QUANTRX BIOMEDICAL CORP - Annual Report: 2008 (Form 10-K)
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 December 31, 2008
OR
o 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: 000-17119
QUANTRX BIOMEDICAL
CORPORATION
(Exact
name of registrant as specified in its charter)
Nevada
(State
or other jurisdiction of incorporation or organization)
|
33-0202574
(IRS
Employer Identification No.)
|
100 South Main Street, Suite
300,
Doylestown, Pennsylvania 18901
(Address
of principal executive offices) (Zip Code)
Registrant's
telephone number, including area code (267)
880-1595
Securities
registered pursuant to Section 12(b) of the Act:
None
Securities
registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 par
value
(Title of
class)
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.
Note –
Checking the box above will not relieve any registrant required to file reports
pursuant to Section 13 or 15(d) of the Exchange Act from their obligations under
those Sections.
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. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o (Do
not check if smaller reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No x
State the
aggregate market value of the voting and non-voting common equity held by
non-affiliates computed by reference to the price at which the common equity was
last sold, or the average bid and asked price of such common equity, as of the
last business day of the registrant's most recently completed second fiscal
quarter (June 30, 2008): $26,139,639
DOCUMENTS
INCORPORATED BY REFERENCE
None
PART
I
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|||||
Item
1.
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Business
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4 | |||
Item
1A.
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Risk
Factors
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15 | |||
Item
1B.
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Unresolved
Staff Comments
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20 | |||
Item
2.
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Properties
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20 | |||
Item
3.
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Legal
Proceedings
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20 | |||
Item
4.
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Submission
of Matters to a Vote of Security Holders
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20 | |||
PART
II
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|||||
Item
5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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21 | |||
Item
6.
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Selected
Financial Data
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23 | |||
Item
7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operation
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23 | |||
Item
7A.
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Quantitative
and Qualitative Disclosures about Market Risk
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29 | |||
Item
8.
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Financial
Statements and Supplementary Data
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29 | |||
Item
9.
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Change
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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29 | |||
Item
9A(T).
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Controls
and Procedures
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30 | |||
Item
9B.
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Other
Information
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31 | |||
PART
III
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|||||
Item
10.
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Directors,
Executive Officers and Corporate Governance
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32 | |||
Item
11.
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Executive
Compensation
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35 | |||
Item
12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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37 | |||
Item
13.
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Certain
Relationships and Related Transactions, and Director
Independence
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39 | |||
Item
14.
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Principal
Accounting Fees and Services
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40 | |||
Item
15.
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Exhibits
and Financial Statement Schedules
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41 | |||
SIGNATURES
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44 |
3
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING INFORMATION
THIS
ANNUAL REPORT ON FORM 10-K, INCLUDING EXHIBITS THERETO, CONTAINS FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
THESE FORWARD-LOOKING STATEMENTS ARE TYPICALLY IDENTIFIED BY THE WORDS
“ANTICIPATES”, “BELIEVES”, “EXPECTS”, “INTENDS”, “FORECASTS”, “PLANS”, “FUTURE”,
“STRATEGY”, OR WORDS OF SIMILAR MEANING. VARIOUS FACTORS COULD CAUSE ACTUAL
RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED IN THE FORWARD-LOOKING
STATEMENTS, INCLUDING THOSE DESCRIBED IN “RISK FACTORS” ON PAGE SEVEN HEREOF.
THE COMPANY ASSUMES NO OBLIGATIONS TO UPDATE THESE FORWARD-LOOKING STATEMENTS TO
REFLECT ACTUAL RESULTS, CHANGES IN ASSUMPTIONS, OR CHANGES IN OTHER FACTORS,
EXCEPT AS REQUIRED BY LAW.
PART
I
As used
in this annual report on Form 10-K, “we,” “us,” “our,” “QuantRx” and “Company”
refer to QuantRx Biomedical Corporation and its subsidiary, unless the context
otherwise requires.
Overview
QuantRx
Biomedical Corporation is a broad-based diagnostics company focused on the
development and commercialization of innovative point-of-care diagnostic
products based on its patented technology platforms for the worldwide healthcare
industry. The Company’s strategy is to commercialize its products through
partners or distributors, maintaining full control over the regulatory
processes, limiting manufacturing to critical technology and contracting the
high volume manufacturing to third party partners.
QuantRx
was incorporated December 5, 1986 under the laws of the state of Nevada. In
April 2007, QuantRx increased its ownership in FluoroPharma, Inc., a
development-stage molecular imaging company, to 57.78% of outstanding capital
stock, resulting in its consolidation effective April 1, 2007. The investment in
FluoroPharma is intended to strategically expand QuantRx’s diagnostic
platforms.
Our
Business
The
Company’s technologies and investments target significant market opportunities
through the following platforms:
Lateral Flow
Diagnostics
|
·
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RapidSense®
point-of-care testing products based on QuantRx core intellectual property
related to lateral flow techniques for the consumer and healthcare
professional markets. QuantRx is also developing a unique, quantitative,
point-of-care optical reader for use with RapidSense to provide economical
and efficient results.
|
4
PAD/Health and
Wellness
|
·
|
PAD
products based on QuantRx technology for aiding the treatment of
hemorrhoids, minor vaginal infection, urinary incontinence, and other
medical needs, including diagnostic sampling products which enable self
collection and worldwide transport.
|
Molecular Imaging (through
FluoroPharma)
|
·
|
Molecular
imaging agents for Positron Emission Tomography (PET) and fluorescence
imaging, with initial application in cardiovascular disease, addressing
significant unmet medical needs by providing clinicians with important
tools for early discovery and
assessment.
|
Genomic Testing (through our affiliate,
Genomics USA)
|
·
|
Single
Nucleotide Polymorphism (SNP) chips; genome-based diagnostic chips for the
laboratory and healthcare professional
markets.
|
Diagnostic
and therapeutic products constitute the core of the QuantRx short-term product
development focus and should provide near-term revenue opportunities beginning
in 2009. Molecular imaging agents constitute long-term revenue opportunities
either through commercialization or through investment by a strategic
partner.
These
healthcare technologies are in different stages of development ranging from
commercialization to proof of concept. The Company plans to bring all products
to commercialization when economically feasible with manufacturing control
maintained by QuantRx and sales and marketing managed through distributors, OEM,
or strategic partners where appropriate. When not economically feasible, the
Company will pursue investment from strategic partners. The Company’s goal is to
maintain cost and technical leadership through the entire process, when
applicable.
Product
and Product Candidates
QuantRx
operates under a two-fold product development strategy: (1) Maximization of the
value of internally developed products that are market-ready for near-term
distribution, and (2) Aggressive development of technology platforms for
products that QuantRx believes will address medical diagnostic and treatment
issues into the future.
In order
to capitalize on short-term revenue opportunities, QuantRx – in introducing its
lateral flow diagnostic devices, PAD product lines and other products – looks to
align itself with experienced marketing partners that have established
distribution channels. QuantRx teams with a manufacturing partner in Asia, as
well as niche United States manufacturers, in order to bring products to market
in an efficient manner while controlling product
quality.
FluoroPharma,
Inc., a private company in which QuantRx has a majority ownership interest, is
engaged in clinical trials in the development of next-generation imaging agents
for PET diagnostics with initial indications for cardiovascular disease.
Genomics USA, Inc., another company in which QuantRx has invested, is working
toward completion of its HLA – human leukocyte antigen – chip technology for
vaccine validity testing and initiation of field tests with the United States
Department of Homeland Security.
5
The
QuantRx internal development efforts are in parallel with the Company’s
investigation of technologies and products for acquisition or licensing to help
the Company expand and enhance its current platforms and succeed in its mission
to be a market leader in medical diagnostic platforms and products for
professionals, industry and consumers.
Lateral
Flow Diagnostics
QuantRx
has developed a patented RapidSense technology – a one-step lateral flow test
with unique features such as: positive read indication for drugs-of-abuse,
improved sensitivity, and the ability to read both large and small molecules.
The rapid, disposable, and point-of-care diagnostic technology is ideal for
collection of either urine or oral fluids. QuantRx also has patented an
innovative oral fluid collection device specifically designed for its RapidSense
technology. This distinctive collection device has applications in the growing
market of oral sample collections for issues ranging from drug-abuse testing,
gathering biological evidence for criminal investigation, and screening for
numerous communicable diseases including HIV/AIDS and other STDs.
The
QuantRx device incorporates a removable barrier that prevents test chemicals
from washing into the oral cavity during the collection process, and allows the
controlled start of the test or tests within the device. Because the QuantRx
device is designed for either single or multiple tests using the same sample, it
is ideal for emerging drugs-of-abuse analyses and testing for a range of
communicable diseases. The patented technology has a feature that provides a
more secure "chain of custody" system, helping to ensure the identity and
integrity of a specimen from collection through the reporting of test
results.
In late
2008, the Company commenced joint development of a unique, quantitative,
point-of-care optical reader to be used with its RapidSense technology. This
technology, when coupled with RapidSense, would allow for the transfer of key
laboratory tests to be performed at the point-of-care and would provide
economical and efficient laboratory quality results.
In
October 2007, the United States Food and Drug Administration (FDA) granted
QuantRx 510(k) clearance on its Follicle Stimulating Hormone (FSH) lateral flow
immunoassay test for FSH at 10ng/ml. This female fertility test is a one-step
lateral flow device that determines ovarian reserve indirectly by measuring FSH
in first morning urine. The Company has licensed this technology for the OTC
market and anticipates the commencement of royalties in the second quarter of
2009. The Company is currently exploring the feasibility of developing a male
fertility test.
In 2008,
QuantRx filed four 510(k) applications with the FDA for its RapidSense urine
based drugs-of-abuse test product line and to date, has received clearance on
three of these applications. QuantRx has numerous additional RapidSense-based
products in the 510(k) pipeline, and anticipates additional 510(k) applications
as funding provides. With the validation of the technology, QuantRx is exploring
the economic viability of developing additional tests for drugs-of-abuse, as
well as tests for infectious disease and cardiac markers. The
clearance on urine-based tests also sets the stage for development of saliva
based tests.
The
technology has numerous potential applications. For this reason, QuantRx is
pursuing collaborative research and development and original equipment
manufacturer (OEM) relationships with companies and organizations interested in
exploring new and existing analytes to drive the development of new products for
the diagnostic marketplace to advance healthcare worldwide.
6
In the
fourth quarter of 2007, QuantRx introduced its QuikSense® drugs-of-abuse product
line in the United States and European markets. This OEM product line was
intended to develop distribution channels to stage the introduction of its
RapidSense line. The Company did not have the resources to penetrate the market
with the generic QuikSense product line and are now focusing on introducing
products based on QuantRx’s unique technology through strategic partners and
third party distributors. QuantRx is also developing rapid test POC
products in oral care for ALT BioScience. This development agreement grants
certain rights related to manufacturing upon successful development and
commercialization of the products, which is expected to commence in late
2009.
PADs
for Diagnosis and Treatment
The
miniform PAD is a QuantRx patented technology that provides the basis for a line
of products that address an array of consumer health issues including: temporary
relief of hemorrhoid and minor vaginal infection itch and discomfort, feminine
urinary incontinence, drug delivery, and medical sample collection and transport
for diagnostic testing.
The
QuantRx PAD products for the consumer markets are FDA Class I OTC devices, and
are easy to use, non-invasive, fully biodegradable, highly absorbent pads.
Additionally, the technology allows for the PAD to be used as a sample
collection device for diagnostic purposes, or to provide local or systemic
therapy.
PADKit®
The
PADKit integrates the miniform technology with QuantRx’s diagnostic expertise.
The PADKit contains a miniform used as a collection device to collect a sample
for diagnostic evaluation. Vaginally, the miniform collects blood along with
numerous cells, vaginal mucous and discharge flushed out by the menstrual flow
or during normal daily exfoliation. The PADKit is designed to provide
the preferred sample collection system population scale testing for indications
such as HPV, Human Immunodeficiency Virus (HIV), and general health screening,
where healthcare professionals are not readily accessible.
Although
significant improvements have been made in the area of Pap test sample reading
and sample preparation, clinical indications support broad testing for HPV will
have a greater impact in lowering the incidence of cervical
cancer. The Company believes the PADKit will provide a superior and
more consistent sample, as well as a simpler, more comfortable and convenient
procedure for HPV testing. The Company further hopes to demonstrate
viability of the PADKit as the basis of various other diagnostic and screening
tests. The Company has formed a strategic alliance with CytoCore,
Inc. to target the Pap testing market using this technology.
The
Company has been issued several patents for the method and apparatus for
collecting vaginal fluid and exfoliated vaginal cells for diagnostic purposes,
collection of a sample for general diagnostic screening, and the collection of
an anal sample for prostate and other diagnostic purposes. Several
clinical studies have been conducted on the PADKit, which have provided data
needed to show the degree to which the sample collected can be used to replace
other accepted samples. QuantRx plans to proceed with further
clinical trials and submission to the FDA for marketing approval of the PADKit,
together with an appropriate strategic partner, and will continue to pursue
additional patent protection.
Unique®
Miniforms
The
Company's Unique miniform is a safe, convenient, and flushable technology for
the underserved OTC hemorrhoid and feminine urinary incontinence
markets. The disposable miniform pads contain no adhesives and
require no insertion, and it is small enough to fit in the palm of a
hand.
7
The
Unique miniform is available as a treated pad for the temporary relief of the
itch and discomfort associated with hemorrhoids and minor vaginal infection, and
as an untreated pad, for the daily protection of light urinary or anal
leakage.
While
QuantRx initiated a limited web-based domestic roll-out of the Unique miniform
in late 2007, it is in search of a strategic partnership(s) to expand the retail
availability of the product across the United States and
internationally.
QuantRx
has significant experience manufacturing its miniform and a clear understanding
of its costs. The Company currently has contracted with a firm based
in Taiwan to manufacture its pads. The miniform technology is
protected by numerous patents covering various applications, the manufacturing
process, and certain materials.
Molecular
Diagnostic Imaging
The
Company, through FluoroPharma, is developing proprietary diagnostic imaging
products, with initial focus on the development of novel PET imaging agents for
efficient detection and assessment of acute and chronic forms of Coronary Artery
Disease (CAD). To date, the technology has been applied to the development of
three cardiovascular imaging agents – CardioPET, BFPET, and VasoPET. The agents
rapidly target either the myocardial cells within the heart or the vulnerable
plaque within the coronary arteries and, combined with PET scanning, provide a
non-invasive, highly specific, and efficient assessment of heart metabolism and
physiology. Future applications exist in the broader cardiovascular, oncology,
and neurology arenas.
CardioPET,
FluoroPharma’s lead product, is a novel metabolic agent in development for the
following intended uses: (a) detection of ischemic and infarcted tissue in
patients with suspected or proven forms of acute and chronic CAD, particularly
in those patients that cannot undergo stress-testing; and, (b) Cardiac Viability
Assessment (CVA), for the prediction of functional improvement prior to, or
following, revascularization in patients with acute CAD, including myocardial
infarction.
CardioPET
represents a potentially highly sensitive means of detecting ischemia at rest,
because it can detect subtle metabolic insufficiency in
myocardium. Thus, a primary application of CardioPET is its use in
the assessment of patients with acute and chronic CAD that cannot undergo
stress-testing.
CardioPET
may also be ideal as the metabolic component in CVA due to its ability to
specifically identify damaged but viable myocardial tissue. In
contrast to non-viable scar tissue, viable myocardial tissue can undergo
revascularization, which has been documented to improve left ventricular
function and increase survival.
CardioPET
will address two separate populations: (1) the estimated 1.75 million patients
with chronic forms of CAD in the United States that undergo pharmacologic
stress-testing due to stress-test contraindication; and, (2) the 350,000
patients with presumptive hibernating or stunned myocardium. For
at-rest assessment of the former population, we believe CardioPET may be readily
adopted by the cardiology community for the assessment of this patient pool. For
CVA testing, we believe that CardioPET’s “first mover” advantage, when combined
with the favorable technical parameters relative to currently available
glucose-based agents such as fluorodeoxyglucose (FDG), should result in
favorable market adoption. Another potential application for
CardioPET is as a substitute for regular stress testing, as physicians see the
benefit of fewer total scans and potentially faster diagnoses.
8
Following
the filing of an Investigational New Drug (IND) application with the FDA, a
Phase I clinical trial for CardioPET was successfully completed in the first
quarter of 2008. The Phase I trial was a single center, open label study,
designed to evaluate safety, distribution, and dosimetry of CardioPET as a PET
tracer for myocardial imaging in healthy subjects and in patients with CAD. The
Company commenced a limited Phase II study in early 2008 focused on evaluation
of cardiac ischemia in subjects with chronic and acute forms of
CAD.
BFPET is
a blood flow imaging device being developed for use as a myocardial perfusion
agent in conjunction with stress-testing for the detection of ischemic and
infarcted myocardial tissue in patients with suspected or proven chronic
CAD.
BFPET has
been designed to enter the myocardial cells of the heart muscle in direct
proportion to blood flow and membrane potential—the two most important
physiological indicators of adequate blood supply to the heart. BFPET
effectively differentiates between those cells of the myocardium that are
ischemic (reversibly damaged), infarcted (irreversibly damaged), and those that
are healthy. Because ischemic and infarcted cells take up significantly less
BFPET than normal healthy myocardial cells, the signal emitted by the tracer
attached to BFPET is inversely proportional to the extent of myocardial injury,
the result of which can be visualized with PET imaging
technologies.
Currently,
it is estimated that approximately 80% of the 7 million patients with suspected
acute and chronic forms of CAD in the United States are evaluated using the
combination of blood flow imaging agents (blood flow agents) and stress-testing.
An additional 350,000 patients undergo CVA in which a blood flow agent, such as
BFPET, is used in combination with a metabolic imaging agent such as FDG or the
Company’s CardioPET. We believe that BFPET may represent the first commercially
feasible cardiovascular blood flow agent for the PET market.
Following
the filing of an IND application with the FDA, a Phase I clinical trial for
BFPET begun in the first quarter of 2008, was successfully completed in the
third quarter of 2008. The Phase I trial was designed to evaluate safety,
distribution and dosimetry of BFPET in 12 healthy subjects following a single
dose injection at rest.
VasoPET
is a novel imaging agent for the detection of inflamed and/or coronary artery
plaque formation in patients with CAD. VasoPET, if successful and approved,
could represent the first cardiovascular PET product to reliably differentiate
between vulnerable and stable coronary artery plaque.
Coronary
artery plaques grow over time and progressively narrow the lumen of the coronary
artery until blood flow to the heart diminishes to a critical
level. The rupture of atherosclerotic plaque and the subsequent
formation of clots overlying the plaque are currently recognized as the primary
mechanisms of myocardial and cerebral infarctions. Therefore, the detection of
vulnerable plaque in atherosclerotic lesions is a highly desirable goal and to
this date remains both a significant clinical objective and large unaddressed
market opportunity.
VasoPET
is positioned to capture a small percentage of the entire atherosclerosis
scanning market, which represents more than 50 million Americans. Preliminary
estimates for the VasoPET market are a direct function of the more than 100,000
patients that undergo carotid artery procedures annually. There is a significant
need to follow up after treatment to track the success of these procedures. We
conservatively estimate that VasoPET will gradually become the standard follow
up for carotid artery procedures and that 75% of patients will be scanned with
VasoPET one year post-surgery.
9
FluoroPharma
has completed the studies necessary for the filing of an IND for the
atherosclerotic plaque imaging agent, VasoPET. Single-dose preclinical
toxicology studies revealed no untoward affects of the compound when it was
administered in doses up to one million times the anticipated clinical dose. The
Company has submitted the IND application for BFPET, and following institutional
review board (IRB) approval of the proposed studies, commenced Phase I clinical
trials to evaluate safety and dosimetry in healthy subjects in the first quarter
of 2008.
Each of
these products will require significant clinical validation and a lengthy FDA
approval process. While the approval process is not as long for these
products as for a true drug, the process will entail several years and a large
number of patients. We anticipate that it will be several years before our first
New Drug Application (NDA) will be filed with the FDA. The development to
commercialization will require significant resources, and the Company is
exploring alternative funding options, such as the possibility of investment by
third-party investors directly into FluoroPharma.
SNPchip
Genome-based Diagnostic Microarray Chips
Genomics
USA (GUSA), an affiliate of which QuantRx owns approximately 20% on a fully
diluted basis, has developed a proprietary, low cost and accurate microarray
technology to support large-scale personalized medicine. The first
GUSA product, in late development, is “The HLA-Chip”, a low cost microarray with
customized analytical software for high throughput clinical genetics and public
health testing. The HLA-Chip is being developed to become the replacement for
all DNA based Human Lymphocyte Antigen (HLA) testing in solid organ and stem
cell transplantation.
The test
array resides on a one-square-centimeter silicon chip that contains thousands of
DNA probes that identify specific human gene sequences of diagnostic interest.
The current competitive technologies require dispensing of a 10-fold excess of
DNA, over that required to actually cover the microarray surface. In GUSA’s
technology, the adsorptive self assembly is nearly quantitative, requiring no
more that a one fold excess of applied material.
Since the
ability of an individual to respond to a particular drug or vaccine is
essentially determined by his/her immune response - determined by the HLA type-
a key application for this HLA-based technology will be related to vaccine
development and personalized vaccine delivery; assuring a vaccine’s
effectiveness for a particular individual. Other uses for a defined HLA type
will include tissue transplantation, population scale testing for viral
diseases, personalized treatment of microbial infection, and personalized
treatment for autoimmune diseases such as arthritis and multiple
sclerosis.
The
biophysical properties of these "self-assembling" DNA microarrays allow
SNP-based hybridizations simply and directly, without the need to perform
single-base extension or any other secondary biochemical treatment. This
simplification reduces the cost of the product, increases signal quality, and
allows the product to be used by non-experts, especially in field-testing or
small-clinic environments.
Follow-on
products in the personalized medicine market will service chemical therapeutics,
especially those applications in which personal genetic variation at a number of
gene sites can cooperate to alter treatment responsiveness for conditions such
as obesity, depression, cardiovascular risk, and others. Properly validated,
awareness of a patient’s HLA type will be as vital to medical practice as
knowledge of one’s blood type, and testing and typing of an infant’s HLA at
birth will become common practice.
10
Development
of this critical HLA determinate test has been primarily funded by a Defense
Advanced Research Projects Agency (DARPA) sponsored Small Business Innovation
Research (SBIR) grant of approximately $3 million, with the focus being to
provide the military with information necessary to determine who would benefit
from various vaccines in the event of a biowarfare release. A prototype of this
test is anticipated in the fourth quarter of 2009.
Competition
Our industry
is highly competitive and characterized by rapid and significant technological
change. Significant competitive factors in our industry include, among others,
product efficacy and safety; the timing and scope of regulatory approvals; the
government reimbursement rates for and the average selling price of products;
the availability of raw materials and qualified manufacturing capacity;
manufacturing costs; intellectual property and patent rights and their
protection; and sales, marketing and distribution capabilities.
We face,
and will continue to face, competition from organizations such as pharmaceutical
and biotechnology companies, as well as academic and research institutions. Some
of these organizations, including Inverness Medical Innovations, Inc., Biosite,
Inc., Quidel Corporation, and Meridian Bioscience, Inc., are pursuing products
based on technologies similar to our technologies. These organizations have
developed and are currently marketing products, and are pursuing other
technological approaches designed to produce products that compete with our
product candidates.
Any
product candidates that we successfully develop, which are approved for sale by
the FDA or similar international regulatory authorities in other countries, may
compete with competitive products currently being used or that may become
available in the future. Many of our competitors have substantially greater
capital resources than we have, and greater capabilities and resources for
research, conducting preclinical studies and clinical trials, regulatory
affairs, manufacturing, marketing and sales. As a result, we may face
competitive disadvantages relative to these organizations should they develop or
commercialize a competitive product.
Raw
Materials and Manufacturing
The
Company has limited manufacturing capacity for research and development projects
and contracts the manufacturing of all of its products to third-party
manufacturers in and outside the United States. All manufactured products are
produced under standard operating procedures developed and controlled by the
Company’s quality system, which specifies approved raw materials, vendors, and
manufacturing methodology.
Intellectual
Property Rights and Patents
The
Company's technology portfolio, with more than three dozen patents, patents
pending and licensed patents, includes: (1) RapidSense point-of-care diagnostic
products based on QuantRx core intellectual property related to lateral flow
techniques for the consumer and healthcare professional markets; (2) PAD
technology for diagnosis and treatment of women's health concerns and other
medical needs; (3) through FluoroPharma, molecular imaging agents for positron
emission tomography (PET) and fluorescence imaging, with initial application in
cardiovascular disease, addressing significant unmet medical needs by providing
clinicians with important tools for early discovery and assessment; and (4)
through our affiliate, GUSA, genome-based diagnostic chips for the laboratory
and healthcare professional markets.
Patents
and other proprietary rights are an integral part of our business. It is our
policy to seek patent protection for our inventions and also to rely upon trade
secrets and continuing technological innovations and licensing opportunities to
develop and maintain our competitive position.
11
However,
the patent positions of companies like ours involve complex legal and factual
questions and, therefore, their enforceability cannot be predicted with any
certainty. Our issued patents, those licensed to us, and those that may be
issued to us in the future may be challenged, invalidated or circumvented, and
the rights granted thereunder may not provide us with proprietary protection or
competitive advantages against competitors with similar technology. Furthermore,
our competitors may independently develop similar technologies or duplicate any
technology developed by us. Because of the extensive time required for
development, testing and regulatory review of a potential product, it is
possible that, before any of our product candidates can be approved for sale and
commercialized, our relevant patent rights may expire or remain in force for
only a short period following commercialization. Expiration of patents we own or
license could adversely affect our ability to protect future product development
and, consequently, our operating results and financial position.
QuantRx
and its subsidiary have 14 patents issued, 11 patents pending, and 13 licensed
patents and patents pending. Our issued patents expire between 2010
and 2027; however, QuantRx may obtain continuations which would extend the
expirations dates of our issued patents.
|
·
|
12
related to Point-of-Care Diagnostics
technology
|
|
·
|
15
related to PAD technology
|
|
·
|
11
related to Molecular Imaging
technology
|
QuantRx
also holds numerous United States trademarks, including QuantRx, PADkit,
RapidSense and Unique.
Licensing,
Distribution and Development Agreements
In 2007
QuantRx entered into two development agreements to develop rapid test
point-of-care products in oral care for ALT BioScience (ALT), and an at-home
diagnostic test jointly with Church & Dwight Co., Inc.
The ALT
agreement, and subsequent renewals, commenced March 2007 and stipulated an up
front fee, recognized over the initial five month term, and monthly fees.
Currently, the agreement is on a month-to-month basis, subject to termination
with 45 days notice. The agreement grants QuantRx certain manufacturing rights
for the developed products, which shall be negotiated in good faith in a
separate manufacturing agreement upon the completion of design and verification
testing. These manufacturing rights will survive any potential termination of
the development agreement.
The
Church & Dwight agreement was accounted for using the Performance Method –
Expected Revenue. The agreement included an up front payment which was
recognized fully in 2007, and stipulated milestone based payments, which were
recognized in 2007 and 2008. On August 14, 2008, QuantRx entered into a
Technology License Agreement with Church & Dwight Co., Inc. Under
the terms of the agreement, Church & Dwight acquired exclusive world-wide
rights to use certain QuantRx technology related to the jointly developed test.
Under the ten-year agreement, QuantRx will receive royalties on net sales of the
product beginning in 2009.
