QUANTRX BIOMEDICAL CORP - Annual Report: 2009 (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, 2009
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
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33-0202574
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(State
or other jurisdiction of incorporation or
organization)
|
|
(IRS
Employer Identification No.)
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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 ¨ 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¨ 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
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). Yes ¨ No
¨
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. ¨
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 ¨
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Accelerated
filer ¨
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Non-accelerated filer ¨
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(Do not check if smaller
reporting
company)
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Smaller
reporting company x
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes¨
Nox
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, 2009): $13,089,935
DOCUMENTS
INCORPORATED BY REFERENCE
None
PART
I
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Item
1.
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Business
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3
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Item
1A.
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Risk
Factors
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13
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Item
1B.
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Unresolved
Staff Comments
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18
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Item
2.
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Properties
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18
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Item
3.
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Legal
Proceedings
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18
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Item
4.
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Reserved
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18
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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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19
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Item
6.
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Selected
Financial Data
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20
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Item
7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operation
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21
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Item
7A.
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Quantitative
and Qualitative Disclosures about Market Risk
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28
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Item
8.
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Financial
Statements and Supplementary Data
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28
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Item
9.
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Change
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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28
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Item
9A(T).
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Controls
and Procedures
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28
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Item
9B.
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Other
Information
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31
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PART
III
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Item
10.
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Directors,
Executive Officers and Corporate Governance
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32
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Item
11.
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Executive
Compensation
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35
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Item
12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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37
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Item
13.
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Certain
Relationships and Related Transactions, and Director
Independence
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39
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Item
14.
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Principal
Accounting Fees and Services
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39
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Item
15.
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Exhibits
and Financial Statement Schedules
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40
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SIGNATURES
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43
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2
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 THIRTEEN 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, 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 overall growth strategy is to: (i) leverage its
broad-based intellectual property (IP) and patent portfolio to develop new and
innovative diagnostic products; (ii) commercialize products through corporate
partners and distributors; and (iii) contract manufacturing to third parties
while maintaining control over the manufacturing process.
QuantRx
was incorporated December 5, 1986 under the laws of the state of
Nevada. Effective May 5, 2009, QuantRx and its formerly
majority-owned subsidiary, FluoroPharma, Inc., executed transactions that
resulted in QuantRx no longer having a controlling ownership interest, resulting
in the deconsolidation of FluoroPharma. As of May 5, 2009, QuantRx accounts for
this investment utilizing the equity method of accounting.
On July
30, 2009, QuantRx and NuRx Pharmaceuticals, Inc. entered into agreements to
form QN Diagnostics, LLC (QND), a Delaware limited liability company. Pursuant
to the agreements, QuantRx contributed certain intellectual property and other
assets related to its lateral flow strip technology and related lateral flow
strip reader technology with a fair value of $5,450,000, and NuRx
contributed $5,000,000 in cash to QND. Following the respective
contributions by NuRx and QuantRx to the joint venture, NuRx and QuantRx each
own a 50% interest in QND. Under the terms of the agreements, QND
made a $2,000,000 cash distribution to QuantRx. The purpose of the joint venture
is to develop and commercialize products incorporating the lateral flow strip
technology and related lateral flow strip readers.
The joint
venture is managed by a board consisting of two QuantRx designees, two NuRx
designees and an independent designee mutually selected by QuantRx and
NuRx. Subject to certain exceptions, board decisions are made by
majority vote, provided that QuantRx and NuRx have veto rights with respect to
certain matters. Since QuantRx does not have control of the joint venture,
QuantRx accounts for the investment in QND utilizing the equity method of
accounting.
3
Recent
Developments
On
January 29, 2010, QuantRx entered into an Agreement and Plan of Merger (the
“Merger Agreement”) with NuRx Pharmaceuticals, Inc. (NuRx) and NP Acquisition
Corporation, a wholly-owned subsidiary of QuantRx (“Merger Sub”). The Merger
Agreement provides that at the effective time (the “Effective Time”), Merger Sub
will be merged with and into NuRx, with NuRx continuing as the surviving
corporation and a wholly-owned subsidiary of QuantRx.
