiting, we expect that different systems will compete to be the leading
standards by which products can be tracked across world
markets. Historically, counterfeiting, product diversion and other
types of fraud have been combatted by embedding various authentication systems
and rare and easily distinguishable materials into products, such as radio
frequency identification (RFID) devices and banknote threads in packaging,
integrated circuit chips and magnetic strips in automatic teller machine cards,
holograms on currency, elemental taggants in explosives, and radioactivity and
rare molecules in crude oil. These techniques are effective but have
generally been reverse-engineered and replicated by counterfeiters, which limits
their usefulness as forensic methods for authentication of the sources of
products and other items.
Every
living organism has a unique DNA code that determines the character and
composition of its cells. The core technologies of our business allow us to use
the DNA of everyday plants to mark objects in a unique manner that we believe
cannot be replicated, and then identify these objects by detecting the absence
or presence of the DNA. Our scientific team was able to develop
genetic based assays and protocols to identify DNA markers that are endogenous
to a particular plant in order to differentiate between biological strains of
cotton and we are now employing the same methodology in wool, wine and other
natural products. In addition, in the case of Pima cotton, we have developed
proprietary technologies to differentiate between Pima (G. barbadense) and Non-Pima (G. hirsutum) cotton with absolute
certainty. In the process, we were also able to develop an approach
to attach an exogenous DNA marker to a finished textile
product. Cotton classification and the authentication of cotton
geographic origin are issues of global significance, important to brand owners
and to governments that must regulate the international cotton trade. The use of
DNA to identify the cotton fiber content of finished textiles is a significant
opportunity for license holders to control their brand and for governments to
improve their ability to enforce compliance with trade agreements between
nations. In addition to the global cotton trade, the markets for
BioMaterial Genotyping include biotherapeutics, nutraceuticals, natural foods,
wines and fermented alcohols and other natural textiles.
The
global market for specialty raw materials for cosmetics and toiletries, which
includes BioActive Ingredients, was reported to be $5.9 billion in 2006 with an
estimated growth of 5% per year (Freedonia).
Our
Offerings
SigNature
DNA
We
believe our SigNature DNA offering is as broadly applicable, convenient and
inexpensive as existing authentication systems, while highly resistant to
reverse-engineering or replication, so that it can either be applied
independently or supplement existing systems in order to allow for a forensic
level of authentication of the sources of a broad range of items, such as
artwork and collectibles, fine wine, consumer products, digital and recording
media, pharmaceuticals, financial instruments, identity cards and official
documents. Each SigNature DNA Marker is first designed and
manufactured to be a highly customized and encrypted botanical DNA
marker. The SigNature DNA Marker is then encapsulated and stabilized
so that it is resistant to heat, organic solvents, chemicals and most
importantly, ultraviolet, or UV radiation. Once it has been
encapsulated, our SigNature DNA Embedment system can be used to embed the
SigNature DNA Marker directly onto products or other items or into special inks,
threads and other media, which in turn can be incorporated into packaging or
products. Once it is embedded, our SigNature DNA Encryption Detector
pen can instantly test for the presence or absence of any of our SigNature DNA
Markers, and our SigNature polymerase chain reaction (PCR) Kits can provide
rapid forensic level authentication of specific SigNature DNA
Markers.
We
believe that the key characteristics and benefits of the SigNature DNA offering
are as follows:
We
Believe Our SigNature DNA Markers Are Virtually Impossible to Copy
In
creating unique SigNature DNA Markers, we use DNA segments from one or more
botanical sources, rearrange them into unique encrypted sequences, and then
implement one or more layers of anti-counterfeit techniques. Because
the portion of DNA in a SigNature DNA Marker used to identify the marker is so
minute, it cannot be detected unless it is replicated billions of times over, or
amplified. This amplification can only be achieved by applying
matching strands of DNA, or a primer, and polymerase chain reaction (PCR)
techniques to the SigNature DNA Marker. The sequence of the relevant
DNA in a SigNature DNA Marker must be known in order to manufacture the primer
for that DNA. As a result, we believe the effort required to find,
amplify, select and clone the relevant DNA in a SigNature DNA Marker would
involve such enormous effort and expense that SigNature DNA Markers are
virtually impossible to copy without our proprietary systems.
Simple
and Rapid Authentication
We
offer rapid readers capable of instantly testing for the presence or
absence of any of our SigNature DNA Markers. In addition, when a
forensic level of authentication is necessary, we offer in-field or in-house
forensic DNA authentication with a handheld battery powered PCR-based device
that will confirm authentication sequences in approximately 10
minutes.
Low
Cost and High Accuracy
The costs
associated with the DNA required to manufacture our SigNature DNA Markers are
not significant since the amount of DNA required for each marker is so minute
(for instance, only 3-5 parts per million when incorporated in an
ink). We manufacture the identifying segment of DNA to be used
in a SigNature DNA Marker by cloning them inside microorganisms such as yeast or
bacteria, which are highly productive and inexpensive to grow. As a
result, SigNature DNA Markers are relatively inexpensive when compared to other
anti-counterfeiting devices such as RFIDs, EPCs, integrated circuit chips, and
holograms. The probability of mistakenly identifying a SigNature DNA
Marker is less than 1 in 1 trillion, so our authentication systems are highly
accurate, and in fact, our SigNature PCR Kits can authenticate to a forensic
level.
Easily
Integrated with Other Anti-Counterfeit Technologies
Our
SigNature DNA Markers can be embedded onto RFID devices, banknote threads,
labels, serial numbers, holograms, and other marking systems using inks, threads
and other media. We believe that combined with other traditional
methods, our SigNature DNA solution provides a significant deterrent against
counterfeiting, product diversion, piracy, fraud and identity
theft.
Broad
Applicability and Ingestible
Our
SigNature DNA Markers can be embedded into almost any consumer product, and
virtually any other item. For instance, the indelible SigNature DNA
Ink we produce is safe to consume and can be used in pharmaceutical drug tablets
and capsules. Use of our SigNature DNA in ingestible products and
drugs will require approval of the U.S. Food and Drug
Administration.
BioMaterial
Genotyping
We
believe our BioMaterial Genotyping solution offers a unique means for
determining the authenticity of biomaterials, such as cotton, wool, tobacco,
fermented beverages, natural drugs and foods. Just as a person’s DNA
specifies all of their unique qualities, biomaterials typically contain genomic
DNA or fragments thereof that can be utilized to authenticate
originality. We have initially developed two proprietary
genetic-based assays and protocols to identify DNA markers that are endogenous
(internal) to a particular product in order to differentiate between biological
strains. In a process we call Fibertyping™, we are able to
differentiate between Pima cotton (G.
barbadense) and upland cotton (G.
hirsutum). Our FiberTyping offering enables our customers and
potential clients to cost-effectively give assurance to manufacturers,
suppliers, distributors, retailers and end-users that their products are
authentic, that they are made from the fibers and textiles as
labeled. In a process we call Pimatyping™, we are able to
differentiate between Pima cotton grown in different regions of the
world. Cotton classification and the authentication of cotton
geographic origin are issues of global significance, important to brand owners
and to governments that must regulate international cotton
trade. Similar offerings are currently being developed for use in
biomaterials other than cotton. Biomaterials can now be tracked from
field to final purchase guaranteeing the authenticity of the item. As
we are testing for innate genomic DNA, we believe these assays cannot be
counterfeited.
We
believe our BioMaterial Genotyping allows us to:
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Identify
U.S. produced Pima cotton;
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Establish
an authentication protocol for cotton and other biomaterials;
and
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Deter
counterfeits and protect the integrity of
brands.
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We
believe our two genetic assays accurately distinguish between:
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Pima
cotton (G. barbadense) and upland
cotton (G. hirsutum) cultivars in
mature cotton fibers and in cotton fabrics (Fibertyping);
and
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American
Pima and Extra Long Staple (ELS) Pima cotton
(Pimatyping),
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We
believe that our new DNA extraction protocol and methodologies are more
effective than existing forensic systems. We believe that the
combination of our SigNature DNA and BioMaterial Genotyping solutions covers the
total authentication market, is applicable to multiple industry verticals, and
can mark physical products on the front end and authenticate forensic DNA
sequences on the back end.
BioActive
Ingredients
Our
BioActive Ingredients program began in 2007, based on the biofermentation
expertise developed from our experience with the manufacture of DNA for our
SigNature DNA and BioMaterial Genotyping solutions. We initially
targeted potential customers in the personal care products industry, and we
developed DermalRx, a range of high performance ingredients used by
our customers for skin care applications. We subsequently
developed DermalRx HydroSeal, which has been incorporated into the fabric of a
new line of intimate apparel currently being test marketed by a global marketer
of intimate apparel. In addition, we developed DermalRx SRC, Skin
Resurfacing Complex, an ingredient designed to promote smoother more radiant
skin by stimulating the skin's own exfoliation process.
Our
Strategy
We have
begun to generate revenues principally from sales of our SigNature DNA,
BioMaterial Genotyping and BioActive Ingredients offerings. Key
aspects of our strategy include:
Customize
and Refine our Solutions to Meet Potential Customers’ Needs
We are
continuously attempting to improve our SigNature DNA solution by testing the
incorporation of our SigNature DNA Markers into different media, such as newly
configured labels, inks or packing elements, for use in new
applications. Each prospective customer has specific needs and
employs varying levels of existing security technologies with which our solution
must be integrated. Our goal is to develop a secure and
cost-effective system for each potential customer that can be incorporated into
that potential customer’s products or items themselves or their packaging so
that they can, for instance, be tracked throughout the entire supply chain and
distribution system.
Continue
to Enhance Detection Technologies for Authentication of our SigNature DNA
Markers
We have
also identified and are further examining opportunities to collaborate with
companies and universities to develop a new line of detection technologies that
will provide faster and more convenient ways to authenticate our SigNature DNA
Markers.
Target
Potential High-Volume Markets
We will
continue to focus our efforts on target vertical markets that are characterized
by a high level of vulnerability to counterfeiting, product diversion, piracy,
fraud, identity theft, and unauthorized intrusion into physical locations and
databases. Today our target markets include art and collectibles,
cash-in-transit, fine wine, consumer products, digital and recording media,
pharmaceuticals, textile and apparel authentication and secure
documents/homeland security. If and when we have significantly
penetrated these markets, we intend to expand into additional related high
volume markets.
Pursue
Strategic Acquisitions and Alliances
We intend
to pursue strategic acquisitions of companies and technologies that strengthen
and complement our core technologies, improve our competitive positioning, allow
us to penetrate new markets, and grow our customer base. We also
intend to work in collaboration with potential strategic partners in order to
continue to market and sell new product lines derived from, but not limited to,
DNA technology.
Target
Markets
We have
begun offering our products and services in Europe and the United States and are
targeting the following principal markets:
Art
& Collectibles
The fine
art and collectibles markets are particularly vulnerable to counterfeiting,
forgeries and fraud. Phony artwork and collectibles are often sold
with fake or questionable signatures or attributions. We believe our
SigNature DNA Markers can safely be embedded directly in, and so can be used to
designate and then authenticate all forms of artwork and collectibles, including
paintings, books, porcelain, marble, stone, bronzes, tapestries, glass and fine
woodwork, including frames. They can also be embedded in any original
supporting documentation related to the artwork or collectible, the signature of
the artist and any other relevant material that would provide provenance, such
as:
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A
signed certificate or statement of authenticity from a respected authority
or expert on the artist;
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An
exhibition or gallery sticker attached to the art or
collectible;
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An
original sales receipt;
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A
film or recording of the artist talking about the art or
collectible;
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An
appraisal from a recognized authority or expert on the art or collectible;
and
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Letters
or papers from recognized experts or authorities discussing the art or
collectible.
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Cash-in-Transit
Cash-in-transit
businesses transport and store bank notes and ATM cassettes. In
the U.K. alone, there is an estimated £500 billion being transported each year,
or £1.4 billion per day. The nature of this business makes
cash-in-transit an attractive target for criminals, and as a result the industry
invests in excess of £100 million per year in security equipment and
devices. Currently, a system of cash degradation, using a smoke or
liquid dye to permanently mark and essentially destroy stolen bank notes, is
used. The incidence of cash-in-transit based crime has increased over
170% in London since 2006, according to the Metropolitan Police and the UK
boasts the highest levels of cash-in-transit crime in Europe.
We are
able to incorporate our SigNature DNA Markers in cash degradation ink that is
used in the cash-in-transit industry. This solvent-based ink
marks bank notes if the cash box is compromised and has the ability to
penetrate the bank notes rapidly and permanently. We believe our
SigNature DNA Markers are more resilient and detectable than other competing
products.
Fine
Wine
Vintners
and purveyors of fine wine are also vulnerable to counterfeiting or product
diversion. We believe our SigNature and BioMaterial Genotyping
solutions can provide vintners, purveyors of fine wines and organizations within
the wine community several benefits:
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Verifed
authenticity increases potential customers' confidence in the product and
their purchase decision;
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For
the vintner, the SigNature and BioMaterial Genotyping solutions can
strengthen brand support and recognition, and offers the potential for
improved marketability and sales; and
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SigNature
DNA Markers can be embedded in bottles, labels, or both at the winery, and
easily authenticated at the location of the wine distributor or
auctioneer; BioMaterial Genotyping allows the identification of wine based
on the varietal of grape and the region it is grown
in.
|
Consumer
Products
Counterfeit
items are a significant and growing problem with all kinds of consumer packaged
goods, especially in the retail and apparel industries. According to
the World Customs Organization, up to $12 billion worth of clothing and
accessories worldwide are fake, and Interpol reported $3 billion worth of
fragrances and cosmetics are counterfeit each year. In the United
States, $1.29 billion dollars worth of seizures and losses were incurred
resulting from counterfeit of apparel and other consumer products. We
have developed and are currently marketing a number of solutions aimed at brand
protection and authentication for the retail and apparel industries, including
the clothing, accessories, fragrances and cosmetics segments. Our
SigNature DNA solution can be used by manufacturers in these industries to
combat counterfeiting and piracy of primary, secondary and tertiary packaging,
as well as the product itself, and to track products that have been lost in
transit, whether misplaced or stolen.
Digital
and Recording Media
The
digital and recording media industry, including the segment that records
computer software on compact discs, faces significant threats from piracy and
the counterfeiting and distribution of imitation media or
software. In 2008 the Business Software Alliance ("BSA") reported
that in 2007, the United States software industry lost $8.9 billion as a result
of software piracy, an increase of $1.6 billion over the previous
year. An independent study conducted by IDC for the BSA reported that
33 percent of software in the United States is unlicensed. Our
SigNature DNA Markers can be embedded onto digital and recording media products,
such as CDs, DVDs, videotapes and computer software, as well as the packaging of
these products.
Pharmaceuticals
The
pharmaceutical industry also faces major problems relative to counterfeit,
diluted, or falsely labeled drugs that make their way through healthcare systems
worldwide, posing a health threat to patients and a financial threat to
drugmakers and distributors. As a result, the pharmaceutical industry
and regulators are examining emerging anti-counterfeit technologies, including
RFID tags and EPCs to help stem the wave of counterfeit drugs and better track
legitimate drugs from manufacturing through the supply chain. Our
SigNature DNA Markers can easily be embedded directly into pharmaceutical
packaging or into RFID tags or EPCs attached to packaging, and since they are
ingestible, may be applied as part of a unit dose. In its 2004
report "Combating Counterfeit Drugs," the U.S. Food and Drug Administration
noted that authentication technologies for pharmaceuticals (such as
color-shifting inks, holograms, taggants, or chemical markers embedded in a drug
or its label) have been sufficiently perfected that they can now serve as a
critical component of a layered approach to control counterfeit drugs. The
U.S. Food and Drug Administration’s 2004 Report acknowledged the importance of
using one or more authentication technologies for drug products.
Secure
Documents/Homeland Security
Governments
worldwide are increasingly faced with the problems of counterfeit currencies,
official documents, and identity and security cards, as well as terrorism and
other security threats. Governments must also enforce the various
anti-counterfeiting and anti-piracy regimes of their respective jurisdictions
which becomes increasingly difficult with the continued expansion of global
trade. Our SigNature DNA solution can provide secure, forensic, and
cost-effective anti-counterfeiting, anti-piracy and identification solutions to
local, state, and federal governments as well as the defense contractors and the
other companies that do business with them. Our SigNature solution
can be used for all types of identification and official documents, such
as:
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passports;
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lawful
permanent resident, or “green” cards;
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visas;
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drivers’
licenses;
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Social
Security cards;
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military
identification cards;
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national
transportation cards;
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security
cards for access to sensitive physical locations; and
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other
important identity cards, official documents and security-related
cards.
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Textile
and Apparel Authentication
Cotton
classification and the authentication of cotton geographic origin are issues of
global significance, important to brand owners and to governments that must
regulate international cotton trade. We believe that our SigNature
DNA and BioMaterial Genotyping solutions could have significant potential
applications for the enforcement of cotton trade quotas in the U.S. and across
the globe, and for legislated quality improvement within the
industry. We believe that similar issues face the wool and other
natural product industries which is the next area we plan to
target.
Our
Technology
Every
living organism has a unique DNA code that determines the character and
composition of its cells. The core technologies of our business allow
us to use the DNA of everyday plants to mark objects in a unique manner that we
believe can only be replicated at great expense, and then identify these objects
by detecting the absence or presence of the DNA.
SigNature
DNA Encryption
Our
patent pending encryption system allows us to isolate strands of botanical DNA
and then fragment and reconstitute them to form unique “DNA chimers”, or
encrypted DNA segments, whose sequences are known only to us.
SigNature
DNA Encapsulation
Our
patented encapsulation system allows us to apply a protective coating to
encrypted DNA chimers, creating a SigNature DNA Marker that is resistant to
heat, organic solvents, chemicals and UV radiation, and so can be identified for
hundreds of years after being embedded directly, or into media applied or
attached to the item to be marked.
SigNature
DNA Embedment
Our
patented embedment system allows us to incorporate our SigNature DNA Markers
into a broad variety of media, such as petroleum and petroleum derivatives,
inks, dyes, laminates, glues, threads, and textiles.