12
On May
19, 2008, QuantRx and CytoCore, Inc. entered into a worldwide distribution and
supply agreement for specified PAD technology of QuantRx. The agreement
specifies monthly license fees during CytoCore’s expected development period and
additional milestone payments based upon CytoCore’s achievement of certain
development and sales milestones. The expected development period of
the agreement is estimated as 18 months.
The
Company had a licensing agreement with Branan Medical Corporation to license its
use of the RapidSense technology in connection with the oral screening of
drugs-of-abuse. In early 2008, QuantRx and Branan terminated their license
agreement.
In 2006,
QuantRx and Synova Healthcare, Inc. entered into a distribution agreement
pursuant to which Synova would act as the exclusive distributor of specified
hemorrhoid products of QuantRx in the United States. QuantRx received an
up-front, non-refundable payment of $500,000 upon execution of the distribution
agreement. In December 2007, in accordance with the terms of the distribution
agreement, QuantRx delivered notice of termination of the
agreement.
QuantRx
entered into a patent license agreement with The Procter & Gamble Company
effective July 1, 2006. The agreement licenses patent rights and know-how for
certain hemorrhoid treatment pads and related coatings. The term of the
agreement is five years with a five year automatic renewal option.
Regulatory
Requirements
Our
products and manufacturing activities are subject to regulation by the FDA, and
by other federal, state, local and foreign regulatory authorities. Pursuant to
the Food, Drug, and Cosmetic Act of 1938, commonly known as the FD&C Act,
and the regulations promulgated under it, the FDA regulates the research,
development, clinical testing, manufacture, packaging, labeling, storage,
distribution, promotion, advertising and sampling of medical devices and medical
imaging products. Before a new device or pharmaceutical product can be
introduced to the market, the manufacturer must generally obtain marketing
clearance through a section 510(k) notification, through a Premarket Approval
(PMA), or NDA.
In the
United States, medical devices intended for human use are classified into three
categories, Class I, II or III, on the basis of the controls deemed reasonably
necessary by the FDA to assure their safety and effectiveness with Class I
requiring the fewest controls and Class III the most controls. Class I, unless
exempted, and Class II devices are marketed following FDA clearance of a Section
510(k) premarket notification. Since Class III devices (e.g., a device whose
failure could cause significant human harm or death) tend to carry the greatest
risks, the manufacturer must demonstrate that such a device is safe and
effective for its intended use by submitting a PMA application. PMA approval by
the FDA is required before a Class III device can be lawfully marketed in the
United States. Usually, the PMA process is significantly more time consuming and
costly than the 510(k) process.
The
U.S. regulatory scheme for the development and commercialization of new
pharmaceutical products, which includes our targeted molecular imaging agents,
can be divided into three distinct phases: an investigational phase including
both preclinical and clinical investigations leading up to the submission of an
NDA; a period of FDA review culminating in the approval or refusal to approve
the NDA; and the post-marketing period.
All of
our OTC products derived from the Miniform technology, including Unique, are
currently classified as Class I – exempt devices, requiring written notification
to the FDA before marketing. The Company’s RapidSense product candidates
generally require validation and notification to the FDA under Section 510(k)
prior to commercialization. The Company does not currently market any product
that requires full clinical validation as a Class III product under FDA
regulations.
13
In
addition, the FD&C Act requires device manufacturers to obtain a new FDA
510(k) clearance when there is a substantial change or modification in the
intended use of a legally marketed device, or a change or modification,
including product enhancements, changes to packaging or advertising text and, in
some cases, manufacturing changes, to a legally marketed device that could
significantly affect its safety or effectiveness. Supplements for approved PMA
devices are required for device changes, including some manufacturing changes
that affect safety or effectiveness, or disclosure to the consumer, such as
labeling. For devices marketed pursuant to 510(k) determinations of substantial
equivalence, the manufacturer must obtain FDA clearance of a new 510(k)
notification prior to marketing the modified device. For devices marketed with
PMA, the manufacturer must obtain FDA approval of a supplement to the PMA prior
to marketing the modified device. Such regulatory requirements may require the
Company to retain records for up to seven years, and be subject to periodic
regulatory review and inspection of all facilities and documents by the
FDA.
The
FD&C Act requires device manufacturers to comply with Good Manufacturing
Practices regulations. The regulations require that medical device manufacturers
comply with various quality control requirements pertaining to design controls,
purchasing contracts, organization and personnel, including device and
manufacturing process design, buildings, environmental control, cleaning and
sanitation; equipment and calibration of equipment; medical device components;
manufacturing specifications and processes; reprocessing of devices; labeling
and packaging; in-process and finished device inspection and acceptance; device
failure investigations; and record keeping requirements including complaint
files and device tracking. Company personnel and non-affiliated contract
auditors periodically inspect the contract manufacturers to assure they remain
in compliance.
The
Company’s Portland, Oregon, facility is in compliance with current FDA
requirements.
Certain
of our product candidates will require significant clinical validation prior to
obtaining marketing clearance from the FDA. The Company intends to contract with
appropriate and experienced CROs (contract research organizations) to prepare
for and review the results from clinical field trials. The Company engages
certain scientific advisors, consisting of scientific Ph.D.s and M.D.s, who
contribute to the scientific and medical validity of its clinical trials when
appropriate.
Research
and Development Activities
We spent
the following amounts on research and development activities during the years
ended December 31, 2008 and 2007:
2008:
$2,032,677
2007:
$2,012,419
We expect
that our research and development expenses will continue to increase due to the
initiation of numerous clinical trials and the continued development of our
product lines.
14
Employees
As of
December 31, 2008, we had 14 full-time employees; 12 of whom were full-time
employees of QuantRx and 2 of whom were employees of FluoroPharma, a subsidiary
of QuantRx. Our employees are not represented by a labor organization or covered
by a collective bargaining agreement.
ITEM
1A. RISK FACTORS.
You should consider carefully the
following risks, along with other information contained in this Form
10-K. The
risks and uncertainties described below are not the only ones that may affect
us. Additional risks and uncertainties also may adversely affect our
business and operations, including those discussed in Item
7 – Management’s
Discussion and Analysis of Financial Condition and Results of
Operation. If any of the following risks
actually occur, our business, results of operations, and financial condition
could be adversely
affected.
Our
ability to operate as a going concern is dependent upon raising adequate
financing.
Management
believes that given our current cash position, there is substantial doubt about
our ability to continue as a going concern. We are actively pursuing various
funding options, including equity offerings, debt financing, strategic corporate
alliances, and business combinations, to obtain additional financing to continue
the development of our products and bring them to commercial markets. We are
actively seeking to raise capital, including through the direct investment in
our subsidiary, FluoroPharma, by either strategic partners or third party
investors. There can be no assurance that we will be successful in our efforts
to raise additional capital. Should we be unable to raise adequate financing or
generate revenue in the future, the Company’s business, results of operations,
liquidity and financial condition would be materially and adversely harmed.
Moreover, direct investment in FluoroPharma would dilute our ownership
percentage.
We
have a history of incurring net losses and we may never become
profitable.
For the
year ended December 31, 2008, the Company had an accumulated deficit of
$45,109,623. Our losses resulted principally from costs related to our research
programs and the development of our product candidates and general and
administrative costs relating to our operations. Since the Company presently has
limited sources of revenues and is committed to continuing its research and
development activities, we may incur substantial and increasing losses in 2009.
We cannot assure you that we will ever become profitable.
We
will need to obtain additional funding to support our operations, and we may not
be able to obtain such capital on a timely basis or under commercially
reasonable terms, if at all.
We expect
that our need for additional capital will be substantial and the extent of this
need will depend on many factors, some of which are beyond our control,
including the successful and continued development of our product candidates;
the costs associated with maintaining, protecting and expanding our patent and
other intellectual property rights; future payments, if any, received or made
under existing or possible future collaborative arrangements; the timing of
regulatory approvals needed to market our product candidates; and market
acceptance of our products.
15
It is
possible that the Company will not generate positive cash flow from operations
for several years. We cannot assure you that funds will be available to us in
the future on favorable terms, if at all. If adequate funds are not available to
us on terms that we find acceptable, or at all, we may be required to delay,
reduce the scope of, or eliminate research and development efforts or clinical
trials on any or all of our product candidates. We may also be forced to curtail
or restructure our operations, obtain funds by entering into arrangements with
collaborators on unattractive terms or relinquish rights to certain technologies
or product candidates that we would not otherwise relinquish in order to
continue independent operations.
Our
substantial indebtedness could adversely affect our business and financial
condition.
We now
have, and will continue to have in the foreseeable future, a significant amount
of debt. Subject to the terms of the agreements and instruments governing our
senior secured convertible notes, our ability to incur additional indebtedness
is limited. We have been successful in the past in obtaining waivers permitting
us to incur additional debt to meet our operating requirements; however, there
is no assurance that we will be successful in the future in obtaining these
waivers.
Additionally,
all of our outstanding notes are short-term in nature and we have been
successful in obtaining extensions for them. We may not be able to
obtain extensions in the future.
Certain
of our outstanding notes are secured by our intellectual property and our equity
holdings. If we are unable to meet the obligations or acquire extensions for
these notes, the holders of the notes could exercise their rights with regards
to the security interests.
Further
testing of certain of our product candidates is required and regulatory approval
may be delayed or denied, which would limit or prevent us from marketing our
product candidates and significantly impair our ability to generate
revenues.
Human
pharmaceutical products are subject to rigorous preclinical testing and clinical
trials and other approval procedures mandated by the FDA and foreign regulatory
authorities. Various federal and foreign statutes and regulations also govern or
influence the manufacturing, safety, labeling, storage, record keeping and
marketing of pharmaceutical products. The process of obtaining these approvals
and the subsequent compliance with appropriate U.S. and foreign statutes and
regulations is time-consuming and requires the expenditure of substantial
resources. In addition, these requirements and processes vary widely from
country to country.
To
varying degrees based on the regulatory plan for each product candidate, the
effect of government regulation and the need for FDA and other regulatory agency
approval will delay commercialization of our product candidates, impose costly
procedures upon our activities, and put us at a disadvantage relative to larger
companies with which we compete. There can be no assurance that FDA or other
regulatory approval for any products developed by us will be granted on a timely
basis, or at all. If we discontinue the development of one of our product
candidates, our business and stock price may suffer.
The
Company may face intense competition.
The
Company is engaged in a segment of the biomedical industry that is highly
competitive. If successfully brought into the marketplace, any of the Company’s
products will likely compete with several existing products. The Company
anticipates that it will face intense and increasing competition in the future
as new products enter the market and advanced technologies become available. We
cannot assure that existing products or new products developed by competitors
will not be more effective, or more effectively marketed and sold than those by
the Company. Competitive products may render the Company’s products obsolete or
noncompetitive prior to the Company’s recovery of development and
commercialization expenses.
16
Many of
the Company’s competitors will also have significantly greater financial,
technical and human resources and will likely be better equipped to develop,
manufacture and market products. Smaller companies may also prove to be
significant competitors, particularly through collaborative arrangements with
large biotechnology companies. Furthermore, academic institutions, government
agencies and other public and private research organizations are becoming
increasingly aware of the commercial value of their inventions and are actively
seeking to commercialize the technology they have developed. Accordingly,
competitors may succeed in commercializing products more rapidly or effectively
than the Company, which would have a material adverse effect on the
Company.
There
is no assurance that the Company’s products will have market
acceptance.
The
success of the Company will depend in substantial part on the extent to which
our products achieve market acceptance. We cannot predict or guarantee that
physicians, patients, healthcare insurers or maintenance organizations, or the
medical community in general, will accept or utilize any products of the
Company.
If
we fail to establish marketing and sales capabilities or fail to enter into
effective sales, marketing and distribution arrangements with third parties, we
may not be able to successfully commercialize our products.
We are
primarily dependent on third parties for the sales, marketing and distribution
of our products. We may enter into various agreements providing for the
commercialization of our product candidates. We intend to sell our product
candidates primarily through third parties and establish relationships with
other companies to commercialize them in other countries around the world. We
currently have limited internal sales and marketing capabilities, or an
infrastructure to support such activities. Therefore, our future profitability
will depend in part on our ability to enter into effective marketing agreements.
To the extent that we enter into sales, marketing and distribution arrangements
with other companies to sell our products in the United States or abroad, our
product revenues will depend on their efforts, which may not be successful.
The
Company’s success will be dependent on licenses and proprietary rights it
receives from other parties, and on any patents it may obtain.
Our
success will depend in large part on the ability of the Company and its
licensors to (i) maintain license and patent protection with respect to our
products, (ii) defend patents and licenses once obtained, (iii) maintain trade
secrets, (iv) operate without infringing upon the patents and proprietary rights
of others, and (v) maintain and obtain appropriate licenses to patents or
proprietary rights held by third parties if infringement would otherwise occur,
both in the United States and in foreign countries.
The
patent positions of biomedical companies, including those of the Company, are
uncertain and involve complex legal and factual questions. There is no guarantee
that the Company or its licensors have or will develop or obtain the rights to
products or processes that are patentable, that patents will issue from any of
the pending applications or that claims allowed will be sufficient to protect
the technology licensed to the Company. In addition, we cannot be certain that
any patents issued to or licensed by the Company will not be challenged,
invalidated, infringed or circumvented, or that the rights granted thereunder
will provide competitive disadvantages to the Company.
17
Litigation,
which could result in substantial cost, may also be necessary to enforce any
patents to which the Company has rights, or to determine the scope, validity and
unenforceability of other parties’ proprietary rights, which may affect the
rights of the Company. United States patents carry a presumption of validity and
generally can be invalidated only through clear and convincing evidence. There
can be no assurance that the Company’s patents would be held valid by a court or
administrative body or that an alleged infringer would be found to be
infringing. The mere uncertainty resulting from the institution and continuation
of any technology-related litigation or interference proceeding could have a
material adverse effect on the Company pending resolution of the disputed
matters.
The
Company may also rely on unpatented trade secrets and know-how to maintain its
competitive position, which it seeks to protect, in part, by confidentiality
agreements with employees, consultants and others. There can be no assurance
that these agreements will not be breached or terminated, that the Company will
have adequate remedies for any breach, or that trade secrets will not otherwise
become known or be independently discovered by competitors.
Protecting
our proprietary rights is difficult and costly.
The
patent positions of biotechnology companies can be highly uncertain and involve
complex legal and factual questions. Accordingly, we cannot predict the breadth
of claims allowed in these companies’ patents or whether the Company may
infringe or be infringing these claims. Patent disputes are common and could
preclude the commercialization of our products. Patent litigation is costly in
its own right and could subject us to significant liabilities to third parties.
In addition, an adverse decision could force us to either obtain third-party
licenses at a material cost or cease using the technology or product in
dispute.
We
may be unable to retain skilled personnel and maintain key
relationships.
The
success of our business depends, in large part, on our ability to attract and
retain highly qualified management, scientific and other personnel, and on our
ability to develop and maintain important relationships with leading research
institutions and consultants and advisors. Competition for these types of
personnel and relationships is intense from numerous pharmaceutical and
biotechnology companies, universities and other research institutions. There can
be no assurance that the Company will be able to attract and retain such
individuals on commercially acceptable terms or at all, and the failure to do so
would have a material adverse effect on the Company.
The
Company has limited manufacturing capabilities and may not be able to
efficiently develop manufacturing capabilities or contract for such services
from third parties on commercially acceptable terms.
The
Company has limited manufacturing capacity. The Company has established
relationships with third-party manufacturers for the commercial production of
our products. There can be no assurance that the Company will be able to
maintain relationships with third-party manufacturers on commercially acceptable
terms or that third-party manufacturers will be able to manufacture our products
on a cost-effective basis in commercial quantities under good manufacturing
practices mandated by the FDA.
The
dependence upon third parties for the manufacture of products may adversely
affect future costs and the ability to develop and commercialize our products on
a timely and competitive basis. Further, there can be no assurance that
manufacturing or quality control problems will not arise in connection with the
manufacture of our products or that third party manufacturers will be able to
maintain the necessary governmental licenses and approvals to continue
manufacturing such products. Any failure to establish relationships with third
parties for its manufacturing requirements on commercially acceptable terms
would have a material adverse effect on the Company.
18
In
the future, we anticipate that we will need to obtain additional or increased
product liability insurance coverage and it is uncertain that such increased or
additional insurance coverage can be obtained on commercially reasonable
terms.
The
business of the Company will expose it to potential product liability risks that
are inherent in the testing, manufacturing and marketing of pharmaceutical
products. There can be no assurance that product liability claims will not be
asserted against the Company. The Company has obtained insurance coverage;
however, there can be no assurance that the Company will be able to obtain
additional product liability insurance on commercially acceptable terms or that
the Company will be able to maintain such insurance at a reasonable cost or in
sufficient amounts to protect against potential losses. A successful product
liability claim or series of claims brought against the Company could have a
material adverse effect on the Company.
Insurance
coverage is increasingly more difficult to obtain or maintain.
Obtaining
insurance for our business, property and products is increasingly more costly
and narrower in scope, and we may be required to assume more risk in the future.
If we are subject to third-party claims or suffer a loss or damage in excess of
our insurance coverage, we may be required to share that risk in excess of our
insurance limits. Furthermore, any first- or third-party claims made on any of
our insurance policies may impact our ability to obtain or maintain insurance
coverage at reasonable costs or at all in the future.
The
market price of our shares, like that of many biotechnology companies, is highly
volatile.
Market
prices for the Company’s common stock and the securities of other medical and
biomedical technology companies have been highly volatile and may continue to be
highly volatile in the future. Factors such as announcements of technological
innovations or new products by the Company or its competitors, government
regulatory action, litigation, patent or proprietary rights developments, and
market conditions for medical and high technology stocks in general can have a
significant impact on any future market for common stock of the
Company.
Trading
of our common stock is limited, which may make it difficult for you to sell your
shares at times and prices that you feel are appropriate.
Trading
of our common stock, which is conducted on the OTC Bulletin Board, has been
limited. This adversely affects the liquidity of our common stock,
not only in terms of the number of shares that can be bought and sold at a given
price, but also through delays in the timing of transactions and reduction in
security analysts and the media’s coverage of us. This may result in
lower prices for our common stock than might otherwise be obtained and could
also result in a larger spread between the bid and ask prices for our common
stock.
The
issuance of shares of our preferred stock may adversely affect our common
stock.
The board
of directors of the Company is authorized to designate one or more series of
preferred stock and to fix the rights, preferences, privileges and restrictions
thereof, without any action by the stockholders. The designation and issuance of
such shares of our preferred stock may adversely affect the common stock, if the
rights, preferences and privileges of such preferred stock (i) restrict the
declaration or payment of dividends on common stock, (ii) dilute the voting
power of common stock, (iii) impair the liquidation rights of the common stock,
or (iv) delay or prevent a change in control of the Company from occurring,
among other possibilities.
19
Because
we do not expect to pay dividends, you will not realize any income from an
investment in our common stock unless and until you sell your shares at a
profit.
We have
never paid dividends on our common stock and do not anticipate paying any
dividends for the foreseeable future. You should not rely on an
investment in our stock if you require dividend income. Further, you
will only realize income on an investment in our shares in the event you sell or
otherwise dispose of your shares at a price higher than the price you paid for
your shares. Such a gain would result only from an increase in the
market price of our common stock, which is uncertain and
unpredictable.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM
2. PROPERTIES.
Our
corporate headquarters are located at 100 South Main Street, Suite 300,
Doylestown, Pennsylvania, in 3,034 square feet of space occupied under a five
year lease that expires on July 31, 2011. This lease contains a termination
option after the third year for a fee of $5,000. We also lease 6,310 square feet
of commercial space used primarily for research and development at 5920 NE 112th
Avenue, Portland, Oregon. This lease expires on September 30, 2011.
We expect
that our current facilities will be sufficient for the foreseeable future. To
the extent that we require additional space in the near future, we believe that
we will be able to secure additional leased facilities at commercially
reasonable rates.
As of the
date hereof, the Company is not a party to or engaged in any material legal
proceeding.
No matter
was submitted to a vote of security holders during the fourth quarter of
2008.
20
ITEM
5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES.
Our
Common Stock
Our
common stock trades on the OTC Bulletin Board under the symbol “QTXB”. The
prices below are based on high and low reported sales prices as reported by the
OTC Bulletin Board during the calendar quarters indicated. The prices represent
quotations between dealers without adjustment for retail mark-up, mark-down or
commission and do not necessarily represent actual transactions.
High
|
Low
|
|||||||
Year
ended December 31, 2008
|
||||||||
Fourth
Quarter
|
$ | 0.55 | $ | 0.20 | ||||
Third
Quarter
|
$ | 0.80 | $ | 0.35 | ||||
Second
Quarter
|
$ | 0.95 | $ | 0.61 | ||||
First
Quarter
|
$ | 1.11 | $ | 0.45 | ||||
Year
ended December 31, 2007
|
||||||||
Fourth
Quarter
|
$ | 0.89 | $ | 0.43 | ||||
Third
Quarter
|
$ | 1.20 | $ | 0.80 | ||||
Second
Quarter
|
$ | 1.39 | $ | 0.91 | ||||
First
Quarter
|
$ | 1.60 | $ | 1.16 |
Stockholders
As of
March 20, 2009 there were approximately 328 holders of record of our common
stock, one of which was Cede & Co., a nominee for the Depository Trust
Company or DTC. Shares of common stock that are held by financial
institutions, as nominees for beneficial owners, are deposited into principal
accounts at the DTC, and are considered to be held of record by Cede & Co.
as one stockholder.
Dividends
We have
not declared nor paid any cash dividends on our common stock. We currently
anticipate that we will retain all of our future earnings for use in the
expansion and operation of our business, thus we do not anticipate paying any
cash dividends on our common stock in the foreseeable future.
Recent
Sales of Unregistered Securities
In December 2008, the Company issued
25,000 shares of common stock and warrants to purchase 25,000 shares of common
stock with a term of five years and an exercise price of $0.55 in connection
with the issuance of 10% senior secured convertible notes in the aggregate
amount of $100,000 to certain accredited investors. The notes are convertible
into 200,000 shares of common stock, subject to certain
restrictions.
On
November 15, 2008, the Company issued an aggregate of 7,500 shares of common
stock and warrants to purchase 7,500 shares of common stock with a five year
term for $0.85 pursuant to certain note extensions with accredited note
holders.
21
In
December 2008, 6,250 non-qualified common stock options were granted to a member
of the board of directors and issued from the Company’s Incentive and
Non-Qualified Stock Option Plan. The options were issued with an exercise price
of $0.35, have a term of five years and vested immediately.
At
December 31, 2008 the Company issued a 10% senior secured convertible note in
the amount of $53,911 pursuant to one holder’s election to receive quarterly
interest in the form of a paid-in-kind note. The note is convertible into
107,822 shares of common stock, subject to certain restrictions.
In the
first quarter of 2009, the Company issued 81,250 shares of common stock and
warrants to purchase 81,250 shares of common stock with a term of five years and
an exercise price of $0.55 in connection with the issuance of a 10% senior
secured convertible notes in the aggregate amount of $325,000 to certain
accredited investors. The notes are convertible into 650,000 shares of common
stock, subject to certain restrictions. See Note 17, Subsequent
Events.
In the
first quarter of 2009, the Company issued warrants to purchase 115,000 shares of
common stock with a term of five years and an exercise price of $0.55 in
connection with the issuance of certain 8% promissory notes to accredited
investors. On April 1, 2009, QuantRx granted warrants to purchase an aggregate
of 80,500 shares of common stock with a five year term and an exercise price of
$0.55 pursuant to an extension of the due date for these notes. See Note 17,
Subsequent Events.
In the
first quarter of 2009, the Company issued 100,000 shares of common stock and
warrants to purchase 100,000 shares of common stock with a five year term and an
exercise price of $0.55 pursuant to a note extension with an accredited note
holder. See Note 17, Subsequent Events.
In the
first quarter of 2009, the Company issued warrants to purchase 100,000 shares of
common stock with a five year term and an exercise price of $0.55 pursuant to a
note extension with an accredited note holder. See Note 17,
Subsequent Events.
In the
first quarter of 2009, an aggregate of 130,000 qualified common stock options
were granted to certain employees and issued from the Company’s 2007 Incentive
and Non-Qualified Stock Option Plan. The options were issued with an exercise
price of $0.31, have a term of five years, and vest monthly over one
year.
In the
first quarter of 2009, the Company issued warrants to purchase 860,000 shares of
common stock with a five year term and an exercise price of $0.31 to certain
executives, key employees, and consultants of the Company.
In the
second quarter of 2009, the Company issued warrants to purchase an aggregate of
50,000 shares of common stock with a five year term and an exercise price of
$0.55 in connection with the issuance of certain 8% promissory notes to
accredited investors. See Note 17, Subsequent Events
There
were no additional sales of unregistered securities other than as reported in
prior reports on Forms 10-K, 10-Q or 8-K.
The
issuances of the above securities were deemed to be exempt from registration
under the Securities Act of 1933, as amended (the “Securities Act”), in reliance
on Section 4(2) of the Securities Act or Regulation D promulgated under the
Securities Act, as transactions by an issuer not involving a public
offering.
22
Purchases
of Equity Securities
During
the year ended December 31, 2008, we did not purchase any outstanding shares of
our equity securities, nor did any person or entity purchase any outstanding
equity securities of the Company on our behalf.
Equity
Compensation Plan Information
ITEM
6. SELECTED FINANCIAL DATA.
Not
required under Regulation S-K for “smaller reporting companies.”
ITEM
7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATION.
QuantRx
Biomedical Corporation was incorporated on December 5, 1986 in the State of
Nevada. The Company’s principal business office is located at 100 South Main
Street, Suite 300, Doylestown, Pennsylvania. QuantRx also has a research and
development facility in Portland, Oregon.
QuantRx
is a broad-based diagnostics company focused on the development and
commercialization of innovative diagnostic products based on its patented
technology platforms for the worldwide healthcare industry. The Company’s
strategy is to commercialize its products through partners or distributors,
contracting the manufacturing to third-party partners while maintaining control
over the manufacturing process.
The
Company's platforms include: (1) POC testing products based on QuantRx core
intellectual property related to lateral flow techniques; (2) through
FluoroPharma, molecular imaging agents for positron emission tomography (PET);
(3) through our affiliate, Genomics USA, Inc., genome-based diagnostic chips;
and (4) PAD miniform technology.
In April
2007, QuantRx increased its ownership in FluoroPharma, Inc., a development-stage
molecular imaging company, to 57.78% of outstanding capital stock, resulting in
its consolidation effective April 1, 2007. The investment in FluoroPharma is
intended to strategically expand QuantRx’s diagnostic platforms.
The
following discussion of our financial condition should be read together with our
financial statements and related notes included in this annual report on Form
10-K.
23
Our
Consolidated Results of Operations
We
recognized revenues of $624,495 and $747,119 for the years ended December 31,
2008 and 2007, respectively. Total costs and operating expenses for the years
ended December 31, 2008 and 2007 were $6,324,179 and $6,735,285, respectively.
Highlights of the major components of our results of operations are detailed and
discussed below:
Year
Ended December 31, 2008
|
Year
Ended December 31, 2007
|
|||||||
Revenues
|
$ | 624,495 | $ | 747,119 | ||||
General
and Administrative
|
$ | 2,894,432 | $ | 2,377,866 | ||||
Professional
Fees
|
$ | 957,135 | $ | 1,881,179 | ||||
Research
and Development
|
$ | 2,032,677 | $ | 2,012,419 | ||||
Other
Expense, net
|
$ | 2,229,050 | $ | 474,227 |
Revenues
decreased by $122,624 from 2007 to 2008 primarily due to the recognition in 2007
of $459,901 in deferred revenue from a cancelled distribution
agreement. This decrease was substantially offset by increased
revenues from short-term development agreements of $193,736 and increased
licensing revenue of $37,307.