Under the
terms of the Merger Agreement, at the Effective Time, each outstanding share of
NuRx’s common stock (other than shares held by NuRx or any wholly-owned
subsidiary of NuRx or by QuantRx or Merger Sub or any of their respective
subsidiaries, or by stockholders of NuRx who have properly demanded appraisal
rights for their shares in accordance with Nevada law) will be converted into
the right to receive approximately 1.54 shares of QuantRx common
stock. All options and warrants of NuRx outstanding at the Effective
Time will be assumed by QuantRx and converted into rights with respect to
QuantRx’s common stock.
On March
26, 2010, QuantRx entered into a Security Purchase Agreement with a qualified
institutional buyer in which QuantRx sold 333,333 shares of FluoroPharma, Inc.
class A common stock at a price of $0.75 per share for an aggregate amount of
$250,000. Subsequent to this transaction, QuantRx’s ownership interest in
FluoroPharma was reduced to approximately 36%.
Our
Business
The
Company’s technologies and investments target significant market opportunities
through the following platforms:
Lateral Flow Diagnostics
(through QN Diagnostics)
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·
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RapidSense®
point-of-care testing products based on QuantRx core intellectual property
related to lateral flow methods, devices, and processes for the consumer
and healthcare professional markets. QuantRx has developed a prototype of
the Q-Reader™, a unique, quantitative, point-of-care optical reader for
use with RapidSense to provide economical and efficient quantitative
results.
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PAD/Health and
Wellness
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·
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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.
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Genomic Testing (through our
affiliate, Genomics USA)
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·
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Single
Nucleotide Polymorphism (SNP) chips; genome-based diagnostic chips for the
laboratory and healthcare professional
markets.
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4
Molecular Imaging (through
our affiliate, FluoroPharma)
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·
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Molecular
imaging agents for Positron Emission Tomography (PET), with initial
application in cardiovascular disease, addressing significant unmet
medical needs by providing clinicians with important tools for early
discovery and assessment.
|
Diagnostic
products constitute the core of the QuantRx short-term product development
focus. Genomic testing and molecular imaging 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.
Genomics
USA, Inc., a private company in which QuantRx has invested, is working toward
completion of its HLA – human leukocyte antigen – chip technology for vaccine
validity testing. It anticipates the initiation of field tests with the United
States Department of Homeland Security, prior to market launch. FluoroPharma,
Inc., another private company in which QuantRx has invested, is engaged in
clinical validation for the development of next-generation imaging agents for
PET diagnostics with initial indications for cardiovascular
disease.
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 (through QN Diagnostics)
Quantrx
has developed and patented its RapidSense technology - a one-step lateral flow
test with unique features such as a positive indication for a positive test –
which when combined with the Q-Reader platform allows the company to target
quantified point-of-care (POC) diagnostics previously limited to the diagnostic
laboratory. These applications include but are not limited to thyroid disease,
therapeutic drug monitoring, cancer diagnostics, diagnosis of cardiac disease,
and other critical tests. This rapid POC diagnostic technology is ideal for
testing any body fluid, including whole blood, serum, oral fluids and urine.
QuantRx has also patented innovative oral fluid collection devices specifically
designed for its RapidSense technology. These distinctive collection devices
coupled with RapidSense and the reader platform enable us to target the large
and growing markets for diagnostics using oral sample collections which have
heretofore been limited to blood or urine testing.