SigNature
DNA Authentication
Our
patent pending forensic level authentication methods allow us to unlock the
encrypted DNA chimers by using PCR techniques and proprietary primers that were
specifically designed by us to detect the DNA sequences we encrypted and
embedded into the product or other item. Detection of the DNA chimers
unique to a particular item or series of items allows us to authenticate its or
their origin.
Products
and Services
Our
SigNature DNA solution consists of three steps: creating and encapsulating a
specific encrypted DNA segment, applying it to a product or other item, and
detecting the presence or absence of the specific segment. We plan
for the first two steps to be controlled exclusively by Applied DNA and its
certified agents to ensure the security of SigNature DNA
Markers. Once applied, the presence of any of our SigNature DNA
Markers can be detected by us or a customer in a simple spot test, or a sample
taken from the product or other item can be analyzed forensically to obtain
definitive proof of the presence or absence of a specific type of SigNature DNA
Marker (e.g., one designed to mark a particular product).
Creating
a Customer or Product-Specific SigNature DNA Marker
Our
SigNature DNA Markers are botanical DNA segments custom manufactured by us to
identify a particular class of or individual products or
items. During this manufacturing process, we scramble and encrypt a
naturally occurring botanical DNA code segment or segments, and then encapsulate
the resulting DNA segment utilizing our proprietary SigNature DNA Encapsulation
system. We then record and store the sequence of the DNA segment in a secure
database in order that we can later detect it.
Embedding
the SigNature DNA Marker
Our
SigNature DNA Markers may be directly embedded in products or other items, or
otherwise attached by embedding them into media that is incorporated in or
attached to the product or item. For example, we can embed SigNature
DNA Markers directly in paper, metal, plastics, stone, ceramic, and other
materials. Media in which we can embed SigNature DNA Markers
include:
SigNature DNA Ink: Our
SigNature DNA Ink can be applied directly or on a label that is then affixed to
the product or item. SigNature DNA Ink is highly durable and
degradation resistant. SigNature DNA Ink can be visible (colored) or
invisible. This makes it possible to mark products with a visible, or
overt, and/or invisible, or covert, SigNature DNA Marker on any tangible surface
such as a label. The location of covert Signature DNA Markers on a
product are recorded and stored in a secure database. Similar media
like varnish and paints can also be used instead of ink. Sporting event tickets
have been prototyped using our SigNature DNA Ink. In addition, our
SigNature DNA Ink is being tested in government documents, auto parts, luxury
goods and consumer products. Other examples of where our SigNature DNA Inks can
be used include:
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artwork
and collectibles (paintings, artifacts, antiques, stamps, coins,
documents, collectibles and memorabilia);
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corporate
documents: (confidential, date and time dependent documents or security
clearance documents);
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financial
instruments (currency, stock certificates, checks, bonds and
debentures);
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retail
items (event tickets, VIP tickets, clothing labels, luxury
products);
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pharmaceuticals
(tablet, capsule and pill surface printing); and
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other
miscellaneous items (lottery tickets, inspection stamps, custom seals,
passports and visas, etc.).
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We have
also developed a portfolio of SigNature DNA containing thermal transfer
ribbons. These products will allow retailers to protect at the
point-of-sale by printing price labels, hang tags, event tickets and even
credentials with customized SigNature markers. We are also able to mark
cartridges of laser printers with SigNature DNA.
AzSure™ Security Ink: We have
developed AzSure bank note marking ink at the request of our cash-in-transit
customer. This security ink is being marketed to governments and industry
to protect bank notes and other financial instruments. We believe the
unique visible and fluorescent blue signature of our highly substantive dye/DNA
system distinguishes AzSure from all other dyes used within the cash-in-transit
industry.
SigNature DNA
Thread: Our SigNature DNA Thread, which can consist of any
fabric from cotton to wool, is embedded with SigNature DNA Markers and can be
used to mark and authenticate products and other items incorporating
textiles. For example, SigNature DNA Thread can be incorporated in a
finished garment, bag, purse, shoe or other product or
item. SigNature DNA Thread can help textile vendors, clothing and
accessory manufacturers and governments authenticate thread, yarn and fabric at
any stage in the supply chain. We can also embed our SigNature DNA
Markers into raw cotton fiber before manufacture of a finished cotton textile
product (e.g., a t-shirt) and authenticate a finished cotton product. We are
currently working with the Textile Centre of Excellence consortium of companies
(Leeds, UK) to demonstrate how our SigNature DNA can be used to authenticate
textiles at all points of the supply chain through to the end user. In addition,
we are working to demonstrate the integration of SigNature DNA with existing
manufacturing processes to produce threads, labels and fabrics manufactured by
Yorkshire-based companies.
Other Security
Devices: Our SigNature DNA Markers can also be embedded onto
printed barcodes, RFID tags, optical memory strips, holograms, tamper proof
labels and other security devices incorporated into products and other items for
various security-related purposes.
SigNature
DNA Detection and Product Authentication
We now
offer a full range of detection options from instant rapid screening to more
detailed forensic level authentication:
Level 1 “Spot Test”
Detection: We offer rapid readers capable of instantly
testing for the presence or absence of any of our SigNature DNA Markers.
Level 2 Forensic DNA
Authentication: When a forensic level of authentication is
necessary, we offer in-field or in-house forensic DNA authentication with a
handheld battery powered PCR-based device that will confirm authentication
sequences in approximately 10 minutes.
Sales
and Marketing
As of
December 15, 2008, we had 2 employees devoted to and 3 employees engaged in
direct sales. We expect to hire additional sales directors and/or
consultants to assist us with sales and marketing efforts with respect to our 6
target vertical markets.
Research
and Development
Our
research and development efforts are primarily focused on the development of
prototypes of new versions of our products using our existing technologies for
review by prospective customers, such as different types of SigNature DNA Ink
and SigNature DNA Thread. We are also focused on the identification
of additional genotyping markers and on the development of new ingredients for
the personal care products industry. Nonetheless, we believe that our
development of new and enhanced technologies relating to our business may be
important to our future success, and we continue to examine whether investments
in the research and development of such technologies is merited.
Manufacturing
We have
the capability to manufacture SigNature DNA Markers, covert DNA Ink, and
SigNature PCR Kits at our laboratories in Stony Brook. We rely upon
other companies to manufacture our overt color-changing DNA Ink . We also have
in-house capabilities to manufacture all BioActive Ingredients and to complete
all BioMaterial Genotyping authentications.
Commercial
Agreements and Distribution of our Products
HPT Agreement. On
March 19, 2007, we entered into a Technology Reseller Agreement (the “HPT
Agreement”) with HPT International, LLC (“HPT”). In the HPT Agreement
we agreed to supply our SigNature DNA Markers to HPT to be affixed onto HPT's
holograms, Nylon 6 tags and other plastic or metal food tags. HPT has
been granted exclusive rights to affix our SigNature DNA Markers onto its
tagging products for distribution to its customers in the United States in the
poultry and kosher foods markets, and non-exclusive rights to attach our
SigNature DNA Markers onto its tagging products for distribution to its
customers worldwide. We will receive a fee for each SigNature DNA Marker that is
attached to an HPT product and distributed to a third party, and for each
forensic level authentication test that we perform at HPT's request. HPT has
been granted exclusive rights in the U.S. poultry and kosher foods markets with
respect to new customers through March 18, 2008. After that date, HPT
will lose its exclusive rights if it does not realize certain sales goals or
does not agree to certain minimum purchases during the subsequent year of the
agreement. Under the HPT Agreement, HPT has the right to permanent
exclusivity in the U.S. poultry and kosher foods markets if it realizes its
sales goals for the first two years under the HPT Agreement and achieves an
additional milestone to be agreed by us and HPT prior to March 18,
2009.
IIMAK
Agreement. On April 18, 2007, we entered into a Joint
Development and Marketing Agreement with International Imaging Materials, Inc.,
or IIMAK. In this agreement with IIMAK, the parties agreed to jointly develop
thermal transfer ribbons incorporating our SigNature DNA Markers to help prevent
counterfeiting and product diversion for an initial six (6) month period. Upon
the successful development of commercially feasible ribbons incorporating
SigNature DNA Markers, we will be paid royalties based on a calculation of net
receipts by IIMAK from sales of such products. We will receive the exclusive
right to supply DNA taggants to IIMAK and IIMAK will receive the exclusive right
to manufacture and sell such products worldwide. In February 2008, we completed
the joint development stage of this agreement and initiated pilot manufacturing
of IIMAK thermal transfer ribbons embedded with SigNature DNA.
Champion Thread: On May 8,
2007, we entered into a Product Development, Marketing and Distribution
Agreement with Champion Thread Company, or Champion Thread. Under the
terms of the Agreement, Champion Thread has been granted exclusive
worldwide rights to be the reseller for the thread, yarn, woven labels, and
printed labels for textiles markets for an initial period of four years with
automatic annual renewals thereafter, subject to either party’s right not to
renew. We will be paid certain royalties on all sales made by
Champion Thread.
Printcolor Screen Ltd.
Agreement. On May 30, 2007, we entered into a Technology
Reseller Agreement with Printcolor Screen Ltd., or Printcolor. Under
the terms of the agreement, we have been granted the exclusive right to supply
our SigNature DNA Markers to Printcolor and Printcolor has been granted rights
to affix our SigNature DNA Markers onto Printcolor products for distribution to
its customers for an initial period of three years. This initial period will
automatically renew for successive one year periods unless terminated earlier.
We will be paid certain fees based on purchase orders received from
Printcolor.
Supima Cotton
Agreement. On June 27, 2007, we entered into a Feasibility
Study Agreement with Supima, a non-profit organization for the promotion of U.S.
pima cotton growers. In connection with the agreement we undertook a
study of the feasibility of establishing a method or methods to authenticate and
identify U.S. produced pima cotton fibers. We received payments from
Supima upon signing of the agreement and in installments beginning on July 6,
2007 through completion of the feasibility study. The feasibility
study was successfully completed in the first quarter of 2008. We
plan to begin a preliminary launch of authentication services in 2009 and we may
in the future offer authentication services to member companies of Supima (as
well as non-member companies) to confirm the Supima cotton content of textile
items such as apparel and home fashion products. We are obligated to
pay Supima a percentage of any fees that we receive from such companies for
authentication services we provide them. We are also obligated to pay Supima
fifty percent of the aggregate amount of payments that we received from Supima
for the feasibility study out of any fees we receive from providing
authentication services. In addition, until the earlier of either (i)
five years or (ii) the repayment to Supima of fifty percent of the aggregate
amount of payments that we received from Supima for the feasibility study, we
are obligated to pay Supima a fee for each authentication service that we
provide. The agreement may be terminated by us or Supima after sixty (60) days
upon fourteen (14) days prior written notice.
Textile Centre of
Excellence. On
August 11, 2008, we entered into an Agreement with Huddersfield and District
Textile Training Company Limited. We have agreed to undertake a study
to demonstrate how our SigNature DNA can be used to authenticate textiles at all
points of the supply chain through to the end user. In addition, this
study will demonstrate the integration of SigNature DNA with existing
manufacturing processes to produce threads, labels and fabrics manufactured by
Yorkshire-based companies. The funding for Phase I of the study,
which runs through December 2008, totals £50,000. Upon successful
completion of Phase I of the study, we anticipate beginning Phase II, which
could result in continued funding.
Biowell
Agreement. In the first half of 2005, Biowell Technology, Inc.
("Biowell") transferred substantially all of its intellectual property to
Rixflex Holdings Limited, a British Virgin Islands company, and on July 12,
2005, Rixflex Holdings Limited merged with and into our wholly-owned subsidiary
APDN (B.V.L.) Inc., a British Virgin Islands company. The shareholders of
Rixflex Holdings Limited recieved 36 million shares of our common stock in
consideration of this merger. In connection with the acquisition of this
Biowell intellectual property, we terminated our existing license agreement and
on July 12, 2005, we entered into a license agreement with Biowell, under which
we granted Biowell an exclusive license to sell, market, and sub-license certain
of our products in Australia, certain countries in Asia and certain Middle
Eastern countries. By letter dated November 1, 2007, we terminated
Biowell's rights as license with respect to Australia, China and certain other
countries in Asia because of Biowell's failure to pay us certain fees, payments
or consideration in connection with the grant of the license. In addition,
we terminated the exclusivity of the license with respect to certain Middle
Eastern and other Asian countries because of Biowell's failure to meet certain
minimum annual net sales in each of the various countries coverred by the
license.
Competition
The
principal markets for our offerings are intensely competitive. We
compete with many existing suppliers and new competitors continue to enter the
market. Many of our competitors, both in the United States and
elsewhere, are major pharmaceutical, chemical and biotechnology companies, or
have strategic alliances with such companies, and many of them have
substantially greater capital resources, marketing experience, research and
development staff, and facilities than we do. Any of these companies
could succeed in developing products that are more effective than the products
that we have or may develop and may be more successful than us in producing and
marketing their existing products. Some of our competitors that
operate in the anti-counterfeiting and fraud prevention markets include: Applied
Optical Technologies, Authentix, ChemTAG, Collectors Universe Inc., Collotype,
Data Dot Technology, Digimarc Corp., DNA Technologies, Inc., ID Global,
Informium AG, Inksure Technologies, Kodak, L-1 Identity Solutions, Manakoa,
SmartWater Technology, Inc., Sun Chemical Corp, Tracetag and
Warnex.
Some
examples of competing security products include:
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fingerprint scanner (a
system that scans fingerprints before granting access to secure
information or facilities);
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voice recognition
software (software that authenticates users based on individual
vocal patterns);
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cornea scanner (a
scanner that scan the iris of a user’s eye to compare with data in a
computer database);
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face scanner (a
scanning system that use complex algorithms to distinguish one face from
another);
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integrated circuit chip &
magnetic strips (integrated circuit chips that receive and, if
authentic, send a correct electric signal back to the reader, and magnetic
strips that contain information, both of which are common components of
debit and credit cards);
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optically variable
microstructures (these include holograms, which display images in
three dimensions and are generally difficult to reproduce using advanced
color photocopiers and printing techniques, along with other devices with
similar features);
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elemental taggants and
fluorescence (elemental taggants are various unique substances that
can be used to mark products and other items, are revealed by techniques
such as x-ray fluorescence); and
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radioactivity & rare
molecules (radioactive substances or rare molecules which are
uncommon and readily detected).
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We expect
competition with our products and services to continue and intensify in the
future. We believe competition in our principal markets is primarily
driven by:
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product
performance, features and liability;
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price;
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timing
of product introductions;
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ability
to develop, maintain and protect proprietary products and
technologies;
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sales
and distribution capabilities;
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technical
support and service;
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brand
loyalty;
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applications
support; and
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breadth
of product line.
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If a
competitor develops superior technology or cost-effective alternatives to our
products, our business, financial condition and results of operations could be
significantly harmed.
Proprietary
Rights
We
believe that our 7 patents, 14 patents pending, 2 registered trademarks, and 2
registered trademarks pending, which are described in the table below, and our
trademarks, trade secrets, copyrights and other intellectual property rights are
important assets for us.
Patents
Issued:
Patent
Name
|
|
Patent
No:
|
Assignee of
Record
|
Dated
Issued
|
Jurisdiction
|
Nucleic
Acid as Marker for Product Anticounterfeiting and
Identification
|
|
89108443
|
APDN
(B.V.I.) Inc.
|
March
17,2000
|
Taiwan
|
|
|
|
|
|
|
Method
of using ribonucleic acid as product antifake mark and for
verification
|
|
00107580.2
|
Rixflex
Holdings
Limited
(2)
|
February
2, 2005
|
China
|
|
|
|
|
|
|
EppenLocker
(A Leakage-Prevention Apparatus of Microcentrifuge)
|
|
89204158
|
APDN
(B.V.I.) Inc.
|
March
10, 2000
|
Taiwan
|
|
|
|
|
|
|
Multiple
Tube Structure for Multiple PCR in a Closed Container
|
|
89210575
|
APDN
(B.V.I.) Inc.
|
June
20, 2000
|
Taiwan
|
|
|
|
|
|
|
A
Device for Multiple Polymerase Chain Reactions In a Closed Container and a
Method of Using Thereof
|
|
89111477
|
APDN
(B.V.I.) Inc.
|
June
12, 2000
|
Taiwan
|
|
|
|
|
|
|
Method
for Mixing Nucleic Acid in Water Insoluble Media and Application
Thereof
|
|
921221973
|
APDN
(B.V.I.) Inc.
|
August
11, 2003
|
Taiwan
|
|
|
|
|
|
|
A
Method of Utilizing Nucleic Acids as Markers for Product Anti-Counterfeit
Labeling and Verification
|
|
US
7,115,301 B2
|
Rixflex
Holdings Limited (2)
|
October
3, 2006
|
United
States
|
Patents
Pending:
Patent
Name
|
|
Application
No.
|
Filed in the Name
of
|
Dated
Filed
|
Jurisdiction
|
Method
for Mixing Nucleic Acid in Water Insoluble Media and Application
Thereof
|
|
2002-294229
03007023.9
10/645,602
|
Biowell
(1)
Rixflex
Holdings
Limited
(2)
Rixflex
Holdings Limited (2)
|
August
31, 2002
March
27, 2003
August
22, 2003
|
Japan
EU
United
States
|
|
|
|
|
|
|
Method
of dissolving nucleic acid in water insoluble medium and its
application
|
|
03155949.2
|
APDN
(B.V.I.) Inc.
|
August
27, 2003
|
China
|
|
|
|
|
|
|
Novel
nucleic acid based steganography system and application
thereof
|
|
10/909,431
|
Rixflex
Holdings
Limited
(2)
|
August
3, 2004
|
United
States
|
|
|
|
|
|
|
Cryptic
method of secret information carried in DNA molecule and its deencryption
method
|
|
921221490
|
APDN
(B.V.I.) Inc.
|
August
6, 2003
|
Taiwan
|
|
|
|
|
|
|
A
novel nucleic acid based steganography system and application
thereof
|
|
03127517.6
61387/2004
|
Biowell
(1)
Rixflex
Holdings
Limited
(2)
|
August
6, 2003
August
4, 2004
|
China
Korea
|
|
|
|
|
|
|
A
novel method for coding based on nucleic acids and utility
thereof
|
|
04018374.1
|
Rixflex
Holdings
Limited
(2)
|
August
3, 2004
|
EU
|
|
|
|
|
|
|
|
|
1-2004-00742
|
Rixflex
Holdings
Limited
(2)
|
August
4, 2004
|
Vietnam
|
Patent
Name
|
|
Patent
No:
|
Assignee of
Record
|
Dated
Issued
|
Jurisdiction
|
|
A
novel nucleic acid based steganography system and applications
thereof
|
|
092819
|
Rixflex
Holdings
Limited
(2)
|
August
4, 2004
|
Thailand
|
|
|
|
|
|
|
|
|
PI20043145
|
Biowell
(1)
|
August
4, 2004
|
Malaysia |
|
|
|
|
|
|
|
|
2004-225987
|
Rixflex
Holdings
Limited
(2)
|
August
2, 2004
|
Japan |
|
|
|
|
|
|
|
|
P-00200400374
|
Rixflex
Holdings
Limited
(2)
|
August
4, 2004
|
Indonesia
|
|
|
|
|
|
|
|
|
764/CHE/2004
|
Rixflex
Holdings
Limited
(2)
|
August
4, 2004
|
India
|
|
|
|
|
|
|
Method
for classifying group ID of shoppers and transferring the shopping
discount to group development funds development
|
|
92119302
|
APDN
(B.V.I.) Inc.
|
July
15, 2003
|
Taiwan
|
|
|
|
|
|
|
Method
for transferring feedback foundation capable of identifying multiple
objects
|
|
03150071.4
|
APDN
(B.V.I.) Inc.
|
July
31, 2003
|
China
|
|
|
|
|
|
|
Method
of Classifying Group ID of Shoppers and Transferring the Shopping Discount
to Group Development Funds
|
|
PI20042889
|
Rixflex
Holdings
Limited
(2)
|
August
4, 2004
|
Malaysia
|
|
|
|
|
|
|
|
|
092217 |
Rixflex
Holdings
Limited
(2)
|
July
12, 2004
|
Thailand |
|
|
|
|
|
|
|
|
2004-200730
|
Biowell
(1)
|
July
7, 2004
|
Japan
|
|
|
|
|
|
|
System
and Method for authenticating multiple components associated with a
particular product.
|
|
11/437,265
PCT/US2006/019660
|
APDN
(B.V.I.) Inc.