General
and administrative expenses include, but are not limited to, payroll and related
expenses, rent, office and insurance expenses. The increase of $516,566 in
general and administrative expenses from 2007 to 2008 is primarily due to
increased personnel expenses of $661,201, primarily related to stock based
compensation. This increase was partially offset by the absence of minimum
royalty payments and a production line up-front modification fee in 2007
aggregating $100,000.
Professional
fees include the costs of legal, consulting and auditing services provided to
us. The decrease of $924,044 in professional fees from 2007 to 2008 is primarily
attributable to efforts to contain costs, resulting in $538,729 in decreased
expenses associated with financial consultants, $185,392 in decreased legal
fees, $126,318 in decreased expenses related to investor and public relations
consultants, and $51,218 in decreased strategic planning expenses. While we are
unable to estimate future costs of this nature with any degree of certainty, we
intend to retain a limited number of skilled management to reduce the need for
extensive assistance from consultants and accounting professionals.
Research
and development expense primarily reflects technical consulting and expenses
incurred in connection with the development of our product candidates. The
increase of $20,258 from 2007 to 2008 in research and development expenses is
primarily due to increased personnel and consulting expenses of $215,486 and
patent licensing fees of $85,704. These increases were substantially
offset by decreased clinical trial and related expenses of $104,432, product
development costs of $89,754, and materials and supplies of
$50,684.
Net loss
for 2008 was $7,721,401, an increase of $1,677,064 from the $6,044,337 net loss
reported for 2007. The increase in net loss was primarily attributable to an
increase in interest expense, including amortization of debt discount and
deferred finance costs of $1,724,373 and a $439,445 loss on extinguishment of
convertible notes in 2008, offset by the absence of bad debt expense of $214,000
in 2008, as well as all the factors previously discussed.
24
Liquidity
and Capital Resources
At
December 31, 2008, the Company had cash and cash equivalents of $66,226 as
compared to $213,332 at December 31, 2007.
During
the year ended December 31, 2008, we used $2,801,308 of cash for operating
activities, as compared to $4,994,726 during the year ended December 31,
2007. The decreased use of cash for operating activities was a result of
increased aging of accounts payable, together with reduced expenses, primarily
related to professional fees. The Company has also met certain operating
expenses with the issuance of common stock, options or warrants, when
possible.
Cash used
in investing activities during the year ended December 31, 2008 was
$178,307 compared to $978,458 during the year ended December 31, 2007. The
cash requirement for the investment in FluoroPharma made in 2007 was $1,277,178,
which included $250,000 initially invested in the form of a note which was
subsequently converted at the acquisition date. Additionally, an investment of
$200,000 during 2007 was made in a development stage company to strategically
expand our diagnostic platforms by adding new product candidates to our
pipeline.
Cash
provided by financing activities during the year ended December 31, 2008
was $2,832,509 as compared to $4,929,604 during the year ended December 31,
2007. Cash provided through the exercise of warrants was $169,189 during 2008
and $567,777 during 2007. Cash provided through the issuance of convertible
promissory notes was $1,292,500 during 2008 and $1,000,000 during 2007. QuantRx
also issued $550,000 in senior secured promissory notes and $1,042,500 in
unsecured promissory notes in 2008. In 2007, the issuance of shares
of common stock provided cash of $3,374,996. In 2008, QuantRx repaid $200,000 in
senior secured notes.
The Company has not generated
sufficient revenues from operations to meet its operating expenses. For this
reason, the Company has historically financed its operations primarily through
issuances of equity and the proceeds of debt instruments. In the past, the
Company has also provided for its cash needs by issuing common stock, options
and warrants for certain operating costs, including consulting and professional
fees.
Management
believes that given our current cash position, there is substantial doubt about
our ability to continue as a going concern. We are actively pursuing various
funding options, including equity offerings, debt financing, strategic corporate
alliances, and business combinations, to obtain additional financing to continue
the development of our products and bring them to commercial markets. We are
actively seeking to raise capital, including through the direct investment in
our subsidiary, FluoroPharma, by either strategic partners or third party
investors. The Company is currently negotiating on several fronts; however,
there can be no assurance that we will be successful in our efforts to raise
additional capital. Additionally, certain of our debt instruments contain
certain covenants which could limit our ability to issue additional debt. Should
we be unable to acquire necessary waivers from certain of our existing note
holders or raise adequate financing or generate sufficient revenue in the
future, the Company’s business, results of operations, liquidity and financial
condition would be materially and adversely harmed.
The
Company believes that the successful growth and operation of its business is
dependent upon its ability to do any or all of the following:
|
·
|
obtain
adequate sources of debt or equity financing to pay operating expenses and
fund long-term business operations;
|
25
|
·
|
manage
or control working capital requirements by reducing operating
expenses;
|
|
·
|
develop
new and enhance existing relationships with product distributors and other
points of distribution for the Company’s products;
and
|
|
·
|
seek
potential mergers or acquisitions that could be expected to generate
positive cash flow for the Company upon consummation, assuming appropriate
financing structures are available on acceptable terms in order to effect
such acquisitions.
|
There can
be no assurance that the Company will be successful in achieving its long-term
plans as set forth above, or that such plans, if consummated, will enable the
Company to obtain profitable operations or continue in the long-term as a going
concern.
The
following table summarizes our material contractual obligations relating to
operating lease obligations at December 31, 2008 and the effect such obligations
are expected to have on our liquidity and cash flows in future periods. At
December 31, 2008, there were no material capital expenditure
commitments.
Payments due by Period | ||||||||||||||||||||
Total
|
Less
than 1 year
|
Years
2
– 3
|
Years
4
– 5
|
More
than 5 Years
|
||||||||||||||||
Operating
lease obligations
|
$ | 202,678 | $ | 101,563 | $ | 101,115 | $ | - | $ | - |
Off-Balance
Sheet Arrangements
We have
not entered into any transactions with unconsolidated entities in which we have
financial guarantees, subordinated retained interests, derivative instruments or
other contingent arrangements that expose us to material continuing risks,
contingent liabilities or any other obligations under a variable interest in an
unconsolidated entity that provides us with financing, liquidity, market risk or
credit risk support.
Critical
Accounting Policies
Revenue
Recognition
The
Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
Topic 13 when persuasive evidence of an arrangement exists and delivery has
occurred, provided the fee is fixed or determinable and collection is probable.
The Company assesses whether the fee is fixed and determinable based on the
payment terms associated with the transaction. If a fee is based upon a variable
such as acceptance by the customer, the Company accounts for the fee as not
being fixed and determinable. In these cases, the Company defers revenue and
recognizes it when it becomes due and payable. Up-front engagement fees are
recorded as deferred revenue and amortized to income on a straight-line basis
over the term of the agreement, although the fee is due and payable at the time
the agreement is signed or upon annual renewal. Payments related to substantive,
performance-based milestones in an agreement are recognized as revenue upon the
achievement of the milestones as specified in the underlying agreement when they
represent the culmination of the earnings process. The Company assesses the
probability of collection based on a number of factors, including past
transaction history with the customer and the current financial condition of the
customer. If the Company determines that collection of a fee is not reasonably
assured, revenue is deferred until the time collection becomes reasonably
assured. Significant management judgment and estimates must be made and used in
connection with the revenue recognized in any accounting period. Material
differences may result in the amount and timing of our revenue for any period if
our management made different judgments or utilized different
estimates.
26
The
Company recognizes revenue from nonrefundable minimum royalty agreements from
distributors or resellers upon delivery of product to the distributor or
reseller, provided no significant obligations remain outstanding, the fee is
fixed and determinable, and collection is probable. Once minimum royalties have
been received, additional royalties are recognized as revenue when earned based
on the distributor’s contractual reporting obligations. QuantRx is able to
recognize minimum royalty payments on an accrual basis, as they are specified in
the contract. However, since the Company cannot forecast product sales by
licensees, royalty payments that are based on product sales by the licensees are
not determinable until the licensee has completed their computation of the
royalties due and/or remitted their cash payment to us. Should information on
licensee product sales become available so as to enable QuantRx to recognize
royalty revenue on an accrual basis, materially different revenues and results
of operations could occur.
Use
of Estimates
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities, revenues and expenses and related disclosures of
contingent assets and liabilities in the financial statements and accompanying
notes. The accounting policies discussed below are considered by management to
be the most important to the Company’s financial condition and results of
operations, and require management to make its most difficult and subjective
judgments due to the inherent uncertainty associated with these matters. All
significant estimates and assumptions are developed based on the best
information available to us at the time made and are regularly reviewed and
adjusted when necessary. We believe that our estimates and assumptions are
reasonable under the circumstances; however, actual results may vary from these
estimates and assumptions. Additional information on significant accounting
principles is provided in Note 2 of the attached financial
statements.
Impairment
of Assets
We assess
the impairment of long-lived assets, including our other intangible assets,
whenever events or changes in circumstances indicate that their carrying value
may not be recoverable in accordance with Statement of Financial Accounting
Standards (SFAS) No. 144, “Accounting for the Impairment or Disposal of
Long-Lived Assets.” The determination of related estimated useful lives and
whether or not these assets are impaired involves significant judgments, related
primarily to the future profitability and/or future value of the assets. Changes
in our strategic plan and/or market conditions could significantly impact these
judgments and could require adjustments to recorded asset balances. We hold
investments in companies having operations or technologies in areas which are
within or adjacent to our strategic focus when acquired, all of which are
privately held and whose values are difficult to determine. We record an
investment impairment charge if we believe an investment has experienced a
decline in value that is other than temporary. Future changes in our strategic
direction, adverse changes in market conditions or poor operating results of
underlying investments could result in losses or an inability to recover the
carrying value of the investments that may not be reflected in an investment’s
current carrying value, thereby possibly requiring an impairment charge in the
future.
27
We
performed annual impairment tests of our equity method goodwill in accordance
with SFAS No. 142, “Goodwill and Other Intangible Assets.” Under SFAS
No. 142, equity method goodwill is not amortized but is subject to
impairment tests in accordance with Accounting Principles Board Opinion No. 18,
“The Equity Method of Accounting for Investments in Common Stock,” under which
QuantRx would have recognized an impairment loss had there been a loss in the
value of the equity method goodwill which was deemed to be other than a
temporary decline.
In
determining fair value of assets, QuantRx bases estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about carrying values of assets that are not readily apparent from
other sources. Actual fair value may differ from management estimates resulting
in potential impairments causing material changes to certain assets and results
of operations.
Share-based
Payments
We grant
options to purchase our common stock to our employees and directors under our
stock option plan subject to the provisions of SFAS No. 123(R), “Share-Based
Payments.” Effective January 1, 2005, we use the fair value method to apply
the provisions of SFAS No. 123(R) with a modified prospective application which
provides for certain changes to the method for valuing share-based compensation.
The valuation provisions of SFAS No. 123(R) apply to new awards and to awards
that are outstanding on the effective date and subsequently modified or
cancelled. Under the modified prospective application, prior periods are not
revised for comparative purposes.
Upon
adoption of SFAS No. 123(R), we began estimating the value of stock option
awards on the date of grant using a Black-Scholes pricing model (Black-Scholes
model). The determination of the fair value of share-based payment awards on the
date of grant using the Black-Scholes model is affected by our stock price as
well as assumptions regarding a number of complex and subjective variables.
These variables include, but are not limited to, our expected stock price
volatility over the term of the awards, actual and projected employee stock
option exercise behaviors, and risk-free interest rate. If factors change and we
employ different assumptions in the application of SFAS No. 123(R) in
future periods, the compensation expense that we record under SFAS No. 123(R)
may differ significantly from what we have recorded in the current
period.
The
Company accounts for share-based payments granted to non-employees in accordance
with EITF No. 96-18, “Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services.” Under EITF 96-18, the Company determines the fair value of the
stock-based payment as either the fair value of the consideration received or
the fair value of the equity instruments issued, whichever is more reliably
measurable. If the fair value of the equity instruments issued is
used, it is measured using the stock price and other measurement assumptions as
of the earlier of either (1) the date at which a commitment for performance by
the counterparty to earn the equity instruments is reached, or (2) the date at
which the counterparty’s performance is complete.
28
In the
case of modifications, the Black-Scholes model is used to value the warrant on
the modification date by applying the revised assumptions. The difference
between the fair value of the warrants prior to the modification and after the
modification on the date of modification determines the incremental
value. In 2008, QuantRx modified warrants in connection with the
issuance of certain notes and note extensions. These modified warrants were
originally issued in connection with previous private placement investments. In
the case of equity issuances, these warrants were originally accounted for as
additional paid-in-capital. In the case of debt issuances, the
warrants were accounted for as original issuance discount based on their
relative fair values. When modified in connection with a note issuance, QuantRx
recognizes the incremental value as a part of the debt discount calculation,
using its relative fair value in accordance with EITF 00-27, “Application of
Issue 98-5 to Certain Convertible Instruments.” When modified in
connection with note extensions, the Company recognized the incremental value as
prepaid interest, which is expensed over the term of the extension.
Estimates
of share-based compensation expenses are significant to our financial
statements, but these expenses are based on option valuation models and will
never result in the payment of cash by us.
Deferred
Taxes
We
recognize deferred tax assets and liabilities based on differences between the
financial statement carrying amounts and tax bases of assets and liabilities,
which requires management to perform estimates of future transactions and their
respective valuations. We review our deferred tax assets for recoverability and
establish a valuation allowance if it is more likely than not that the Company
will not realize the benefit of the net deferred tax asset. At December 31, 2008
and 2007, a valuation allowance has been established. The likelihood of a
material change in the valuation allowance depends on our ability to generate
sufficient future taxable income. In the future, if management determines that
the likelihood exists to utilize the Company’s deferred tax assets, a reduction
of the valuation allowance could materially increase the Company’s net deferred
tax asset.
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not
required under Regulation S-K for “smaller reporting companies.”
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
Audited
consolidated balance sheets for the years ended December 31, 2008 and 2007 and
audited consolidated statements of operations, changes in stockholders’ equity
and cash flows for the years ended December 31, 2008 and 2007 are included
immediately following the signature page to this report, beginning on page
F-1.
ITEM
9. CHANGE IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE.
None.
29
ITEM
9A(T). CONTROLS AND PROCEDURES.
Disclosure
Controls and Procedures
As
required by Rules 13a-15 and 15d-15 of the Securities Exchange Act of 1934,
the Company has evaluated, under the supervision and with the participation of
management, including the Chief Executive Officer and the Chief Financial
Officer, the effectiveness of its disclosure controls and procedures (as defined
in such rules) as of the end of the period covered by this report. Based on such
evaluation, the Chief Executive Officer and Chief Financial Officer concluded
that the Company’s disclosure controls and procedures are effective to ensure
that information required to be disclosed by the Company in reports prepared in
accordance with the rules and regulations of the Securities and Exchange
Commission (SEC) is recorded, processed, summarized and reported within the time
periods specified by the SEC’s rules and forms. Additionally, the
Company’s disclosure controls and procedures are also effective to ensure that
information required to be disclosed by the Company in reports that are filed or
submitted under the Exchange Act is accumulated and communicated to management,
including the Chief Executive Officer and Chief Financial Officer, to allow
timely decisions regarding required disclosure.
Our
management, including the Company’s Chief Executive Officer and Chief Financial
Officer, does not expect that the Company’s disclosure controls and procedures
will prevent all errors and all fraud. A control system, no matter how well
conceived and operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. Further, the design of a
control system must reflect the fact that there are resource constraints, and
the benefits of controls must be considered relative to their costs. Because of
the inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if
any, within the Company have been detected. These inherent limitations include
the realities that judgments in decision-making can be faulty, and that
breakdowns can occur because of simple error or mistake.
Additionally,
controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. The
design of any system of controls also is based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all potential future
conditions; over time, controls may become inadequate because of changes in
conditions, or the degree of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations in a cost-effective control
system, misstatements due to error or fraud may occur and not be
detected.
Changes
in Internal Control over Financial Reporting
There
have been no changes in the Company’s internal control over financial reporting
that occurred during the fourth quarter of the year ended December 31, 2008
that have materially affected, or are reasonably likely to materially affect,
the Company’s internal control over financial reporting. The Company continues
to review its disclosure controls and procedures, including its internal
controls over financial reporting, and may from time to time make changes aimed
at enhancing their effectiveness and to ensure that the Company’s systems evolve
with its business.
30
Management’s
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting. Our internal control system is designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles in the United States (GAAP) and
includes those policies and procedures that:
|
·
|
pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of the assets of the
company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with GAAP, and that
receipts and expenditures of the company are being made only in accordance
with authorizations of management and directors of the company;
and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on its financial
statements.
|
Because
of its inherent limitations, a system of internal control over financial
reporting can provide only reasonable assurance and may not prevent or detect
misstatements. Further, because of changes in conditions, effectiveness of
internal controls over financial reporting may vary over time. Our system
contains self-monitoring mechanisms, and actions are taken to correct
deficiencies as they are identified.
Our
management conducted an evaluation of the effectiveness of the system of
internal control over financial reporting based on the framework in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission. Based on this evaluation, our management concluded
that our system of internal control over financial reporting was effective as of
December 31, 2008.
This
report does not include an attestation report of our registered public
accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by our registered public
accounting firm pursuant to temporary rules of the Securities and Exchange
Commission that permit us to provide only management’s report in this annual
report.
ITEM
9B. OTHER INFORMATION.
31
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The
following table sets forth the Company’s executive officers and directors as of
December 31, 2008:
Directors & Executive
Officers
|
Age
|
Position
|
||
Walter
W. Witoshkin(1)
|
64
|
Chairman
& CEO
|
||
William
H. Fleming, Ph.D.(2)
|
62
|
Director,
CSO & President of Diagnostics
|
||
Sasha
Afanassiev
|
41
|
CFO,
Treasurer & VP of Finance
|
||
Dr.
Shalom Hirschman(2)
|
72
|
Director
|
||
Dr.
Arthur Hull Hayes, Jr.(1)
|
75
|
Director
|
(1)
|
Mr.
Witoshkin and Dr. Hayes have been elected/ratified to hold office until
the next annual meeting of stockholders, or until their successor is duly
elected or appointed, unless their office is earlier
vacated.
|
(2)
|
Drs.
Fleming and Hirschman have been elected to hold office until the 2009
annual meeting of stockholders, or until their successor is duly elected
or appointed, unless their office is earlier
vacated.
|
Walter W.
Witoshkin is Chairman and Chief Executive Officer of QuantRx Biomedical
Corporation. A 40-year veteran of the pharmaceutical, healthcare and biomedical
industries, Mr. Witoshkin began serving as a Director and Chief Executive
Officer in May, 2005. He has held senior executive positions at leading
healthcare product and pharmaceutical companies, most recently SmithKline
Beecham, now Glaxo SmithKline, where he was a Vice President of Business
Development and Chief Financial Officer. In 1989, Mr. Witoshkin established
Menley & James Laboratories, Inc., after purchasing 32 SmithKline Beecham
over-the-counter pharmaceutical and toiletry product brands. Menley & James
had its initial public offering in 1992. He earlier held several senior finance
positions at American Cyanamid, which became American Home and then Wyeth. Mr.
Witoshkin joined QuantRx from Trident Group LLC, global operational consultants
to the pharmaceutical and related healthcare industries. As a founding partner
of Trident Group, Mr. Witoshkin specialized in alternative sourcing for
manufacturing and the acquisition of technologies and products.
Mr.
Witoshkin also serves as a director of Echo Therapeutics, Inc. and a number of
privately held companies, including QuantRx subsidiary
FluoroPharma.
William
H. Fleming, Ph.D., has served as President of Diagnostics since November 2008,
Chief Scientific Officer of QuantRx since July 2005, and as a Director and
Secretary of QuantRx since February 1994. Prior to that, he served as
Vice President of Diagnostics from August 1997 through July 2005, and as Acting
CEO from 2003 until May 2005. From February 1994 through August 1997, Dr.
Fleming served as President and Chief Operating Officer. In addition, he was
President, Chief Operating Officer and a Director of ProFem from July 1993 until
its merger with QuantRx in June 1994. From April 1992 until July 1993, Dr.
Fleming served as an associate with Sovereign Ventures, a healthcare consulting
firm; concurrently he served as director of corporate development of Antivirals,
Inc., a biotechnology company involved in antisense technology. Dr. Fleming is a
director of ERC, a non-profit organization.
Sasha
Afanassiev has served as Chief Financial Officer and Vice President of Finance
of QuantRx Biomedical Corporation since September 2005, and has also served as
Treasurer of the Company since December 2005. Prior to joining QuantRx, Mr.
Afanassiev worked in public accounting from 1989 through 2001, where he serviced
a widely diversified client base. In 2001 Mr. Afanassiev established a
managerial accounting and tax consulting firm as principal and founder. Mr.
Afanassiev holds a bachelor’s degree from Temple University’s School of Business
and Management and is a licensed Certified Public Accountant in the Commonwealth
of Pennsylvania.
32
Independent
Directors
Shalom
Hirschman has served as a Director of QuantRx since September 2005. Dr.
Hirschman was Professor of Medicine, Director of the Division of Infectious
Diseases and Vice-Chairman of the Department of Medicine at Mt. Sinai School of
Medicine and the Mount Sinai Hospital. He spent nearly three decades at Mt.
Sinai until his retirement. He then became the CEO, President and Chief
Scientific Officer of Advanced Viral Research Corp. from which he retired in
2004.
Arthur
Hull Hayes, Jr. has served as a Director of QuantRx since September 2006. Dr.
Hayes served as Commissioner of the United States Food and Drug Administration
from 1981 to 1983. Dr. Hayes founded and was President and Chief Operating
Officer of MediScience Associates, Inc., a consulting organization that works
with pharmaceutical firms, biomedical companies and foreign governments, from
July 1991 to January 2006, and Clinical Professor of Medicine and Pharmacology
at the Pennsylvania State University College of Medicine from 1981 to 2004. From
1986 to 1990, Dr. Hayes was President and Chief Executive Officer of E.M.
Pharmaceuticals, a North American subsidiary of Germany’s E. Merck
AG.
Compliance
with Section 16(a) of the Exchange Act
Section 16(a)
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
requires the Company’s Directors and Officers, and persons who own more than 10%
of a registered class of the Company’s equity securities (“Section 16 Persons”),
to file with the SEC initial reports of ownership and reports of changes in
ownership of common stock and other equity securities of the Company. Section 16
Persons are required by SEC regulation to furnish the Company with copies of all
Section 16(a) reports they file. Based on the Company’s review of the forms
it has received, on other reports filed by Section 16 Persons with the SEC and
on the Company’s records, the Company believes that during 2008, (1) the Form 4
filed on behalf of Arthur H. Hayes, Jr. to report the grant of 6,250 common
stock options was not filed timely.
Family
Relationships
There are
no family relationships among our directors, executive officers or persons
nominated or chosen to become directors or executive officers of
ours.
Involvement
in Certain Legal Proceedings
QuantRx
is not aware of any events that have occurred during the past five years that
are required to be disclosed pursuant to Item 401(F) of Regulation
S-K.
Code
of Ethics
QuantRx
has adopted a code of ethics, which applies to all our directors, officers and
employees. Our code of ethics is intended to comply with the requirements of
Item 406 of Regulation S-K. A copy of the Company’s code of ethics may also be
obtained by any person without charge by sending a written request addressed to:
QuantRx Biomedical Corporation, 100 South Main Street, Suite 300, Doylestown,
Pennsylvania 18901.
33
Audit
Committee
As of the
date hereof, Shalom Hirschman and William Fleming serve on the audit committee
of the Company’s board of directors. William Fleming is the chairperson of
the audit committee. Our board of directors has not yet designated an
independent financial expert, as defined by the SEC, as it is still recruiting
qualified candidates to fill the position. During the last fiscal year the audit
committee held no separate meetings. Until such time as a financial expert is
appointed, all members of our board of directors perform the responsibilities of
the audit committee, providing oversight of our accounting functions and
controls.
Compensation
Committee
As of the
date hereof, Arthur H. Hayes, Jr. and William Fleming serve on the compensation
committee of the Company’s board of directors. Arthur H. Hayes, Jr. is the
chairperson of the compensation committee. The compensation committee reviews
and recommends to the Board the compensation and benefits of our executive
officers, administers our stock option plans, and establishes general policies
relating to compensation and employee benefits. During the last fiscal year the
compensation committee held no meetings.
Nominating
Committee
The
Company’s entire Board participates in consideration of director nominees. The
Board will consider candidates who have experience as a board member or senior
officer of a company or who are generally recognized in a relevant field as a
well-regarded practitioner, faculty member or senior government
officer. The Board will also evaluate whether the candidate’s skills
and experience are complementary to the existing Board’s skills and experience
as well as the Board’s need for operational, management, financial,
international, technological or other expertise. The Board will interview
candidates that meet the criteria, then select nominees that the Board believes
best suit the Company’s needs.
The Board
will consider qualified candidates suggested by stockholders for director
nominations. Stockholders can suggest qualified candidates for
director nominations by writing to the Company’s Corporate Secretary, William
Fleming, at 5920 NE 112th Avenue,
Portland, Oregon, 97220. Submissions that are received that meet the
criteria described above will be forwarded to the Board for further review and
consideration. The Board will not evaluate candidates proposed by
stockholders any differently than other candidates.
34
ITEM
11. EXECUTIVE COMPENSATION.
Summary
Compensation
The
following Summary Compensation Table sets forth summary information as to
compensation received by the Company’s Chief Executive Officer and the two other
most highly compensated executive officers of the Company as of
December 31, 2008.
Name
And
Principal
Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan Compensation
($)
|
Nonqualified
Deferred Compensation Earnings
($)
|
All
other Compensation
($)
|
Total
($)
|
|||||||||||||||||||||||||
Walter
W. Witoshkin, CEO
|
2008
|
240,000 | - | - | 415,692 | (1) | - | - | - | 655,692 | ||||||||||||||||||||||||
2007
|
240,000 | 75,000 | - | 153,712 | (2) | - | - | - | 468,712 | |||||||||||||||||||||||||
Sasha
Afanassiev, CFO,
Treasurer & VP of Finance
|
2008
|
150,000 | - | - | 94,458 | - | - | - | 244,458 | |||||||||||||||||||||||||
2007
|
150,000 | - | - | 10,375 | - | - | - | 160,375 | ||||||||||||||||||||||||||
Dr.
William Fleming, CSO, President of
Diagnostics
|
2008
|
140,000 | - | - | 62,925 | - | - | - | 202,925 | |||||||||||||||||||||||||
2007
|
129,583 | - | - | 42,175 | - | - | - | 171,758 | ||||||||||||||||||||||||||
Cindy Horton, (3)
VP
of Diagnostics
|
2008
|
116,875 | - | - | 88,775 | (4) | - | - | - | 205,650 | ||||||||||||||||||||||||
2007
|
150,000 | - | - | 42,175 | - | - | - | 192,175 |
(1)
|
Includes
$16,244 related to the issuance of options from a subsidiary for his
directorship.
|
(2)
|
Includes
$35,383 related to the issuance of options from a subsidiary for his
directorship.
|
(3)
|
No
longer employed effective November 30, 2008 – reported pursuant to Item
402(M)(2)(iii) of Regulation S-K.
|
(4)
|
All
options related to this compensation were forfeited effective February 28,
2009.
|
The
amounts in the Option Awards column reflect the dollar amount recognized and
expensed for financial statement reporting purposes for the years ended December
31, 2008 and 2007, in accordance with SFAS 123(R) of awards of stock options and
thus do not represent aggregate fair value of grants. The Company used the
Black-Scholes option price calculation to value the options granted in 2008 and
2007 using the following assumptions: risk-free rate of 5.35% and 5.77%;
volatility of 1.17 and 1.35; actual term and exercise price of options granted.