5
Our
RapidSense products target the POC healthcare professional human and veterinary
diagnostic markets. QuantRx is also exploring parallel opportunities in the
veterinary markets. To access the unique capabilities of RapidSense and provide
meaningful data to healthcare professionals, we have been developing a cost
efficient portable device called the Q-Reader for use with
RapidSense. During the past year, we successfully advanced our
Q-Reader initiative with the formation of QN Diagnostics. Q-Reader
enables the translation of lateral flow results beyond a qualitative “positive”
or “negative” and produces a test-specific quantified result so that changes in
body chemistry can be measured in the primary care practitioner’s
office. This has the potential to shift outside lab work to the
physician’s office, thus reducing time and expense while creating a revenue
source for the healthcare professional. Among the initial products being
developed is a line of extremely sensitive Clinical Laboratory Improvement
Amendments (CLIA) waived quantitative POC lateral flow diagnostic tests, with
reliable and repeatable sensitivity at the level needed to provide laboratory
level results to the human medical POC market, as well as developing quantified
POC diagnostic tests for the underserved veterinary market utilizing these
platforms.
In 2009,
commercialization of the licensed Follicle Stimulating Hormone (FSH) lateral
flow immunoassay test for FSH began. QuantRx jointly developed this female
fertility test with Church & Dwight. The Company licensed this technology to
Church & Dwight for the OTC market and royalties commenced in the second
quarter of 2009.
The
Company has received clearance on four 510(k) applications from the FDA for its
RapidSense urine based qualitative drugs-of-abuse test product line. QuantRx has
numerous additional RapidSense-based qualitative products in the 510(k)
pipeline, and could explore additional 510(k) applications as funding becomes
available. The clearance on urine-based tests also sets the stage for
development of saliva based tests to complement its urine drugs-of-abuse
tests. In 2009, as a function of the Company’s Q-Reader development
and strategic focus on the quantitative point-of-care healthcare market, QuantRx
discontinued sales of its qualitative drugs-of-abuse product line, QuikSense®,
and is seeking licensing opportunities for the qualitative applications of its
RapidSense technology. QuantRx is also developing rapid test POC products in
oral care under a development agreement. This development agreement grants
certain rights related to manufacturing upon successful development and
commercialization of the products.
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.
6
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 through a
licensing agreement with CytoCore, Inc. to target the Pap testing market using
this technology.
The
Company holds several patents for the method and apparatus for collecting
vaginal fluid and exfoliated vaginal cells for diagnostic purposes, collection
of a sample for general diagnostic screening, and the collection of an anal
sample for prostate and other diagnostic purposes. Several clinical
studies have been conducted 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, as well as its safety and ease of use.
Unique®
Miniforms
The
Company's Unique miniform is a safe, convenient, and flushable technology for
the underserved OTC hemorrhoid and feminine hygiene and urinary incontinence
markets. The disposable miniform pads contain no adhesives and
require no insertion, and are small enough to fit in the palm of a
hand.
The
Unique miniform is available as a treated pad for the temporary relief of the
itch and discomfort associated with hemorrhoids and minor vaginal infection, and
as an untreated pad, for the daily protection of light urinary, vaginal or anal
leakage.
While
QuantRx initiated a limited web-based domestic roll-out of the Unique miniform,
it is in search of a strategic partnership(s) to expand the retail availability
of the product across the United States and internationally.
QuantRx
has significant experience manufacturing its miniform and a clear understanding
of its costs. The miniform technology is protected by numerous
patents covering various applications, the manufacturing process, and certain
materials. The Company currently has contracted with a firm based in Taiwan to
manufacture its pads.
Affiliate
Product Candidates
SNPchip
Genome-based Diagnostic Microarray Chips (through our affiliate, Genomics
USA)
Genomics
USA, Inc. (GUSA), an affiliate which QuantRx owns approximately 10%, as well as
a note convertible into an additional 10% 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.
7
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.
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.
In 2009,
GUSA strengthened its intellectual property on this product with the issuance of
two patents covering its microarray technology.
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. In September 2009, GUSA
received two multi-year SBIR grants aggregating $3,600,000 for further
development of the HLA Chip and a variant of the HLA Chip, the
“AIDS-Chip”.
Molecular
Diagnostic Imaging (through our affiliate, FluoroPharma)
FluoroPharma,
an affiliate which QuantRx owns approximately 36% as of March 26, 2010, 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.
8
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.
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.