APDN
(B.V.I.) Inc.
|
May
19, 2005
May
19, 2006
|
US
PCT
|
|
|
|
|
|
|
System
and Method for Marking Textiles with Nucleic Acid
|
|
10/825,968
|
APDN
(B.V.I.) Inc.
|
April
15, 2004
|
United
States
|
|
|
|
|
|
|
System
and Method for Marking Textiles with Nucleic Acids
|
|
Publication
#20050112610
|
APDN
(B.V.I.) Inc
|
4/16/2003
|
United
States
|
|
|
|
|
|
|
System
and Method for Authenticating Multiple Components Associated with a
Particular Good
|
|
Publication
# 22070048761
|
APDN
(B.V.I.) Inc
|
5/20/2005
|
United
States
|
|
|
|
|
|
|
System
and Method for Secure Document Printing and Detection
|
|
Application
# 60/874,425
|
APDN
(B.V.I.) Inc
|
12/12/2006
|
United
States
|
|
|
|
|
|
|
System
and Method for Authenticating Tablets
|
|
Application
#60/877,875
|
APDN
(B.V.I.) Inc
|
12/26/2006
|
United
States
|
|
|
|
|
|
|
System
and Method for Authenticating Sports Identification Goods
|
|
Application
# 60/877,869
|
APDN
(B.V.I.) Inc.
|
12/29/2006
|
United
States
|
|
|
|
|
|
|
Optical
Reporter Compositions
|
|
11/954,030
|
APDN
(B.V.I.) Inc.
|
12/11/2007
|
United
States
|
Patent
Name
|
|
Patent
No:
|
Assignee of
Record
|
Dated
Issued
|
Jurisdiction
|
|
Methods
for Covalent Linking of Optical Reporters
|
|
11/954,009
|
APDN
(B.V.I.) Inc.
|
12/11/2007
|
United
States
|
|
|
|
|
|
|
Method
for Authenticating Articles with Optical Reporters
|
|
11/954,038
|
APDN
(B.V.I.) Inc.
|
12/11/2007
|
United
States
|
|
|
|
|
|
|
Method
for Secure Document Printing and Detection
|
|
11/954,044
|
APDN
(B.V.I.) Inc.
|
12/11/2007
|
United
States
|
|
|
|
|
|
|
Method
for Authenticating Sports Identification Goods
|
|
11/954,051
|
APDN
(B.V.I.) Inc.
|
12/11/2007
|
United
States
|
|
|
|
|
|
|
Method
for Authenticating Tablets
|
|
11/954,055
|
APDN
(B.V.I.) Inc.
|
12/11/2007
|
United
States
|
|
|
|
|
|
|
(1) All
patents in the name of and patent applications filed in the name of Biowell have
been assigned to our wholly-owned subsidiary APDN (B.V.I.) Inc., and we are
making efforts to ensure APDN (B.V.I.) is the assignee or filer of record, as
the case may be.
(2) All
patents in the name of and patent applications filed in the name of Rixflex
Holdings Limited, which merged into APDN (B.V.I.) Inc. on July 12, 2005, have
been assigned to APDN (B.V.I.) Inc., and we are making efforts to
ensure APDN (B.V.I.) is the assignee or filer of record, as the case may
be.
Trademarks
Issued:
Trademark
|
|
Registration
No:
|
Registered
Owner
|
Registration
Date
|
Jurisdiction
|
|
|
|
|
|
|
APPLIED
DNA and model molecule design
|
|
846354
|
Applied
DNA Sciences Inc.
|
August
13, 2004
|
Mexico
|
|
|
|
|
|
|
APPLIED
DNA and model molecule design
|
|
846711
|
Applied
DNA Sciences Inc.
|
August
16, 2004
|
Mexico
|
|
|
|
|
|
|
APPLIED
DNA and model molecule design
|
|
3392818
|
Applied
DNA Sciences Inc.
|
March
21, 2005
|
European
Community
|
|
|
|
|
|
|
BIOWELL
and Design
|
|
3,155,578
|
Rixflex
Holdings Limited (1)
|
October
17, 2006
|
United
States
|
|
|
|
|
|
|
BIOWELL
and Design
|
|
2,675,941
|
Rixflex
Holdings Limited (1)
|
January
21, 2003
|
United
States
|
|
|
|
|
|
|
BIOWELL
and Design
|
|
2,611,291
|
Rixflex
Holdings Limited (1)
|
August
27, 2002
|
United
States
|
|
|
|
|
|
|
BIOWELL
and Design
|
|
4101159010000
|
Biowell
(2)
|
May
4, 2005
|
South
Korea
|
|
|
|
|
|
|
BIOWELL
and Design
|
|
4,819,252
|
Rixflex
Holdings Limited (1)
|
November
19, 2004
|
Japan
|
(1) All
registered trademarks in the name of Rixflex Holdings Limited have been assigned
to APDN (B.V.I.) Inc., and we are making efforts to ensure APDN (B.V.I.) Inc. is
the registered owner.
(2) All
registered trademarks in the name of Biowell have been assigned to APDN (B.V.I.)
Inc., and we are making efforts to ensure APDN (B.V.I.) Inc. is the registered
owner.
Trademarks
Pending:
Trademark
|
|
Application
No:
|
Owner
|
Filing
Date
|
Jurisdiction
|
APPLIED
DNA
|
|
76/549,861
|
APDN
(B.V.I.) Inc.
|
September
22, 2003
|
United
States
|
|
|
|
|
|
|
SIGNATURE
|
|
78/871,967
|
APDN
(B.V.I.) Inc.
|
April
28, 2006
|
United
States
|
|
|
|
|
|
|
FIBERTYPING
|
|
77/488.647 |
APDN
(B.V.I.) Inc. |
June
2, 2008 |
United
States |
|
|
|
|
|
|
PIMATYPING
|
|
77/488.531 |
APDN
(B.V.I.) Inc. |
June
2, 2008 |
United
States |
However,
there are events that are outside of our control that pose a threat to our
intellectual property rights as well as to our products and
services. For example, effective intellectual property protection may
not be available in every country in which our products and services are
distributed. The efforts we have taken to protect our proprietary
rights may not be sufficient or effective. Any significant impairment
of our intellectual property rights could harm our business or our ability to
compete. Protecting our intellectual property rights is costly and
time consuming. Any increase in the unauthorized use of our
intellectual property could make it more expensive to do business and harm our
operating results. Although we seek to obtain patent protection for
our innovations, it is possible we may not be able to protect some of these
innovations. Given the costs of obtaining patent protection, we may
choose not to protect certain innovations that later turn out to be
important. There is always the possibility that the scope of the
protection gained from one of our issued patents will be insufficient or deemed
invalid or unenforceable. We also seek to maintain certain
intellectual property as trade secrets. This secrecy could be
compromised by third parties, or intentionally or accidentally by our employees,
which would cause us to lose the competitive advantage resulting from these
trade secrets.
Additionally,
litigation regarding patents and other intellectual property rights is extensive
in the biotechnology industry. In the event of an intellectual property dispute,
we may be forced to litigate. This litigation could involve
proceedings instituted by the U.S. Patent and Trademark Office or the
International Trade Commission, as well as proceedings brought directly by
affected third parties. Intellectual property litigation can be extremely
expensive, and these expenses, as well as the consequences should we not
prevail, could seriously harm our business. If a third party claims
an intellectual property right to technology we use, we might need to
discontinue an important product or product line, alter our products and
processes, pay license fees or cease our affected business
activities. Although we might under these circumstances attempt to
obtain a license to this intellectual property, we may not be able to do so on
favorable terms, or at all.
Employees
Presently, we
currently have 13 full-time employees and two part-time employees,
including two in management, nine in operations, three in sales and marketing
and one in investor relations. None of our employees are covered by
collective bargaining agreements, and we believe our relations with our
employees are favorable.
Available
Information
We are
subject to the informational requirements of the Exchange Act, which requires us
to file our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K, amendments to such reports and other information with the
Securities and Exchange Commission (“SEC”). This information is
available at the SEC’s Public Reference Room at 100 F Street, NE, Washington,
D.C. 20549. Information on the operation of the Public Reference
Room can be obtained by calling the SEC at 1-800-SEC-0330. Because we
file documents electronically with the SEC, you may also obtain this information
by visiting the SEC’s website at www.sec.gov. Our
web site is located at www.adnas.com.
ITEM
1A. RISK FACTORS.
Because
of the following factors, as well as other variables affecting our operating
results and financial condition, past financial performance may not be a
reliable indicator of future performance, and historical trends should not be
used to anticipate results or trends in future periods.
Risks
Relating to Our Business:
We
have a short operating history, a relatively new business model, and have not
produced significant revenues. This makes it difficult to evaluate
our future prospects and increases the risk that we will not be
successful.
We have a
short operating history with our current business model, which involves the
marketing, sale and distribution anti-counterfeiting and product authentication
solutions as well as ingredients for use in personal care and other products.
Our operations since inception have produced insignificant revenues, and may not
produce significant revenues in the near term, or at all, which may harm our
ability to obtain additional financing and may require us to reduce or
discontinue our operations. If we create significant revenues in the future, we
will derive most of such revenues from the sale of anti-counterfeiting and
product authentication solutions as well as ingredients, which are immature
industries. You must consider our business and prospects in light of the risks
and difficulties we will encounter as an early-stage company in a new and
rapidly evolving industry. We may not be able to successfully address these
risks and difficulties, which could significantly harm our business, operating
results, and financial condition.
We
have a history of losses which may continue, and which may harm our ability to
obtain financing and continue our operations.
We
incurred net losses of $6.8 million for the year ended September 30, 2008 and
$13.3 million for the year ended September 30, 2007. These net losses
have principally been the result of the various costs associated with our
selling, general and administrative expenses as we commenced operations,
acquired, developed and validated technologies, began marketing activities, and
incurred interest expense on notes and warrants we issued to obtain
financing. Our operations are subject to the risks and competition
inherent in a company that moved from the development stage to an operating
company. We may not generate sufficient revenues from operations to
achieve or sustain profitability on a quarterly, annual or any other basis in
the future. Our revenues and profits, if any, will depend upon
various factors, including whether our existing products and services or any new
products and services we develop will achieve any level of market
acceptance. If we continue to incur losses, our accumulated deficit
will continue to increase, which might significantly impair our ability to
obtain additional financing. As a result, our business, results of
operations and financial condition would be significantly harmed, and we may be
required to reduce or terminate our operations.
We
will require additional financing which may require the issuance of additional
shares which would dilute the ownership held by our shareholders.
We will
need to raise funds through either debt or the sale of our shares in order to
achieve our business goals. Although there are no present plans,
agreements, commitments or undertakings with respect to the sale of additional
shares or securities convertible into any such shares by us, any shares issued
would further dilute the percentage ownership held by the
stockholders. Furthermore, if we raise funds in equity transactions
through the issuance of convertible securities which are convertible at the time
of conversion at a discount to the prevailing market price, substantial dilution
is likely to occur resulting in a material decline in the price of your
shares.
If
we are unable to obtain additional financing our business operations will be
harmed or discontinued, and if we do obtain additional financing our
shareholders may suffer substantial dilution.
We
believe that our existing capital resources will enable us to fund our
operations until approximately February 2009. We believe we will be required to
seek additional capital to sustain or expand our prototype and sample
manufacturing, and sales and marketing activities, and to otherwise continue our
business operations beyond that date. We have no commitments for any future
funding, and may not be able to obtain additional financing or grants on terms
acceptable to us, if at all, in the future. If we are unable to obtain
additional capital this would restrict our ability to grow and may require us to
curtail or discontinue our business operations. Additionally, while a reduction
in our business operations may prolong our ability to operate, that reduction
would harm our ability to implement our business strategy. If we can obtain any
equity financing, it may involve substantial dilution to our then existing
shareholders.
Our
independent auditors have expressed substantial doubt about our ability to
continue as a going concern, which may hinder our ability to obtain future
financing.
In their
report dated December 15, 2008, our independent auditors stated that our
financial statements for the year ended September 30, 2008 were prepared
assuming that we would continue as a going concern, and that they have
substantial doubt about our ability to continue as a going concern. Our
auditors’ doubts are based on our incurring net losses of $6.8 million for the
year ended September 30, 2008. We continue to experience net operating losses.
Our ability to continue as a going concern is subject to our ability to generate
a profit and/or obtain necessary funding from outside sources, including by the
sale of our securities, obtaining loans from financial institutions, or
obtaining grants from various organizations or governments, where possible. Our
continued net operating losses and our auditors’ doubts increase the difficulty
of our meeting such goals and our efforts to continue as a going concern may not
prove successful.
If
our existing products and services are not accepted by potential customers or we
fail to introduce new products and services, our business, results of operations
and financial condition will be harmed.
There has
been limited market acceptance of our botanical DNA encryption, encapsulation,
embedment and authentication products and services to date. Some of the factors
that will affect whether we achieve market acceptance of our solutions
include:
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availability,
quality and price relative to competitive solutions;
|
|
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|
customers’
opinions of the solutions’ utility;
|
|
●
|
ease
of use;
|
|
●
|
consistency
with prior practices;
|
|
●
|
scientists’
opinions of the solutions’ usefulness;
|
|
●
|
citation
of the solutions in published research; and
|
|
●
|
general
trends in anti-counterfeit and security solutions’
research.
|
The
expenses or losses associated with the continued lack of market acceptance of
our solutions will harm our business, operating results and financial
condition.
Rapid
technological changes and frequent new product introductions are typical for the
markets we serve. Our future success may depend in part on continuous, timely
development and introduction of new products that address evolving market
requirements. We believe successful new product introductions may provide a
significant competitive advantage because customers invest their time in
selecting and learning to use new products, and are often reluctant to switch
products. To the extent we fail to introduce new and innovative products, we may
lose any market share we then have to our competitors, which will be difficult
or impossible to regain. Any inability, for technological or other reasons, to
successfully develop and introduce new products could reduce our growth rate or
damage our business. We may experience delays in the development and
introduction of products. We may not keep pace with the rapid rate of change in
anti-counterfeiting and security products’ research, and any new products
acquired or developed by us may not meet the requirements of the marketplace or
achieve market acceptance.
If
we are unable to retain the services of Drs. Hayward or Liang we may not be able
to continue our operations.
Our
success depends to a significant extent upon the continued service of Dr. James
A. Hayward, one of our directors, our President and Chief Executive Officer; and
Dr. Benjamin Liang, our Secretary and Strategic Technology Development Officer.
We do not have employment agreements with Drs. Hayward or Liang. Loss of the
services of Drs. Hayward or Liang could significantly harm our business, results
of operations and financial condition. We do not maintain key-man insurance on
the lives of Drs. Hayward or Liang.
The
markets for our anti-counterfeiting and product authentication solutions as well
as our BioActive Ingredients are very competitive, and we may be unable to
continue to compete effectively these industries in the future.
The
principal markets for our our anti-counterfeiting and product authentication
solutions as well as our BioActive Ingredients are intensely competitive. We
compete with many existing suppliers and new competitors continue to enter the
market. Many of our competitors, both in the United States and elsewhere, are
major pharmaceutical, chemical and biotechnology companies, or have strategic
alliances with such companies, and many of them have substantially greater
capital resources, marketing experience, research and development staff, and
facilities than we do. Any of these companies could succeed in developing
products that are more effective than the products that we have or may develop
and may be more successful than us in producing and marketing their existing
products. Some of our competitors that operate in the anti-counterfeiting and
fraud prevention markets include: Authentix, Collectors Universe Inc., Data Dot
Technology, Digimarc Corp., DNA Technologies, Inc., ID Global, Informium AG,
Inksure Technologies, Kodak, L-1 Identity Solutions, Manakoa, OpSec Security
Group, SmartWater Technology, Inc., Sun Chemical Corp, and
Tracetag.