See Note 15 to the Consolidated Financial Statements for more details on option
issuances.
Employment
Contracts
We have
entered into an employment contract with our Chief Executive Officer that
provides for the continuation of salary if terminated for reasons other than
cause, as defined in those agreements. At December 31, 2008, the future
employment contract commitment for such key executive based on stated
termination clause was approximately $240,000. All other employees are “at-will”
employees and may be terminated at any time by the Company.
35
Outstanding
Equity Awards at Fiscal Year-End
Option
Awards
|
|||||||||||||||||
Name
|
Number
of Securities Underlying Unexercised Options
(#)
Exercisable
|
Number
of Securities Underlying Unexercised Options
(#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options
(#)
|
Option
Exercise Price
($)
|
Option
Expiration Date
|
||||||||||||
Walter
W. Witoshkin, CEO &
President (1)
|
1,000,000
250,000
291,667
|
-
-
-
|
-
-
58,333
|
0.50
0.85
0.80
|
05/03/2015
10/08/2017
02/28/2018
|
||||||||||||
Sasha
Afanassiev, CFO,
Treasurer & VP of Finance (2)
|
25,000
75,000
50,000
83,333
|
-
-
-
-
|
-
-
-
16,667
|
1.60
1.15
0.85
0.80
|
04/03/2016
07/25/2016
10/08/2017
02/28/2018
|
||||||||||||
Dr.
William Fleming,
CSO, President of
Diagnostics
|
-
50,000
|
-
-
|
100,000
-
|
1.60
0.85
|
04/03/2016
10/08/2017
|
||||||||||||
Cindy
Horton,
VP
of Diagnostics (4)
|
50,000
37,500
|
-
-
|
-
-
|
0.85
0.80
|
10/08/2017
02/28/2018
|
(1)
|
Options
granted 05/03/2005, which expire 05/03/2015 vested as follows; 333,000
shares vested on May 3, 2005 and the remaining options continued to vest
with respect to 18,527 shares each monthly anniversary thereafter until
fully-vested. Options granted 10/08/2007 which expire 10/08/2017 vested
monthly over one year. Options granted 02/29/08 which expire 02/28/2018
vest monthly over one year.
|
(2)
|
Options
granted 04/03/2006 which expire 04/03/2016 vested immediately. Options
granted 07/25/2006 which expire 07/25/2016 vested January 1, 2007. Options
granted 10/08/2007 which expire 10/08/2017 vested monthly over one year.
Options granted 02/29/08 which expire 02/28/18 vest monthly over one
year.
|
(3)
|
Options
granted 04/03/2006 vest upon meeting certain sales milestones which have
not yet been met. Term of the options is ten years. Options granted
10/08/2007 which expire 10/08/2017 vested monthly over one
year.
|
(4)
|
Options
granted 10/08/2007 which were to expire 10/08/2017 vested monthly over one
year. Options granted 02/29/08 which were to expire 02/28/18 vested
monthly over one year. No longer employed effective November 30, 2008 –
all options were forfeited effective February 28,
2009.
|
There are
no outstanding stock awards as of December 31, 2008. Exercise prices of all the
above option awards were equal to or exceeded the closing stock price on the
date of grant.
The
Company used the Black-Scholes option price calculation to value the options
granted in 2008 and 2007 using the following assumptions: risk-free rate of
5.35% and 5.77%; volatility of 1.17 and 1.35; actual term and exercise price of
options granted. See Note 15 to the Consolidated Financial Statements for more
details on option issuances.
Director
Compensation
QuantRx
compensates independent members of the Board of Directors cash compensation of
$5,000 and 6,250 stock options per Board meeting attended in person; up to a
maximum of four meetings per year. All options are granted at year end and have
a term of five years and an exercise price equal to the closing stock price on
date of grant.
36
The
following table summarizes Director Compensation for the year ended December 31,
2008.
Name
|
Fees
Earned or Paid in Cash ($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan Compensation
($)
|
Nonqualified
Deferred Compensation Earnings
($)
|
All
Other Compensation ($)
|
Total
($)
|
|||||||||||||||||||||
Walter
W. Witoshkin
|
- | - | - | - | - | - | - | |||||||||||||||||||||
William
H. Fleming, Ph.D.
|
- | - | - | - | - | - | - | |||||||||||||||||||||
Dr.
Shalom Hirschman (1)
|
- | - | - | - | - | $ | 20,000 | $ | 20,000 | |||||||||||||||||||
Dr.
Arthur Hull Hayes, Jr. (2)
|
$ | 5,000 | - | $ | 1,813 | - | - | - | $ | 6,813 |
(1)
|
Dr.
Shalom Hirschman did not receive compensation related to his directorship
pursuant to the terms of a consulting agreement in effect during 2008. He
received a monthly fee of $4,000 through May 2008. Additional details can
be found in Note 16 to the Consolidated Financial
Statements.
|
(2)
|
Dr.
Arthur H. Hayes, Jr. received an option grant at December 31, 2008 for
6,250 common shares. Material terms are as follows: December 31, 2008
grant date, exercise price of $0.35 and a five year
term.
|
The
Company used the Black-Scholes option price calculation to value the options
granted in 2008 using the following assumptions: risk-free rate of 5.35%;
volatility of 1.17; actual term and exercise price of options
granted.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS.
The
following table sets forth certain information as of March 20, 2009, concerning
the ownership of common stock by (i) each stockholder of the Company known
by the Company to be the beneficial owner of more than 5% of the outstanding
shares of common stock, (ii) each current member of the Board of Directors
of the Company, and (iii) each Executive Officer of the Company named in
the Summary Compensation Table appearing under “Executive Compensation”
above.
The
number and percentage of shares beneficially owned is determined in accordance
with Rule 13(d)(3) of the Securities Exchange Act and the information is not
necessarily indicative of beneficial ownership for any other purpose. Under that
rule, beneficial ownership includes any shares as to which the individual or
entity has voting power or investment power and any shares that the individual
has the right to acquire within 60 days through the exercise of any stock option
or other right. Unless otherwise indicated in the footnotes or table, each
person or entity has sole voting and investment power, or shares such powers
with his or her spouse, with respect to the shares shown as beneficially
owned.
37
The
Company had only common stock outstanding at March 20, 2009; therefore the
following table refers to our common stock.
Name
and Address of Beneficial Owner (1)
|
Amount
and Nature of Beneficial Ownership as of March 20, 2009
|
Percentage
of Class (2)
|
||||||
Walter
W. Witoshkin (3)
|
2,100,000
|
4.65%
|
||||||
William
H. Fleming(4)
|
652,034
|
1.51%
|
||||||
Shalom
Hirschman (5)
|
506,250
|
1.18%
|
||||||
Sasha
Afanassiev (6)
|
400,000
|
0.92%
|
||||||
Arthur
Hull Hayes, Jr. (7)
|
18,750
|
0.04%
|
||||||
Evan
Levine (8)
6725
Mesa Ridge Road, Suite 100
San
Diego, CA 92121
|
3,439,800
|
7.99%
|
||||||
Matthew
Balk (9)
570
Lexington Avenue
New
York, NY 10021
|
5,728,009
|
13.30%
|
||||||
Mark
Capital, LLC
6725
Mesa Ridge Road, Suite 100
San
Diego, CA 92121
|
2,422,700
|
5.63%
|
||||||
Sherbrooke
Partners, LLC
570
Lexington Avenue
New
York, NY 10021
|
4,508,009
|
10.47%
|
(1)
|
Unless
indicated otherwise, the address of each person listed in the table is:
c/o QuantRx Biomedical Corporation, 100 South Main Street, Suite 300,
Doylestown, Pennsylvania 18901.
|
||
(2)
|
The
percentage of beneficial ownership of common stock is based on 43,067,630
shares of common stock outstanding as of March 20, 2009 and excludes all
shares of common stock issuable upon the exercise of outstanding options
or warrants to purchase common stock or conversion of any common stock
equivalents, other than the shares of common stock issuable upon the
exercise of options or warrants to purchase common stock held by the named
person to the extent such options or warrants are exercisable within 60
days of March 20, 2008.
|
||
(3)
|
Ownership
is based upon 1,600,000 common stock options currently exercisable and
common stock warrants currently exercisable for 500,000 common shares
issued January 15, 2009.
|
||
(4)
|
Ownership
includes beneficial ownership of 1,000 shares of common stock held by the
executive’s father, 50,000 common stock options currently exercisable, and
common stock warrants currently exercisable for 110,000 common shares
issued January 15, 2009.
|
||
(5)
|
Ownership
includes 6,250 common stock options currently
exercisable.
|
||
(6)
|
Ownership
is based on 250,000 common stock options currently exercisable and common
stock warrants currently exercisable for 150,000 common shares issued
January 15, 2009.
|
||
(7)
|
Ownership
is based on 18,750 common stock options currently
exercisable.
|
||
(8)
|
Includes
2,422,700 shares of common stock held by Mark Capital, LLC of which Evan
Levine is the managing member; 990,000 shares of common stock held by Mr.
Levine as custodian for his two children; and 27,100 shares of common
stock held by Mr. Levine in an IRA.
|
||
(9)
|
Includes
4,508,009 shares of common stock held by Sherbrooke Partners, LLC, of
which Matthew Balk is the sole member; and 1,220,000 shares of common
stock held by Mr. Balk as custodian for his two
children.
|
38
Equity
Compensation Plan Information
The
following table provides information as of December 31, 2008 regarding
equity compensation plans approved by the Company’s security holders. The
Company does not have any equity compensation plans that have not been approved
by our security holders.
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 the second
column)
|
|||||||||
1997
Equity compensation plans approved by security holders
|
1,272,500 | $ | 0.68 | - | ||||||||
2007
Equity compensation plans approved by security holders
|
965,500 | $ | 0.82 | 7,034,500 |
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
Transactions
with Related Parties
A member
of the Company’s board of directors, Dr. Shalom Hirschman, served as a
consultant to the Company on various business, strategic, and technical issues.
His contract expired May 31, 2008. Fees paid and expensed under these
agreements for these services by the Company during the years ended December 31,
2008 and 2007 were $20,000 and $48,000, respectively. In addition to the
contract fees paid, reimbursable expenses totaling $10,000 were paid in
2007.
In August
2008, in connection with a debt financing, QuantRx incurred cash commissions of
$50,000 to Burnham Hill Partners, of which Matthew Balk, a beneficial owner of
more than 5% of QuantRx common stock is a managing member. Burnham Hill Partners
was the placement agent for the debt financing. These commissions are
outstanding as of December 31, 2008.
On June
16, 2008, in connection with a debt financing, QuantRx issued warrants with a
five-year term valued at $64,000 to purchase an aggregate of 100,000 shares of
common stock at $0.85 per share to Burnham Hill Partners, of which Matthew Balk,
a beneficial owner of more than 5% of QuantRx common stock is a managing member.
Burnham Hill Partners was the placement agent for the debt financing.
Additionally, cash commissions of $55,000 are due to Burnham Hill Partners for
its role as placement agent in the transaction as of December 31,
2008.
In the
first quarter of 2008, in connection with a debt financing, QuantRx issued
warrants with a five-year term valued at $55,750 to purchase an aggregate of
100,000 shares of common stock at $1.10 per share to Burnham Hill Partners, of
which Matthew Balk, a beneficial owner of more than 5% of QuantRx common stock
is a managing member. Burnham Hill Partners was the placement agent for the debt
financing. Additionally, cash commissions of $70,000 are due to Burnham Hill
Partners for its role as placement agent in the transaction as of December 31,
2008.
39
In
October 2007, in connection with a debt financing, QuantRx issued warrants with
a five-year term valued at $65,000 to purchase an aggregate of 100,000 shares of
common stock at $1.10 per share to Burnham Hill Partners, of which Matthew Balk,
a beneficial owner of more than 5% of outstanding shares of common stock, is a
managing member. Burnham Hill Partners was the placement agent for the debt
financing. Additionally, cash commissions of $70,000 were incurred for Burnham
Hill Partners for its role as placement agent in the transaction, of which
$50,000 was paid in the third quarter of 2008, and $20,000 remains outstanding
as of December 31, 2008.
On March
9, 2007 the Company issued 200,000 common stock warrants with a five year term
to purchase 200,000 shares of common stock at an exercise price of $1.50. The
warrants were issued as payment for financial advisory services to Burnham Hill
Partners, of which Matthew Balk, a beneficial owner of more than 5% of
outstanding shares of common stock, is a managing member. The fair value for
these warrants is estimated to be $250,000. Additionally, cash compensation of
$200,000 was paid pursuant to the terms of the agreement.
Director
Independence
The
Company has determined that two of the four Directors serving at December 31,
2008 (Dr. Shalom Hirschman and Dr. Arthur Hull Hayes, Jr.), were
independent.
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
Audit
Fees
The
aggregate fees billed for professional services rendered by Williams &
Webster, P.S. for the audit of our annual financial statements and the reviews
of financial statements included in our Forms 10-Q/QSB for years 2008 and 2007
are set forth in the table below.
2008
|
2007
|
|||||||
Williams
& Webster, P.S.
|
$ | 31,169 | $ | 80,905 |
Audit-Related
Fees
During
the years ended December 31, 2008 and 2007, no assurance or related
services were performed by Williams & Webster P.S. that were reasonably
related to the performance of the audit or review of our financial
statements.
Tax
Fees
During
the years ended December 31, 2008 and 2007, $2,392 and $7,579 in fees were
billed by Williams & Webster, P.S. for tax compliance, tax advice or tax
planning services.
All
Other Fees
During
the years ended December 31, 2008 and 2007, no fees were billed by Williams
& Webster, P.S. other than the fees set forth under the captions “Audit
Fees” and “Tax Fees” above.
40
Pre-Approval
Policies and Procedures of the Audit Committee
The Audit
Committee has the sole authority to appoint, terminate and replace our
independent auditor. The Audit Committee may not delegate these
responsibilities. The Audit Committee has the sole authority to approve the
scope, fees and terms of all audit engagements, as well as all permissible
non-audit engagements of our independent auditor. 100% of the services provided
by Williams & Webster, P.S. were pre-approved by the Audit
Committee.
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
Exhibit
No.
|
Description
|
|
3.1
|
Amended
and Restated Articles of Incorporation of the Company (incorporated by
reference to Exhibit 3.1 filed with Form 10-KSB filed on April 16,
2001)
|
|
3.2
|
Certificate
of Amendment to the Articles of Incorporation of the Company, dated
November 30, 2005 (incorporated by reference to Exhibit 3.2 filed with
Form 10-KSB on March 31, 2006)
|
|
3.3
|
Bylaws
of the Company (incorporated by reference to Exhibit 3.2 filed with Form
10KSB40/A filed on September 23, 1999)
|
|
3.4
|
Certificate
of Amendment to the Bylaws of the Company dated December 2, 2005
(incorporated by reference to Exhibit 3.4 filed with Form 10-KSB on March
31, 2006)
|
|
4.1
|
Form
of 8% Convertible Promissory among the Company and
investors (incorporated by reference to Exhibit 4.1 filed with Form
10-KSB on March 31, 2006)
|
|
4.2
|
Form
of Warrant to Purchase Shares of Common Stock among the Company and
investors (incorporated by reference to Exhibit 4.2 filed with Form 10-KSB
on March 31, 2006)
|
|
4.3
|
Form
of Warrant to Purchase Common Stock among the Company and investors
(incorporated by reference to Exhibit 4.3 filed with Form 10-KSB on March
31, 2006)
|
|
4.4
|
Warrant
to Purchase Common Stock, dated November 8, 2005, between the Company and
Burnham Hill Partners (incorporated by reference to Exhibit 4.4 filed with
Form 10-KSB on March 31, 2006)
|
|
4.5
|
Form
of Senior Convertible Promissory Note, dated October __, 2007, from
QuantRx Biomedical Corporation in favor of Investor (incorporated by
reference to Exhibit 4.1 filed with Form 8-K on October 24,
2007)
|
|
4.6
|
Form
of Warrant to Purchase Shares of Common Stock of QuantRx Biomedical
Corporation, dated October __, 2007 (incorporated by reference to Exhibit
10.2 filed with Form 8-K on October 24, 2007)
|
|
4.7
|
Form
of 10% Senior Secured Convertible Promissory Note maturing January 23,
2009, issued by QuantRx in favor of Investors (incorporated by
reference to Exhibit 4.1 filed with Form 8-K on January 29,
2008).
|
|
4.8
|
Form
of Warrant to Purchase Shares of Common Stock of QuantRx issued by QuantRx
in favor of Investors (incorporated by reference to Exhibit 4.2 filed
with Form 8-K on January 29, 2008).
|
|
4.9
|
Form
of Senior Secured Bridge Note, dated June 2008 and maturing September 15,
2008, issued by QuantRx in favor of lender (incorporated by reference to
Exhibit 4.1 filed with Form 8-K on July 28,
2008).
|
41
4.10
|
Form
of Warrant to Purchase Shares of Common Stock of QuantRx, dated June 2008,
issued by QuantRx in favor of lender (incorporated by reference to Exhibit
4.2 filed with Form 8-K on July 28, 2008).
|
|
4.11
|
Form
of Promissory Bridge Note, dated August 2008 and maturing October 31,
2008, issued by QuantRx in favor of lender (incorporated by reference to
Exhibit 4.1 filed with Form 8-K on August 27, 2008).
|
|
4.12
|
Form
of Warrant to Purchase Shares of Common Stock of QuantRx, dated August
2008, issued by QuantRx in favor of lender. (incorporated by reference to
Exhibit 4.2 filed with Form 8-K on August 27, 2008).
|
|
10.1
|
Letter
Agreement, dated December 3, 2005, between the Company and Univest Capital
Limited (incorporated by reference to Exhibit 10.1 filed with Form 10-KSB
on March 31, 2006)
|
|
10.2
|
Letter
Agreement, dated November 8, 2005, between the Company and Burnham Hill
Partners (incorporated by reference to Exhibit 10.2 filed with Form 10-KSB
on March 31, 2006)
|
|
10.3
|
Letter
Agreement, dated November 1, 2005, between the Company and Dawson James
Securities, Inc. (incorporated by reference to Exhibit 10.3 filed with
Form 10-KSB on March 31, 2006)
|
|
10.4
|
Letter
Agreement, dated April 13, 2005, between the Company and Dawson James
Securities, Inc. (incorporated by reference to Exhibit 10.4 filed with
Form 10-KSB on March 31, 2006)
|
|
10.5
|
Distribution
Agreement, dated as of July 7, 2006, between Synova, Inc. and the Company
(incorporated by reference to Exhibit 10.1 filed with Form 10-QSB on
November 14, 2006)
|
|
10.6
|
Common
Stock and Warrant Purchase Agreement, dated as of December 6, 2006, among
the Company and the purchasers specified therein (incorporated by
reference to Exhibit 10.1 filed with Form 8-K on December 12,
2006)
|
|
10.7
|
Form
of Warrant to Purchase Common Stock among the Company and investors
(incorporated by reference to Exhibit 10.2 filed with Form 8-K on December
12, 2006)
|
|
10.8
|
Registration
Rights Agreement, dated as of December 6, 2006, among the Company and the
purchasers specified therein (incorporated by reference to Exhibit 10.3
filed with Form 8-K on December 12, 2006)
|
|
10.9
|
Investment
Agreement, dated as of February 17, 2006, between QuantRx Biomedical
Corporation and FluoroPharma, Inc.("Investment Agreement”) (incorporated
by reference to Exhibit 10.1 filed with Form 10-QSB/A on December 1,
2006)
|
|
10.10
|
Amendment
No. 1, dated as of February 28, 2006, to Investment Agreement
(incorporated by reference to Exhibit 10.2 filed with Form 10-QSB/A on
December 1, 2006)
|
|
10.11
|
Amendment
No. 2, dated as of March 10, 2006, to Investment Agreement (incorporated
by reference to Exhibit 10.3 filed with Form 10-QSB/A on December 1,
2006)
|
|
10.12
|
Option
Agreement, dated as of February 17, 2006, between QuantRx Biomedical
Corporation and FluoroPharma, Inc. ("Option Agreement") (incorporated by
reference to Exhibit 10.4 filed with Form 10-QSB/A on December 1,
2006)
|
|
10.13
|
Amendment
No. 1, dated as of February 28, 2006, to Option Agreement (incorporated by
reference to Exhibit 10.5 filed with Form 10-QSB/A on December 1,
2006)
|
|
10.14
|
Amended
and Restated Investors Rights Agreement, dated as of February 17, 2006, by
and among QuantRx Biomedical Corporation, FluoroPharma, Inc. and the
stockholders of FluoroPharma, Inc. (incorporated by reference to Exhibit
10.6 filed with Form 10-QSB/A on December 1, 2006)
|
|
10.15
|
Letter
Agreement, dated October 20, 2006, between the Company and Legend Merchant
Group, Inc. (incorporated by reference to exhibit 10.15 filed with Form
10-K on April 2, 2007)
|
|
10.16
|
Stage
2 Investment Agreement, dated as of April 5, 2007, between QuantRx
Biomedical Corporation and FluoroPharma, Inc. (incorporated by reference
to Exhibit 10.1 filed with Form 8-K on April 19,
2007)
|
42
10.17
|
2007
Incentive and Non-Qualified Stock Option Plan (incorporated by reference
to Exhibit C filed with Schedule 14A on June 5, 2007)
|
|
10.18
|
Form
of Letter Loan Agreement, dated October __, 2007, between Investor and
QuantRx Biomedical Corporation (incorporated by reference to Exhibit 10.1
filed with Form 8-K on October 24, 2007)
|
|
10.19
|
Form
of Letter Loan Agreement issued by QuantRx in favor of Investors
(incorporated by reference to Exhibit 10.1 filed with Form 8-K on January
29, 2008).
|
|
10.20
|
Form
of Stock Pledge Agreement, dated January 23, 2008, issued by QuantRx in
favor of Investors (incorporated by reference to Exhibit 10.2 filed with
Form 8-K on January 29, 2008).
|
|
10.21
|
Form
of Patent, Trademark and Copyright Security Agreement issued by QuantRx in
favor of Investors (incorporated by reference to Exhibit 10.3 filed with
Form 8-K on January 29, 2008).
|
|
10.22
|
Form
of Bridge Letter Loan Agreement, dated June 2008, between QuantRx and
lender (incorporated by reference to Exhibit 10.1 filed with Form 8-K on
July 28, 2008).
|
|
10.23
|
Form
of Stock Pledge Agreement, dated June 2008, between QuantRx and lender
(incorporated by reference to Exhibit 10.2 filed with Form 8-K on July 28,
2008).
|
|
10.24
|
Form
of Patent, Trademark and Copyright Security Agreement, dated June 2008,
between QuantRx and lender (incorporated by reference to Exhibit 10.3
filed with Form 8-K on July 28, 2008).
|
|
10.25
|
Form
of Letter Loan Agreement, dated August 2008, between QuantRx and lender
(incorporated by reference to Exhibit 10.1 filed with Form 8-K on August
27, 2008).
|
|
14.1
|
Ethical
Guidelines adopted by the Board of Directors of the Company on May 31,
2005 (incorporated by reference to Exhibit 14.1 filed with Form
10-KSB on March 31, 2006)
|
|
21.1
|
List
of subsidiaries of the Company as of December 31, 2008
|
|
31.1
|
Certification
of Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2
|
Certification
of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
32.1*
|
Certification
of Principal Executive Officer pursuant to 18 USC Section 1350 as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
32.2*
|
Certification
of Principal Financial Officer pursuant to 18 USC Section 1350 as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
*
The certifications attached as Exhibits 32.1 and 32.2 accompany this Annual
Report on Form 10-K pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
and shall not be deemed "filed" by QuantRx Biomedical Corporation for purposes
of Section 18 of the Exchange Act.
43
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
QuantRx Biomedical Corporation | |||
Date: April
15, 2009
|
By:
|
/s/ Walter W. Witoshkin | |
Walter W. Witoshkin, Chairman & CEO |
Date: April
15, 2009
|
By:
|
/s/ Sasha Afanassiev | |
Sasha Afanassiev, CFO, Treasurer & VP of Finance |
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.
QuantRx Biomedical Corporation | |||
Date:
April 15, 2009
|
By:
|
/s/ Walter W. Witoshkin | |
Walter W. Witoshkin, Director |
Date:
April 15, 2009
|
By:
|
/s/ William H. Fleming | |
William H. Fleming, Director |
Date:
April 15, 2009
|
By:
|
/s/ Shalom Hirschman | |
Shalom Hirschman, Director |
44
STATEMENT
OF INFORMATION FURNISHED
The
following financial statements have been prepared in accordance with Form 10-K
instructions and in the opinion of management contain all adjustments
(consisting of only normal and recurring accruals) necessary to present fairly
the consolidated financial position as of December 31, 2008 and 2007, the
consolidated results of operations for the years ended December 31, 2008 and
2007, consolidated cash flows for the years ended December 31, 2008 and 2007,
and Consolidated Statements of Stockholders’ Equity for the years ended December
31, 2008 and 2007. These results have been determined on the basis of generally
accepted accounting principles and practices applied consistently.
45
QUANTRX
BIOMEDICAL CORPORATION
FINANCIAL
STATEMENTS
Table
of Contents
Report
of Independent Registered Public Accounting Firm
|
F-2 | |||
Consolidated
Balance Sheets as of December 31, 2008 and 2007
|
F-3 | |||
Consolidated
Statements of Operations for the Years Ended December 31, 2008 and
2007
|
F-4 | |||
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2008 and
2007
|
F-5 | |||
Consolidated
Statements of Stockholders’ Equity for the Years Ended December 31, 2008
and 2007
|
F-7 | |||
Notes
to Consolidated Financial Statements
|
F-8 |
F-1
QuantRx
Biomedical Corporation
Doylestown,
Pennsylvania
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have
audited the accompanying consolidated balance sheets of QuantRx Biomedical
Corporation as of December 31, 2008 and 2007, and the related statements of
operations, stockholders’ equity and cash flows for the years then
ended. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We conducted our audit in
accordance with the standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are
free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also
includes assessing the accounting principles used and significant estimates made
by management, as well as evaluating the overall financial statement
presentation. We believe that our audit provides a reasonable basis
for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of QuantRx Biomedical Corporation as
of December 31, 2008 and 2007 and the results of its operations, stockholders
equity and its cash flows for the years then ended in conformity with accounting
principles generally accepted in the United States of America.
The
accompanying consolidated financial statements have been prepared assuming the
Company will continue as a going concern. As discussed in Note 2 to the
financial statements, the Company has suffered recurring losses from operations
and has a net capital deficiency that raises substantial doubt about its ability
to continue as a going concern. Management’s plans in regard to these
matters are also described in Note 2. The financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.
Williams
& Webster, P.S.