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. They anticipate that it will be several years before their
first New Drug Application (NDA) will be filed with the FDA, however,
Investigational New Drug applications (INDs) and Phase I trials have been
completed for the first two applications, and is contemplated for the final
product in the near future. The development to commercialization will require
significant resources, and FluoroPharma is exploring alternative funding
options.
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., 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 may compete with some or all of our
product candidates.
Any
product candidates that we successfully develop, which are cleared for sale by
the FDA or similar international regulatory authorities in other countries, may
compete with competitive products currently being used or that may become
available in the future. 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 its products to third-party manufacturers in
and outside the United States. All manufactured products are produced under FDA
mandated Good Manufacturing Practices (GMP) standard operating procedures
developed and controlled by the Company’s quality system, which specifies
approved raw materials, vendors, and manufacturing methodology.
9
Intellectual
Property Rights and Patents
In July
2009, Quantrx contributed certain intellectual property related to its lateral
flow strips and related reader to QN Diagnostics (QND). As of December 31, 2009,
QuantRx directly owned, 21 patents, patents pending and licensed patents related
to PAD technology for diagnosis and treatment of women's health concerns and
other medical needs.
Patents
and other proprietary rights are an integral part of our business. It is our
policy to seek patent protection for our inventions and also to rely upon trade
secrets and continuing technological innovations and licensing opportunities to
develop and maintain our competitive position.
However,
the patent positions of companies like ours involve complex legal and factual
questions and, therefore, their enforceability cannot be predicted with any
certainty. Our issued patents, those licensed to us, and those that may be
issued to us in the future may be challenged, invalidated or circumvented, and
the rights granted thereunder may not provide us with proprietary protection or
competitive advantages against competitors with similar technology. Furthermore,
our competitors may independently develop similar technologies or duplicate any
technology developed by us. Because of the extensive time required for
development, testing and regulatory review of a potential product, it is
possible that, before any of our product candidates can be approved for sale and
commercialized, our relevant patent rights may expire or remain in force for
only a short period following commercialization. Expiration of patents we own or
license could adversely affect our ability to protect future product development
and, consequently, our operating results and financial position.
QuantRx
has eight patents issued, 11 patents pending, and two licensed
patents. Our issued patents expire between 2014 and 2021; however,
QuantRx may obtain continuations which would extend the rights granted under our
issued patents. QuantRx also holds numerous United States trademarks,
including QuantRx, PADkit, and Unique, and has applied for rights to several
others.
Licensing,
Distribution and Development Agreements
On July
30, 2009, QuantRx and QN Diagnostics (QND) entered into a Development and
Services Agreement, pursuant to which QND pays a monthly fee to QuantRx in
exchange for QuantRx providing all services related to the development,
regulatory approval and commercialization of lateral flow products.
On May
19, 2008, QuantRx and CytoCore, Inc. entered into a worldwide distribution and
supply agreement for specified PAD technology of QuantRx. The agreement
specified monthly license fees during CytoCore’s expected development period and
additional milestone payments based upon CytoCore’s achievement of certain
development and sales milestones.
In 2007
QuantRx entered into two development agreements to develop point-of-care
products in human 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.
10
The
Church & Dwight agreement included milestone based payments, which were
recognized in 2007 and 2008. On August 14, 2008, QuantRx entered into a ten-year
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
and began distributing the product in early 2009, resulting in QuantRx receiving
royalties on net sales of the product in 2009.
QuantRx
licenses patent rights and know-how for certain hemorrhoid treatment pads and
related coatings from The Procter & Gamble Company. The five year license
agreement was entered into July 2006 and has a five year automatic renewal
option.
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 the targeted molecular imaging agents,
can be divided into three distinct phases: an investigational phase including
both preclinical and clinical investigations leading up to the submission of an
NDA; a period of FDA review culminating in the approval or refusal to approve
the NDA; and the post-marketing period.
All of
our OTC products derived from the Miniform technology, including Unique, are
currently classified as Class I – exempt devices, requiring written notification
to the FDA before marketing. 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.
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.
11
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, 2009 and 2008:
2009:
$2,324,286
2008:
$2,032,677
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.