We expect this competition to continue and intensify in the future. Competition in our markets is primarily driven by:
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product
performance, features and liability;
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price;
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timing
of product introductions;
|
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●
|
ability
to develop, maintain and protect proprietary products and
technologies;
|
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|
sales
and distribution capabilities;
|
|
●
|
technical
support and service;
|
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●
|
brand
loyalty;
|
|
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|
applications
support; and
|
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●
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breadth
of product line.
|
If a
competitor develops superior technology or cost-effective alternatives to our
products, our business, financial condition and results of operations could be
significantly harmed.
We
need to expand our sales, marketing and support organizations and our
distribution arrangements to increase market acceptance of our products and
services.
We
currently have few sales, marketing, customer service and support personnel and
will need to increase our staff to generate a greater volume of sales and to
support any new customers or the expanding needs of existing customers. The
employment market for sales, marketing, customer service and support personnel
in our industry is very competitive, and we may not be able to hire the kind and
number of sales, marketing, customer service and support personnel we are
targeting. Our inability to hire qualified sales, marketing, customer service
and support personnel may harm our business, operating results and financial
condition. We do not currently have any arrangements with any distributors and
we may not be able to enter into arrangements with qualified distributors on
acceptable terms or at all. If we are not able to develop greater distribution
capacity, we may not be able to generate sufficient revenue to support our
operations.
A
manufacturer’s inability or willingness to produce our goods on time and to our
specifications could result in lost revenue and net losses.
Though we
manufacture prototypes, samples and some of our own products, we currently do
not own or operate any significant manufacturing facilities and depend upon
independent third parties for the manufacture of some of our products to our
specifications. The inability of a manufacturer to ship orders of such products
in a timely manner or to meet our quality standards could cause us to miss the
delivery date requirements of our customers for those items, which could result
in cancellation of orders, refusal to accept deliveries or a reduction in
purchase prices, any of which could harm our business by resulting in decreased
revenues or net losses upon sales of products, if any sales could be
made.
If
we need to replace manufacturers, our expenses could increase, resulting in
smaller profit margins.
We
compete with other companies for the production capacity of our manufacturers
and import quota capacity. Some of these competitors have greater financial and
other resources than we have, and thus may have an advantage in the competition
for production and import quota capacity. If we experience a significant
increase in demand, or if our existing manufacturers must be replaced, we will
need to establish new relationships with another or multiple manufacturers. We
cannot assure you that this additional third party manufacturing capacity will
be available when required on terms that are acceptable to us or terms similar
to those we have with our existing manufacturers, either from a production
standpoint or a financial standpoint. We do not have long-term contracts with
our manufacturers, and our manufacturers do not produce our products
exclusively. Should we be forced to replace our manufacturers, we may experience
an adverse financial impact, or an adverse operational impact, such as being
forced to pay increased costs for such replacement manufacturing or delays upon
distribution and delivery of our products to our customers, which could cause us
to lose customers or lose revenues because of late shipments.
If
a manufacturer fails to use acceptable labor practices, we might have delays in
shipments or face joint liability for violations, resulting in decreased revenue
and increased expenses.
While we
require our independent manufacturers to operate in compliance with applicable
laws and regulations, we have no control over their ultimate actions. While our
internal and vendor operating guidelines promote ethical business practices and
our staff and buying agents periodically visit and monitor the operations of our
independent manufacturers, we do not control these manufacturers or their labor
practices. The violation of labor or other laws by our independent
manufacturers, or by one of our licensing partners, or the divergence of an
independent manufacturer’s or licensing partner’s labor practices from those
generally accepted as ethical in the United States, could interrupt, or
otherwise disrupt the shipment of finished products to us or damage our
reputation. Any of these, in turn, could have a material adverse effect on our
financial condition and results of operations, such as the loss of potential
revenue and incurring additional expenses.
Failure
to license new technologies could impair sales of our existing products or any
new product development we undertake in the future.
To
generate broad product lines, it is advantageous to sometimes license
technologies from third parties rather than depend exclusively on the
development efforts of our own employees. As a result, we believe our ability to
license new technologies from third parties is and will continue to be important
to our ability to offer new products. In addition, from time to time we are
notified or become aware of patents held by third parties that are related to
technologies we are selling or may sell in the future. After a review of these
patents, we may decide to seek a license for these technologies from these third
parties. There can be no assurance that we will be able to successfully identify
new technologies developed by others. Even if we are able to identify new
technologies of interest, we may not be able to negotiate a license on favorable
terms, or at all. If we lose the rights to patented technology, we may need to
discontinue selling certain products or redesign our products, and we may lose a
competitive advantage. Potential competitors could license technologies that we
fail to license and potentially erode our market share for certain products.
Intellectual property licenses would typically subject us to various
commercialization, sublicensing, minimum payment, and other obligations. If we
fail to comply with these requirements, we could lose important rights under a
license. In addition, certain rights granted under the license could be lost for
reasons beyond our control, and we may not receive significant indemnification
from a licensor against third party claims of intellectual property
infringement.
Our
failure to manage our growth in operations and acquisitions of new product lines
and new businesses could harm our business.
Any growth in our operations, if any, will place a significant strain on our current management resources. To manage such growth, we would need to improve our:
|
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operations
and financial systems;
|
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●
|
procedures
and controls; and
|
|
●
|
training
and management of our employees.
|
Our
future growth, if any, may be attributable to acquisitions of new product lines
and new businesses. Future acquisitions, if successfully consummated, would
likely create increased working capital requirements, which would likely precede
by several months any material contribution of an acquisition to our net income.
Our failure to manage growth or future acquisitions successfully could seriously
harm our operating results. Also, acquisition costs could cause our quarterly
operating results to vary significantly. Furthermore, our stockholders would be
diluted if we financed the acquisitions by incurring convertible debt or issuing
securities.
Although we currently only have operations within the United States, if we were to acquire an international operation; we would face additional risks, including:
|
●
|
difficulties
in staffing, managing and integrating international operations due to
language, cultural or other differences;
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different
or conflicting regulatory or legal requirements;
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foreign
currency fluctuations; and
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diversion
of significant time and attention of our
management.
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Failure
to attract and retain qualified scientific, production and managerial personnel
could harm our business.
Recruiting
and retaining qualified scientific and production personnel to perform and
manage prototype, sample, and product manufacturing and business development
personnel to conduct business development are critical to our success. In
addition, our desired growth and expansion into areas and activities requiring
additional expertise, such as clinical testing, government approvals,
production, and marketing will require the addition of new management personnel
and the development of additional expertise by existing management personnel.
Because the industry in which we compete is very competitive, we face
significant challenges attracting and retaining a qualified personnel base.
Although we believe we have been and will be able to attract and retain these
personnel, we may not be able to continue to successfully attract qualified
personnel. The failure to attract and retain these personnel or, alternatively,
to develop this expertise internally would harm our business since our ability
to conduct business development and manufacturing will be reduced or eliminated,
resulting in lower revenues. We generally do not enter into employment
agreements requiring our employees to continue in our employment for any period
of time.
Our
intellectual property rights are valuable, and any inability to protect them
could reduce the value of our products, services and brand.
Our
patents, trademarks, trade secrets, copyrights and all of our other intellectual
property rights are important assets for us. There are events that are outside
of our control that pose a threat to our intellectual property rights as well as
to our products and services. For example, effective intellectual property
protection may not be available in every country in which our products and
services are distributed. The efforts we have taken to protect our proprietary
rights may not be sufficient or effective. Any significant impairment of our
intellectual property rights could harm our business or our ability to compete.
Protecting our intellectual property rights is costly and time consuming. Any
increase in the unauthorized use of our intellectual property could make it more
expensive to do business and harm our operating results. Although we seek to
obtain patent protection for our innovations, it is possible we may not be able
to protect some of these innovations. Given the costs of obtaining patent
protection, we may choose not to protect certain innovations that later turn out
to be important. There is always the possibility that the scope of the
protection gained from one of our issued patents will be insufficient or deemed
invalid or unenforceable. We also seek to maintain certain intellectual property
as trade secrets. The secrecy could be compromised by third parties, or
intentionally or accidentally by our employees, which would cause us to lose the
competitive advantage resulting from these trade secrets.
Intellectual
property litigation could harm our business.
Litigation
regarding patents and other intellectual property rights is extensive in the
biotechnology industry. In the event of an intellectual property dispute, we may
be forced to litigate. This litigation could involve proceedings instituted by
the U.S. Patent and Trademark Office or the International Trade Commission, as
well as proceedings brought directly by affected third parties. Intellectual
property litigation can be extremely expensive, and these expenses, as well as
the consequences should we not prevail, could seriously harm our
business.
If a
third party claims an intellectual property right to technology we use, we might
need to discontinue an important product or product line, alter our products and
processes, pay license fees or cease our affected business activities. Although
we might under these circumstances attempt to obtain a license to this
intellectual property, we may not be able to do so on favorable terms, or at
all. Furthermore, a third party may claim that we are using inventions covered
by the third party’s patent rights and may go to court to stop us from engaging
in our normal operations and activities, including making or selling our product
candidates. These lawsuits are costly and could affect our results of operations
and divert the attention of managerial and technical personnel. A court may
decide that we are infringing the third party’s patents and would order us to
stop the activities covered by the patents. In addition, a court may order us to
pay the other party damages for having violated the other party’s patents. The
biotechnology industry has produced a proliferation of patents, and it is not
always clear to industry participants, including us, which patents cover various
types of products or methods of use. The coverage of patents is subject to
interpretation by the courts, and the interpretation is not always uniform. If
we are sued for patent infringement, we would need to demonstrate that our
products or methods of use either do not infringe the patent claims of the
relevant patent and/or that the patent claims are invalid, and we may not be
able to do this. Proving invalidity, in particular, is difficult since it
requires a showing of clear and convincing evidence to overcome the presumption
of validity enjoyed by issued patents.
Because
some patent applications in the United States may be maintained in secrecy until
the patents are issued, because patent applications in the United States and
many foreign jurisdictions are typically not published until eighteen months
after filing, and because publications in the scientific literature often lag
behind actual discoveries, we cannot be certain that others have not filed
patent applications for technology covered by our or our licensor’s issued
patents or pending applications or that we or our licensors were the first to
invent the technology. Our competitors may have filed, and may in the future
file, patent applications covering technology similar to ours. Any such patent
application may have priority over our or our licensors’ patent applications and
could further require us to obtain rights to issued patents covering such
technologies. If another party has filed a United States patent application on
inventions similar to ours, we may have to participate in an interference
proceeding declared by the United States Patent and Trademark Office to
determine priority of invention in the United States. The costs of these
proceedings could be substantial, and it is possible that such efforts would be
unsuccessful, resulting in a loss of our United States patent position with
respect to such inventions.
Some of
our competitors may be able to sustain the costs of complex patent litigation
more effectively than we can because they have substantially greater resources.
In addition, any uncertainties resulting from the initiation and continuation of
any litigation could have a material adverse effect on our ability to raise the
funds necessary to continue our operations.
Accidents
related to hazardous materials could adversely affect our business.
Some of
our operations require the controlled use of hazardous materials. Although we
believe our safety procedures comply with the standards prescribed by federal,
state, local and foreign regulations, the risk of accidental contamination of
property or injury to individuals from these materials cannot be completely
eliminated. In the event of an accident, we could be liable for any damages that
result, which could seriously damage our business and results of
operations.
Potential
product liability claims could affect our earnings and financial
condition.
We
face a potential risk of liability claims based on our products and services,
and we have faced such claims in the past. Though we have product liability
insurance coverage which we believe is adequate, we may not be able to maintain
this insurance at reasonable cost and on reasonable terms. We also cannot assure
that this insurance, if obtained, will be adequate to protect us against a
product liability claim, should one arise. In the event that a product liability
claim is successfully brought against us, it could result in a significant
decrease in our liquidity or assets, which could result in the reduction or
termination of our business.
Litigation
generally could affect our financial condition and results of
operations.
We
generally may be subject to claims made by and required to respond to litigation
brought by customers, former employees, former officers and directors, former
distributors and sales representatives, and vendors and service
providers. We have faced such claims and litigation in the past and
we cannot assure that we will not be subject to claims in the
future. In the event that a claim is successfully brought against us,
considering our lack of material revenue and the losses our business has
incurred for the period from our inception to September 30, 2008, this could
result in a significant decrease in our liquidity or assets, which could result
in the reduction or termination of our business.
We
were obligated to pay liquidated damages as a result of our failure to have our
registration statement declared effective prior to June 15, 2005, and any
payment of liquidated damages will either result in depletion of our limited
working capital or issuance of shares of common stock which would cause dilution
to our existing shareholders.
Pursuant
to the terms of a registration rights agreement with respect to common stock
underlying convertible notes and warrants we issued in private placements in
November and December, 2003, December, 2004, and January and February, 2005, for
each month after June 15, 2005 that we did not have a registration statement
registering the shares underlying these convertible notes and warrants declared
effective, we were obligated to pay liquidated damages in the amount of 3.5% per
month of the face amount of the notes, an amount equal to $367,885. On July 24,
2008, the SEC declared effective our registration statement with respect to
common stock underlying convertible notes and warrants we issued in private
placements in November and December, 2003, December, 2004, and January and
February, 2005. At our option, these liquidated damages can be paid in cash or
unregistered shares of our common stock. To date we have decided to pay certain
of these liquidated damages in common stock, although any future payments of
liquidated damages may, at our option, be made in cash. If we decide to pay such
liquidated damages in cash, we would be required to use our limited working
capital and potentially raise additional funds. If we decide to pay the
liquidated damages in shares of common stock, the number of shares issued would
depend on our stock price at the time that payment is due. Based on the closing
market prices of $0.66, $0.58, $0.70, $0.49, $0.32 and $0.20 for our common
stock on July 15, 2005, August 15, 2005, September 15, 2005, October 17, 2005,
November 15, 2005 and December 15, 2005, respectively, we issued a total of
3,807,375 shares of common stock in liquidated damages from August, 2005 to
January, 2006 to persons who invested in the January and February, 2005 private
placements. The issuance of shares upon any payment by us of further liquidated
damages will have the effect of further diluting the proportionate equity
interest and voting power of holders of our common stock, including investors in
this offering.
We paid
liquidated damages in the form of common stock only for the period from June 15,
2005 to December 15, 2005, and only to persons who invested in the January and
February, 2005 private placements. We believe that we have no
enforceable obligation to pay liquidated damages to holders of any shares we
agreed to register under the registration rights agreement for periods after the
first anniversary of the date of issuance of such shares, since they were
eligible for resale under Rule 144 of the Securities Act during such periods,
and such liquidated damages are grossly inconsistent with actual damages to such
persons. Nonetheless, as of September 30, 2008 we have accrued
approximately $12.0 million in penalties representing further liquidated damages
associated with our failure to have the registration statement declared
effective by the deadline, and have included this amount in accounts payable and
accrued expenses.
Matter
voluntarily reported to the Securities and Exchange Commission
During
the months of March, May, July and August 2005, we issued a total of 8,550,000
shares of our common stock to certain employees and consultants pursuant to the
2005 Incentive Stock Plan. We engaged our outside counsel to conduct an
investigation of the circumstances surrounding the issuance of these shares. On
April 26, 2006, we voluntarily reported the findings from this investigation to
the SEC, and agreed to provide the SEC with further information arising from the
investigation. We believe that the issuance of 8,000,000 shares to employees in
July 2005 was effectuated by both our former President and our former Chief
Financial Officer/Chief Operating Officer without approval of our board of
directors. These former officers received a total of 3,000,000 of these shares.
In addition, it appears that the 8,000,000 shares issued in July 2005, as well
as an additional 550,000 shares issued to employees and consultants in March,
May and August 2005, were improperly issued without a restrictive legend stating
that the shares could not be resold legally except in compliance with the
Securities Act of 1933, as amended. The members of the Company's management who
effectuated the stock issuances no longer work for the Company. These shares
were not registered under the Securities Act of 1933, or the securities laws of
any state, and we believe that certain of these shares may have been sold on the
open market, though we have been unable to determine the magnitude of such
sales. Since our voluntary report of the findings of our internal investigation
to the SEC on April 26, 2006, we have received no communication from the SEC or
any third party with respect to this matter. If violations of securities laws
occurred in connection with the resale of certain of these shares, the employees
and consultants or persons who purchased shares from them may have rights to
have their purchase rescinded or other claims against us for violation of
securities laws, which could harm our business, results of operations, and
financial condition.
Risks
Relating to Our Common Stock:
There
are a large number of shares underlying our options and warrants that may be
available for future sale and the sale of these shares may depress the market
price of our common stock and will cause immediate and substantial dilution to
our existing stockholders.
As of
December 15, 2008, we had 231,870,731 shares of common stock issued and
outstanding and outstanding options and warrants to purchase 70,635,964 shares
of common stock. All of the shares issuable upon exercise of our
options and warrants may be sold without restriction. The sale of
these shares may adversely affect the market price of our common
stock. The issuance of shares upon exercise of options and warrants
will cause immediate and substantial dilution to the interests of other
stockholders since the selling stockholders may convert and sell the full amount
issuable on exercise.
If
we fail to remain current on our reporting requirements, we could be removed
from the OTC bulletin board which would limit the ability of broker-dealers to
sell our securities and the ability of stockholders to sell their securities in
the secondary market.
Companies
trading on The Over The Counter Bulletin Board (the “OTC Bulletin Board”), such
as us, must be reporting issuers under Section 12 or Section 15(d) of the
Securities Exchange Act of 1934, as amended, and must be current in their
reports under Section 13, in order to maintain price quotation privileges on the
OTC Bulletin Board. If we fail to remain current on our reporting
requirements, we could be removed from the OTC Bulletin Board. As a
result, the market liquidity for our securities could be severely adversely
affected by limiting the ability of broker-dealers to sell our securities and
the ability of stockholders to sell their securities in the secondary
market. Prior to May 2001, we were delinquent in our reporting
requirements, having failed to file our quarterly and annual reports for the
years ended 1998 – 2000 (except the quarterly reports for the first two quarters
of 1999). We have been current in our reporting requirements for
the last six years, however, there can be no assurance that in the future we
will always be current in our reporting requirements.