Certified
Public Accountants
Spokane,
Washington
April 14,
2009
F-2
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
BALANCE SHEETS
December
31, 2008
|
December
31, 2007
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ | 66,226 | $ | 213,332 | ||||
Accounts
receivable
|
45,760 | 80,758 | ||||||
Interest
receivable, net of allowance for bad debt of $14,000
|
- | - | ||||||
Interest
receivable – related party
|
31,689 | 15,650 | ||||||
Inventories
|
40,138 | 37,313 | ||||||
Prepaid
expenses
|
189,049 | 227,022 | ||||||
Note
receivable, net of allowance for bad debt of $200,000
|
- | - | ||||||
Note
receivable – related party
|
200,000 | 200,000 | ||||||
Deferred
finance costs, net
|
8,693 | 107,507 | ||||||
Deposits
|
104,146 | 4,448 | ||||||
Total
Current Assets
|
685,701 | 886,030 | ||||||
Investments
|
200,000 | 200,000 | ||||||
Property
and equipment, net
|
496,206 | 391,720 | ||||||
Intangible
assets, net
|
2,012,097 | 2,162,225 | ||||||
Security
deposits
|
10,667 | 10,667 | ||||||
Total
Assets
|
$ | 3,404,671 | $ | 3,650,642 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 2,205,661 | $ | 720,408 | ||||
Accrued
expenses
|
298,692 | 233,283 | ||||||
Deferred
revenue, current
|
58,781 | - | ||||||
Short-term
convertible notes payable, net of discount
|
2,510,054 | 795,476 | ||||||
Short-term
secured promissory notes payable
|
350,000 | - | ||||||
Short-term
promissory notes payable, net of discount
|
1,061,278 | - | ||||||
Security
deposits
|
2,000 | 2,000 | ||||||
Loans
payable, current portion
|
5,731 | 10,882 | ||||||
Total
Current Liabilities
|
6,492,197 | 1,762,049 | ||||||
Loans
payable, long-term portion
|
- | 5,733 | ||||||
Notes
payable, long-term portion
|
44,000 | 44,000 | ||||||
Total
Liabilities
|
6,536,197 | 1,811,782 | ||||||
Commitments
and Contingencies
|
||||||||
Minority
Interest
|
- | - | ||||||
Stockholders’
Equity (Deficit):
|
||||||||
Convertible
preferred stock; $0.01 par value, 25,000,000 authorized
|
||||||||
Series
A shares 9,750,000 designated; no shares issued and
|
||||||||
outstanding
|
- | - | ||||||
Common
stock; $0.01 par value, 75,000,000 authorized;
|
||||||||
42,886,380
and 41,699,681 shares issued and outstanding
|
428,863 | 416,996 | ||||||
Additional
paid-in capital
|
41,549,234 | 38,810,086 | ||||||
Accumulated
deficit
|
(45,109,623 | ) | (37,388,222 | ) | ||||
Total
Stockholders’ Equity (Deficit)
|
(3,131,526 | ) | 1,838,860 | |||||
Total
Liabilities and Stockholders’ Equity (Deficit)
|
$ | 3,404,671 | $ | 3,650,642 |
The
accompanying notes are an integral part of these financial
statements.
F-3
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
STATEMENTS OF OPERATIONS
For
the Years Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Revenues
|
$ | 624,495 | $ | 747,119 | ||||
Costs
and Operating Expenses:
|
||||||||
Cost
of goods sold (excluding depreciation and amortization)
|
61,896 | 4,056 | ||||||
Sales
and marketing
|
94,603 | 244,958 | ||||||
General
and administrative
|
2,894,432 | 2,377,866 | ||||||
Professional
fees
|
957,135 | 1,881,179 | ||||||
Research
and development
|
2,032,677 | 2,012,419 | ||||||
Amortization
|
179,444 | 132,875 | ||||||
Depreciation
|
103,992 | 81,932 | ||||||
Total
Costs and Operating Expenses
|
6,324,179 | 6,735,285 | ||||||
Loss
from Operations
|
(5,699,684 | ) | (5,988,166 | ) | ||||
Other
Income (Expense):
|
||||||||
Interest
and dividend income
|
22,622 | 76,571 | ||||||
Interest
expense
|
(369,895 | ) | (23,401 | ) | ||||
Bad
debt expense
|
- | (214,000 | ) | |||||
Rental
income
|
23,373 | 20,008 | ||||||
Grant
income
|
- | 14,000 | ||||||
Amortization
of debt discount to interest expense
|
(1,148,512 | ) | (52,304 | ) | ||||
Amortization
of deferred financing costs to interest expense
|
(309,164 | ) | (27,493 | ) | ||||
Loss
on equity investee
|
- | (267,608 | ) | |||||
Loss
on extinguishment of debt
|
(439,445 | ) | - | |||||
Loss
on disposition of fixed assets
|
(8,029 | ) | - | |||||
Total
Other Income (Expense), net
|
(2,229,050 | ) | (474,227 | ) | ||||
Loss
before Minority Interest and Taxes
|
(7,928,734 | ) | (6,462,393 | ) | ||||
Minority
Interest
|
207,333 | 418,056 | ||||||
Provision
for Income Taxes
|
- | - | ||||||
Net
Loss
|
$ | (7,721,401 | ) | $ | (6,044,337 | ) | ||
Basic
and Diluted Net Loss per Common Share
|
$ | (0.18 | ) | $ | (0.15 | ) | ||
Basic
and Diluted Weighted Average Shares Used in per Share
Calculation
|
42,133,840 | 40,627,309 |
The
accompanying notes are an integral part of these financial
statements.
|
F-4
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
STATEMENTS OF CASH FLOWS
For
the Years Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (7,721,401 | ) | $ | (6,044,337 | ) | ||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||
Depreciation
and amortization
|
283,436 | 214,807 | ||||||
Interest
expense related to amortization of non-cash discount, non-
|
||||||||
cash
beneficial conversion feature and deferred financing costs
|
1,457,676 | 79,797 | ||||||
Bad
debt expense
|
- | 214,000 | ||||||
Expenses
related to employee stock options
|
947,322 | 235,378 | ||||||
Expenses
related to stock options issued to non-employees
|
6,667 | - | ||||||
Expenses
related to common stock warrants issued
|
39,437 | 150,902 | ||||||
Non-cash
fair value of warrants and options issued for consulting
|
255,429 | 638,459 | ||||||
Non-cash
fair value of common stock and warrants issued for
interest
|
142,526 | - | ||||||
Non-cash
incremental fair value of modified warrants issued for
interest
|
400 | - | ||||||
Loss
on extinguishment of debt
|
439,445 | - | ||||||
Loss
on disposition of fixed assets
|
8,029 | - | ||||||
Issuance
of convertible notes for accrued interest
|
164,924 | - | ||||||
Loss
on equity investee
|
- | 267,608 | ||||||
Minority
interest
|
(207,333 | ) | (418,056 | ) | ||||
(Increase)
decrease in:
|
||||||||
Accounts
receivable
|
34,998 | (80,758 | ) | |||||
Interest
receivable
|
(16,040 | ) | (27,569 | ) | ||||
Inventories
|
(2,825 | ) | (37,313 | ) | ||||
Prepaid
expenses
|
37,974 | (36,156 | ) | |||||
Deposits
|
302 | 23,402 | ||||||
Increase
(decrease) in:
|
||||||||
Accounts
payable
|
1,203,535 | 145,920 | ||||||
Accrued
expenses
|
65,410 | 137,092 | ||||||
Security
deposits
|
- | 2,000 | ||||||
Deferred
revenue
|
58,781 | (459,902 | ) | |||||
Net
Cash Used by Operating Activities
|
(2,801,308 | ) | (4,994,726 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Cash
paid for purchases of fixed assets
|
(73,992 | ) | (218,853 | ) | ||||
Cash
paid for equity interest in FluoroPharma
|
- | (1,027,178 | ) | |||||
Cash
obtained from equity interest in FluoroPharma
|
- | 764,223 | ||||||
Issuance
of notes receivable – related party
|
- | (450,000 | ) | |||||
Cash
paid for deposit on asset acquisition
|
(75,000 | ) | - | |||||
Cash
paid for licensing agreements
|
(28,715 | ) | (15,000 | ) | ||||
Cash
paid for capitalized website development costs
|
(600 | ) | (31,650 | ) | ||||
Net
Cash Used by Investing Activities
|
(178,307 | ) | (978,458 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from sale of common stock and warrants, net of issuance costs of
$157,504
|
- | 3,374,996 | ||||||
Proceeds
from exercise of common stock warrants, net of placement fees of $0 and
$16,429
|
169,189 | 567,777 | ||||||
Proceeds
from long-term note payable
|
- | 44,000 | ||||||
Payments
on loan payable used to finance equipment purchase
|
(10,882 | ) | (7,763 | ) | ||||
Proceeds
from issuance of convertible notes, net of legal fees of $7,500 and
$0
|
1,292,500 | 1,000,000 |
F-5
Proceeds
from issuance of senior secured promissory notes
|
550,000 | - | ||||||
Proceeds
from issuance of promissory notes, net of issuance costs of
$57,500
|
1,042,500 | - | ||||||
Payments
of senior secured promissory notes
|
(200,000 | ) | - | |||||
Payment
of payables related to fixed asset purchases
|
(10,798 | ) | (49,406 | ) | ||||
Net
Cash Provided by Financing Activities
|
2,832,509 | 4,929,604 | ||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(147,106 | ) | (1,043,580 | ) | ||||
|
||||||||
Cash
and Cash Equivalents, Beginning of Period
|
213,332 | 1,256,912 | ||||||
Cash
and Cash Equivalents, End of Period
|
$ | 66,226 | $ | 213,332 | ||||
Supplemental
Cash Flow Disclosures:
|
||||||||
Interest
expense paid in cash
|
$ | 58,577 | $ | 23,401 | ||||
Income
tax paid
|
- | - | ||||||
Supplemental
Disclosure of Non-Cash Financing and Investing Activities:
|
||||||||
Fair
value of warrants issued to placement agents for debt financing
costs
|
$ | 119,750 | $ | 65,000 | ||||
Fair
value of warrants issued with senior secured convertible
notes
|
140,955 | 134,452 | ||||||
Fair
value of beneficial conversion feature embedded in senior secured
convertible notes
|
649,187 | 97,164 | ||||||
Fair
value of common stock issued with senior secured convertible
notes
|
7,816 | - | ||||||
Incremental
fair value of modified warrants issued pursuant to debt
financing
|
30,132 | 25,210 | ||||||
Fair
value of common stock issued with senior secured promissory
notes
|
79,806 | - | ||||||
Fair
value of warrants issued with senior secured promissory
notes
|
58,050 | - | ||||||
Fair
value of warrants issued with promissory notes
|
108,159 | - | ||||||
Fair
value of common stock issued with promissory notes
|
203,523 | - | ||||||
Fair
value of warrants issued with common stock
|
- | 1,243,087 | ||||||
Fair
value of warrants issued to placement agents for equity financing
costs
|
- | 277,778 | ||||||
Increase
in payables related to purchase of fixed assets
|
142,516 | 10,798 | ||||||
Increase
in loans payable related to equipment purchase financing
|
- | 24,377 | ||||||
Increase
in payables for debt financing costs
|
125,000 | 70,000 | ||||||
Increase
in payables related to asset acquisition deposit
|
25,000 | - | ||||||
Decrease
in note receivable settled in FluoroPharma common stock
|
- | 500,000 | ||||||
Decrease
in interest receivable settled in FluoroPharma common
stock
|
- | 8,822 |
The
accompanying notes are an integral part of these financial
statements.
|
F-6
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
Total
|
||||||||||||||||||||
Common
Stock
|
Additional
|
Stockholders’
|
||||||||||||||||||
Number
of
|
Paid-in
|
Accumulated
|
Equity
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
(Deficit)
|
||||||||||||||||
BALANCE,
DECEMBER 31, 2006
|
37,378,080 | $ | 373,780 | $ | 33,706,733 | $ | (30,514,237 | ) | $ | 3,566,276 | ||||||||||
|
||||||||||||||||||||
Issuance
of common stock, net of cash issuance costs of $157,504
|
3,532,500 | 35,325 | 3,339,671 | - | 3,374,996 | |||||||||||||||
Fair
value of warrants issued for consulting
|
- | - | 316,120 | - | 316,120 | |||||||||||||||
Fair
value of employee stock based compensation
|
- | - | 219,564 | - | 219,564 | |||||||||||||||
Expenses
related to common stock warrants issued
|
- | - | 150,902 | - | 150,902 | |||||||||||||||
Fair
value of subsidiary stock based compensation (less minority interest
portion)
|
- | - | 195,384 | - | 195,384 | |||||||||||||||
Retroactive
adjustment for prior year equity method loss (equity method
goodwill)
|
- | - | - | (829,648 | ) | (829,648 | ) | |||||||||||||
Exercise
of common stock warrants, net of placement fees of $16,429
|
789,101 | 7,891 | 559,886 | - | 567,777 | |||||||||||||||
Fair
value of warrants issued with convertible notes
|
- | - | 134,452 | - | 134,452 | |||||||||||||||
Fair
value of embedded beneficial conversion feature of convertible
notes
|
- | - | 97,164 | - | 97,164 | |||||||||||||||
Incremental
fair value of modified warrants issued pursuant to debt
financing
|
- | - | 25,210 | - | 25,210 | |||||||||||||||
Fair
value of warrants issued for debt financing costs
|
- | - | 65,000 | - | 65,000 | |||||||||||||||
Net
loss for the year ended December 31, 2007
|
- | - | - | (6,044,337 | ) | (6,044,337 | ) | |||||||||||||
|
||||||||||||||||||||
BALANCE,
DECEMBER 31, 2007
|
41,699,681 | 416,996 | 38,810,086 | (37,388,222 | ) | 1,838,860 | ||||||||||||||
|
||||||||||||||||||||
Fair
value of employee stock based compensation for options
issued
|
- | - | 673,023 | - | 673,023 | |||||||||||||||
Fair
value of non-employee stock based compensation for options
issued
|
- | - | 6,667 | - | 6,667 | |||||||||||||||
Fair
value of subsidiary stock based compensation (less minority interest
portion)
|
- | - | 283,745 | - | 283,745 | |||||||||||||||
Fair
value of common stock warrants issued for consulting
|
- | - | 78,087 | - | 78,087 | |||||||||||||||
Fair
value of warrants issued with convertible notes
|
- | - | 140,955 | - | 140,955 | |||||||||||||||
Fair
value of common stock issued with senior secured convertible
notes
|
25,000 | 250 | 7,566 | - | 7,816 | |||||||||||||||
Fair
value of embedded beneficial conversion feature of convertible
notes
|
- | - | 649,187 | - | 649,187 | |||||||||||||||
Incremental
fair value of modified warrants issued pursuant to debt
financing
|
- | - | 30,132 | - | 30,132 | |||||||||||||||
Fair
value of warrants issued for debt financing costs
|
- | - | 119,750 | - | 119,750 | |||||||||||||||
Exercise
of common stock warrants
|
241,699 | 2,417 | 166,772 | - | 169,189 | |||||||||||||||
Fair
value of common stock issued with senior secured promissory
notes
|
137,500 | 1,375 | 78,431 | - | 79,806 | |||||||||||||||
Fair
value of warrants issued with senior secured promissory
notes
|
- | - | 58,050 | - | 58,050 | |||||||||||||||
Fair
value of common stock issued with promissory notes
|
450,000 | 4,500 | 199,023 | - | 203,523 | |||||||||||||||
Fair
value of warrants issued with promissory notes
|
- | - | 108,159 | - | 108,159 | |||||||||||||||
Fair
value of warrants issued for interest
|
- | - | 17,301 | - | 17,301 | |||||||||||||||
Fair
value of common stock issued for interest
|
332,500 | 3,325 | 121,900 | - | 125,225 | |||||||||||||||
Incremental
fair value of modified warrants issued for interest
|
- | - | 400 | - | 400 | |||||||||||||||
Net
loss for the year ended December 31, 2008
|
- | - | - | (7,721,401 | ) | (7,721,401 | ) | |||||||||||||
|
||||||||||||||||||||
BALANCE,
DECEMBER 31, 2008
|
42,886,380 | $ | 428,863 | $ | 41,549,234 | $ | (45,109,623 | ) | $ | (3,131,526 | ) |
The
accompanying notes are an integral part of these financial
statements
|
F-7
QUANTRX
BIOMEDICAL CORPORATION
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION
OF BUSINESS
QuantRx
Biomedical Corporation was incorporated on December 5, 1986 in the State of
Nevada. The Company’s principal business office is located at 100 South Main
Street, Suite 300, Doylestown, Pennsylvania. QuantRx also has a research and
development facility in Portland, Oregon.
QuantRx
is a broad-based diagnostics company focused on the development and
commercialization of innovative diagnostic products based on its patented
technology platforms for the worldwide healthcare industry. The Company’s
strategy is to commercialize its products through partners or distributors,
contracting the manufacturing to third party partners while maintaining control
over the manufacturing process.
In April
2007, QuantRx increased its ownership in FluoroPharma, Inc., a development-stage
molecular imaging company, to 57.78% of outstanding capital stock, resulting in
its consolidation effective April 1, 2007. When used in these notes, the terms
“Company,” “we,” “our,” “ours,” or “us” mean QuantRx Biomedical Corporation, a
Nevada corporation, and its subsidiary.
2. MANAGEMENT
STATEMENT REGARDING GOING CONCERN
The Company has not generated
sufficient revenues from operations to meet its operating expenses. For this
reason, the Company has historically financed its operations primarily through
issuances of equity and the proceeds of debt instruments. In the past, the
Company has also provided for its cash needs by issuing common stock, options
and warrants for certain operating costs, including consulting and professional
fees.
Management
believes that given our current cash position, there is substantial doubt about
our ability to continue as a going concern. We are actively pursuing various
funding options, including equity offerings, debt financing, strategic corporate
alliances, and business combinations, to obtain additional financing to continue
the development of our products and bring them to commercial markets. We are
actively seeking to raise capital, including through the direct investment in
our subsidiary, FluoroPharma, by either strategic partners or third party
investors. The Company is currently negotiating on several fronts; however,
there can be no assurance that we will be successful in our efforts to raise
additional capital. Additionally, certain of our debt instruments contain
certain covenants which could limit our ability to issue additional debt. Should
we be unable to acquire necessary waivers from certain of our existing note
holders or raise adequate financing or generate sufficient revenue in the
future, the Company’s business, results of operations, liquidity and financial
condition would be materially and adversely harmed.
F-8
The
Company believes that the successful growth and operation of its business is
dependent upon its ability to do any or all of the following:
·
|
obtain
adequate sources of debt or equity financing to pay operating expenses and
fund long-term business operations;
|
·
|
manage
or control working capital requirements by reducing operating
expenses;
|
·
|
develop
new and enhance existing relationships with product distributors and other
points of distribution for the Company’s products;
and
|
·
|
seek
potential mergers or acquisitions that could be expected to generate
positive cash flow for the Company upon consummation, assuming appropriate
financing structures are available on acceptable terms in order to effect
such acquisitions.
|
There can
be no assurance that the Company will be successful in achieving its long-term
plans as set forth above, or that such plans, if consummated, will enable the
Company to obtain profitable operations or continue in the long-term as a going
concern.
3. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
This
summary of significant accounting policies of QuantRx Biomedical Corporation is
presented to assist in understanding the Company’s financial statements. The
financial statements and notes are representations of the Company’s management,
which is responsible for their integrity and objectivity. These accounting
policies conform to accounting principles generally accepted in the United
States of America and have been consistently applied in the preparation of the
financial statements.
Accounting for Share-Based
Payments
QuantRx
follows the provisions of Statement of Financial Accounting Standards (SFAS) No.
123(R), “Share-Based Payments.” SFAS No. 123(R) establishes the accounting for
transactions in which an entity exchanges equity securities for services and
requires companies to expense the estimated fair value of these awards over the
requisite service period. QuantRx uses the Black-Scholes option pricing model in
determining fair value. Accordingly, compensation cost has been recognized using
the fair value method and expected term accrual requirements as prescribed in
SFAS No. 123(R), which resulted in employee stock-based compensation expense for
the year ended December 31, 2008 and 2007 of $947,322 and $235,378, respectively
(including $274,299 and $15,814 relating to subsidiary options in 2008 and
2007).
The
Company accounts for share-based payments granted to non-employees in accordance
with Emerging Issues Task Force (EITF) No. 96-18, “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services.” Under EITF 96-18, the Company
determines the fair value of the stock-based payment as either the fair value of
the consideration received or the fair value of the equity instruments issued,
whichever is more reliably measurable. If the fair value of the
equity instruments issued is used, it is measured using the stock price and
other measurement assumptions as of the earlier of either (1) the date at which
a commitment for performance by the counterparty to earn the equity instruments
is reached, or (2) the date at which the counterparty’s performance is
complete.
In the
case of modifications, the Black-Scholes model is used to value the warrant on
the modification date by applying the revised assumptions. The difference
between the fair value of the warrants prior to the modification and after the
modification on the date of modification determines the incremental
value. In 2008, QuantRx modified warrants in connection with the
issuance of certain notes and note extensions. These modified warrants were
originally issued in connection with previous private placement investments. In
the case of equity issuances, these warrants were originally accounted for as
additional paid-in-capital. In the case of debt issuances, the
warrants were accounted for as original issuance discount based on their
relative fair values. When modified in connection with a note issuance, QuantRx
recognizes the incremental value as a part of the debt discount calculation,
using its relative fair value in accordance with EITF 00-27, “Application of
Issue 98-5 to Certain Convertible Instruments.” When modified in
connection with note extensions, the Company recognized the incremental value as
prepaid interest, which is expensed over the term of the extension.
F-9
The fair
value of each share based payment is estimated on the measurment date using the
Black-Scholes model with the following assumptions, which are determined at the
beginning of each year and utilized in all calculations for that
year:
2008
|
2007
|
|||||||
Risk-free
interest rate
|
5.35 | % | 5.75 | % | ||||
Expected
volatility
|
117 | % | 135 | % | ||||
Dividend
yield
|
0 | % | 0 | % |
Risk-Free Interest Rate. The
interest rate used is based on the yield of a U.S. Treasury security as of the
beginning of the year.
Expected Volatility. The
Company calculates the expected volatility based on historical volatility of
monthly stock prices over a three year period.
Dividend Yield. The Company
has never paid cash dividends, and does not currently intend to pay cash
dividends, and thus has assumed a 0% dividend yield.
Expected Term. For options,
since the Company has no history of employee exercise patterns; therefore, uses
the option term as the expected term. For warrants, the Company uses the actual
term of the warrant.
Pre-Vesting Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience. The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future
periods.
Accounts and Notes
Receivable and Bad Debts
QuantRx
carries its receivables at net realizable value. Interest on notes receivable is
accrued based upon the terms of the note agreement. The Company provides
reserves against receivables and related accrued interest for estimated losses
that may result from a debtor’s inability to pay. The amount is determined by
analyzing known uncollectible accounts, economic conditions, historical losses
and customer credit-worthiness. Additionally, all accounts with aged balances
greater than one year are fully reserved. Amounts later determined and
specifically identified to be uncollectible are charged or written off against
the reserve. The allowance for bad debts was $214,000 in 2008 and
2007.
F-10
Cash and Cash
Equivalents
The
Company considers all highly liquid investments and short-term debt instruments
with maturities of three months or less from date of purchase to be cash
equivalents. Cash equivalents consisted of money market funds at December 31,
2008 and 2007.
Concentration of
Risks
Financial
instruments that potentially expose the Company to concentrations of credit risk
consist primarily of cash and cash equivalents. The Company maintains most of
its cash balances in accounts that may exceed federally insured limits. The
Company has not experienced any losses to date resulting from this
practice.
Earnings per
Share
The
Company computes net income (loss) per common share in accordance with SFAS
No. 128, “Earnings per Share.” Net income (loss) per share is based upon
the weighted average number of outstanding common shares and the dilutive effect
of common share equivalents, such as options and warrants to purchase common
stock, convertible preferred stock and convertible notes, if applicable, that
are outstanding each year. Basic and diluted earnings per share were the same at
the reporting dates of the accompanying financial statements, as including
common stock equivalents in the calculation of diluted earnings per share would
have been antidilutive.
As of
December 31, 2008, the Company had outstanding common stock options of
2,238,000, common stock warrants of 7,926,684, and convertible debt currently
subject to conversion into 5,215,959 shares. The above options, warrants and
convertible debt were deemed to be antidilutive for the Company’s year end of
December 31, 2008.
As of
December 31, 2007, the Company had outstanding common stock options of
1,791,750, common stock warrants of 7,113,383, and convertible debt subject to
conversion into 1,250,000 shares. The above options, warrants and convertible
debt were deemed to be antidilutive for the Company’s year end of December 31,
2007.
Fair Value of Financial
Instruments
Effective
January 1, 2008, the Company adopted SFAS No. 157, “Fair Value
Measurements.” In February 2008, the Financial Accounting Standards Board
(FASB) issued FASB Staff Position (FSP) No. FAS 157-2, “Effective Date of
FASB Statement No. 157,” which provides a one year deferral of the
effective date of SFAS No. 157 for non-financial assets and non-financial
liabilities, except those that are recognized or disclosed in the financial
statements at fair value at least annually. Therefore, the Company has adopted
the provisions of SFAS No. 157 with respect to its financial assets and
liabilities only. The adoption of SFAS No. 157 had no impact on the Company’s
consolidated results of operations or financial condition.
Effective
January 1, 2008, the Company adopted SFAS No. 159, “The Fair Value
Option for Financial Assets and Financial Liabilities.” SFAS No. 159 allows an
entity the irrevocable option to elect to measure specified financial assets and
liabilities in their entirety at fair value on a contract-by-contract basis. If
an entity elects the fair value option for an eligible item, changes in the
item’s fair value must be reported as unrealized gains and losses in earnings at
each subsequent reporting date. In adopting SFAS No. 159, we did not elect the
fair value option for any of our financial assets or financial
liabilities.
F-11
The
Company's financial instruments primarily consist of cash and cash equivalents,
prepaid expenses and other deferred charges, short-term accounts and notes
receivable, accounts payable, accrued expenses and other current liabilities.
All instruments are accounted for on an historical cost basis, which, due to the
short maturity of these financial instruments, approximates the fair value at
the reporting dates of these financial statements.
In
determining fair value of our cost method investment, QuantRx estimated fair
value based on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying value of this investment that are
not readily apparent from other sources. QuantRx has determined that the
carrying value for its cost method investment approximates fair
value.
Impairments
The
Company assesses the impairment of long-lived assets, including other intangible
assets, whenever events or changes in circumstances indicate that their carrying
value may not be recoverable in accordance with SFAS No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets.” The determination of
related estimated useful lives and whether or not these assets are impaired
involves significant judgments, related primarily to the future profitability
and/or future value of the assets. The Company holds investments in companies
having operations or technologies in areas which are within or adjacent to our
strategic focus when acquired, all of which are privately held and whose values
are difficult to determine. The Company records an investment impairment charge
if it believes an investment has experienced a decline in value that is other
than temporary.
The
Company performed annual impairment tests of our equity method goodwill in
accordance with SFAS No. 142, “Goodwill and Other Intangible Assets.” Under
SFAS No. 142, equity method goodwill is not amortized but is subject to
impairment tests in accordance with Accounting Principles Board Opinion No. 18,
“The Equity Method of Accounting for Investments in Common Stock,” under which
QuantRx would have recognized an impairment loss had there been a loss in the
value of the equity method goodwill which was deemed to be other than a
temporary decline. See Note 4 for additional information.
Management
has determined that no impairments were required during the years ended December
31, 2008 and 2007, respectively.
Income
Taxes
The
Company accounts for income taxes and the related accounts under the liability
method. Deferred tax assets and liabilities are determined based on the
differences between the financial statement carrying amounts and the income tax
bases of assets and liabilities. A valuation allowance is applied against any
net deferred tax asset if, based on available evidence, it is more likely than
not that some or all of the deferred tax assets will not be
realized.