Employees
As of
December 31, 2009, we had 12 employees. Our employees are not represented by a
labor organization or covered by a collective bargaining agreement. We believe
our relations with employees are good.
12
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.
We have
limited funds to support our operations, and neither we nor our joint venture
have generated revenues sufficient to finance our operations. In
addition, the joint venture will require additional funding to complete the
development and launch of its initial products. We are actively pursuing various
funding options, including licensing opportunities and the sale of investment
holdings, as well as a strategic transaction with our joint venture partner, to
obtain additional funding to continue the development of our products and bring
them to commercial markets. There can be no assurance that we will be
successful in our efforts. 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. As a
result, management believes that given the current economic environment and the
continuing need to strengthen our cash position, there is substantial doubt
about our ability to continue as a going concern.
We
have a history of incurring net losses and we may never become
profitable.
For the
year ended December 31, 2009, the Company had an accumulated deficit of
$48,263,119. 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 development
activities, we may incur substantial and increasing losses in 2010. 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.
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.
13
Our
Joint Venture with NuRx involves numerous risks.
We have
entered into a joint venture agreement with NuRx focused on the
commercialization of medical diagnostic products. The joint venture
is subject to various risks that could adversely affect our results of
operations. These risks include the following:
|
·
|
our
interests could diverge from NuRx in the future or we may not be able to
agree with NuRx on ongoing manufacturing and operational activities, or on
the amount, timing or nature of further investments in the joint
venture;
|
|
·
|
due
to financial constraints, NuRx may be unable to meet their commitments to
our joint venture and may pose credit risks for our transactions with
them;
|
|
·
|
the
terms of our joint venture arrangements may turn out to be
unfavorable;
|
|
·
|
cash
flows may be inadequate to fund increased capital
requirements;
|
|
·
|
should
we be unable to meet sustaining capital contributions as required by the
joint venture, our ownership interest will be
reduced;
|
|
·
|
we
may experience delays in obtaining any necessary regulatory approvals to
market the medical diagnostic products produced by the joint
venture;
|
|
·
|
we
may experience difficulties and delays in ramping production of joint
venture’s products; and
|
|
·
|
if
our joint venture is unsuccessful, our business, results of operations or
financial condition will be adversely
affected.
|
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.
14
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.
15
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. Additionally, the Company
may rely upon foreign manufacturers. Any event which negatively impacts these
manufacturing facilities, manufacturing systems or equipment, or suppliers,
including, among others, wars, terrorist activities, natural disasters and
outbreaks of infectious disease, could delay or suspend shipments of products or
the release of new products.
16
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.
17
The
issuance of shares of our preferred stock may adversely affect our common
stock.
The board
of directors of the Company is authorized to designate one or more series of
preferred stock and to fix the rights, preferences, privileges and restrictions
thereof, without any action by the stockholders. The designation and issuance of
such shares of our preferred stock may adversely affect the common stock, if the
rights, preferences and privileges of such preferred stock (i) restrict the
declaration or payment of dividends on common stock, (ii) dilute the voting
power of common stock, (iii) impair the liquidation rights of the common stock,
or (iv) delay or prevent a change in control of the Company from occurring,
among other possibilities.
Because
we do not expect to pay dividends, you will not realize any income from an
investment in our common stock unless and until you sell your shares at a
profit.
We have
never paid dividends on our common stock and do not anticipate paying any
dividends for the foreseeable future. You should not rely on an
investment in our stock if you require dividend income. Further, you
will only realize income on an investment in our shares in the event you sell or
otherwise dispose of your shares at a price higher than the price you paid for
your shares. Such a gain would result only from an increase in the
market price of our common stock, which is uncertain and
unpredictable.
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 subject to 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, there are no material pending legal proceedings to which we are a
party to or of which any of our party is the subject.