We may
not
be able to implement section 404 of the Sarbanes Oxley
Act of 2002 on a timely basis.
The SEC,
as directed by Section 404 of the Sarbanes-Oxley Act, adopted rules generally
requiring each public company to include a report of management on the company's
internal controls over financial reporting in its annual report on Form 10-K
that contains an assessment by management of the effectiveness of the company's
internal controls over financial reporting. This requirement first applied to
our annual report on Form 10-K for the fiscal year ending September 30, 2008.
Under current rules, commencing with our annual report for the fiscal year
ending September 30, 2010 our independent registered accounting firm must attest
to and report on management's assessment of the effectiveness of our internal
controls over financial reporting.
We have
not yet developed a Section 404 implementation plan. We have in the past
discovered, and may in the future discover, areas of our internal controls that
need improvement. How companies should be implementing these new requirements
including internal control reforms to comply with Section 404's requirements and
how independent auditors will apply these requirements and test companies'
internal controls, is still reasonably uncertain.
We expect
that we will need to hire and/or engage additional personnel and incur
incremental costs in order to complete the work required by Section 404. We may
not be able to complete a Section 404 plan on a timely basis. Additionally, upon
completion of a Section 404 plan, we may not be able to conclude that our
internal controls are effective, or in the event that we conclude that our
internal controls are effective, our independent accountants may disagree with
our assessment and may issue a report that is qualified. Any failure to
implement required new or improved controls, or difficulties encountered in
their implementation, could harm our operating results or cause us to fail to
meet our reporting obligations.
Our
common stock is subject to the “penny stock” rules of the SEC and the trading
market in our securities is limited, which makes transactions in our stock
cumbersome and may reduce the value of an investment in our stock.
The
SEC has adopted Rule 15g-9 which establishes the definition of a “penny stock,”
for the purposes relevant to us, as any equity security that has a market price
of less than $5.00 per share or with an exercise price of less than $5.00 per
share, subject to certain exceptions. For any transaction involving a penny
stock, unless exempt, the rules require:
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that
a broker or dealer approve a person’s account for transactions in penny
stocks; and
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the
broker or dealer receive from the investor a written agreement to the
transaction, setting forth the identity and quantity of the penny stock to
be purchased.
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In order to approve a person’s account for transactions in penny stocks, the broker or dealer must:
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obtain
financial information and investment experience objectives of the person;
and
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make
a reasonable determination that the transactions in penny stocks are
suitable for that person and the person has sufficient knowledge and
experience in financial matters to be capable of evaluating the risks of
transactions in penny stocks.
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The
broker or dealer must also deliver, prior to any transaction in a penny stock, a
disclosure schedule prescribed by the SEC relating to the penny stock market,
which, in highlight form:
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sets
forth the basis on which the broker or dealer made the suitability
determination; and
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that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
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Generally,
brokers may be less willing to execute transactions in securities subject to the
“penny stock” rules. This may make it more difficult for investors to dispose of
our common stock and cause a decline in the market value of our
stock.
Disclosure
also has to be made about the risks of investing in penny stocks in both public
offerings and in secondary trading and about the commissions payable to both the
broker-dealer and the registered representative, current quotations for the
securities and the rights and remedies available to an investor in cases of
fraud in penny stock transactions. Finally, monthly statements have to be sent
disclosing recent price information for the penny stock held in the account and
information on the limited market in penny stocks.
ITEM
1B. UNRESOLVED STAFF COMMENTS.
We have
received no written comments regarding our periodic or current reports from the
staff of the Securities and Exchange Commission that were issued 180 days or
more preceding the end of our 2008 fiscal year and that remained
unresolved.
ITEM
2. PROPERTIES.
We
maintain our principal office at 25 Health Sciences Drive, Suite 113, Stony
Brook, New York 11790. We moved our principal office to the Long Island
High Technology Incubator, which is located on the campus of
Stony Brook University, in November 2005. We believe that
our current office space and facilities are sufficient to meet our present needs
and do not anticipate any difficulty securing alternative or additional space,
as needed, on terms acceptable to us.
ITEM
3. LEGAL PROCEEDINGS.
From time
to time, we may become involved in various lawsuits and legal proceedings which
arise in the ordinary course of business. However, litigation is
subject to inherent uncertainties, and an adverse result in these or other
matters may arise from time to time that may harm our business. Except as
described below, we are currently not aware of any such legal proceedings that
we believe will have, individually or in the aggregate, a material adverse
affect on our business, financial condition or operating results.
Douglas
A. Falkner v. Applied DNA Sciences, Inc./N.C. Industrial Commission File No.
585698
Plaintiff
Douglas Falkner ("Falkner") filed a worker’s compensation claim in North
Carolina for an alleged work-related neck injury that he alleges occurred on
January 14, 2004. Falkner worked as Business Development and
Operations Manager at our sole East Coast office at the time of the alleged
injury. Falkner was the only employee employed by us in North
Carolina at the time of the alleged injury and we have employed no other
employees in North Carolina at any other time. The claim has been
denied and is being defended on several grounds, including the lack of both
personal and subject matter jurisdiction. Specifically, we contend
that we did not employ the requisite minimum number of employees in North
Carolina at the time of the alleged injury and that the company is therefore not
subject to the North Carolina Workers' Compensation Act. The claim
was originally set for hearing in January 2007, but was continued to allow the
parties to engage in further discovery.
Douglas
A. Falkner v. Applied DNA Sciences, Inc. (Los Angeles County Superior Court Case
No. BC 386557):
Falkner
filed a claim on March 3, 2008 asserting counts for breach of contract under his
employment agreements dated March 10, 2003 and June 16, 2003 and wrongful
discharge in violation of public policy. The relief sought includes
compensatory damages in an aggregate amount of approximately $1.7 million,
unspecified exemplary and punitive damages, and attorneys’ fees. We
have filed a motion for summary judgment that will be heard on February 19,
2009. The trial is currently set for March 24, 2009. We
intend to vigorously defend against the claims asserted against us.
Intervex,
Inc. v. Applied DNA Sciences, Inc. (Supreme Court of the State of New York Index
No.08-601219):
Intervex,
Inc., or Intervex, the plaintiff, filed a complaint on or about April 23, 2008
related to a claim for breach of contract. In March 2005, we entered
into a consulting agreement with Intervex, which provided for, among other
things, a payment of $6,000 per month for a period of 24 months, or an aggregate
of $144,000. In addition, the consulting agreement provided for the
issuance by us to Intervex of a five-year warrant to purchase 250,000 shares of
our common stock with an exercise price of $.75. Intervex asserts
that we owe it 17 payments of $6,000, or an aggregate of $102,000, plus accrued
interest thereon, and a warrant to purchase 250,000 shares of our common
stock. We have counterclaimed for compensatory and punitive damages,
restitution, attorneys’ fees and costs, interest and other relief the court
deems proper. This matter is in the early stages of
discovery. We intend to vigorously defend against the claims asserted
against us.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
PART
II
ITEM
5. MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES.
Market
Information
Our
Common Stock is quoted on The Over The Counter Bulletin Board (the “OTC Bulletin
Board”) maintained by the National Association of Securities Dealers under the
symbol “APDN.” There is no certainty that the Common Stock will continue to be
quoted or that any liquidity exists for our shareholders.
The
following table sets forth the quarterly quotes of high and low prices for our
Common Stock on the OTC Bulletin Board during the fiscal years ended September
30, 2007 and September 30, 2008.
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Fiscal
2007
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Fiscal
2008
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High
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Low
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High
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Low
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First
Quarter
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$ |
0.12 |
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$ |
0.07 |
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$ |
0.17 |
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$ |
0.09 |
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Second
Quarter
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$ |
0.28 |
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$ |
0.09 |
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$ |
0.22 |
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$ |
0.09 |
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Third
Quarter
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$ |
0.23 |
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$ |
0.10 |
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$ |
0.14 |
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$ |
0.09 |
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Fourth
Quarter
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$ |
0.15 |
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$ |
0.08 |
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$ |
0.10 |
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$ |
0.03 |
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Holders
As of
December 15, 2008, we had approximately 1,119 holders of our common
stock. The number of record holders was determined from the records
of our transfer agent and does not include beneficial owners of common stock
whose shares are held in the names of various security brokers, dealers, and
registered clearing agencies. The transfer agent of our common stock
is American Stock Transfer & Trust Company, 6201 15th Avenue,
Brooklyn, New York 11219.
Dividends
We have
never declared or paid any cash dividends on our common stock. We do not
anticipate paying any cash dividends to stockholders in the foreseeable future.
In addition, any future determination to pay cash dividends will be at the
discretion of the Board of Directors and will be dependent upon our financial
condition, results of operations, capital requirements, and such other factors
as the Board of Directors deem relevant.
Recent
Sales of Unregistered Securities
Other
than as previously described in our Quarterly Reports on Form 10-Q-SB or in our
Current Reports on Form 8-K, there were no sales of unregistered securities
during fiscal 2008.
ITEM
6. SELECTED FINANCIAL DATA.
The
Company is a smaller reporting company as defined by Rule 12-b-2 of the Exchange
Act and is not required to provide the information required under this
item.
ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
The
following discussion should be read in conjunction with our Consolidated
Financial Statements and Notes thereto, included elsewhere within this report.
The Annual Report on Form 10-K contains forward-looking statements within
the meaning of Section 27A of the Securities Act and Section 21E of the Exchange
Act, including statements using terminology such as “can”, “may”, “believe”,
“designated to”, “will”, “expect”, “plan”, “anticipate”, “estimate”, “potential”
or “continue”, or the negative thereof or other comparable terminology regarding
beliefs, plans, expectations or intentions regarding the future. You should read
statements that contain these words carefully because they:
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discuss
our future expectations;
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contain
projections of our future results of operations or of our financial
condition; and
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state
other “forward-looking”
information.
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We
believe it is important to communicate our expectations. However, forward
looking statements involve risks and uncertainties and our actual results and
the timing of certain events could differ materially from those discussed in
forward-looking statements as a result of certain factors, including those set
forth under “Risk Factors,” “Business” and elsewhere in this report. All
forward-looking statements and risk factors included in this document are made
as of the date hereof, based on information available to us as of the date
thereof, and we assume no obligations to update any forward-looking statement or
risk factor, unless we are required to do so by law.
Introduction
We use
the DNA of plants and innovative technologies to provide anti-counterfeiting and
product authentication solutions and to manufacture ingredients for personal
care products and textiles. SigNature® DNA and BioMaterial™
Genotyping, our principal anti-counterfeiting and product authentication
solutions, allow users to accurately and effectively protect branded products,
artwork and collectibles, fine wine, digital media, financial instruments,
identity cards and other official documents. Our BioActive™
Ingredients, which are being used by our customers in personal care products,
such as skin care products, and in textiles, such as intimate apparel, are
custom-manufactured to address a customer’s specific need.
SigNature
DNA. We use the DNA of plants to manufacture highly customized
and encrypted botanical DNA markers, or SigNature DNA Markers, which we believe
are virtually impossible to replicate. We have embedded SigNature DNA
Markers into a range of our customers’ products, including various inks, thermal
ribbon, thread, varnishes and adhesives. These items can then be
tested for the presence of SigNature DNA Markers through an instant field
detection or a forensic level authentication. Our SigNature DNA
solution provides a secure, accurate and cost-effective means for users to
incorporate our SigNature DNA Markers in, and then quickly and reliably
authenticate and identify, a broad range of items such as branded products,
artwork and collectibles, cash-in-transit, fine wine, digital media, financial
instruments, identity cards and other official documents. Having the
ability to reliably authenticate and identify counterfeit versions of such items
enables companies and governments to detect, deter, interdict and prosecute
counterfeiting enterprises and individuals.
BioMaterial
GenoTyping. Our BioMaterial GenoTyping solution refers to the
development of genetic assays to distinguish between varieties or strains of
biomaterials, such as cotton, wool, tobacco, fermented beverages, natural drugs
and foods, that contain their own source DNA. We have developed two
proprietary genetic tests (FiberTyping™ and PimaTyping™) to track American Pima
cotton from the field to finished garments. These genetic assays
provide the cotton industry with the first authentication tools that can be
applied throughout the U.S. and worldwide cotton industry from cotton growers,
mills, wholesalers, distributors, manufacturers and retailers through trade
groups and government agencies.
BioActive
Ingredients. Our BioActive Ingredients program began in 2007,
based on the biofermentation expertise developed from our experience with the
manufacture of DNA for our SigNature DNA and BioMaterial Genotyping
solutions. We initially targeted potential customers in the personal
care products, industry, and we developed DermalRx Hydroseal, which has
been incorporated into the fabric of a new line of intimate apparel currently
being test marketed by a global marketer of intimate apparel. In addition,
we developed DermalRx SRC, Skin Resurfacing Complex, an ingredient designed to
promote smoother more radiant skin by stimulating the skin's own exfoliation
process.
General
We expect
to generate revenues principally from sales of our SigNature Program,
BioMaterial Genotyping and BioActive Ingredients. We are currently
attempting to develop business in the following target markets: art and
collectibles, cash-in-transit, fine wine, consumer products, digital recording
media, pharmaceuticals, and homeland security driven programs. We
intend to pursue both domestic and international sales opportunities in each of
these vertical markets.
Critical Accounting
Policies
Financial
Reporting Release No. 60, published by the SEC, recommends that all companies
include a discussion of critical accounting policies used in the preparation of
their financial statements. While all these significant accounting policies
impact our financial condition and results of operations, we view certain of
these policies as critical. Policies determined to be critical are those
policies that have the most significant impact on our consolidated financial
statements and require management to use a greater degree of judgment and
estimates. Actual results may differ from those estimates.
We
believe that given current facts and circumstances, it is unlikely that applying
any other reasonable judgments or estimate methodologies would cause a material
effect on our consolidated results of operations, financial position or
liquidity for the periods presented in this report.
The
accounting policies identified as critical are as follows:
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Equity
issued with registration rights;
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Revenue
recognition;
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Allowance
for Doubtful Accounts; and
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Fair
value of intangible assets.
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Equity
Issued with Registration Rights
In
connection with placement of our convertible notes and warrants to certain
investors during the fiscal quarters ended December 31, 2003, December 31, 2004,
March 31, 2005, March 31, 2006 and June 30, 2006, we granted certain
registration rights that provide for liquidated damages in the event of failure
to timely perform under the agreements. Although these notes and warrants do not
provide for net-cash settlement, the existence of liquidated damages provides
for a defacto net-cash settlement option. Therefore, the common stock
underlying the notes and warrants subject to such liquidated damages does not
meet the tests required for shareholders’ equity classification in the past, and
accordingly has been reflected between liabilities and equity in our previous
consolidated balance sheet.
In
September 2007, we exchanged our common stock for the remaining Secured
Convertible Promissory Note that contained embedded derivatives such as certain
conversion features, variable interest features, call options and default
provisions.
We had an
accumulative accrual of $12,023,888 in liquidating damages in relationship to
the previously outstanding convertible promissory notes and related
warrants.
Revenue
Recognition
Revenues
are derived from research, development, qualification and production testing for
certain commercial products.
Revenue
from fixed price testing contracts is generally recorded upon completion of the
contracts, which are generally short-term, or upon completion of identifiable
contractual tasks. At the time the Company enters into a contract that includes
multiple tasks, the Company estimates the amount of actual labor and other costs
that will be required to complete each task based on historical experience.
Revenues are recognized which provide for a profit margin relative to the
testing performed. Revenue relative to each task and from contracts which are
time and materials based is recorded as effort is expended. Billings in excess
of amounts earned are deferred. Any anticipated losses on contracts are charged
to income when identified. To the extent management does not accurately forecast
the level of effort required to complete a contract, or individual tasks within
a contract, and the Company is unable to negotiate additional billings with a
customer for cost over-runs, the Company may incur losses on individual
contracts. All selling, general and administrative costs are treated as period
costs and expensed as incurred.
Allowance
for Uncollectible Receivables
The
Company maintains an allowance for doubtful accounts for estimated losses
resulting from the inability of customers to make required payments. The Company
uses a combination of write-off history, aging analysis and any specific known
troubled accounts in determining the allowance. If the financial condition of
customers were to deteriorate, resulting in an impairment of their ability to
make payments, additional allowances could be required.
Fair
Value of Intangible Assets
We have
adopted SFAS No. 142, Goodwill and Other Intangible Assets, whereby we
periodically test our intangible assets for impairment. On an annual basis, and
when there is reason to suspect that their values have been diminished or
impaired, these assets are tested for impairment, and write-downs will be
included in results from operations. During the years ended September
30, 2008 and 2007, our management performed an evaluation of the Company’s
intangible assets (intellectual property) for purposes of determining the
implied fair value of the assets at September 30, 2008 and 2007, respectively.
The tests indicated that the recorded remaining book value of its intellectual
property did not exceed its fair value for those respective years, as determined
by discounted future cash flows. Considerable management judgment is
necessary to estimate the fair value. Accordingly, actual results
could vary significantly from management’s estimates.
Use
of Estimates
In
preparing financial statements in conformity with accounting principles
generally accepted in the United States of America, management is required to
make estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date
of the financial statements and revenue and expenses during the reporting
period. The most significant estimates relate to the estimation of percentage of
completion on uncompleted contracts, valuation of inventory, allowance for
doubtful accounts and estimated life of customer lists. Actual results could
differ from those estimates.
Comparison
of the year Ended September 30, 2008 to the year ended September 30,
2007
Revenues
For the
years ended September 30, 2008 and 2007, we generated $873,010 and $121,920 in
revenues from operations, respectively. Our cost of sales for the
year ended September 30, 2008 was $171,332, netting us a gross profit of
$701,678. Our cost of sales for the year ended September 30, 2007 was
$23,073, netting us a gross profit of $98,847.
Costs
and Expenses
Selling,
General and Administrative
Selling,
general and administrative expenses for the twelve months ended September 30,
2008 decreased 65% to $4.3 million from $12.1 million in the same period in
2007. Included within the selling, general and administrative expenses for
the years ended September 30, 2008 and 2007 were expenses relating to
liquidation damage accrual, fund raising and consultant costs of $1.1 million
and $7.9 million, respectively.