In
July 2006, FASB issued FASB Interpretation No. (FIN) 48, “Accounting
for Uncertainty in Income Taxes - an Interpretation of FASB Statement 109,”
which clarifies the accounting for uncertainty in tax positions. Under FIN 48,
the impact of an uncertain income tax position on the income tax return must be
recognized at the largest amount that is more-likely-than-not to be sustained
upon audit by the relevant taxing authority. An uncertain income tax position
will not be recognized if it has less than a 50% likelihood of being sustained.
Additionally, FIN 48 provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosure and
transition. We adopted the provisions of FIN 48 on January 1, 2007. There were
no unrecognized tax benefits as of the date of adoption. As a result of the
implementation of FIN 48, we did not recognize an increase in the liability for
unrecognized tax benefits. There are no unrecognized tax benefits included in
the consolidated balance sheet that would, if recognized, affect the effective
tax rate. The adoption of FIN 48 did not impact our consolidated financial
condition, results of operations or cash flows.
F-12
Our
policy is to recognize interest and/or penalties related to income tax matters
in income tax expense. We had no accrual for interest or penalties on our
consolidated balance sheets at December 31, 2008 or 2007, and have not
recognized interest and/or penalties in the consolidated statement of operations
for the year ended December 31, 2008. See Note 12, Income
Taxes.
Intangible
Assets
The
Company’s intangible assets consist of patents, patents under licensing, website
development costs, and acquired intangibles, and are carried at the legal cost
to obtain them. Intangible assets are amortized using the straight line method
over the estimated useful life. Useful lives are as follows: patents, 17 years;
patents under licensing, 10 years; website development costs, three years, and;
acquired intangibles, estimated remaining useful life, between three and 15
years. Amortization expense totaled $179,444 and $132,875 for the years ended
December 31, 2008 and 2007, respectively. The estimated aggregate amortization
expense for 2009 through 2013 is $178,931; $168,403; $161,695; $157,672; and
$157,672.
Principles of
Consolidation
These
consolidated financial statements include the accounts of the Company and, from
April 1, 2007, its majority-owned subsidiary, FluoroPharma, Inc. All
significant intercompany accounts and transactions have been eliminated in
consolidation. See Note 4 for additional information.
Property and
Equipment
Property
and equipment are stated at cost. Depreciation is computed using the
straight-line method over the estimated useful lives of the assets. The
Company’s property and equipment at December 31, 2008 and 2007 consisted of
computer and office equipment, machinery and equipment and leasehold
improvements with estimated useful lives of three to seven years. Estimated
useful lives of leasehold improvements do not exceed the remaining lease term.
Depreciation expense was $103,992 and $81,932 for the years ended December 31,
2008 and 2007. Expenditures for repairs and maintenance are expensed as
incurred.
Recent Accounting
Pronouncements
In
May 2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally
Accepted Accounting Principles”. SFAS 162 is intended to improve financial
reporting by identifying a consistent framework, or hierarchy, for selecting
accounting principles to be used in preparing financial statements that are
presented in conformity with U.S. GAAP for nongovernmental entities. SFAS No.
162 is effective 60 days following the Securities and Exchange Commission’s
approval of the Public Company Accounting Oversight Board auditing amendments to
AU Section 411, “The Meaning of Present Fairly in Conformity with Generally
Accepted Accounting Principles.” The Company does not expect this statement to
have an effect on its consolidated financial statements.
F-13
In May
2008, the FASB issued FSP Accounting Principles Board (APB) 14-1, "Accounting
for Convertible Debt Instruments That May Be Settled in Cash upon Conversion
(Including Partial Cash Settlement)". FSP APB 14-1 requires the issuer of
certain convertible debt instruments that may be settled in cash (or other
assets) on conversion to separately account for the liability (debt) and equity
(conversion option) components of the instrument in a manner that reflects the
issuer's non-convertible debt borrowing rate. FSP APB 14-1 is effective for
QuantRx beginning with the first quarter of 2009. QuantRx is currently
evaluating the effect, if any, that the adoption will have on its consolidated
results of operations or financial position.
In April
2008, the FASB issued FSP 142-3, “Determination of the Useful Life of Intangible
Assets”. FSP 142-3 amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful life of a
recognized intangible asset under SFAS No. 142. FSP 142-3 is effective for
fiscal years beginning after December 15, 2008. The implementation of this
standard is not expected to have a material impact on our consolidated financial
position, results of operations or cash flows.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities – an amendment of FASB Statement
No. 133”. This
statement changes the disclosure requirements for derivative instruments and
hedging activities. Entities are required to provide enhanced disclosures about
(a) how and why an entity uses derivative instruments, (b) how
derivative instruments and related hedged items are accounted for under SFAS No.
133 and its related interpretations, and (c) how derivative instruments and
related hedged items affect an entity’s financial position, financial
performance and cash flows. SFAS No. 161 is effective for fiscal years and interim periods
beginning after November 15, 2008, with early application permitted. The
Company does not expect the implementation of this
standard to have a material impact on its consolidated financial statements at
this time.
In
December 2007, FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements—an amendment of ARB No. 51”. SFAS No. 160
requires noncontrolling interests or minority interests to be treated as a
separate component of equity, not as a liability or other item outside of
permanent equity. Upon a loss of control, the interest sold, as well as any
interest retained, is required to be measured at fair value, with any gain or
loss recognized in earnings. Based on SFAS No. 160, assets and liabilities will
not change for subsequent purchase or sale transactions with non-controlling
interests as long as control is maintained. Differences between the fair value
of consideration paid or received and the carrying value of noncontrolling
interests are to be recognized as an adjustment to the parent interest’s equity.
SFAS No. 160 requires that the noncontrolling interest continue to be attributed
its share of losses even if that attribution results in a deficit noncontrolling
interest balance; if this would result in a material change to consolidated net
income, pro forma financial information is required. SFAS No. 160 is effective
for QuantRx beginning in the first quarter of 2009. Earlier adoption is
prohibited. The Company has not fully determined the effects of implementation
of this standard on its financial statements, but does anticipate that
allocating the noncontrolling interest its full share of the subsidiary’s losses
will result in a material change to consolidated net income and will require pro
forma disclosure. Moreover, should the Company sustain a loss of control in its
subsidiary resulting in deconsolidation, the financial statements would be
materially affected.
In
December 2007, the FASB issued SFAS No. 141(R), “Business Combinations.” SFAS
No. 141(R) will change the accounting for business combinations. Under SFAS No.
141(R), an acquiring entity will be required to recognize all the assets
acquired and liabilities assumed in a transaction at the acquisition-date at
fair value with limited exceptions. SFAS No. 141(R) will change the accounting
treatment and disclosure for certain specific items in a business combination.
SFAS No. 141(R) applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. Accordingly, any business
combinations the Company engages in will be recorded and disclosed following
existing GAAP until January 1, 2009. QuantRx does not expect the adoption of
this statement to have a material impact on its consolidated financial
statements unless the Company enters into business acquisitions in the
future.
F-14
In
November 2007, EITF No. 07-01, “Accounting for Collaborative
Arrangements” was issued. EITF No. 07-01 requires collaborators to present
the results of activities for which they act as the principal on a gross basis
and report any payments received from (made to) other collaborators based on
other applicable GAAP or, in the absence of other applicable GAAP, based on
analogy to authoritative accounting literature or a reasonable, rational, and
consistently applied accounting policy election. Further, EITF 07-01 clarified
that transactions within a collaborative arrangement that are part of a
vendor-customer (or analogous) relationship are subject to Issue 01-9,
“Accounting for Consideration Given by a Vendor to a Customer.” EITF 07-01 is
effective for fiscal years beginning after December 15, 2008. QuantRx does
not expect the adoption of EITF 07-01 to have a material impact on the Company’s
consolidated results of operations or financial position.
In
June 2007, the FASB ratified the EITF consensus on EITF No. 07-3,
“Accounting for Nonrefundable Advance Payments for Goods or Services Received
for Use in Future Research and Development Activities.” EITF 07-3 provides that
nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities should be capitalized
and deferred. Such amounts should be recognized as an expense as the related
goods are delivered or the related services are performed or such time when an
entity does not expect the goods to be delivered or services to be performed.
EITF 07-3 is effective for fiscal periods beginning after December 15,
2007. The adoption of EITF 07-3 has not had a material impact on the Company’s
consolidated results of operations or financial position.
Reclassifications
Certain
amounts from prior periods have been reclassified to conform to the current
period presentation. These reclassifications have resulted in no changes to the
Company’s accumulated deficit or net losses presented.
Research and Development
Costs
Research
and development costs are expensed as incurred. The cost of intellectual
property purchased from others that is immediately marketable or that has an
alternative future use is capitalized and amortized as intangible assets.
Capitalized costs are amortized using the straight-line method over the
estimated economic life of the related asset.
Revenue
Recognition
The
Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
Topic 13 when persuasive evidence of an arrangement exists and delivery or
performance has occurred, provided the fee is fixed or determinable and
collection is probable. The Company assesses whether the fee is fixed and
determinable based on the payment terms associated with the transaction. If a
fee is based upon a variable such as acceptance by the customer, the Company
accounts for the fee as not being fixed and determinable. In these cases, the
Company defers revenue and recognizes it when it becomes due and payable.
Up-front engagement fees are recorded as deferred revenue and amortized to
income on a straight-line basis over the term of the agreement, although the fee
is due and payable at the time the agreement is signed or upon annual renewal.
Payments related to substantive, performance-based milestones in an agreement
are recognized as revenue upon the achievement of the milestones as specified in
the underlying agreement when they represent the culmination of the earnings
process. The Company assesses the probability of collection based on a number of
factors, including past transaction history with the customer and the current
financial condition of the customer. If the Company determines that collection
of a fee is not reasonably assured, revenue is deferred until the time
collection becomes reasonably assured.
F-15
The
Company recognizes revenue from nonrefundable minimum royalty agreements from
distributors or resellers upon delivery of product to the distributor or
reseller, provided no significant obligations remain outstanding, the fee is
fixed and determinable, and collection is probable. Once minimum royalties have
been received, additional royalties are recognized as revenue when earned based
on the distributor’s or reseller’s contractual reporting
obligations.
The
Company’s strategy includes entering into collaborative agreements with
strategic partners for the development, commercialization and distribution of
its product candidates. Such collaboration agreements may have multiple
deliverables. The Company evaluates multiple deliverable arrangements pursuant
to EITF 00-21, “Revenue Arrangements with Multiple Deliverables.” Pursuant to
EITF 00-21, in arrangements with multiple deliverables where the Company has
continuing performance obligations, contract, milestone and license fees are
recognized together with any up-front payments over the term of the arrangement
as performance obligations are completed, unless the deliverable has stand alone
value and there is objective, reliable evidence of fair value of the undelivered
element in the arrangement. In the case of an arrangement where it is determined
there is a single unit of accounting, all cash flows from the arrangement are
considered in the determination of all revenue to be recognized. Cash received
in advance of revenue recognition is recorded as deferred
revenue.
CytoCore,
Inc.
On May
19, 2008, QuantRx and CytoCore, Inc. entered into a worldwide distribution and
supply agreement for specified PAD technology of QuantRx. The agreement
specifies monthly license fees during CytoCore’s expected development period and
additional milestone payments based upon CytoCore’s achievement of certain
development and sales milestones. QuantRx received an up-front,
non-refundable payment of $100,000 upon execution of this agreement, which was
recorded as deferred revenue and is being amortized into revenue over the
expected development period of the agreement, which is estimated as 18 months.
QuantRx recognized revenue of $80,111 in the year ended December 31, 2008
related to this agreement.
Branan
Medical Corporation
In early
2008, QuantRx and Branan Medical Corporation terminated their license agreement
for certain of QuantRx’s technology. QuantRx recognized royalties of $8,561 and
$51,364 from this agreement in 2008 and 2007, respectively.
Synova
Healthcare, Inc.
In 2006,
QuantRx and Synova Healthcare, Inc. entered into a distribution agreement
pursuant to which Synova would act as the exclusive distributor of specified
hemorrhoid products of QuantRx in the United States. QuantRx received an
up-front, non-refundable payment of $500,000 upon execution of the distribution
agreement, which was recorded as deferred revenue and was amortized into revenue
over the expected term of the agreement, which was six years. In December 2007,
in accordance with the terms of the distribution agreement, QuantRx delivered
notice of termination of the agreement and recognized the remaining deferred
revenue at that time of $383,513. QuantRx recognized aggregate revenue of
$459,901 in 2007.
F-16
Development
Agreements
In 2007
QuantRx entered into two development agreements to develop rapid test POC
products in oral care for ALT BioScience (ALT), and an at-home diagnostic test
jointly with Church & Dwight Co., Inc. In 2008 and 2007, QuantRx recognized
revenues $419,025 and $235,146 related to these agreements in accordance with
its revenue recognition policies, and costs of approximately $286,246 and
$346,845, respectively.
The ALT
agreement, and subsequent renewals, commenced March 2007 and stipulated an up
front fee, recognized over the initial five month term, and monthly fees.
Currently, the agreement is on a month-to-month basis, subject to termination
with 45 days notice. The agreement grants QuantRx certain manufacturing rights
for the developed products, which shall be negotiated in good faith in a
separate manufacturing agreement upon the completion of design and verification
testing. These manufacturing rights will survive any potential termination of
the development agreement.
The
Church & Dwight agreement was accounted for using the Performance Method –
Expected Revenue. The agreement included an up front payment which was
recognized fully in 2007, and stipulated milestone based payments, which were
recognized in 2007 and 2008. On August 14, 2008, QuantRx entered into a
Technology License Agreement with Church & Dwight Co., Inc. Under
the terms of the agreement, Church & Dwight acquired exclusive world-wide
rights to use certain QuantRx technology related to the jointly developed test.
Under the ten-year agreement, QuantRx will receive royalties on net sales of the
product beginning in 2009.
The
accompanying financial statements are prepared in conformity with accounting
principles generally accepted in the United States of America, and include
certain estimates and assumptions which affect the reported amounts of assets
and liabilities at the date of the financial statements, and the reported
amounts of revenues and expenses during the reporting period. Accordingly,
actual results may differ from those estimates.
4. CONSOLIDATION
OF FLUOROPHARMA, INC.
In March
2006, QuantRx purchased 1,096,170 shares of FluoroPharma common stock for a
total purchase price of $1,566,023. Contemporaneously, QuantRx negotiated the
purchase of an additional 300,000 shares from private investors for $429,000. In
February 2007, QuantRx purchased an additional 200,000 shares from private
investors for $286,000. On April 13, 2007, QuantRx and FluoroPharma
closed the transactions contemplated by a “stage 2” investment agreement. Under
the investment agreement, effective April 1, 2007, QuantRx purchased 627,058
shares of common stock of FluoroPharma for $1,250,000, consisting of (i) cash
payments aggregating $741,178; and (ii) cancellation in full of two promissory
notes issued by FluoroPharma in favor of QuantRx, in the aggregate principal
amount of $500,000, and with accrued and unpaid interest of $8,822, for a total
of $508,822. As a result of these equity purchases, QuantRx’s ownership in
FluoroPharma exceeded 50%, requiring QuantRx to consolidate
FluoroPharma. FluoroPharma, Inc. is a privately held molecular
imaging company based in Boston, Massachusetts, engaged in the discovery,
development, and commercialization of proprietary products for positron emission
tomography. The investment in FluoroPharma is intended to strategically expand
QuantRx’s diagnostic platforms.
F-17
As of
December 31, 2008, QuantRx owned approximately 57.78% of the issued and
outstanding capital stock of FluoroPharma. Effective April 1, 2007,
FluoroPharma’s results of operations have been included in the accompanying
consolidated financial statements.
The
investment in FluoroPharma of $2,281,023 at the date of consolidation was
accounted for in accordance with the equity method of accounting. Since
FluoroPharma’s liabilities exceeded assets on the investment dates, each
investment was recorded as equity method goodwill. In accordance with SFAS No.
142, equity method goodwill is not amortized or tested for impairment in
accordance with this standard. QuantRx reviewed the equity method goodwill in
accordance with APB Opinion No. 18 under which QuantRx would have recognized an
impairment loss had there been a loss in the value of the equity method goodwill
which was deemed to be other than a temporary decline. No impairment was
recognized through March 31, 2007.
QuantRx
did not account for the acquisition of FluoroPharma’s equity as a business
combination since FluoroPharma is a development-stage enterprise and did not
meet the definition of a business in accordance with SFAS No. 141, “Business
Combinations” and EITF 98-3, “Determining Whether a Nonmonetary Transaction
Involves Receipt of Productive Assets or of a Business.” As a result of the
consolidation and pursuant to Accounting Research Bulletin (ARB) No. 51,
“Consolidated Financial Statements,” effective April 1, 2007, QuantRx recognized
previously unrecognized equity method losses relating to its investment in
FluoroPharma of $829,648, attributable to 2006, as an adjustment to retained
earnings, and $267,608, attributable to 2007, in the second quarter of
2007. These losses were previously unrecognized since APB No. 18
stipulated that the entire investment be treated as equity method goodwill with
no equity method loss recognition.
QuantRx’s
aggregate investment in the equity of FluoroPharma of $3,531,023 was reduced at
April 1, 2007, by the $1,097,256 in previously unrecognized equity method losses
required to be recorded upon consolidation in accordance with ARB No. 51. The
remaining investment balance of $2,433,767 at April 1, 2007, has been allocated
upon consolidation based on fair value estimates as follows:
Cash
|
$ | 764,223 | ||
Prepaid
expenses
|
99,980 | |||
Property
and equipment
|
62,802 | |||
Intangible
assets
|
2,134,783 | |||
Current
liabilities
|
(352,733 | ) | ||
Minority
interests
|
(275,288 | ) | ||
$ | 2,433,767 |
Acquired
intangibles primarily consist of licensed patent rights and technology licenses
and are estimated to have a weighted average life of 15
years. Amortization expense related to these intangibles (subsequent
to the acquisition) in 2008 and 2007 was $152,060 and $114,044,
respectively.
Minority
interests of $275,288 at April 1, 2007, resulted from the consolidation of
FluoroPharma reflecting the interests held by third parties of
FluoroPharma. Since acquisition, and as of December 31, 2008, the
portion of FluoroPharma’s losses attributable to the minority interest have been
recorded, reducing the minority interest to zero.
F-18
In early
2008 and late 2007, QuantRx advanced an aggregate of $300,000 and $600,000,
respectively, to FluoroPharma through eight short-term convertible promissory
notes. Additionally, QuantRx advanced $553,700 and $40,000 as of December 31,
2008 and 2007, respectively. These advances, notes and accrued
interest ($83,067 and $14,252 for the years ended December 31, 2008 and 2007,
respectively) were eliminated in consolidation.
Under the
initial investment agreement with FluoroPharma, QuantRx has the option to
acquire additional shares of FluoroPharma through a series of staged
investments. Such staged investments will take the form of cash at increasing
valuations upon FluoroPharma’s achievement of certain milestones with respect to
the successful completion of Phase I and Phase II FDA trials for certain
compounds being developed by FluoroPharma. The final staged investment to wholly
acquire FluoroPharma will be settled in QuantRx’s common stock. Any subsequent
investment in FluoroPharma by QuantRx will be consummated pursuant to the terms
and subject to the conditions set forth in separate definitive
agreements.
In
connection with the initial investment, QuantRx received an option to purchase
an additional 260,000 shares of FluoroPharma common stock at an exercise price
of $0.75. FluoroPharma has outstanding common stock equivalents which, if
exercised together with the Company’s option and convertible notes, would reduce
the Company’s ownership percentage to approximately 48.17% on a fully diluted
and as converted basis as of December 31, 2008.
F-19
5.
|
OTHER
BALANCE SHEET INFORMATION
|
Components
of selected captions in the accompanying balance sheets as of December 31, 2008
and 2007 consist of:
2008
|
2007
|
|||||||
Prepaid
expenses:
|
||||||||
Prepaid
consulting
|
$ | 92,649 | $ | 159,410 | ||||
Prepaid
consulting – related party
|
4,674 | 17,377 | ||||||
Prepaid
insurance
|
37,473 | 31,829 | ||||||
Prepaid
interest
|
44,426 | - | ||||||
Prepaid
rent
|
5,310 | 5,310 | ||||||
Other
|
4,517 | 13,096 | ||||||
Prepaid
expenses
|
$ | 189,049 | $ | 227,022 | ||||
Deferred
financing costs:
|
||||||||
Deferred
financing costs
|
$ | 133,250 | $ | 135,000 | ||||
Less:
accumulated amortization
|
(124,557 | ) | (27,493 | ) | ||||
Deferred
financing costs, net
|
$ | 8,693 | $ | 107,507 | ||||
Property
and equipment:
|
||||||||
Computers
and office furniture, fixtures and equipment
|
$ | 136,690 | $ | 148,141 | ||||
Machinery
and equipment
|
466,338 | 252,681 | ||||||
Leasehold
improvements
|
92,233 | 92,233 | ||||||
Less:
accumulated depreciation
|
(199,055 | ) | (101,335 | ) | ||||
Property
and equipment, net
|
$ | 496,206 | $ | 391,720 | ||||
Accrued
expenses:
|
||||||||
Payroll
and related
|
$ | 156,750 | $ | - | ||||
Professional
fees
|
43,800 | 72,050 | ||||||
Clinical
trials
|
- | 110,833 | ||||||
Accrued
interest
|
41,142 | - | ||||||
Other
|
57,000 | 50,400 | ||||||
Accrued
expenses
|
$ | 298,692 | $ | 233,283 |
6. NOTES
RECEIVABLE
FluoroPharma,
Inc.
In 2007
and 2006, QuantRx advanced an aggregate of $500,000 to FluoroPharma through two
$250,000, 8% promissory notes due May 16 and March 31, 2007, respectively.
QuantRx accrued interest of $7,836 on these notes for the year ended December
31, 2007. The principal balances and unpaid accrued interest were settled
through a staged investment transaction in the second quarter of 2007; see Note
4.
Genomics USA,
Inc.
In
January 2007, QuantRx advanced $200,000 to Genomics USA, Inc. (GUSA) through an
8% promissory note due April 8, 2007. The note is currently convertible at
QuantRx’s discretion into 10% of GUSA’s outstanding capital stock on a fully
diluted and as converted basis. QuantRx continues to explore the possibility of
further investment, and has postponed settlement of the note during this
exploratory period, during which the note shall continue to accrue interest.
QuantRx accrued interest of $16,040 and $15,649 on this note for the years ended
December 31, 2008 and 2007. GUSA, a privately held Illinois corporation, is a
technology company focused on the development of Micro-Array Detection for DNA.
This technology may strategically expand QuantRx’s diagnostic platforms. See
Note 7 for additional information on GUSA.
F-20
Rockland Technimed,
Ltd.
In April
2006, QuantRx advanced $200,000 to Rockland Technimed, Ltd. (Rockland) through a
7% convertible promissory note due twelve months from the date of
issuance. Rockland, a privately held Delaware corporation, is a
development stage company focused on the research and development of tissue
viability imaging diagnostics using magnetic resonance imaging (MRI) scanners.
QuantRx had accrued interest of $4,083 for the year ended December 31,
2007. The note is convertible at QuantRx’s discretion into 20% of
Rockland’s outstanding capital stock on a fully diluted and as converted basis
to satisfy the note and accrued interest. QuantRx ceased accruing interest as of
the maturity date and established an allowance for bad debt in the amount equal
to the principal balance and accrued interest, $214,000, as the Company attempts
to resolve this matter.
7. INVESTMENTS
Genomics USA,
Inc.
In May
2006, QuantRx purchased 144,024 shares of GUSA common stock for $200,000. As of
December 31, 2008, QuantRx owned approximately 10% of the issued and outstanding
capital stock of GUSA on a fully diluted and as converted basis.
QuantRx
uses the cost method to account for this investment since QuantRx does not
control nor have the ability to exercise significant influence over operating
and financial policies. In accordance with the cost method, the investment is
recorded at cost and impairment is considered in accordance with the Company’s
impairment policy. No impairment was recognized for the year ended December 31,
2008.
8. INTANGIBLE
ASSETS
Intangible
assets as of December 31, 2008 and 2007 consisted of the following:
2008
|
2007
|
|||||||
Licensed
patents and patent rights
|
$ | 2,197,020 | $ | 2,168,305 | ||||
Patents
|
82,008 | 82,008 | ||||||
Technology
license
|
22,517 | 22,517 | ||||||
Website
development
|
49,711 | 49,111 | ||||||
Less:
accumulated amortization
|
(339,159 | ) | (159,716 | ) | ||||
Intangibles,
net
|
$ | 2,012,097 | $ | 2,162,225 |
Acquired
Intangibles
In April
2007, QuantRx obtained a majority interest in FlouroPharma, resulting in
$2,134,783 allocated to acquired intangible assets based upon estimated fair
values as of the purchase date. These acquired intangibles primarily
consist of licensed patent rights and technology licenses and are estimated to
have a weighted average life of 15 years.
F-21
Patent under
Licensing
In 2006,
QuantRx entered into a patent license agreement with The Procter & Gamble
Company, effective July 1, 2006. The agreement licenses patent rights and
know-how for certain hemorrhoid treatment pads and related coatings. The term of
the agreement is five years with a five year automatic renewal option. In
consideration of this agreement, QuantRx paid a one-time, non-refundable
engagement fee, and will pay royalties based on future net sales of such
licensed products.
The
Company has capitalized this engagement fee and will amortize the capitalized
cost over the expected term of the patent license agreement. Amortization of
$5,000 and $5,000 in connection with this licensed patent was recognized in the
years ended December 31, 2008 and 2007. All royalties due pursuant to the terms
of the agreement are expensed as incurred. Impairment is considered in
accordance with the Company’s impairment policy. No impairment was recognized as
of December 31, 2008.
9. PORTLAND
DEVELOPMENT COMMISSION
In
February 2007, QuantRx received a $44,000 loan from the Portland Development
Commission. The loan matures in 20 years and is interest free through March 1,
2010, and no payments are due until April 1, 2010. The terms of the promissory
note stipulate that the interest rate will accrue beginning in March 1, 2010, at
an annual rate between 1% and 8.5% based upon the level of compliance with
certain employment milestones beginning in 2008.
Additionally,
QuantRx received a $14,000 grant for qualified expenditures related to its
research facility. QuantRx satisfied the grant terms and recorded the grant as
other income.
10. NOTES
PAYABLE
Notes
payable as of December 31, 2008 and 2007 were comprised of the
following:
2008
|
2007
|
|||||||
Short-term
convertible notes payable, net:
|
||||||||
Senior
secured convertible notes payable
|
$ | 2,607,979 | $ | 1,000,000 | ||||
Less:
discount for common stock, warrants and conversion feature,
net
|
(97,925 | ) | (204,524 | ) | ||||
Short-term
convertible notes payable, net
|
$ | 2,510,054 | $ | 795,476 | ||||
Short-term
secured promissory notes payable:
|
||||||||
Secured
promissory notes payable
|
$ | 350,000 | $ | - | ||||
Less:
discount for common stock and warrants, net
|
- | - | ||||||
Short-term
secured promissory notes payable, net
|
$ | 350,000 | $ | - | ||||
Short-term
promissory notes payable, net:
|
||||||||
Unsecured
promissory notes payable
|
$ | 1,107,890 | $ | - | ||||
Less:
discount for common stock and warrants, net
|
(46,612 | ) | - | |||||
Short-term
promissory notes payable, net
|
$ | 1,061,278 | $ | - |
F-22
2007 Convertible Promissory
Notes
On
October 16, 2007, QuantRx completed a private placement of 10% senior secured
convertible promissory notes (the “2007 Notes”) and warrants to purchase shares
of QuantRx' common stock. In connection with the private placement, QuantRx
issued notes in the aggregate principal amount of $1,000,000 and warrants to
purchase 250,000 shares of QuantRx' common stock at an exercise price of $1.25
(relative fair value of $134,454). Proceeds of the financing will be used for
general corporate purposes. The notes and the warrants were offered only to
certain private accredited investors.