ITEM
4. RESERVED.
18
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, 2009
|
||||||||
Fourth
Quarter
|
$ | 0.50 | $ | 0.25 | ||||
Third
Quarter
|
$ | 0.59 | $ | 0.30 | ||||
Second
Quarter
|
$ | 0.44 | $ | 0.18 | ||||
First
Quarter
|
$ | 0.50 | $ | 0.20 | ||||
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 |
Stockholders
As of
March 22, 2010 there were approximately 264 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 the
fourth quarter of 2009, 25,000 non-qualified common stock options were granted
to members 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 $0.38, have a term of five years and vested immediately.
In the
fourth quarter of 2009, qualified stock options to purchase an aggregate of
50,000 shares of common stock were granted and issued from the Company’s 2007
Incentive and Non-Qualified Stock Option Plan to employees in accordance with
employment agreements and the successful completion of development milestones.
The options were fully vested, have a five year term and an exercise price of
$0.40.
19
In the
fourth quarter of 2009, warrants to purchase 1,750,000 shares of common stock
were granted in settlement of $195,000 in outstanding accounts payable and a six
month financial advisory services contract. The warrants have an exercise price
of $0.55 and a term of five years.
In the
fourth quarter of 2009, a warrant to purchase 25,000 shares of common stock was
granted to a consultant in connection with the successful completion of a
development milestone. The warrants have a five year term and an exercise price
of $0.40.
Through
the date of filing, March 30, 2010, 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.
Purchases
of Equity Securities
During
the year ended December 31, 2009, 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
The
following table provides information as of December 31, 2009 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
|
1,583,000 | $ | 0.65 | 6,417,000 |
ITEM
6. SELECTED FINANCIAL DATA.
Not
required under Regulation S-K for “smaller reporting
companies.”
20
ITEM
7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATION.
QuantRx
Biomedical Corporation was incorporated December 5, 1986 under the laws of 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 point-of-care diagnostic products based on its
patented technology platforms for the worldwide healthcare industry. The
Company’s overall growth strategy is to: (i) leverage its broad-based
intellectual property (IP) and patent portfolio to develop new and innovative
diagnostic products; (ii) commercialize products through corporate partners and
distributors; and (iii) contract manufacturing to third parties while
maintaining control over the manufacturing process.
QN
Diagnostics
On July
30, 2009, QuantRx and NuRx Pharmaceuticals, Inc. entered into agreements to
form QN Diagnostics, LLC (QND), a Delaware limited liability company. Pursuant
to the agreements, QuantRx contributed certain intellectual property and other
assets related to its lateral flow strip technology and related lateral flow
strip reader technology with a fair value of $5,450,000, and NuRx
contributed $5,000,000 in cash to QND. Following the respective
contributions by NuRx and QuantRx to the joint venture, NuRx and QuantRx each
own a 50% interest in QND. The purpose of the joint venture is to
develop and commercialize products incorporating the lateral flow strip
technology and related lateral flow strip readers.
The joint
venture is managed by a board consisting of two QuantRx designees, two NuRx
designees and an independent designee mutually selected by QuantRx and
NuRx. Subject to certain exceptions, board decisions are made by
majority vote, provided that QuantRx and NuRx have veto rights with respect to
certain matters. Since QuantRx does not have control of the joint venture,
QuantRx accounts for the investment in QND utilizing the equity method of
accounting.
Under the
terms of the agreements, QND made a $2,000,000 cash distribution to QuantRx.
QuantRx is committed to further capital contributions aggregating $1.55 million,
comprised of: payment of milestone payments with PRIA Diagnostics (see Note 5 of
the financial statements) in QuantRx common stock (fair value of $750,000);
transfer of fixed assets with a fair value of $100,000 at QND’s discretion; and
a $700,000 sustaining capital contribution as required by QND. Subsequent
sustaining capital contributions will be made by QuantRx and NuRx on an equal
basis.
QuantRx
and QND also entered into a Development and Services Agreement, pursuant to
which QND shall pay a monthly fee to QuantRx in exchange for QuantRx providing
all services related to the development, regulatory approval and
commercialization of lateral flow products.