Research
and Development
Research
and development expenses increased $34,987 for the twelve months ended September
30, 2008 compared to the same period in 2007 from $110,845 to $145,832,
primarily due to customer related activity in research and development with our
change in focus to marketing activities.
Depreciation
and Amortization
In the
twelve months ended September 30, 2008, depreciation and amortization increased
$1,834 for the period compared to 2007 from $432,582 to $434,416. The
increase is attributable to the increase of fixed assets acquired during the
year ended September 30, 2008.
Total
Operating Expenses
Total
operating expenses decreased to $4.9 million from $12.6 million, or a decrease
of $7.7 million, primarily due to the reduction in accrual for liquidation
damages and less consulting costs for the year ended September 30, 2008 as
compared to September 30, 2007.
Other
Income/Loss
Other
income for the twelve months ended September 30, 2008 decreased from a gain of
$1.4 million to $0 million. Other income for the year ended September
30, 2007 was a result primarily from the change in fair value of our recorded
warrant liabilities.
As of
September 30, 2007, we exchanged common stock for the previously issued
Convertible Promissory Notes that contained certain embedded derivative
financial instruments. As a result, we reclassified the warrant
liabilities recorded in conjunction with the convertible promissory notes to
equity as of the conversion date of the remaining note.
Interest
Expenses
Interest
expenses for the twelve months ended September 30, 2008, increased to $2.6
million from $2.2 million in the same period of 2007, a increase of $0.4
million, as a result of additional borrowings.
Net
Income (loss)
Net loss
for the twelve months ended September 30, 2008 decreased to a loss of $6.8
million from a loss of $13.3 million in the prior period as a result of the
combination of factors described above.
Liquidity
and Capital Resources
Our
liquidity needs consist of our working capital requirements, indebtedness
payments and research and development expenditure
funding. Historically, we have financed our operations through the
sale of equity and convertible debt as well as borrowings from various credit
sources.
As of
September 30, 2008, we had a working capital deficit of $15.6
million. For the year ended September 30, 2008, we generated a net
cash flow deficit from operating activities of $2.9 million consisting primarily
of year to date losses of $6.8 million. Non cash adjustments included
$3.2 million in depreciation and amortization charges and $1.0 million for
common stock issued in exchange for services. Additionally we had a
net increase in current assets of $0.05 million and a net decrease in current
liabilities of $0.3 million. Cash provided by investing activities
totaled $0.4 million, primarily provided by reduction in cash held in escrow net
with $0.02 million in acquisition of property and equipment. Cash
provided by financing activities for the year ended September 30, 2008 totaled
$2.7 million consisting of proceeds from issuance of convertible
debt.
We expect
capital expenditures to be less than $150,000 in fiscal 2009. Our primary
investments will be in laboratory equipment to support prototyping and our
authentication services.
Exploitation
of potential revenue sources will be financed primarily through the sale of
securities and convertible debt, exercise of outstanding warrants, issuance of
notes payable and other debt or a combination thereof, depending upon the
transaction size, market conditions and other factors.
While we
have raised capital to meet our working capital and financing needs in the past,
additional financing is required within the next 3 months in order to meet
our current and projected cash flow deficits from operations and development. We
have sufficient funds to conduct our operations for approximately nine
months. Our financing through a private placement offering since our
year end is discussed below. There can be no assurance that financing will be
available in amounts or on terms acceptable to us, if at all.
By
adjusting our operations and development to the level of capitalization, we
believe we have sufficient capital resources to meet projected cash flow
deficits. However, if during that period or thereafter, we are not successful in
generating sufficient liquidity from operations or in raising sufficient capital
resources, on terms acceptable to us, this could have a material adverse effect
on our business, results of operations liquidity and financial
condition.
Our
registered independent certified public accountants have stated in their report
dated December 15, 2008, that we have incurred operating losses in the last
two years, and that we are dependent upon management's ability to develop
profitable operations and raise additional capital. These factors among
others may raise substantial doubt about our ability to continue as a going
concern.
Recent
Debt and Equity Financing Transactions
Fiscal
2007
During
the year ended September 30, 2007, we issued and sold an aggregate principal
amount of $850,000 in secured convertible promissory notes bearing interest at
10% per annum and warrants to purchase an aggregate of 1,700,000 shares of our
common stock to James A. Hayward, our President, Chairman, Chief Executive
Officer and a director.
On April
23, 2007, we issued and sold to James A. Hayward a $100,000 principal amount
secured promissory note (“April Note”) bearing interest at a rate of 10% per
annum and a warrant (“April Warrant”) to purchase 200,000 shares of our common
stock. On June 30, 2007, we issued and sold to James A. Hayward a
$250,000 principal amount secured promissory note (“June Note”) bearing interest
at a rate of 10% per annum and a warrant (“June Warrant”) to purchase 500,000
shares of our common stock. On July 30, 2007, we issued and sold to James A.
Hayward a $200,000 principal amount secured promissory note (“July Note”)
bearing interest at a rate of 10% per annum and a warrant (“July Warrant”) to
purchase 400,000 shares of our common stock. On September 28, 2007,
we issued and sold to James A. Hayward a $300,000 principal amount secured
promissory note (“September Note”) bearing interest at a rate of 10% per annum
and a warrant (“September Warrant”) to purchase 600,000 shares of our common
stock.
The April
Note and accrued but unpaid interest thereon converted on April 22, 2008 at a
conversion price of $0.15 into 733,334 shares of our common
stock. The April Warrant is exercisable for a four-year period
commencing on April 23, 2008, and expiring on April 22, 2012, at a price of
$0.50 per share. The April Warrant may be redeemed at our option at a redemption
price of $0.01 upon the earlier of (i) April 22, 2010, and (ii) the date our
common stock is quoted on The Over the Counter Bulletin Board at or above $1.00
per share for 20 consecutive trading days.
The June
Note and accrued but unpaid interest thereon converted on June 30, 2008 at a
conversion price of $0.087732076 per share, which is equal to a 20% discount to
the average volume, weighted average price of our common stock for the ten
trading days prior to issuance into 3,134,543 shares of our common stock. The
June Warrant is exercisable for a four-year period commencing on June 30, 2008,
and expiring on June 29, 2012, at a price of $0.50 per share. The June Warrant
may be redeemed at our option at a redemption price of $0.01 upon the earlier of
(i) June 29, 2010, and (ii) the date our common stock has traded on The Over the
Counter Bulletin Board at or above $1.00 per share for 20 consecutive trading
days.
The July
Note and accrued but unpaid interest thereon converted on July 30, 2008 at a
conversion price of $0.102568072 per share, which is equal to a 20% discount to
the average volume, weighted average price of our common stock for the ten
trading days prior to issuance, into 2,144,917 shares of our common
stock. The July Warrant is exercisable for a four-year period
commencing on July 30, 2008, and expiring on July 29, 2012, at a price of $0.50
per share. The July Warrant may be redeemed at our option at a redemption price
of $0.01 upon the earlier of (i) July 29, 2010, and (ii) the date our common
stock has traded on The Over the Counter Bulletin Board at or above $1.00 per
share for 20 consecutive trading days.
The
September Note and accrued but unpaid interest thereon converted on September
28, 2008 at a conversion price of $0.066429851 per share, which is equal to a
30% discount to the average volume, weighted average price of our common stock
for the ten trading days prior to issuance, into 4,967,646 shares of our common
stock. The September Warrant is exercisable for a four-year period
commencing on July 30, 2008, and expiring on September 27, 2012, at a price of
$0.50 per share. The September Warrant may be redeemed at our option at a
redemption price of $0.01 upon the earlier of (i) September 27, 2010, and (ii)
the date our common stock has traded on The Over the Counter Bulletin Board at
or above $1.00 per share for 20 consecutive trading days.
In
addition, on June 27, 2007, we completed a private placement offering of
convertible debt and associated warrants in which we issued and sold to certain
investors an aggregate of 3 units of our securities, each unit consisting of (i)
a $50,000 Principal Amount of 10% Secured Convertible Promissory Note and (ii)
warrants to purchase 100,000 shares of our common stock. The notes
and accrued but unpaid interest thereon converted at $0.15 per share on June 27,
2008 into an aggregate of 1,100,000 shares of our common stock. The
warrants are exercisable for a four year period commencing on June 27, 2008, and
expiring on June 26, 2012, at a price of $0.50 per share. On August
8, 2007, we issued and sold a $100,000 principal amount secured promissory note
bearing interest at a rate of 10% per annum and a warrant to purchase 200,000
shares of our common stock to an “accredited investor,” as defined in
regulations promulgated under the Securities Act. The promissory note
and accrued but unpaid interest thereon converted on August 8, 2008 at a
conversion price of $0.096274883 per share, which is equal to a 20% discount to
the average volume, weighted average price of our common stock for the ten
trading days prior to issuance, into 1,142,562 shares of our common
stock. The warrant is exercisable for a four-year period commencing
on August 8, 2008, and expiring on August 7, 2012, at a price of $0.50 per
share.
Fiscal
2008
During
the year ended September 30, 2008, we sold an aggregate of thirty-six units at a
price of $100,000 per unit for sale to “accredited investors,” as defined in
regulations promulgated under the Securities Act, for aggregate gross proceeds
of $3,600,000. Each unit consists of (i) a $100,000 Principal Amount
10% Secured Convertible Promissory Note and (ii) a warrant to purchase 200,000
shares of our common stock. The promissory notes and accrued but
unpaid interest thereon automatically convert one year after issuance at a
conversion price equal to a discount to the average volume, weighted average
price of our common stock for the ten trading days prior to issuance, and are
convertible into shares of our common stock at the option of the holder at any
time prior to such automatic conversion at a price equal to the greater of (i)
50% of the average price of our common stock for the ten trading days prior to
the date of the notice of conversion and (ii) the automatic conversion
price. In addition, any time prior to conversion, we have the
irrevocable right to repay the unpaid principal and accrued but unpaid interest
under the notes on three days notice. The promissory notes bear
interest at the rate of 10% per annum and are due and payable in full on the one
year anniversary of their issuance. The warrants are exercisable for
cash or on a cashless basis for a period of four years commencing one year after
issuance at a price of $0.50 per share. Each warrant may be redeemed
at our option at a redemption price of $0.01 upon the earlier of (i) three years
after the issuance, and (ii) the date our common stock has traded on The Over
the Counter Bulletin Board at or above $1.00 per share for 20 consecutive
trading days.
Fiscal
2009
On
October 21, 2008, we issued and sold to James A. Hayward a $500,000 principal
amount secured promissory note (“October Note”) bearing interest at a rate of
10% per annum and a warrant (“October Warrant”) to purchase 1,000,000 shares of
our common stock. The October Note and accrued but unpaid interest
thereon is convertible into shares of our common stock at a price of $0.50 per
share by the holder at any time from October 21, 2008, through October 20,
2009, and shall automatically convert on October 21, 2009 at a conversion price
of $0.026171520 per share, which is equal to a 30% discount to the average
volume, weighted average price of our common stock for the ten trading days
prior to issuance. At any time prior to conversion, we have the right
to prepay the October Note and accrued but unpaid interest thereon upon 3 days
prior written notice (during which period the holder can elect to convert the
note). The October Warrant is exercisable for a four-year period commencing on
October 21, 2009, and expiring on October 20, 2013, at a price of $0.50 per
share. The October Warrant may be redeemed at our option at a
redemption price of $0.01 upon the earlier of (i) October 20, 2011, and (ii) the
date our common stock has traded on The Over the Counter Bulletin Board at or
above $1.00 per share for 20 consecutive trading days.
We
presently do not have any available credit, bank financing or other external
sources of liquidity. Due to our brief history and historical operating losses,
our operations have not been a source of liquidity. We will need to obtain
additional capital in order to expand operations and become profitable. We
intend to pursue the building of a re-seller network outside the United States,
and if successful, the re-seller agreements would constitute a source of
liquidity and capital over time. In order to obtain capital, we may need to sell
additional shares of our common stock or borrow funds from private lenders.
There can be no assurance that we will be successful in obtaining additional
funding and execution of re-seller agreements outside the Unites
States.
We
believe we may be required to seek additional capital to sustain or expand our
prototype and sample manufacturing, and sales and marketing activities, and to
otherwise continue our business operations beyond that date. We have
no commitments for any future funding, and may not be able to obtain additional
financing or grants on terms acceptable to us, if at all, in the
future. If we are unable to obtain additional capital this would
restrict our ability to grow and may require us to curtail or discontinue our
business operations. Additionally, while a reduction in our business
operations may prolong our ability to operate, that reduction would harm our
ability to implement our business strategy. If we can obtain any
equity financing, it may involve substantial dilution to our then existing
shareholders.
Additional
investments are being sought, but we cannot guarantee that we will be able to
obtain such investments. Financing transactions may include the issuance of
equity or debt securities, obtaining credit facilities, or other financing
mechanisms. However, the trading price of our common stock and the downturn in
the U.S. stock and debt markets could make it more difficult to obtain financing
through the issuance of equity or debt securities. Even if we are able to raise
the funds required, it is possible that we could incur unexpected costs and
expenses, fail to collect significant amounts owed to us, or experience
unexpected cash requirements that would force us to seek alternative financing.
Further, if we issue additional equity or debt securities, stockholders may
experience additional dilution or the new equity securities may have rights,
preferences or privileges senior to those of existing holders of our common
stock. If additional financing is not available or is not available on
acceptable terms, we will have to curtail our operations.
Substantially
all of the real property used in our business is leased under operating lease
agreements.
Product
Research and Development
We
anticipate spending approximately $150,000 for product research and development
activities during the next twelve months.
Acquisition
of Plant and Equipment and Other Assets
We do not
anticipate the sale of any material property, plant or equipment during the next
12 months. We do anticipate spending approximately $30,000 on the
acquisition of leasehold improvements during the next 12 months. We
believe our current leased space is adequate to manage our growth, if any, over
the next 2 to 3 years.
Number
of Employees
We
currently have 13 full-time employees and two part-time employees,
including two in management, nine in operations, three in sales and marketing
and one in investor relations. The company expects to increase its
staffing dedicated to sales, product prototyping, manufacturing of DNA markers
and forensic authentication services. Expenses related to travel,
marketing, salaries, and general overhead will be increased as necessary to
support our growth in revenue. In order for us to attract and retain
quality personnel, we anticipate we will have to offer competitive salaries to
future employees. We anticipate that it may become desirable to add
additional full and or part time employees to discharge certain critical
functions during the next 12 months. This projected increase in
personnel is dependent upon our ability to generate revenues and obtain sources
of financing. There is no guarantee that we will be successful in
raising the funds required or generating revenues sufficient to fund the
projected increase in the number of employees. As we continue to
expand, we will incur additional costs for personnel.
Off-Balance
Sheet Arrangements
We do not
have any off-balance sheet arrangements.
Inflation
The
effect of inflation on the Company's revenue and operating results was not
significant.
Going
Concern
The
financial statements included in this filing have been prepared in conformity
with generally accepted accounting principles that contemplate our continuance
as a going concern. Our auditors, in their report dated
December 15, 2008, have expressed substantial doubt about our ability
to continue as going concern. Our cash position may be inadequate to pay all of
the costs associated with the testing, production and marketing of our products.
Management intends to use borrowings and the sale of equity or convertible debt
to mitigate the effects of its cash position, however no assurance can be given
that debt or equity financing, if and when required will be available. The
financial statements do not include any adjustments relating to the
recoverability and classification of recorded assets and classification of
liabilities that might be necessary should we be unable to continue
existence.
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
The
Company is a smaller reporting company as defined by Rule 12b-2 under the
Exchange Act and is not required to provide the information required under this
item.
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
See pages
F-1 through F-34 following the Exhibits List.
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE.
Not
applicable.
ITEM
9A. CONTROLS AND PROCEDURES.
Not
applicable.
ITEM 9A(T). CONTROLS AND
PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures, as defined in Rule 13a-15(e)
promulgated under the Exchange Act that are designed to ensure that information
required to be disclosed by us in the reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SEC’s rules and forms and that such information is
accumulated and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer, as appropriate to allow timely decisions
regarding required disclosure. We carried out an evaluation, under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures as of September
30, 2008. Based on the evaluation of these disclosure controls and
procedures, and in light of the material weaknesses found in our internal
controls, the Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures were not effective.
Management
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting. Under the supervision of our Chief Executive
Officer, the Company conducted an evaluation of the effectiveness of our
internal control over financial reporting as of September 30, 2008 using the
criteria established in Internal Control—Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
(COSO).
A
material weakness is a deficiency, or combination of deficiencies, in internal
control over financial reporting, such that there is a reasonable possibility
that a material misstatement of our annual or interim financial statements will
not be prevented or detected on a timely basis. In its assessment of the
effectiveness of internal control over financial reporting as of September 30,
2008, we determined that control deficiencies existed that constituted material
weaknesses, as described below:
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lack
of documented policies and procedures;
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we
have no audit committee;
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there
is a risk of management override given that our officers have a high
degree of involvement in our day to day operations.
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there
is no policy on fraud and no code of ethics at this time, though we plan
to implement such policies in fiscal 2009; and
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there
is no effective separation of duties, which includes monitoring controls,
between the members of management.
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Management
is currently evaluating what steps can be taken in order to address these
material weaknesses.
Accordingly,
we concluded that these control deficiencies resulted in a reasonable
possibility that a material misstatement of the annual or interim financial
statements will not be prevented or detected on a timely basis by the company’s
internal controls.
As a
result of the material weaknesses described above, management has concluded that
the Company did not maintain effective internal control over financial reporting
as of September 30, 2008 based on criteria established in Internal
Control—Integrated Framework issued by COSO.
RBSM LLP,
an independent registered public accounting firm, was not required to and has
not issued a report concerning the effectiveness of our internal control over
financial reporting as of September 30, 2008.
Changes
in Internal Controls
During
the fiscal quarter ended September 30, 2008, there were no changes in our
internal control over financial reporting that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
ITEM
9B. OTHER INFORMATION.
Not
applicable.