In the
first quarter of 2008, the 2007 Notes were exchanged for 2008 Senior Secured
Convertible Notes (the “2008 Notes”) resulting in a loss on extinguishment, as
described below under “2008 Senior Secured Convertible Notes.”
The 2007
Notes were automatically convertible into shares of QuantRx common stock upon
completion of a “qualified” equity financing (or financings) with aggregate
gross proceeds of at least $3,000,000. Under the terms of the convertible notes,
holders of the notes would have been deemed to have tendered 115% of their
aggregate outstanding principal balance and accrued interest for purchase of
securities in the qualified equity financing, entitling the holders to all
rights afforded to purchasers in such financing (“contingent embedded conversion
option”). Alternatively, the 2007 Notes allowed the holders to convert their
outstanding principal and accrued interest into common stock at a price of $0.80
per common share (“embedded conversion option”). Either conversion would result
in the satisfaction of all of QuantRx’s obligations under the 2007
Notes.
In the
event QuantRx did not complete a qualified financing and holders did not
voluntarily convert, QuantRx was to repay the outstanding principal balance and
accrued and unpaid interest on October 31, 2008. At the payee’s option, accrued
interest could have been converted to additional 2007 Notes. QuantRx had the
right to prepay the 2007 Notes at 115% of face value and 100% of accrued
interest by providing ten days notice.
In
accordance with APB Opinion No. 14, “Accounting for Convertible Debt and Debt
Issued with Stock Purchase Warrants,” QuantRx allocated $134,454 of the
principal amount of the 2007 Notes to the warrants as original issue discount,
which represented the relative fair value of the warrants at the date of
issuance.
The
conversion option embedded in the 2007 Notes described above was not considered
a derivative instrument and was not required to be bifurcated pursuant to the
scope exception in paragraph 11(a) of SFAS No. 133, “Accounting for Derivative
Instruments and Hedging Activities,” since it was indexed to QuantRx’s stock and
was classified as stockholders’ equity. Equity classification of the embedded
conversion option was met through the requirements of EITF 00-19, “Accounting
for Derivative Financial Instruments to, and Potentially Settled in, a Company’s
Own Stock,” paragraphs 12-32. QuantRx also concluded, pursuant to EITF 00-27,
“Application of Issue 98-5 to Certain Convertible Instruments,” that while the
embedded conversion option was not required to be bifurcated, the instruments
did contain a beneficial conversion feature, as the share prices on the dates of
issuance exceeded the effective conversion price of the embedded conversion
option. QuantRx measured the intrinsic value of the embedded conversion option
($97,164) based upon the effective conversion price, which is defined by EITF
00-27 as the allocated proceeds divided by the number of shares to be received
on conversion. This amount was recorded as original issue discount.
F-23
The
contingent conversion option embedded in the 2007 Notes qualified as an embedded
contingent conversion option in accordance with EITF 98-5 and 00-27 since
execution was contingent upon a qualified equity financing and was not within
the control of QuantRx. The intrinsic value of the contingent embedded
conversion option was not recognized because the 2007 Notes were exchanged and
satisfied in full.
In
connection with the 2007 Notes, certain warrants that were previously issued to
the holders were modified by reducing their exercise price from $1.50 to $0.75.
The incremental fair value of this modification, accounted for in accordance
with SFAS No. 123(R), was $30,000, while the relative fair value was calculated
to be $25,210 and was recorded as additional original issue discount. The
initial warrants were originally granted in connection with a private placement
of common stock and were accounted for as additional
paid-in-capital. In association with the issuance of the 2007 Notes,
QuantRx issued warrants to purchase 100,000 shares of common stock at $1.10 per
share valued at $65,000 to the placement agent, and also incurred cash
commissions of $70,000 in connection with the private placement resulting in
total deferred debt offering cost of $135,000.
The fair
value of the warrants issued to placement agents and the cash commissions have
been recorded as deferred financing costs. The total original issue discount
related to the warrants issued to the investors, the modified warrants and the
beneficial conversion feature, and the deferred financing costs were being
amortized to interest expense over the original term of the 2007 Notes in
accordance with EITF 00-27, paragraph 19. Interest expense, including
amortization of original issue discount and deferred financing costs related to
the 2007 Notes, was $29,832 for 2008 through the date of extinguishment and
$101,168 for 2007. The remaining unamortized debt discount of $189,101 and
deferred financing costs of $99,399 were included in the loss on extinguishment
of debt in the first quarter of 2008 upon the exchange of the 2007 Notes into
the 2008 Notes; see below.
The
Black-Scholes option pricing model was used to calculate the fair values of all
of the above warrants. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share Based Payments.”
2008 Senior Secured
Convertible Notes
In
the first quarter of 2008, the Company issued 10% senior secured convertible
notes (the “2008 Notes”) to certain accredited investors. In
connection with the private placement, QuantRx issued notes in the aggregate
principal amount of $2,157,247 and warrants with a five-year term to purchase
250,000 shares of QuantRx’s common stock at an exercise price of $1.25. The
warrants provide for full anti-dilution protection to the holders and allow for
cashless exercise.
The 2008
Notes are automatically convertible into shares of QuantRx common stock upon
completion of a “qualified” equity financing (or financings) with aggregate
gross proceeds of at least $5,660,000 (amount to be reduced by the 2008 Notes,
up to a maximum of $2,250,000). Under the terms of the 2008 Notes, holders will
be deemed to have tendered 115% of their aggregate outstanding principal balance
and accrued and unpaid interest for the purchase of securities in the qualified
equity financing, entitling the holders to all rights afforded to purchasers in
such financing (“contingent embedded conversion option”). Alternatively, the
2008 Notes allow the holders to convert their outstanding principal and accrued
interest into common stock at a price of $0.50 per common share (“embedded
conversion option”). Either conversion would result in the satisfaction of all
of QuantRx’s obligations under the 2008 Notes.
In the
event QuantRx does not complete a qualified financing and holders do not
voluntarily convert, QuantRx was to repay the outstanding principal balance and
accrued and unpaid interest on January 23, 2009. All holders subsequently have
extended this maturity date to July 31, 2009. Interest on the outstanding
principal amount of the 2008 Notes is payable quarterly in cash or, at the
holders’ option, in additional 10% senior secured convertible notes with a
principal amount equal to the calculated interest amount. QuantRx has the right
to prepay the 2008 Notes at 106% of face value and 100% of accrued interest by
providing ten days notice. In connection with the financing QuantRx entered into
1) a stock pledge agreement, pursuant to which QuantRx granted to the holders a
continuing and perfected first priority security interest in certain equity
securities owned by QuantRx of two private companies and specified rights and
interests associated with the pledged shares, as well as 2) a patent, trademark
and copyright security agreement, pursuant to which QuantRx granted to the
holders a continuing and perfected first priority security interest in all of
its owned or acquired patents, trademarks and copyrights and specified
intellectual property and related rights and interests associated therewith. If
an event of default occurs under the 2008 Notes, the holders have agreed not to
take any action with respect to the collateral for 120 days after the holders
provide QuantRx with notice of the holders’ proposed action. The stock pledge
agreement and the patent, trademark and copyright security agreement, and the
security interests created thereby, will terminate upon QuantRx’s satisfaction
in full of its payment obligations under the 2008 Notes. In connection with the
2008 Notes, QuantRx may not issue any new indebtedness while at least 50% of the
original principal amount of the notes remains outstanding without the consent
of holders of at least 75% of the principal amount of the then outstanding
notes.
F-24
In
connection with the financing and in accordance with the terms of the 2007
Notes, the holders representing $1,000,000 face value of QuantRx’s 2007 Notes
exchanged their notes at 115% of the outstanding principal and accrued and
unpaid interest as payment toward the purchase price of the 2008 Notes purchased
by such holders. Accordingly, the Company issued notes in the financing in the
aggregate principal balance of $1,157,247 to the former holders upon their
surrender of the 2007 Notes. In the aggregate, the Company received
gross cash proceeds of $1,000,000 in connection with the issuance of the 2008
Notes.
QuantRx
used the net proceeds from the offering for product development, working capital
and general corporate purposes.
QuantRx
has determined that the terms of the 2008 Notes are “substantially different”,
as described in EITF Issue No. 96-19, “Debtor’s Accounting for a
Modification or Exchange of Debt Instruments”, from the terms of the 2007 Notes
based on the greater than 10% change in the present value of the cash flows
associated with the 2008 Notes and the 2007 Notes. As a result, the Company
recorded the 2008 Notes issued in exchange for the 2007 Notes at fair value on
the date of issuance and recorded a loss on extinguishment of $439,445, which
includes $189,101 and $99,399 representing the remaining unamortized debt
discount and deferred finance costs related to the 2007 Notes, respectively. In
accordance with EITF Issue No. 98-5, “Accounting for Convertible Securities
with Beneficial Conversion Features or Contingently Adjustable Conversion
Ratios”, the Company also remeasured the intrinsic value of the beneficial
conversion feature embedded in the 2007 Notes at the time of extinguishment and
determined that it had no value as the closing stock price on the date of
extinguishment was less than the effective conversion price; therefore no
allocation of the reacquisition price for the repurchase of the beneficial
conversion feature embedded in the 2007 Notes was required. Additionally, there
were no warrants issued to the holders of the 2007 Notes related to their
exchange of 2007 Notes for 2008 Notes.
The cash
proceeds from the 2008 Notes issued in the first quarter of $1,000,000 were
allocated between the notes and the warrants on a relative fair value basis in
accordance with APB Opinion No. 14, “Accounting for Convertible Debt and Debt
Issued with Stock Purchase Warrants.” QuantRx allocated $122,035 of the
principal amount of $1,000,000 to the warrants as original issue discount, which
represented the relative fair value of the warrants at the date of
issuance.
F-25
Like the
2007 Notes, the conversion option embedded in the 2008 Notes described above is
not considered a derivative instrument and is not required to be bifurcated
pursuant to the scope exception in paragraph 11(a) of SFAS No. 133, “Accounting
for Derivative Instruments and Hedging Activities,” since it is indexed to
QuantRx’s stock and is classified as stockholders’ equity. Equity classification
of the embedded conversion option is met through the requirements of EITF 00-19,
“Accounting for Derivative Financial Instruments to, and Potentially Settled in,
a Company’s Own Stock,” paragraphs 12-32. QuantRx also concluded, pursuant to
EITF 00-27, “Application of Issue 98-5 to Certain Convertible Instruments,” that
while the embedded conversion option is not required to be bifurcated, the
instruments do contain a beneficial conversion feature, as the share prices on
the dates of issuance exceeded the effective conversion price of the embedded
conversion option. QuantRx measured the intrinsic value of the embedded
conversion option ($647,760) based upon the effective conversion price, which is
defined by EITF 00-27 as the allocated proceeds divided by the number of shares
to be received on conversion. This amount was recorded as original issue
discount.
The
contingent conversion option embedded in the 2008 Notes qualifies as an embedded
contingent conversion option in accordance with EITF 98-5 and 00-27 since
execution is contingent upon a qualified equity financing and is not within the
control of QuantRx. The intrinsic value of the contingent embedded conversion
option will not be recognized until and unless such financing occurs (the
triggering event); which will then enable QuantRx to measure the intrinsic value
associated with the automatic conversion feature.
In
association with the issuance of the 2008 Notes in the first quarter, QuantRx
issued warrants to purchase 100,000 shares of common stock at $1.10 per share
valued at $55,750 to the placement agent, and also incurred cash commissions of
$70,000 and legal fees of $7,500 in connection with the private placement,
resulting in total deferred debt financing costs of $133,250.
In the
fourth quarter of 2008, the Company issued three additional 2008 Notes maturing
July 31, 2009 aggregating $300,000 with substantially the same terms as the 2008
Notes. In connection with these note issuances, warrants with a five-year term
to purchase 75,000 shares of common stock at an exercise price of $0.55 and
25,000 shares of common stock were also issued. Additionally, certain warrants
that were previously issued to the holders through previous financing
transactions were modified by reducing their exercise prices to
$0.55.
The
accounting for these 2008 Notes is consistent with the 2008 Notes above. The
cash proceeds from the fourth quarter 2008 Notes of $300,000 were allocated
between the notes, common stock, the new and modified warrants on a relative
fair value basis. QuantRx allocated the relative fair values of the common stock
($7,817), new warrants ($18,918), and modified warrants ($30,131) at the date of
issuance to original issue discount. Additionally, a beneficial conversion
feature of $1,427 was accounted for as original issue discount. No deferred
finance costs were incurred on these fourth quarter 2008 Notes.
In the
aggregate for all 2008 Notes, the fair value of the warrants issued to placement
agents and the cash commissions and legal fees have been recorded as deferred
financing costs. The total original issue discount related to the common stock
and warrants issued to the investors, the beneficial conversion feature, and the
deferred financing costs are being amortized to interest expense over the
original term of each 2008 Note in accordance with EITF 00-27, paragraph 19.
QuantRx recorded $1,060,435 in interest expense, including amortization of
original issue discount and deferred financing costs, related to the 2008 Notes
for the year ended December 31, 2008. As of December 31, 2008, the
Company issued three 2008 Notes in the aggregate amount of $150,733 pursuant to
one holder’s election to receive quarterly interest in the form of paid-in-kind
notes.
F-26
The
Black-Scholes option pricing model was used to calculate the fair values of all
of the above warrants. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share Based Payments.”
2008 Secured Promissory
Notes Payable
In the
second quarter of 2008, the Company commenced a private placement to certain
accredited investors through the issuance of 8% senior secured promissory notes
(the “2008 Secured Promissory Notes”). The private placement closed in the third
quarter of 2008. In connection with the private placement, QuantRx
issued notes in the aggregate principal amount of $550,000, and an aggregate of
137,500 shares of common stock and warrants with a five-year term to purchase
137,500 shares of common stock warrants at a per share exercise price of
$0.85. The warrants provide for full anti-dilution protection to the
holders and allow for cashless exercise. The 2008 Secured Promissory Notes were
originally due on September 15, 2008, along with all accrued and unpaid
interest. QuantRx used the net proceeds from the offering for product
development, working capital and general corporate purposes.
In
connection with the financing QuantRx entered into 1) a stock pledge agreement,
pursuant to which QuantRx granted to the holders a continuing and perfected
first priority security interest in certain equity securities owned by QuantRx
of two private companies and specified rights and interests associated with the
pledged shares, as well as 2) a patent, trademark and copyright security
agreement, pursuant to which QuantRx granted to the holders a continuing and
perfected first priority security interest in all of its owned or acquired
patents, trademarks and copyrights and specified intellectual property and
related rights and interests associated therewith. If an event of default occurs
under the 2008 Secured Promissory Notes, the holders have agreed not to take any
action with respect to the collateral for 120 days after the holders provide
QuantRx with notice of the holders’ proposed action. The stock pledge agreement
and the patent, trademark and copyright security agreement, and the security
interests created thereby, will terminate upon QuantRx’s satisfaction in full of
its payment obligations under the 2008 Secured Promissory Notes.
The
cash proceeds from the 2008 Secured Promissory Notes of $550,000 were allocated
between the notes, common stock and warrants on a relative fair value basis.
QuantRx allocated $79,806 and $58,050 of the principal amount of $550,000 to the
common stock and warrants as original issue discount, which represented the
relative fair values of each at the date of issuance.
In
association with the issuance of the 2008 Secured Promissory Notes, QuantRx
issued warrants to purchase 100,000 shares of common stock at $0.85 per share
valued at $64,000 to the placement agent, and also incurred cash commissions of
$55,000 in connection with the private placement resulting in total deferred
finance costs of $119,000.
The fair
value of the warrants issued to placement agents and the cash commissions were
recorded as deferred financing costs. The total original issue discount related
to the common stock and warrants issued to the investors and the deferred
financing costs were amortized to interest expense over the original term of the
2008 Secured Promissory Notes in accordance with EITF 00-27, paragraph
19.
F-27
On the
original maturity date, September 15, 2008, one note for $100,000 was settled in
full and the Company negotiated monthly extensions of one to three months on the
remaining notes. At September 15, 2008, QuantRx granted an aggregate of 22,500
shares of common stock (fair value $11,475) and warrants to purchase 22,500
shares of common stock with a five year term for $0.85 (fair value $9,000) which
for a one-month extension. The second and third one-month extensions were
executed on October and November 15, 2008, on 2008 Secured Promissory Notes with
an aggregate principal of $150,000. In consideration for these
stages, QuantRx granted an aggregate of 15,000 shares of common stock (fair
value $5,250) and warrants to purchase 15,000 shares of common stock (fair value
$3,900) with a five year term for $0.85. The consideration for the extensions
was recognized as prepaid interest and was amortized over the extension periods.
On December 15, 2008, when these Notes matured, the holders agreed to extend the
maturity date to July 31, 2009. In consideration for one of these seven and a
half month extensions, QuantRx modified the holder’s warrants to purchase 20,000
shares of common stock by reducing the exercise price from $0.85 to $0.55. The
incremental value of this modification was $400, which was recorded as prepaid
interest and is being amortized over the term of the extension as interest
expense.
On
October 15, 2008, QuantRx executed an eleven-month extension with a holder of a
$100,000 2008 Secured Promissory Note. In consideration for this
extension, QuantRx granted 75,000 shares of common stock with a fair value of
$22,500, which will be expensed over the term of the extension.
QuantRx
executed an extension with a holder of a $200,000 2008 Secured Promissory Note
as of October 15, 2008, extending the maturity dates as follows: $50,000 and
related accrued interest due October 31, 2008; $50,000 and related accrued
interest due November 30, 2008; $100,000 and related accrued interest due
December 31, 2008. In consideration for this extension, QuantRx granted 20,000
shares of common stock (fair value $6,000) and warrants to purchase 20,000
shares of common stock (fair value $4,400) with a five year term for $0.85; the
fair values of which were expensed over the term of the extension. As of
December 31, 2008, this holder agreed to an extension of the remaining $100,000
outstanding principal as follows: $10,000 and related accrued interest due
monthly beginning January 31, 2009, with a final payment due June 30,
2009. In consideration for this further extension, QuantRx granted a
warrant in January 2009 to purchase 100,000 shares of common stock (fair value
$18,000) with a five year term for $0.50; the fair value of which will be
expensed over the term of the extension. See also Note 17, Subsequent
Events.
In the
aggregate, QuantRx recorded $321,001 in interest expense, including amortization
of original issue discount, deferred financing costs and prepaid interest,
related to the 2008 Secured Promissory Notes for the year ended December 31,
2008.
The
Black-Scholes option pricing model was used to calculate the fair values of all
of the above warrants. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share Based Payments.”
2008 Unsecured Promissory
Notes Payable
In August
2008, the Company completed a private placement to certain accredited investors
through the issuance of 8% promissory notes (the “2008 Promissory Notes”). In
connection with the private placement, QuantRx issued notes in the aggregate
principal amount of $1,000,000, and an aggregate of 250,000 shares of common
stock and warrants with a five-year term to purchase 250,000 shares of common
stock at a per share exercise price of $0.85. The warrants provide
for full anti-dilution protection to the holders and allow for cashless
exercise. The 2008 Promissory Notes were due on October 31, 2008, along with all
accrued and unpaid interest. QuantRx used the net proceeds from the offering for
product development, working capital and general corporate
purposes.
F-28
The
net cash proceeds from the 2008 Promissory Notes were $942,500. QuantRx
allocated $132,827 and $108,159 of the principal amount of $1,000,000 to the
common stock and warrants as original issue discount, which represented the
relative fair values of each at the date of issuance.
In
association with the issuance of the 2008 Promissory Notes, QuantRx incurred
cash commissions and legal fees of $57,500, which were recorded as deferred
financing costs and expensed over the original term.
As of
October 31, 2008, QuantRx settled a $500,000 2008 Promissory Note with the
issuance of a $607,890 8% unsecured promissory note which included additional
principal of $100,000 and accrued interest of $7,890. The maturity
date is April 30, 2009. In connection with the issuance of this note,
QuantRx granted 200,000 shares of common stock (fair value of $80,000; relative
fair value of $70,696); the relative fair value of the common stock was recorded
as debt discount and is being amortized over the term of the new
note.
QuantRx
executed an extension with a holder of a $500,000 2008 Promissory Note as of
October 31, 2008, extending the maturity date to January 31, 2009. In
consideration for this extension, QuantRx granted 200,000 shares of common stock
with a fair value of $80,000 and revised the interest rate on the original 8%
note to 10% effective as of the origination date. The fair value of
common stock granted in connection with this extension is being expensed over
the term of the extension. See also Note 17, Subsequent
Events.
The total
original issue discount related to the common stock and warrants issued to the
investors and the deferred financing costs are being amortized to interest
expense over the original terms of the 2008 Promissory Notes in accordance with
EITF 00-27, paragraph 19. In the aggregate, QuantRx recorded $410,274 in
interest expense, including amortization of original issue discount and deferred
financing costs, related to the 2008 Promissory Notes for the year ended
December 31, 2008.
The
Black-Scholes option pricing model was used to calculate the fair values of all
of the above warrants. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share Based Payments.”
11. COMMITMENTS
AND CONTINGENCIES
Operating
Leases
The
Company has operating leases for its office and research and development space,
both of which have initial lease terms of five years. The corporate office lease
contains an option for QuantRx to terminate the lease after the third year for a
fee of $5,000. Certain leases contain rent escalation clauses that require
higher rental payments in later years. Leases may also contain rent holidays, or
free rent periods, during the lease term.
Rent
expense is recognized on a straight-line basis over the initial lease term.
Leasehold improvements have been included in fixed assets. Rent expense relating
to our operating leases was $174,099 and $155,396 for the years ended December
31, 2008 and 2007, respectively. Minimum lease payments for the years 2009
through 2013 are as follows: $101,563; $57,240; $43,875; $0 and $0; and in the
aggregate is $202,678. Sublease income relating to our operating leases was
$23,373 and $20,008 for the years ending December 31, 2008 and 2007, and is
recorded in other income.
F-29
Executive Employment
Contracts
The
Company has entered into an employment contract with a key Company executive
that provides for the continuation of salary to the executive if terminated for
reasons other than cause, as defined in those agreements. At December 31, 2008,
the future employment contract commitment for such key executive based on this
termination clause was approximately $240,000.
12. INCOME
TAXES
We are
subject to taxation in the U.S., the state of Oregon, and the Commonwealths of
Pennsylvania and Massachusetts. With few exceptions, the Company is no longer
subject to U.S. federal, state and local income tax examinations by tax
authorities for years before 2003.
At
December 31, 2008 and 2007, the Company had gross deferred tax assets calculated
at an expected blended rate of 38% of approximately $16,085,386 and $13,942,444
respectively, principally arising from net operating loss carryforwards for
income tax purposes. As management of the Company cannot determine that it is
more likely than not that the Company will realize the benefit of the deferred
tax asset, a valuation allowance of $16,065,431 and $13,917,226 has been
established at December 31, 2008 and 2007, respectively.
Additionally,
the future utilization of our net operating loss and R&D credit
carryforwards to offset future taxable income may be subject to an annual
limitation, pursuant to IRC Sections 382 and 383, as a result of ownership
changes that may have occurred previously or that could occur in the
future.
The
significant components of the Company’s net deferred tax assets (liabilities) at
December 31, 2008 and 2007 are as follows:
2008
|
2007
|
|||||||
Gross
deferred tax assets:
|
||||||||
Net
operating loss carryforwards
|
$ | 14,040,021 | $ | 12,472,607 | ||||
Stock
based expenses
|
1,590,554 | 1,136,836 | ||||||
Tax
credit carryforwards
|
358,869 | 247,303 | ||||||
All
others
|
95,942 | 85,698 | ||||||
16,085,386 | 13,942,444 | |||||||
Gross
deferred tax liabilities:
|
||||||||
Difference
between book and tax bases of tangible and intangible
assets
|
(19,955 | ) | (25,218 | ) | ||||
Deferred
tax asset valuation allowance
|
(16,065,431 | ) | (13,917,226 | ) | ||||
Net
deferred tax asset (liability)
|
$ | - | $ | - |
At
December 31, 2008, the Company has net operating loss carryforwards of
approximately $36,947,425, which expire in the years 2009 through 2028. The net
change in the allowance account was an increase of $2,148,205 for the year ended
December 31, 2008.
In
accordance with SFAS No. 109, the accounting for the tax benefits of acquired
deductible temporary differences and NOL carryforwards, which are not recognized
at the acquisition date because a valuation allowance is established and which
are recognized subsequent to the acquisition, will be applied first to reduce to
zero any goodwill and other non-current intangible assets related to the
acquisition. Any remaining benefits would be recognized as a
reduction of income tax expense. As of December 31, 2008,
approximately $1,186,330 of deferred tax assets with a valuation allowance
relates to our newly consolidated, majority owned subsidiary, the future
benefits of which will be applied first to reduce to zero any goodwill and other
non-current intangible assets related to the acquisition, prior to reducing our
income tax expense.
F-30
13. CAPITAL
STOCK
Common
Stock
The
Company has authorized 75,000,000 shares of its common stock, $0.01 par value.
The Company had issued and outstanding 42,886,380 and 41,699,681 shares of its
common stock at December 31, 2008 and 2007, respectively.
In
December 2008, QuantRx issued 25,000 shares of common stock (fair value $9,250)
and warrants to purchase 25,000 shares of common stock (fair value $7,375) in
connection with the issuance of two 2008 Notes, maturing July 31, 2009.
Additionally, warrants issued to these investors in connection with previous
debt financings were modified, reducing their exercise prices to
$0.55. The aggregate incremental fair value of these modifications
was $1,650; the relative fair value was $1,390, which was recorded as debt
discount and is being amortized over the term of each Note.
On
October 31, 2008, QuantRx issued 200,000 shares of common stock (fair value
$80,000) in connection with the issuance of a 2008 Promissory Note.
On
October 31, 2008, QuantRx negotiated an extension on one of the 2008 Promissory
Notes. In consideration for this extension, QuantRx issued 200,000 shares of
common stock (fair value $80,000).
On
September, October and November 15, 2008, QuantRx negotiated extensions on each
of the outstanding 2008 Secured Promissory Notes. In consideration for these one
to eleven month extensions, QuantRx granted an aggregate of 132,500 shares of
common stock (fair value $45,225) and warrants to purchase 57,500 shares of
common stock with a five year term for $0.85 (fair value $17,300).
In August
2008, QuantRx completed a private placement of 8% promissory notes, common
stock, and warrants to purchase shares of QuantRx’s common stock. In connection
with the private placement, QuantRx issued 250,000 shares of common stock (with
a relative fair value of $132,827) and warrants with a five-year term to
purchase 250,000 shares of QuantRx’s common stock at an exercise price of $0.85
(with a relative fair value of $108,159). The notes, common stock and warrants
were offered only to certain private accredited investors.