QuantRx
recognized a gain on the contribution of the intellectual property of $1.36
million, representing the net gain of $4.72 million from the disposition,
reduced by the fair value of warrants issued to NuRx ($1.0 million) and the
elimination of the portion of the intercompany gain associated with QuantRx’s
50% interest in QND ($2.36 million).
21
FluoroPharma
On May 5,
2009, QuantRx and FluoroPharma reorganized their relationship by terminating
their investment agreement and related agreements. The termination of these
agreements, which were originally executed on March 10, 2006, allowed
FluoroPharma to close an equity financing with third party
investors. In conjunction with the termination of these agreements
and the additional investment in FluoroPharma, QuantRx agreed to convert all
outstanding receivables from FluoroPharma, consisting of previously issued notes
and related accrued interest and advances in the aggregate amount of $1,568,567,
into 1,148,275 shares of common stock of FluoroPharma. As a result of these
transactions and the third party investment, QuantRx’s ownership interest in
FluoroPharma’s issued and outstanding capital stock was reduced to a
noncontrolling interest, which resulted in the deconsolidation of FluoroPharma
as a subsidiary of the Company. Subsequent to the termination of the agreements
between QuantRx and FluoroPharma, QuantRx has no continuing obligations or
commitments to FluoroPharma.
At May 5,
2009, QuantRx’s remaining net basis of the investment in FluoroPharma, inclusive
of receivables from FluoroPharma, was $43,286, after taking into account
previously recorded losses of $5,056,304 ($272,579 in 2009) related to the
consolidated results of FluoroPharma. These losses have been included in our
consolidated financial statements commencing April 1, 2007, the original date of
consolidation, through May 4, 2009, and are net of losses allocated to the then
noncontrolling (formerly minority) interests as applicable. On May 5, subsequent
to the execution of the aforementioned transactions which led to the
deconsolidation of FluoroPharma, QuantRx’s ownership of the outstanding capital
stock of FluoroPharma was reduced to a noncontrolling interest of 45.55%. At
deconsolidation the fair market value of QuantRx’s remaining noncontrolling
interest in FluoroPharma was $842,876, based on the third party investment;
however, FluoroPharma had a deficit equity balance, which resulted in QuantRx
writing off the remaining basis in the investment of $43,286 and recording a
loss from deconsolidation of $43,286. QuantRx has reflected the results of its
former subsidiary as a one-line item as of January 1, 2009. QuantRx’s allocation
of FluoroPharma’s net loss for the period commencing May 5 through December 31,
2009, was not recorded ($314,000), since the remaining investment in
FluoroPharma had a carrying value of $0 as of the deconsolidation of
FluoroPharma at May 5, 2009.
Effective
May 5, 2009, our financial statements reflect our investment in FluoroPharma
under the equity method of accounting. As of December 31, 2009 and December 31,
2008, QuantRx owned 39.81% and 57.78%, respectively, of the issued and
outstanding capital stock of FluoroPharma. However, at December 31, 2009, due to
FluoroPharma’s issuance of a separate class of common stock in 2009, QuantRx
held 17.53% of the voting rights of FluoroPharma.
On March
26, 2010, QuantRx entered into a Security Purchase Agreement with a qualified
institutional buyer in which QuantRx sold 333,333 shares of FluoroPharma, Inc.
class A common stock at a price of $0.75 per share for an aggregate amount of
$250,000. Subsequent to this transaction, QuantRx’s ownership interest in
FluoroPharma was reduced to approximately 36%.
FluoroPharma
is currently seeking financing which could result in a disposition of all or a
portion of QuantRx’s investment in FluoroPharma as part of a strategic
transaction.
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.