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The
following is a list of our directors, executive officers and significant
employees.
Name
|
Age
|
Title
|
Board of
Directors
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James
A. Hayward
|
55
|
Chief
Executive Officer,
President,
and
Chairman
of the Board
|
Director
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Sanford
R. Simon
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65
|
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Director
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Yacov
Shamash
|
58
|
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Director
|
Kurt
Jensen
|
51
|
Chief
Financial Officer
|
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Ming-Hwa
Benjamin Liang
|
45
|
Secretary
and Strategic Technology Development Officer
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Directors
are elected to serve until the next annual meeting of stockholders and until
their successors are elected and qualified. Currently there are three seats on
our board of directors.
Currently,
the members of our board of directors do not receive any fees for being a
director or attending meetings. Our directors are reimbursed for out-of-pocket
expenses relating to attendance at meetings. Officers are elected by the Board
of Directors and serve until their successors are appointed by the Board of
Directors. Biographical resumes of each officer and director are set forth
below.
Chief
Executive Officer – James A. Hayward
Dr. James
A. Hayward has been our Chief Executive Officer since March 17, 2006 and our
President and the Chairman of the Board of Directors since June 12,
2007. He was previously our acting Chief Executive Officer since
October 5, 2005. Since June 2004, Dr. Hayward has been the Chairman
of Evotope Biosciences, Inc., a drug development company based in Stony Brook,
New York. Since 2001, Dr. Hayward has been a director of Q-RNA, Inc.,
a biotech company based in New York, New York. Since 2000, Dr.
Hayward has been a General Partner of Double D Venture Fund, a venture capital
firm based in New York, New York. Between 1990 and July 2004, Dr.
Hayward was the Chairman, President and CEO of The Collaborative Group, Ltd., a
provider of products and services to the biotechnology, pharmaceutical and
consumer-product industries based in Stony Brook, New York. Dr.
Hayward received his bachelor’s degree in Biology and Chemistry from the State
University of New York at Oneonta in 1976, his Ph.D. in Molecular Biology from
the State University of New York at Stony Brook in 1983, and an honorary Doctor
of Science from Stony Brook in 2000. Dr. Hayward has served on the
boards of the Council on Biotechnology, the Long Island Association, the Stony
Brook Foundation, The Research Foundation of State University of New York Board
of Directors, the New York Biotechnology Association, the Long Island Life
Sciences Initiative and the Ward Melville Heritage Organization.
Director
– Yacov Shamash
Dr. Yacov
Shamash has been a member of the Board of Directors since March 17,
2006. Dr. Shamash is Vice President of Economic Development at the
State University of New York at Stony Brook. Since 1992, he has been
the Dean of Engineering and Applied Sciences and the Harriman School for
Management and Policy at the University, and Founder of the New
York State Center for Excellence in Wireless Technologies at the
University. Dr. Shamash developed and directed the NSF
Industry/University Cooperative Research Center for the Design of Analog/Digital
Integrated Circuits from 1989 to 1992 and also served as Chairman of the
Electrical and Computer Engineering Department at
Washington State University from 1985 until 1992. Dr.
Shamash also serves on the Board of Directors of Keytronic Corp., Netsmart
Technologies, Inc., American Medical Alert Corp., and Softheon
Corp.
Director
– Sanford R. Simon
Dr.
Sanford R. Simon has been a member of the Board of Directors since March 17,
2006. Dr. Simon has been a Professor of Biochemistry, Cell Biology
and Pathology at Stony Brook since 1997. He joined the faculty at
Stony Brook as an Assistant Professor in 1969 and was promoted to Associate
Professor with tenure in 1975. Dr. Simon was a member of the Board of
Directors of The Collaborative Group from 1995 to 2004. From 1967 to
1969 Dr. Simon was a Guest Investigator at
Rockefeller University. Dr. Simon received a B.A. in Zoology and
Chemistry from Columbia University in 1963, a Ph.D. in Biochemistry from
Rockefeller University in 1967, and studied as a postdoctoral fellow with
Nobel Prize winner Max Perutz in Cambridge, England.
Chief
Financial Officer – Kurt Jensen
Kurt H.
Jensen, M.Sc.(Cand. Merc.) has been our Chief Financial Officer since
December 21, 2007, taking over the position from Dr. Hayward. Mr.
Jensen has been our Controller since February 2006. Prior to that
date, for a period of more than 23 years, he was employed by Point of Woods
Homes, Inc. Mr. Jensen was awarded a M.Sc. in Economics and Business
Administration from the Copenhagen Business School in
1983.
Secretary
and Strategic Technology Development Officer – Ming-Hwa Benjamin
Liang
Ming-Hwa
Benjamin Liang has been our Secretary and Strategic Technology Development
Officer since October 2005. Between May 1999 and September 2005, Mr.
Liang had been the director of research and development at Biowell Technology
Inc. Mr. Liang received a B.S. in Bio-Agriculture from
Colorado State University in 1989, a M.S. in Horticulture from the
University of Missouri at Columbia in 1991, his Ph.D. in Plant Science from the
University of Missouri at Columbia in 1997 and his LL.M. in Intellectual
Property Law from Shih Hsin University, Taiwan in 2004.
BOARD
MEETINGS AND COMMITTEES
During
the year ended September 30, 2008, the Board of Directors held five board
meetings to conduct business. The Board also approved certain actions
by unanimous written consent.
Compensation
Committee
In June
2008, our Board of Directors created a standing compensation committee. Our
compensation committee is composed of our independent
directors, Dr. Sanford R. Simon and Dr. Yacov Shamash. The
compensation committee reviews and approves salaries and bonuses for all
officers, administers options outstanding under our stock incentive plan,
provides advice and recommendations to the Board regarding directors’
compensation and carries out the responsibilities required by SEC rules.
The compensation committee believes that its processes and oversight
should be directed toward attracting, retaining and motivating employees and
non-employee directors to promote and advance the interests and strategic goals
of the Company. As requested by the compensation committee, the Chief
Executive Officer will provide information and may participate in discussion
regarding compensation for other executive officers. The compensation
committee does not utilize outside compensation consultants but considers other
general industry information and trends if available. The Board of
Directors has not adopted a written charter for the compensation
committee.
Nominating
and Audit Committees
We do not
have a standing nominating or audit committee. As a small public
company, we believe that all of our directors acting together, as opposed to a
subset of them acting by means of a committee, is the most efficient and
effective framework for us to perform the functions otherwise associated with
nominating and audit committees.
Nominating
Committee Functions
Since we
do not have a nominating committee, all of the members of the Board of Directors
participate in the consideration of director nominees. We do not
currently have a written nominating committee charter or similar
document.
Audit
Committee Functions
Since we
do not have an audit committee, the entire Board of Directors acts as the audit
committee. The Board has determined that we do not have an audit
committee financial expert, as that term is defined in Item 407(d)(5)(ii) of
Regulation S-K, serving on the Board of Directors. We have not been
able to identify a suitable candidate for our Board of Directors that would
qualify as an audit committee financial expert. Dr. Hayward does
not meet the definition of an “independent” director set forth in Rule
4200(a)(15) of the Market Place Rules of the Nasdaq Stock Market, which is the
independence standard that we have chosen to report under. We do not
currently have a written audit committee charter or similar
document.
Compliance
with Section 16(A) of the Exchange Act
Since we
are governed under Section 15(d) of the Exchange Act, we are not required to
file reports of executive officers and directors and persons who own more than
10% of a registered class of the Company's equity securities pursuant to Section
16(a) of the Exchange Act.
Code
of Ethics
We have
not yet adopted a Code of Ethics. Our Board of Directors periodically
reviews whether it should adopt a Code of Ethics given the scale and character
of its operations at this time.
ITEM
11. EXECUTIVE COMPENSATION.
Overview
We
currently have three named executive officers, Dr. James A. Hayward, a director,
our Chief Executive Officer, President and Chairman of the Board of Directors,
Mr. Kurt H. Jensen, who was appointed our Chief Financial Officer on December
21, 2007, and Dr. Ming-Hwa Ben Liang, our Chief Technology Officer and
Secretary.
Our Board
of Directors has not adopted or established a formal policy or procedure for
determining the amount of compensation paid to our executive
officers. No pre-established, objective performance goals or metrics
have been used by the Board of Directors in determining the compensation of our
executive officers. Dr. Hayward is involved in the Board's
deliberations regarding executive compensation and provides recommendations with
respect to his and the compensation of Mr. Jensen and Dr. Liang based on, among
other things, our financial and operating performance and prospects and the
contributions made by Mr. Jensen and Dr. Liang to the success of the
Company.
Summary
Compensation Table
The
following table sets forth the compensation of our principal executive officer
and our two other executive officers for the two fiscal years ended September
30, 2008. We refer to these executive officers as our “named
executive officers.”
Name
and Principal
Position
|
|
Year
(b)
|
|
Salary
($)(2)
(c)
|
|
|
Bonus
($)
(d)
|
|
|
Stock
Awards
($)
(e)
|
|
|
Option
Awards
($)(3)
(f)
|
|
|
Non-Equity
Incentive
Plan
Compensation
($)
(g)
|
|
|
Non-qualified
Deferred
Compensation
Earnings
($)
(h)
|
|
|
All
Other
Compensation
($)
(i)
|
|
|
Total
($)
(j)
|
|
James
A. Hayward
Chairman,
President and
|
|
2008
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,666,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,666,000 |
|
Chief Executive
Officer
|
|
2007
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kurt
H. Jensen
|
|
2008
|
|
|
135,871 |
|
|
|
— |
|
|
|
— |
|
|
|
490,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
625,871 |
|
Chief
Financial Officer
|
|
2007
|
|
|
108,077 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
108,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ming-Hwa
Liang
Chief
Technology Officer
|
|
2008
|
|
|
123,382 |
|
|
|
— |
|
|
|
— |
|
|
|
686,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
809,382 |
|
and
Secretary
|
|
2007
|
|
|
103,027 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
103,027 |
|
(1) We
have no employment agreements with our named executive officers.
(2) Dr.
Hayward has elected not to receive cash compensation until there is an
improvement in the Company’s financial and operating performance and
prospects.
(3) The
amounts in column (f) represent the grant date fair value under SFAS 123R based
on the average of the bid and asked prices of our common stock on the grant
date. The grant date for the stock options was June 17, 2008, and the
average of the bid and asked prices of our common stock was
$0.11. The grant date fair value for the stock options was
$0.098. The options granted to the named executive officers vested
with respect to 25% of the underlying shares on the date of grant, and the
remaining will vest ratably each anniversary thereafter until fully vested on
the third anniversary of the date of grant. The exercise of the stock
options by the named executive officers is subject to stockholder approval of
the share increase amendment by the Company’s stockholders at the 2008 annual
meeting of stockholders.
Outstanding
Equity Awards at Fiscal Year-End
The
following table shows information concerning outstanding equity awards as of
September 30, 2008 held by the Named Executive Officers.
|
|
Option
Awards
|
|
Stock
Awards
|
|
Name
|
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
(1)
(b)
|
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
(1)
(c)
|
|
Equity
Incentive
Plan
Awards:
Number
of
Securities
Underlying
Unexercised
Unearned
Options
(#)
(d)
|
|
Option
Exercise
Price
($)
(1)
(e)
|
|
Option
Expiration
Date
(1)
(f)
|
|
Number
of Shares
or
Units
of
Stock
That Have
Not
Vested
(#)
(g)
|
|
Market
Value of
Shares
or
Units
of
Stock
That
Have
Not
Vested
($)
(h)
|
|
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
(#)
(i)
|
|
Equity
Incentive
Plan
Awards:
Market
or
Payout
Value
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
($)
(j)
|
|
James
A. Hayward
|
|
|
0 |
|
|
17,000,000 |
|
|
|
$ |
0.11 |
|
6/17/2013
|
|
—
|
|
— |
|
— |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kurt
H. Jensen
|
|
|
500,000 |
|
|
0 |
|
|
|
$ |
0.09 |
|
9/01/2011
|
|
—
|
|
— |
|
— |
|
— |
|
|
|
|
0 |
|
|
5,000,000 |
|
|
|
$ |
0.11 |
|
6/17/2013
|
|
—
|
|
— |
|
— |
|
— |
|
Ming-Hwa
Liang
|
|
|
0 |
|
|
7,000,000 |
|
|
|
$ |
0.11 |
|
6/17/2013
|
|
—
|
|
— |
|
— |
|
— |
|
(1) On
June 17, 2008, the Board of Directors of the Company granted nonstatutory stock
options under the 2005 Incentive Stock Plan to certain key employees, including
our named executive officers. The options granted to the named
executive officers vested with respect to 25% of the underlying shares on the
date of grant, and the remaining will vest ratably each anniversary thereafter
until fully vested on the third anniversary of the date of grant. The
exercise of the stock options by the named executive officers is subject to
stockholder approval of the share increase amendment by the Company’s
stockholders at the 2008 annual meeting of stockholders.
Pension
Benefits
None of
our named executive officers participates in or has account balances in
qualified or non-qualified defined benefit plans sponsored by us.
Nonqualified
Contribution Plans
None of
our named executive officers participate in or have account balances in
non-qualified defined contribution plans maintained by us.
Deferred
Compensation
None of
our named executive officers participates in or has account balances in deferred
compensation plans or arrangements maintained by us.
Employment
Agreements
We have
no employment agreements with our named executive officers.
Payment
of Post-Termination Compensation
We do not
have change-in-control agreements with any of our executive officers, and we are
not obligated to pay severance or other enhanced benefits to executive officers
upon termination of their employment.
Director
Compensation Table for Fiscal 2008
We
currently have no policy in effect for providing compensation to our directors
for their services on our Board of Directors. During the year ended
September 30, 2008, we did not provide any cash compensation to our directors
for their service on our Board of Directors.
The
following table sets forth summary information concerning compensation paid or
accrued to the members of our Board of Directors (other than Dr. Hayward,
our Chief Executive Officer, who is a named executive officer) for services
rendered to us in all capacities for the fiscal year ended September 30,
2008.
|
Fees
Earned or
Paid
in Cash ($)
|
|
Stock
Awards ($)
|
|
Option
Awards ($)(1)
|
|
All
Other Compensation ($)
|
|
Total
($)
|
|
Yacov
Shamash
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
49,000 |
|
|
$ |
— |
|
|
$ |
49,000 |
|
Sanford
R. Simon
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
49,000 |
|
|
$ |
— |
|
|
$ |
49,000 |
|
(1) The
amount reported in column (l) represents the grant date fair value under SFAS
123R based on the average of the bid and asked prices of our common stock on the
grant date. The grant date for the stock options was June 17, 2008,
and the average of the bid and asked prices of our common stock was
$0.11. The grant date fair value for the stock options was
$0.098.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS.
The
following table sets forth certain information regarding the shares of our
common stock beneficially owned as of December 15, 2008, (i) by each of the
executive officers named in the table under “Executive Compensation” and each of
our directors, and (ii) by all officers and directors as a group
NAME
AND ADDRESS OF
BENEFICIAL
OWNER
|
TITLE
OF
CLASS
|
|
NUMBER
OF
SHARES
OWNED
(1)(2)
|
|
PERCENTAGE
OF
CLASS (3)
|
|
|
|
|
|
|
James
A. Hayward
25
Health Sciences Drive, Suite 113
Stony
Brook, New York 11790
|
Common
Stock
|
|
|
20,439,840
|
(4)
|
8.48%
|
|
|
|
|
|
|
|
Yacov
Shamash
25
Health Sciences Drive, Suite 113
Stony
Brook, New York 11790
|
Common
Stock
|
|
|
250,000
|
(5)
|
*
|
|
|
|
|
|
|
|
Kurt
Jensen
25
Health Sciences Drive, Suite 113
Stony
Brook, New York 11790
|
Common
Stock
|
|
|
580,000
|
(6)
|
*
|
|
|
|
|
|
|
|
Ben
Liang
25
Health Sciences Drive, Suite 113
Stony
Brook, New York 11790
|
Common
Stock
|
|
|
373,650
|
(7)
|
*
|
|
|
|
|
|
|
|
Sanford
R. Simon
25
Health Sciences Drive, Suite 113
Stony
Brook, New York 11790
|
Common
Stock
|
|
|
250,000
|
(5)
|
*
|
|
|
|
|
|
|
|
All
directors and officers as a group (5 persons)
|
Common
Stock
|
|
|
21,893,490
|
(8)
|
9.04%
|
|
|
|
|
|
|
|
*
indicates less than one percent
|
|
|
|
|
|
|
(1)
|
Beneficial
ownership is determined in accordance with the rules of the SEC and
generally includes voting or investment power with respect to the shares
shown. Except as indicated by footnote and subject to community property
laws where applicable, to our knowledge, the stockholders named in the
table have sole voting and investment power with respect to all common
stock shares shown as beneficially owned by them. A person is deemed to be
the beneficial owner of securities that can be acquired by such person
within 60 days upon the exercise of options, warrants or convertible
securities (in any case, the "Currently Exercisable Options"). Each
beneficial owner's percentage ownership is determined by assuming that the
Currently Exercisable Options that are held by such person (but not those
held by any other person) have been exercised and
converted.
|
(2)
|
Does
not include shares subject to options granted on June 17, 2008 pursuant to
the 2005 Incentive Stock Plan, which vested with respect to 25% of the
underlying shares on the date of grant and will vest with respect to the
remaining shares ratably on each anniversary thereafter until fully vested
on the third anniversary of the date of grant, including 17,000,000 to
James A. Hayward, 500,000 to Yacov Shamash, 5,000,000 to Kurt H. Jensen,
7,000,000 to Ben Liang and 500,000 to Sanford R. Simon. The
exercise of the stock options is subject to approval by our stockholders
at the 2008 annual meeting of stockholders of an amendment to the 2005
Incentive Stock Plan that will increase the total number of shares of
common stock issuable thereunder and limit the number of shares that can
be covered by awards made to any participant in any calendar
year.
|
(3)
|
Based
upon 231,870,731 shares of common stock outstanding as of
December 15, 2008.
|
(4)
|
Includes
9,200,000 shares underlying currently exercisable warrants.
|
(5)
|
Includes
250,000 shares underlying a currently exercisable
warrant.
|
(6)
|
Includes
40,000 shares held by a spouse and 500,000 immediately exercisable
options.
|
(7)
|
Includes
275,392 shares held by spouse.
|
(8)
|
Includes
10,200,000 shares underlying currently exercisable options and
warrants.
|
|
|
Equity
Compensation Plan Information
2002
Professional/Employee/Consultant Compensation Plan.