In the
second and third quarters of 2008, QuantRx conducted a private placement of 8%
promissory notes, common stock and warrants to purchase shares of QuantRx’s
common stock. In connection with the private placement, QuantRx issued 137,500
shares of common stock (with a relative fair value of $79,806) along with
warrants with a five-year term to purchase 137,500 shares of QuantRx’s common
stock at an exercise price of $0.85 (with a relative fair value of $58,050). The
notes, common stock and warrants were offered only to certain private accredited
investors. At the commencement of the financing, in June 2008, QuantRx issued
warrants for services to purchase 100,000 shares of common stock at $0.85 per
share valued at $64,000.
In April
2008, QuantRx completed a limited warrant exercise inducement targeting large
warrant holders who have expressed an interest to participate. The inducement
was a reduction in the exercise price from $1.50 to $0.70 to a limited number of
warrant holders who acquired the warrants in conjunction with prior common stock
purchases. An aggregate of 241,699 common stock warrants were exercised and
exchanged for 241,699 shares of our common stock for total proceeds of
$169,189.
F-31
In the
third quarter of 2007, QuantRx initiated a limited warrant exercise inducement
targeting certain large warrant holders. The inducement was a reduction in the
exercise price from $1.50 to $0.75 to a limited number of accredited investors
holding warrants acquired in conjunction with prior common stock purchases. As a
result of this inducement, 751,001 common stock warrants were exercised and
exchanged for 751,001 shares of our common stock, $0.01 par value, for aggregate
gross proceeds of $563,251. In connection with the exercise of these warrants,
QuantRx paid cash commissions to Legend Merchant, Inc. of $16,429.
In the
third quarter of 2007, 38,100 common stock warrants were exercised and exchanged
for 38,100 shares of our common stock, $0.01 par value, resulting in proceeds to
the Company of $20,955. The exercise price for these warrants was
$0.55.
On March
1, 2007, QuantRx completed a private placement of 3,532,500 shares of common
stock and warrants with a five-year term valued at $1,243,087 to purchase an
aggregate of 1,059,750 shares of common stock at $1.50 per share to accredited
investors for gross proceeds of $3,532,500 in cash. The Company issued warrants
with a seven-year term to purchase 194,250 shares of common stock at $1.00 per
share valued at $277,778, and paid cash commissions of $155,400 in connection
with the private placement to Legend Merchant Inc., and an additional $2,104 for
related legal services.
Preferred
Stock
The
Company has authorized 25,000,000 shares of preferred stock, of which 9,750,000
are designated Series A convertible preferred stock, $0.01 par value, with a
conversion ratio of 1.5 common shares for each share of Series A preferred
stock. The remaining 15,250,000 authorized preferred shares have not yet been
designated by the Company. The Company had no issued and outstanding shares of
its Series A convertible preferred stock at December 31, 2008 and
2007.
14. STOCK
PURCHASE WARRANTS
Common Stock
Warrants
In
December 2008, QuantRx issued 25,000 shares of common stock (fair value $9,250)
and warrants to purchase 25,000 shares of common stock (fair value $7,375) in
connection with the issuance of two 2008 Notes, maturing July 31, 2009.
Additionally, warrants issued to these investors in connection with previous
debt financings were modified, reducing their exercise prices to
$0.55. The aggregate incremental fair value of these modifications
was $1,650; the relative fair value was $1,390, which was recorded as debt
discount and is being amortized over the term of each Note.
On
December 15, 2008, QuantRx negotiated extensions on each of the then-maturing
2008 Secured Promissory Notes. In consideration for one of these seven and a
half month extensions, QuantRx modified the holder’s warrants to purchase 20,000
shares of common stock by reducing the exercise price from $0.85 to $0.55. The
incremental value of this modification was $400, which was recorded as prepaid
interest and is being amortized over the term of the extension as interest
expense.
On
October 31, 2008, in connection with the issuance of a $200,000 2008 Note, the
holder was issued warrants for the purchase of 50,000 shares of common stock
(fair value $16,000) with a term of five years and an exercise price of $0.55.
Additionally, in connection with the issuance, the exercise price on previously
issued warrants to purchase 437,500 shares of common stock was revised from
$1.25 to $0.55, and previously issued warrants to purchase 375,000 shares of
common stock was revised to $0.75 to $0.55.
F-32
On
September, October and November 15, 2008, QuantRx negotiated extensions on each
of the outstanding 2008 Secured Promissory Notes. In consideration for these one
to eleven month extensions, QuantRx granted an aggregate of 132,500 shares of
common stock (fair value $45,225) and warrants to purchase 57,500 shares of
common stock with a five year term and an exercise price of $0.85 (fair value
$17,300
In August
2008, QuantRx completed a private placement of 8% promissory notes, common
stock, and warrants to purchase shares of QuantRx’s common stock. In connection
with the private placement, QuantRx issued 250,000 shares of common stock (with
a relative fair value of $132,827) and warrants with a five-year term to
purchase 250,000 shares of QuantRx’s common stock at an exercise price of $0.85
(with a relative fair value of $108,159). The notes, common stock and warrants
were offered only to certain private accredited investors.
On August
18, 2008, the Company issued a warrant in consideration of a three month
consulting and investor relations services agreement. The warrant has a term of
five years and represents the right to purchase 40,000 shares of common stock at
an exercise price of $1.25. The fair value of this warrant was calculated to be
$22,400 and will be expensed over the term of the agreement.
In the
second and third quarters of 2008, QuantRx conducted a private placement of 8%
promissory notes, common stock and warrants to purchase shares of QuantRx’s
common stock. In connection with the private placement, QuantRx issued 137,500
shares of common stock (with a relative fair value of $79,806) along with
warrants with a five-year term to purchase 137,500 shares of QuantRx’s common
stock at an exercise price of $0.85 (with a relative fair value of $58,050). The
notes, common stock and warrants were offered only to certain private accredited
investors. At the commencement of the financing, in June 2008, QuantRx issued
warrants for services to purchase 100,000 shares of common stock at $0.85 per
share valued at $64,000.
In April
2008, QuantRx completed a limited warrant exercise inducement targeting large
warrant holders who have expressed an interest to participate. The inducement
was a reduction in the exercise price from $1.50 to $0.70 to a limited number of
warrant holders who acquired the warrants in conjunction with prior common stock
purchases. Warrants to purchase an aggregate of 241,699 shares of common stock
were exercised and exchanged for our common stock for total proceeds of
$169,189.
In April
2008, the Company issued common stock warrants with a five year term in
consideration of a financial advisory and investor relations consulting services
agreement. The warrant represents the right to purchase 200,000 shares of common
stock at an exercise price of $0.89 and vests ratably each month over a one year
term. The fair value of the warrant was calculated to be $148,000 on grant date,
and shall be remeasured during the vesting term as required. Consulting expense
related to the issuance of these warrants was $34,000 for the year ended
December 31, 2008.
In April
2008, the Company issued warrants with a five year term to purchase 25,000
shares of common stock at an exercise price of $1.35. The warrants were issued
as payment for technical advisory services related to medical diagnostics. The
fair value of these warrants was calculated to be $16,250, and will be expensed
over a one year term. Consulting expense related to the issuance of these
warrants was $11,576 for the year ended December 31, 2008.
F-33
In the
first quarter of 2008, QuantRx completed a private placement of 10% senior
secured convertible notes and warrants to purchase shares of common stock. In
connection with the private placement, QuantRx issued warrants with a five-year
term to purchase 250,000 shares of QuantRx’s common stock at an exercise price
of $1.25. The notes and the warrants were offered only to certain private
accredited investors. In association with the issuance of these convertible
notes, QuantRx issued warrants for services to purchase 100,000 shares of common
stock at $1.10 per share valued at $55,750.
On
October 16, 2007, QuantRx completed a private placement of 10% senior secured
convertible promissory notes and warrants to purchase shares of QuantRx' common
stock. In connection with the private placement, QuantRx issued warrants to
purchase 250,000 shares of QuantRx' common stock at an exercise price of $0.75
(relative fair value of $134,454). The warrants entitle the holder thereof to
purchase the number of shares of QuantRx' common stock equal to 20% of the
shares underlying such holder's note on the original issue date. The notes and
the warrants were offered only to certain private accredited investors. In
association with the issuance of these convertible notes, QuantRx issued
warrants for services to purchase 100,000 shares of common stock at an exercise
price of $0.75 per share valued at $65,000.
Throughout
2007, the Company issued warrants to purchase an aggregate of 14,000 shares of
common stock with five-year terms and exercise prices equal to the market price
on the dates of grant (varying between $0.61 to $1.15). These
warrants were in consideration of business development consulting services. The
fair value of these warrants was $11,160, and was expensed in 2007.
In the
third quarter 2007, QuantRx initiated a limited warrant exercise inducement
targeting certain large warrant holders. The inducement was a reduction in the
exercise price from $1.50 to $0.75 to a limited number of accredited investors
holding warrants acquired in conjunction with prior common stock purchases. As a
result of this inducement, 751,001 common stock warrants were exercised and
exchanged for 751,001 shares of our common stock, $0.01 par value, for aggregate
net proceeds of $546,822.
In August
2007, 38,100 common stock warrants were exercised and exchanged for 38,100
shares of our common stock, $0.01 par value, resulting in proceeds to the
Company of $20,955. The exercise price for these warrants was
$0.55.
On April
30, 2007, the Company issued a warrant in consideration of financial advisory
and public relations consulting services performed through April 30, 2007. The
warrant has a term of five years and represents the right to purchase 30,000
shares of common stock at an exercise price of $1.20. The fair value of this
warrant was calculated to be $31,800 and was expensed in 2007.
On April
16, 2007, the Company issued a warrant in consideration of a financial advisory
and investor relations consulting services agreement with an initial one year
term. The original agreement was modified June 20, 2007. The original warrant
had a term of five years and represented the right to purchase 350,000 shares of
common stock at an exercise price of $1.35 and vested ratably each month over
the initial one year term. The fair value of the original warrant was calculated
to be $420,000. On June 20, 2007, the agreement was modified and the original
warrant was cancelled. The warrant issued upon modification of the agreement has
the same terms as the originally issued warrant other than it represents the
right to purchase 150,000 shares of common stock at an exercise price of $0.95,
which was the closing price on the modification date. The fair value of the
modified warrant was calculated to be $126,000 on the modification date, and
shall be remeasured during the vesting term as required. Consulting expense
related to the issuance of these warrants was $5,438 in 2008 and $114,062 in
2007, which includes $28,000 expensed in the second quarter of 2007 related to
the cancelled warrants.
F-34
On April
16, 2007, the Company issued common stock warrants with a five year term to
purchase 50,000 shares of common stock at an exercise price of $1.35. The
warrants were issued as payment for technical advisory services related to
medical diagnostics. The fair value of these warrants was calculated to be
$60,000, and will be expensed over the initial year of the agreement. Consulting
expense related to the issuance of these warrants was $17,377 in 2008 and
$42,623 in 2007.
In the
first quarter of 2007, QuantRx issued 200,000 common stock warrants with a
five-year term to purchase 200,000 shares of common stock at an exercise price
of $1.50. The warrants were issued pursuant to a financial advisory services
agreement, and the fair value of $250,000 for these warrants was expensed over
the service term of four months.
On March
1, 2007, QuantRx issued warrants with a five-year term valued at $1,243,087 to
purchase an aggregate of 1,059,750 shares of common stock at an exercise price
of $1.50 per share to accredited investors in conjunction with a private
placement of common stock. The Company issued warrants with a seven-year term to
purchase 194,250 shares of common stock at $1.00 per share valued at $277,778 in
connection with the private placement to Legend Merchant Inc.
The
following is a summary of all common stock warrant activity during the two years
ended December 31, 2008:
Number
of Shares Under Warrants
|
Exercise
Price Per Share
|
Weighted
Average Exercise Price
|
||||||||||
Warrants
issued and exercisable at December 31, 2006
|
5,854,484 | $ | 0.50 - 4.25 | $ | 1.23 | |||||||
Warrants
granted
|
2,048,000 | $ | 0.61 - 1.50 | $ | 1.24 | |||||||
Warrants
expired
|
- | - | - | |||||||||
Warrants
exercised
|
(789,101 | ) | $ | 0.55 - 0.75 | $ | 0.74 | ||||||
Warrants
issued and exercisable at December 31, 2007
|
7,113,383 | $ | 0.50 - 4.25 | $ | 1.20 | |||||||
Warrants
granted
|
1,235,000 | $ | 0.55 - 1.35 | $ | 0.96 | |||||||
Warrants
expired
|
(180,000 | ) | $ | 1.92 - 4.25 | $ | 2.57 | ||||||
Warrants
exercised
|
(241,699 | ) | $ | 0.70 | $ | 0.70 | ||||||
Warrants
issued and exercisable at December 31, 2008
|
7,926,684 | $ | 0.50 - $ 2.00 | $ | 1.07 |
F-35
The
following represents additional information related to common stock warrants
outstanding and exercisable at December 31, 2008:
Exercise
Price
|
Number
of Shares Under Warrants
|
Weighted
Average Remaining Contract Life in Years
|
Weighted
Average Exercise Price
|
|||||||||||
$ | 0.50 | 956,873 | 2.58 | $ | 0.50 | |||||||||
$ | 0.55 | 1,136,598 | 3.02 | $ | 0.55 | |||||||||
$ | 0.61 | 4,000 | 3.88 | $ | 0.61 | |||||||||
$ | 0.75 | 2,000 | 3.75 | $ | 0.75 | |||||||||
$ | 0.85 | 1,540,196 | 2.44 | $ | 0.85 | |||||||||
$ | 0.87 | 2,000 | 3.68 | $ | 0.87 | |||||||||
$ | 0.89 | 200,000 | 4.29 | $ | 0.89 | |||||||||
$ | 0.95 | 150,000 | 3.29 | $ | 0.95 | |||||||||
$ | 1.00 | 325,750 | 5.07 | $ | 1.00 | |||||||||
$ | 1.10 | 200,000 | 3.95 | $ | 1.10 | |||||||||
$ | 1.15 | 6,000 | 3.42 | $ | 1.15 | |||||||||
$ | 1.20 | 30,000 | 3.33 | $ | 1.20 | |||||||||
$ | 1.25 | 77,500 | 4.40 | $ | 1.25 | |||||||||
$ | 1.35 | 75,000 | 3.29 | $ | 1.35 | |||||||||
$ | 1.50 | 2,902,267 | 1.41 | $ | 1.50 | |||||||||
$ | 2.00 | 318,500 | 2.23 | $ | 2.00 | |||||||||
7,926,684 | 2.39 | $ | 1.07 |
The
Company used the Black-Scholes option price calculation to value the warrants
granted in 2008 and 2007 using the following assumptions: risk-free rate of
5.35% and 5.77%; volatility of 1.17 and 1.35; actual term and exercise price of
warrants granted. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share Based Payments.”
15. COMMON
STOCK OPTIONS
In 2007,
the Company adopted the 2007 Incentive and Non-Qualified Stock Option Plan
(hereinafter “the Plan”), which replaced the 1997 Incentive and Non-Qualified
Stock Option Plan, as amended in 2001, and under which 8,000,000 shares of
common stock are reserved for issuance under qualified options, nonqualified
options, stock appreciation rights and other awards as set forth in the
Plan.
Under the
Plan, qualified options are available for issuance to employees of the Company
and non-qualified options are available for issuance to consultants and
advisors. The Plan provides that the exercise price of a qualified option cannot
be less than the fair market value on the date of grant and the exercise price
of a nonqualified option must be determined on the date of grant. Options
granted under the Plan generally vest three to five years from the date of grant
and generally expire ten years from the date of grant.
In the
fourth quarter of 2008, 6,250 non-qualified common stock options were granted to
a member of the board of directors and issued from the Company’s Incentive and
Non-Qualified Stock Option Plan. The options were issued with an exercise price
of $0.35, have a term of five years and vested immediately. The fair value of
these options is $1,813.
F-36
In the
first quarter of 2008, an aggregate of 528,000 qualified common stock options
were granted to employees and 25,000 non-qualified stock options were granted to
certain consultants and issued from the Company’s 2007 Incentive and
Non-Qualified Stock Option Plan. The options were issued with an exercise price
of $0.80, and have a term of ten years. The options vest monthly over one year.
The fair value of these options is $420,280.
In the
fourth quarter of 2007, 6,250 non-qualified common stock options were granted to
a member of the board of directors and issued from the Company’s Incentive and
Non-Qualified Stock Option Plan. The options were issued with an exercise price
of $0.69, have a term of five years and vested immediately. The fair value of
these options is $3,813.
In the
fourth quarter of 2007, a total of 413,000 qualified common stock options were
granted to employees and issued from the Company’s Incentive and Non-Qualified
Stock Option Plan. The options were issued with an exercise price of $0.85, and
have a term of ten years. The options vest monthly over one year. The fair value
of these options is $342,790.
Pursuant
to SFAS No. 123(R), the fair value amounts will be accrued to compensation
expense over the expected service terms, not to exceed the vesting period. The
accrued compensation expense related to QuantRx’s options for the years ended
December 31, 2008 and 2007 is $673,023 and $219,564, respectively.
The
following is a summary of all common stock option activity during the two years
ended December 31, 2008:
Shares
Under Options Outstanding
|
Weighted
Average Exercise Price
|
|||||||
Outstanding
at December 31, 2006
|
1,372,500 | $ | 0.74 | |||||
Options
granted
|
419,250 | $ | 0.85 | |||||
Options
forfeited
|
- | - | ||||||
Options
exercised
|
- | - | ||||||
Outstanding
at December 31, 2007
|
1,791,750 | $ | 0.77 | |||||
Options
granted
|
559,250 | $ | 0.79 | |||||
Options
forfeited
|
(113,000 | ) | $ | 1.51 | ||||
Options
exercised
|
- | - | ||||||
Outstanding
at December 31, 2008
|
2,238,000 | $ | 0.74 |
Options
Exercisable
|
Weighted
Average Exercise
Price
Per Share
|
|||||||
Exercisable
at December 31, 2007
|
1,207,872 | $ | 0.63 | |||||
Exercisable
at December 31, 2008
|
2,048,000 | $ | 0.69 |
F-37
The
following represents additional information related to common stock options
outstanding and exercisable at December 31, 2008:
Outstanding
|
Exercisable
|
|||||||||||||||||||||
Exercise
Price
|
Number
of Shares
|
Weighted
Average Remaining Contract Life in Years
|
Weighted
Average Exercise Price
|
Number
of Shares
|
Weighted
Average Exercise Price
|
|||||||||||||||||
$ | 0.35 | 6,250 | 5.00 | $ | 0.35 | 6,250 | $ | 0.35 | ||||||||||||||
$ | 0.50 | 1,000,000 | 6.34 | $ | 0.50 | 1,000,000 | $ | 0.50 | ||||||||||||||
$ | 0.69 | 6,250 | 4.00 | $ | 0.69 | 6,250 | $ | 0.69 | ||||||||||||||
$ | 0.80 | 540,000 | 9.17 | $ | 0.80 | 450,000 | $ | 0.80 | ||||||||||||||
$ | 0.85 | 413,000 | 8.78 | $ | 0.85 | 413,000 | $ | 0.85 | ||||||||||||||
$ | 1.00 | 60,000 | 1.18 | $ | 1.00 | 60,000 | $ | 1.00 | ||||||||||||||
$ | 1.15 | 75,000 | 7.57 | $ | 1.15 | 75,000 | $ | 1.15 | ||||||||||||||
$ | 1.17 | 12,500 | 3.00 | $ | 1.17 | 12,500 | $ | 1.17 | ||||||||||||||
$ | 1.60 | 125,000 | 7.26 | $ | 1.60 | 25,000 | $ | 1.60 | ||||||||||||||
2,238,000 | 7.40 | $ | 0.74 | 2,048,000 | $ | 0.69 |
The
weighted average remaining contractual term for fully vested share options
(exercisable, above) and options expected to vest (outstanding, above) is 7.3
and 7.4 years, respectively. The aggregate intrinsic value of all of
QuantRx’s options is $0.
The
weighted-average grant-date fair value of options granted during 2007 and 2008
was $0.83 and $0.75, respectively. There were no options exercised during 2007
and 2008; therefore there was no intrinsic value of options exercised and no
related tax benefits were realized. The total fair value of shares vested during
2007 and 2008 was $241,708 and $621,695, respectively.
A summary
of the status of the Company’s nonvested stock options as of December 31, 2008
and changes during the year ended December 31, 2008 is presented
below:
Nonvested
Stock Options
|
Shares
|
Weighted
Average Grant Date Fair Value
|
||||||
Nonvested
at December 31, 2007
|
583,878 | $ | 1.02 | |||||
Options
granted
|
559,250 | $ | 0.75 | |||||
Options
vested
|
(840,128 | ) | $ | 0.74 | ||||
Options
forfeited
|
(113,000 | ) | $ | 1.49 | ||||
Nonvested
at December 31, 2008
|
190,000 | $ | 1.20 |
As of
December 31, 2008, there was approximately $133,367 of unrecognized compensation
cost related to nonvested options. Weighted average period of nonvested stock
options was 8.2 years as of December 31, 2008.
The
Company used the Black-Scholes option price calculation to value the options
granted in 2008 and 2007 using the following assumptions: risk-free rate of
5.35% and 5.77%; volatility of 1.17 and 1.35; actual term and exercise price of
options granted. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share Based Payments.”
F-38
16. RELATED
PARTY TRANSACTIONS
In August
2008, in connection with a debt financing, QuantRx incurred cash commissions of
$50,000 to Burnham Hill Partners, of which a beneficial owner of more than 5% of
QuantRx common stock is a managing member. Burnham Hill Partners was the
placement agent for the debt financing. These commissions are outstanding as of
December 31, 2008.
On June
16, 2008, in connection with a debt financing, QuantRx issued warrants with a
five-year term valued at $64,000 to purchase an aggregate of 100,000 shares of
common stock at $0.85 per share to Burnham Hill Partners. Burnham Hill Partners
was the placement agent for the debt financing. Additionally, cash commissions
of $55,000 are due to Burnham Hill Partners for its role as placement agent in
the transaction as of December 31, 2008.
In the
first quarter of 2008, in connection with a debt financing, QuantRx issued
warrants with a five-year term valued at $55,750 to purchase an aggregate of
100,000 shares of common stock at $1.10 per share to Burnham Hill Partners.
Burnham Hill Partners was the placement agent for the debt financing.
Additionally, cash commissions of $70,000 are due to Burnham Hill Partners for
its role as placement agent in the transaction as of December 31,
2008.
An
executive officer of our majority-owned subsidiary, who is also a beneficial
owner of approximately 25% of the subsidiary’s outstanding shares, was due
$40,000 for licensing fees related to patent license agreements, $120,191 for
advances to fund general operating expenses and $142,500 for accrued payroll as
of December 31, 2008, of which $160,191 was included in accounts payable and
$142,500 was included in accrued expenses. At December 31, 2007,
$20,155 was included in accounts payable, of which $20,000 related to licensing
fees.
In
October 2007, in connection with a debt financing, QuantRx issued warrants with
a five-year term valued at $65,000 to purchase an aggregate of 100,000 shares of
common stock at $1.10 per share to Burnham Hill Partners, of which a beneficial
owner of more than 5% of QuantRx common stock is a managing member. Burnham Hill
Partners was the placement agent for the debt financing. Additionally, cash
commissions of $70,000 were incurred for Burnham Hill Partners for its role as
placement agent in the transaction, of which $50,000 was paid in the third
quarter of 2008, and $20,000 remains outstanding as of December 31,
2008.
In April
2007, our subsidiary FluoroPharma, Inc. advanced $100,000 to one of its
executive officers through a 6% promissory note due December 31, 2007. The
Company recognized interest of $2,959 on this note. The note and accrued
interest were paid in full in October 2007.
On March
9, 2007, the Company issued 200,000 common stock warrants with a five year term
to purchase 200,000 shares of common stock at an exercise price of $1.50. The
warrants were issued as payment pursuant to a financial advisory services
agreement with Burnham Hill Partners, of which a beneficial owner of more than
5% of QuantRx common stock is a managing member. The fair value of these
warrants was calculated to be $250,000 and was expensed over the four month
service term. Additionally, cash compensation of $200,000 was paid pursuant to
the terms of the agreement and was also expensed over the four month service
term.
A member
of the Company’s board of directors served as a consultant to the Company on
various business, strategic, and technical issues. His contract expired May 31,
2008. Fees paid and expensed under these agreements for these
services by the Company during the years ended December 31, 2008 and 2007 were
$20,000 and $48,000, respectively. In addition to the contract fees paid,
reimbursable expenses totaling $10,000 were paid in 2007.
F-39
17. SUBSEQUENT
EVENTS
Senior Secured Convertible
Notes
In the
first quarter of 2009, the Company issued additional 10% senior secured
convertible promissory notes maturing July 31, 2009, in the aggregate principal
amount of $325,000, and an aggregate of 81,250 shares of common stock (fair
value $33,813) and warrants to purchase 81,250 shares of common stock with a
five year term and an exercise price of $0.55 (fair value
$18,188). See Note 10, under the heading “2008 Senior Secured
Convertible Notes” for details on the notes, common stock and warrants and their
accounting. At March 31, 2009, the Company issued 10% convertible notes in the
aggregate amount of $66,416 for quarterly interest in the form of paid-in-kind
notes.
Secured Promissory Notes
Payable
As of
December 31, 2008, one holder of a 2008 Secured Promissory Note agreed to an
extension of the remaining $100,000 outstanding principal. In consideration for
this extension, QuantRx granted a warrant in January 2009 to purchase 100,000
shares of common stock with a five year term and an exercise price of $0.50
(fair value $18,000) and modified warrants to purchase an aggregate 80,000
shares of common stock, reducing the exercise price from $0.85 to $0.55. The
fair value of the consideration will be expensed over the term of the
extension. See also Note 10, under the heading “2008 Secured
Promissory Notes Payable” for specifics on the extension period.
Unsecured Promissory Notes
Payable
In the
first quarter of 2009, the Company issued additional 8% Promissory Notes
originally maturing March 31, 2009, in the aggregate principal amount of
$115,000, and warrants to purchase an aggregate of 115,000 shares of common
stock with a five year term and an exercise price of $0.55 (fair value
$28,850). As of March 31, 2009, the holders agreed to extend the
maturity date to June 30, 2009. In consideration for this extension, QuantRx
granted warrants to purchase an aggregate of 80,500 shares of common stock with
a five year term and an exercise price of $0.55 (aggregate fair value $12,075).
The fair value of the consideration will be expensed over the term of the
extension. See Note 10, under the heading “2008 Unsecured Promissory
Notes Payable” for details on these notes and warrants and their
accounting.
In the
second quarter of 2009, the Company issued $50,000 8% Promissory Notes maturing
May 31, 2009 and $50,000 8% Promissory Notes maturing June 30, 2009, and
warrants to purchase an aggregate of 100,000 shares of common stock with a five
year term and an exercise price of $0.55 (aggregate fair value
$15,000). See Note 10, under the heading “2008 Unsecured Promissory
Notes Payable” for details on these notes and warrants and their
accounting.
QuantRx
executed an extension with a holder of a $500,000 2008 Promissory Note as of
January 31, 2009, extending the maturity date to May 31, 2009. In
consideration for this extension, QuantRx granted 100,000 shares of common stock
with a fair value of $48,000 and warrants to purchase 100,000 shares of common
stock with a five year term and an exercise price of $0.55 (fair value
$27,000). Additionally, warrants to purchase 125,000 shares of common
stock were modified, reducing the exercise price from $0.85 to
$0.55. The fair value of the consideration will be expensed over the
term of the extension.
F-40