In
November of 2002, we created a special compensation plan to pay the founders,
consultants and professionals that had been contributing valuable services to us
during the previous nine months. This plan, under which 2,000,000
shares of our common stock were reserved for issuance, is called the
Professional/Employee/Consultant Compensation Plan (the “Compensation
Plan”). Share and option issuances from the Compensation Plan were to
be staggered over the following six to eight months, and consultants that were
to continue providing services thereafter either became employees or received
renewed contracts from us in July of 2003, which contracts contained a more
traditional cash compensation component. Each qualified and eligible
recipient of shares and/or options under the Compensation Plan received
securities in lieu of cash payment for services. Each recipient agreed, in his
or her respective consulting contract with us, to sell a limited number of
shares monthly. In December of 2004, we adjusted the exercise price
of options under the Compensation Plan to $0.60 per share. As of September
30, 2007, a total of 1,440,000 shares have been issued from, and options to
purchase 560,000 shares have been issued under the Compensation Plan, and
options to purchase 264,000 shares have been exercised as of that
date.
2005
Incentive Stock Plan.
On
January 26, 2005, the Board of Directors, and on February 15, 2005, the holders
of a majority of the outstanding common stock of the Company approved the 2005
Incentive Stock Plan and authorized the issuance of 16,000,000 shares of common
stock as stock awards and stock options thereunder. On May 16, 2007,
at the annual meeting of stockholders, the holders of a majority of the
outstanding common stock of the Company approved an increase in the number of
shares subject to the 2005 Incentive Stock Plan to 20,000,000 shares of common
stock. On June 17, 2008, the Board of Directors unanimously adopted
an amendment to the 2005 Incentive Stock Plan that will increase the total
number of shares of common stock issuable pursuant to the 2005 Incentive Stock
Plan from a total of 20,000,000 shares to a total of 100,000,000 shares, which
is subject to approval by our stockholders at the 2008 annual meeting of
stockholders.
The 2005
Incentive Stock Plan is designed to retain directors, executives, and selected
employees and consultants by rewarding them for making contributions to our
success with an award of shares of our common stock. As of November
10, 2008, a total of 8,550,000 shares have been issued and options to purchase
42,410,000 shares have been granted under the 2005 Incentive Stock
Plan.
The Board
of Directors, in their discretion, may award stock and stock options to
executive officers and key employees as part of their compensation for
employment or for retention purposes.
The
following table sets forth certain information regarding our compensation plans
as of September 30, 2008:
Plan
Category
|
|
Number
of Securities
to
be Issued Upon
Exercise
of
Outstanding
Options, Warrants and Rights
|
|
|
Weighted-Average
Exercise
Price of
Outstanding
Options, Warrants and Rights
|
|
|
Number
of Securities Remaining Available for Future Issuance Under Equity
Compensation Plans (Excluding Securities Reflected in Column
(a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional/Consultant/
Employee Stock and Stock Option Compensation Plan approved in November
2002
|
|
|
296,000 |
|
|
$ |
0.60 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
Incentive Stock Plan approved on January 26, 2005
|
|
|
42,410,000 |
|
|
$ |
0.16 |
|
|
|
5,790,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,706,000 |
|
|
$ |
0.59 |
|
|
|
5,790,000 |
|
Amendment to the 2005 Incentive
Stock Plan and Recent Equity Award Grants. On June 17, 2008,
the Board of Directors adopted an amendment to the 2005 Incentive Stock Plan
that will increase the total number of shares of common stock issuable pursuant
to the 2005 Incentive Stock Plan from a total of 20,000,000 shares to a total of
100,000,000 shares, which is subject to approval by our stockholders at the 2008
annual meeting of stockholders. In connection with the share increase
amendment, the Board of Directors granted options to purchase a total of
37,750,000 shares to certain key employees and non-employee directors under the
2005 Incentive Stock Plan, including 17,000,000, 5,000,000 and 7,000,000 to
James A. Hayward, Kurt H. Jensen and Ming-Hwa Liang,
respectively. The options granted to our key employees and
non-employee directors vested with respect to 25% of the underlying shares on
the date of grant and the remaining will vest ratably each anniversary
thereafter until fully vested on the third anniversary of the date of
grant.
The
effectiveness of the share increase amendment and the exercise of these stock
options by the key employees and non-employee directors are subject to approval
by our stockholders at the 2008 annual meeting of stockholders.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
On
October 21, 2008, we issued and sold to James A. Hayward a $500,000 principal
amount secured promissory note (“October Note”) bearing interest at a rate of
10% per annum and a warrant (“October Warrant”) to purchase 1,000,000 shares of
our common stock. The October Note and accrued but unpaid interest
thereon is convertible into shares of our common stock at a price of $0.50 per
share by the holder at any time from October 21, 2008, through October 20,
2009, and shall automatically convert on October 21, 2009 at a conversion price
of $0.026171520 per share, which is equal to a 30% discount to the average
volume, weighted average price of our common stock for the ten trading days
prior to issuance. At any time prior to conversion, we have the right
to prepay the October Note and accrued but unpaid interest thereon upon 3 days
prior written notice (during which period the holder can elect to convert the
note). The October Warrant is exercisable for a four-year period commencing on
October 21, 2009, and expiring on October 20, 2013, at a price of $0.50 per
share. The October Warrant may be redeemed at our option at a
redemption price of $0.01 upon the earlier of (i) October 20, 2011, and (ii) the
date our common stock has traded on The Over the Counter Bulletin Board at or
above $1.00 per share for 20 consecutive trading days.
Until the
principal and interest under the October Note is paid in full, or converted into
our common stock, the October Note will be secured by a security interest in all
of our assets.
We have
no policy regarding entering into transactions with affiliated
parties.
Director
Independence
Although our securities are not
currently listed on a national securities exchange or in an inter-dealer
quotation system, which would subject us to the listing standards pertaining to
director independence, the Board of Directors has determined that currently and
at all times during the year ended September 30, 2008, Drs. Shamash and
Simon, representing two of our three directors, are “independent” as defined by
the listing standards of the Nasdaq Stock Market, constituting a majority of
independent directors of our Board of Directors as required by the rules of the
Nasdaq Stock Market. The Board of Directors considers in its
evaluation of independence whether any director has a relationship with us that
could interfere with the exercise of independent judgment in carrying out his
responsibilities of a director.
The information set forth under “Item
18. Directors, Executive Officers and Corporate Governance–Board
Meetings and Committees” is incorporated herein by reference.
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
The
following table sets forth fees billed to us by our auditors during the fiscal
years ended September 30, 2008 and 2007 for: (i) services rendered for the audit
of our annual financial statements and the review of our quarterly financial
statements, (ii) services by our auditor that are reasonably related to the
performance of the audit or review of our financial statements and that are not
reported as Audit Fees, (iii) services rendered in connection with tax
compliance, tax advice and tax planning, and (iv) all other fees for services
rendered.
|
|
|
September
30, 2008
|
|
|
September
30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(i) |
Audit
Fees
|
|
$ |
157,516 |
|
|
$ |
66,921 |
|
|
|
|
|
|
|
|
|
|
|
(ii) |
Audit
Related Fees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(iii) |
Tax
Fees
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
(iv) |
All
Other Fees
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
157,516 |
|
|
$ |
66,921 |
|
Audit
Fees
Consists
of fees billed for professional services rendered for the audit of the Company’s
consolidated financial statements and review of the interim consolidated
financial statements included in quarterly reports and services that are
normally provided by RBSM LLP in connection with statutory and regulatory
filings or engagements.
Audit
Related Fees
Consists
of fees billed for assurance and related services that are reasonably related to
the performance of the audit or review of our consolidated financial statements
and are not reported under "Audit Fees." These services consist of
responding to SEC comments and the review of and consent to registration
statements.
Tax
Fees
Consists
of fees billed for professional services for tax compliance, tax advice and tax
planning.
All
Other Fees
Consists
of fees for products and services other than the services reported above. There
were no management consulting services provided in fiscal 2008 or
2007.
The Board
of Directors has considered whether the provision of non-audit services is
compatible with maintaining the principal accountant's
independence.
Policy
on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of
Independent Auditors
We
currently do not have a designated Audit Committee, and accordingly, the policy
of our Board of Directors is to pre-approve all audit and permissible non-audit
services provided by the independent auditors. These services may
include audit services, audit-related services, tax services and other
services. Pre-approval is generally provided for up to one year and
any pre-approval is detailed as to the particular service or category of
services and is generally subject to a specific budget. The
independent auditors and management are required to periodically report to our
Board of Directors regarding the extent of services provided by the independent
auditors in accordance with this pre-approval, and the fees for the services
performed to date. Our Board of Directors may also pre-approve
particular services on a case-by-case basis.
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a) We
have filed the following documents as part of this Form 10-K:
1.
Consolidated Financial Statements
Our
consolidated financial statements at September 30, 2008 and 2007, and for the
years ended September 30, 2008 and 2007, and the notes thereto, together with
the report of our independent registered public accounting firm on those
consolidated financial statements, are hereby filed as part of this report
beginning on page F-1.
2.
Financial Statement Schedule
All
financial statement schedules have been omitted since the required information
is not applicable or is not present in amounts sufficient to require submission
of the schedule, or because the information required is included in the
consolidated financial statements and notes thereto.
3.
Exhibits.
The
information required by this item is set forth on the exhibit index that follows
the signature page of this report.
SIGNATURES.
In
accordance with the requirements of the Exchange Act, the registrant caused this
report to be signed on its behalf by the undersigned, thereunto duly
authorized.
|
APPLIED DNA SCIENCES, INC.
|
|
|
|
|
Date:
December 16, 2008
|
/s/JAMES A.
HAYWARD
|
|
|
James
A. Hayward
|
|
|
Chief
Executive Officer
|
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
|
|
|
|
|
|
|
|
|
|
/s/
JAMES
A. HAYWARD
|
|
Chief
Executive Officer (Principal Executive
Officer),
|
|
December 16,
2008
|
James
A. Hayward
|
|
President,
Chairman of the Board of Directors and Director |
|
|
|
|
|
|
/s/
KURT
H. JENSEN
|
|
Chief
Financial Officer (Principal Financial Officer
and
|
|
December 16,
2008
|
Kurt
H. Jensen
|
|
Principal Accounting
Officer) |
|
|
|
|
|
|
|
/s/
YACOV
SHAMASH
|
|
Director
|
|
December 16,
2008
|
Yacov
Shamash
|
|
|
|
|
|
|
|
|
|
/s/
SANFORD
R. SIMON
|
|
Director
|
|
December 16,
2008
|
Sanford
R. Simon
|
|
|
|
|
Exhibit
|
Description
|
|
|
2.1
|
Articles
of Merger of Foreign and Domestic Corporations, filed December 19, 1998
with the Nevada Secretary of State, filed as an exhibit to the annual
report on Form 10-KSB filed with the Commission on December 29, 2003 and
incorporated herein by reference.
|
|
|
3.1
|
Articles
of Incorporation of DCC Acquisition Corporation, filed April 20, 1998 with
the Nevada Secretary of State, filed as an exhibit to the annual report on
Form 10-KSB filed with the Commission on December 29, 2003 and
incorporated herein by reference.
|
|
|
3.2
|
Articles
of Amendment of Articles of Incorporation of DCC Acquisition Corp.
changing corporation name to ProHealth Medical Technologies,
Inc.
|
|
|
3.3
|
Certificate
of Designations, Powers, preferences and Rights of the Founders' Series of
Convertible Preferred Stock, filed as an exhibit to the annual report on
Form 10-KSB filed with the Commission on December 29, 2003 and
incorporated herein by reference.
|
|
|
3.4
|
Articles
of Amendment of Articles of Incorporation of Applied DNA Sciences, Inc.
increasing the par value of the company's common stock, filed on December
3, 2003 with the Nevada Secretary of State, filed as an exhibit to the
annual report on Form 10-KSB filed with the Commission on December 29,
2003 and incorporated herein by reference.
|
|
|
3.5
|
Articles
of Amendment of Articles of Incorporation of Applied DNA Sciences, Inc.
increasing the number of authorized shares of the company's common stock,
filed on March 3, 2005 with the Nevada Secretary of State, filed as an
exhibit to the registration statement on Form SB-2 on Form S-1 filed with
the Commission on April 21, 2008 and incorporated herein by
reference.
|
|
|
3.6
|
Articles
of Amendment of Articles of Incorporation of Applied DNA Sciences, Inc.
increasing the number of authorized shares of the company's common stock,
filed on May 17, 2007 with the Nevada Secretary of State, filed as an
exhibit to the quarterly report on Form 10-QSB filed with the Commission
on February 15, 2007 and incorporated herein by
reference.
|
|
|
3.7
|
By-Laws
of Applied DNA Sciences, Inc., filed as an exhibit to the annual report on
Form 10-KSB filed with the Commission on December 29, 2003 and
incorporated herein by reference.
|
|
|
4.1
|
Form
of Subscription Agreement, filed as an exhibit to the current report on
Form 8-K filed with the Commission on January 28, 2005 and incorporated
herein by reference.
|
|
|
4.2
|
Form
of 10% Secured Convertible Promissory Note, filed as an exhibit to the
current report on Form 8-K filed with the Commission on January 28, 2005
and incorporated herein by reference.
|
|
|
4.3
|
Form
of Warrant Agreement, filed as an exhibit to the current report on Form
8-K filed with the Commission on January 28, 2005 and incorporated herein
by reference.
|
|
|
4.4
|
Registration
Rights Agreement, dated January 28, 2005, between the Company and Vertical
Capital Partners, Inc., on behalf of the investors, filed as an exhibit to
the current report on Form 8-K filed with the Commission on January 28,
2005 and incorporated herein by reference.
|
|
|
4.5
|
Security
Agreement, dated January 28, 2005, between the Company and Vertical
Capital Partners, Inc., on behalf of the investors, filed as an exhibit to
the current report on Form 8-K filed with the Commission on January 28,
2005 and incorporated herein by reference.
|
|
|
4.6
|
Form
of Subscription Agreement, filed as an exhibit to the current report on
Form 8-K filed with the Commission on October 11, 2007 and incorporated
herein by reference.
|
|
|
4.7
|
Form
of 10% Secured Convertible Promissory Note, filed as an exhibit to the
current report on Form 8-K filed with the Commission on October 11, 2007
and incorporated herein by reference.
|
|
|
4.8
|
Form
of Warrant Agreement, filed as an exhibit to the current report on Form
8-K filed with the Commission on October 11, 2007 and incorporated herein
by reference.
|
|
|
10.1
|
Exclusive
License Agreement between Biowell Technology Corp. and Applied DNA
Sciences, Inc. executed on October 8, 2002, filed as an exhibit to the
registration statement on Form SB-2 filed with the Commission on February
15, 2005 and incorporated herein by reference.
|
|
|
10.2#
|
Technology
Reseller Agreement, dated March 19, 2007 by and between Applied DNA
Sciences and HPT International LLC, filed as an exhibit to the current
report on Form 8-K filed with the Commission on March 23, 2007 and
incorporated herein by reference.
|
10.3#
|
Joint
Development and Marketing Agreement, dated April 18, 2007 by and between
Applied DNA Sciences and International Imaging Materials, Inc., filed as
an exhibit to the current report on Form 8-K filed with the Commission on
April 24, 2007 and incorporated herein by reference.
|
|
|
10.4#
|
Product
Development, Marketing and Distribution Agreement, dated May 8, 2007 by
and between Applied DNA Sciences, Inc. and Champion Thread Company, Inc.,
filed as an exhibit to the current report on Form 8-K filed with the
Commission on May 11, 2007 and incorporated herein by
reference.
|
|
|
10.5#
|
Technology
Reseller Agreement, dated May 30, 2007 by and between Applied DNA
Sciences, Inc. and Printcolor Screen Ltd., filed as an exhibit to the
current report on Form 8-K filed with the Commission on June 1, 2007 and
incorporated herein by reference.
|
|
|
10.6#
|
Feasibility
Study Agreement, dated June 27, 2007 by and between Applied DNA Sciences,
Inc. and Supima, filed as an exhibit to the current report on Form 8-K
filed with the Commission on July 3, 2007 and incorporated herein by
reference.
|
|
|
10.7
|
Settlement
Agreement and General Release of All Claims by and between the Applied DNA
parties and Chanty Cheang, filed as an exhibit to the current report on
Form 8-K filed with the Commission on May 4, 2007 and incorporated herein
by reference.
|
|
|
10.8
|
Amendment
to Engagement Letter, dated December 20, 2007, by and between Applied DNA
Sciences, Inc. and ARjENT Limited, filed as an exhibit to the current
report on Form 8-K filed with the Commission on December 28, 2007 and
incorporated herein by reference.
|
|
|
10.9
|
Form
of Employee Stock Option Agreement under The Applied DNA Sciences, Inc.
2005 Incentive Stock Plan of Applied DNA Sciences, Inc. filed as an
exhibit to the quarterly report on Form 10-QSB filed with the Commission
on August 14, 2008 and incorporated herein by
reference.
|
|
|
10.10
|
Form
of Director Stock Option Agreement under The Applied DNA Sciences, Inc.
2005 Incentive Stock Plan of Applied DNA Sciences, Inc. filed as an
exhibit to the quarterly report on Form 10-QSB filed with the Commission
on August 14, 2008 and incorporated herein by
reference.
|
|
|
21.1
|
List
of subsidiaries of Registrant filed as an exhibit to the registration
statement on Form SB-2 filed with the Commission on January 18, 2006 and
incorporated herein by reference.
|
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
32.2 |
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
# A
request for confidentiality has been filed for certain portions of the indicated
document. Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission as required by Rule 24b-2 promulgated under
the Securities Exchange Act of 1934