22
Our
Consolidated Results of Operations
We
recognized total revenues of $2,551,269 and $624,495 for the years ended
December 31, 2009 and 2008, respectively. Total costs and operating expenses for
the years ended December 31, 2009 and 2008 were $4,955,287 and $6,324,179,
respectively. Highlights of the major components of our results of operations
are detailed and discussed below:
Year Ended
December 31, 2009
|
Year Ended
December 31, 2008
|
|||||||
Total
Revenues
|
$ | 2,551,269 | $ | 624,495 | ||||
General
and Administrative
|
$ | 2,002,964 | $ | 2,894,432 | ||||
Professional
Fees
|
$ | 497,582 | $ | 957,135 | ||||
Research
and Development
|
$ | 2,324,286 | $ | 2,032,677 | ||||
Other
Expense, net
|
$ | 749,478 | $ | 2,229,050 |
Total
revenues increased by $1,926,774, primarily due to $2,065,264 in related party
revenues from the QND development agreement.
General
and administrative expenses include, but are not limited to, payroll and related
expenses, rent, office and insurance expenses. The decrease of $891,468 in
general and administrative expenses from 2008 to 2009 is primarily due to the
absence of our formerly majority-owned subsidiary’s 2008 general and
administrative expenses of $751,245, and decreased personnel and related
expenses of $123,589.
Professional
fees include the costs of legal, consulting and auditing services provided to
us. The decrease of $459,553 in professional fees from 2008 to 2009 is primarily
attributable to the absence of our formerly majority-owned subsidiary’s 2008
professional fees of $270,185, efforts to contain costs, resulting in $129,970
in decreased expenses related to investor and public relations consultants and
$102,233 in decreased regulatory consulting expenses, partially offset by
$78,608 in increased legal fees resulting from the formation of our joint
venture and asset purchase transactions.
Research
and development expense primarily reflects technical consulting and expenses
incurred in connection with the development of our product candidates. The
increase of $291,609 from 2008 to 2009 is primarily due to increased consulting
expenses of $1,269,599, and increased personnel expenses of $189,688. These
increases were substantially offset by the absence of our formerly
majority-owned subsidiary’s 2008 research and development expenses of
$1,125,299.
Other
expense for the year ended December 31, 2009 was primarily comprised of
QuantRx’s equity method losses from QND for the period from July through
December 2009 of $1,022,760, interest expense of $465,027, and amortization of
debt discount of $361,666. These expenses and losses were offset by a gain on
the contribution of intellectual property to QND of $1,363,640. In 2008, other
expense was primarily comprised of amortization of debt discount and deferred
finance charges of $1,457,676, interest expense of $369,895, and a $439,445 loss
on extinguishment of convertible notes. Interest expense was impacted in 2009 by
the settlement of all of QuantRx’s short-term notes in July 2009.
Net loss
for 2009 was $3,153,496, a decrease of $4,567,905 from the $7,721,401 net loss
reported for 2008. The decrease in net loss was primarily attributable to the
absence of our formerly majority-owned subsidiary’s 2008 net loss of $2,272,144,
as well as all the factors previously discussed.
23
Liquidity
and Capital Resources
At
December 31, 2009, the Company had cash and cash equivalents of $376,211 as
compared to $66,226 at December 31, 2008.
During
the year ended December 31, 2009, we used $1,116,199 of cash for operating
activities, as compared to $2,801,308 during the year ended December 31,
2008. The decrease in cash used for operating activities was primarily a result
the absence of our formerly majority-owned subsidiary’s 2008 cash used for
operating activities of $837,963, as well as cost reduction efforts, 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, 2009 was
$291,670 compared to $178,307 during the year ended December 31, 2008. The
increase of $113,363 was primarily due to the purchase of intellectual property
in 2009 from PRIA Diagnostics.
Cash
provided by financing activities during the year ended December 31, 2009
was $1,718,267 as compared to $2,832,509 during the year ended December 31,
2008. Cash provided through the issuance of convertible promissory notes was
$425,000 during 2009 and $1,292,500 during 2008. QuantRx also issued $680,000
and $1,592,500 in promissory notes in 2009 and 2008. In 2009 and
2008, QuantRx repaid $1,347,199 and $200,000 in notes. In 2009, QuantRx received
a distribution from QND of $2,000,000. Cash provided through the exercise
of warrants was $0 in 2009 and $169,189 in 2008.
The Company and QND have not generated
sufficient revenues from operations to meet their operating expenses.
In addition, QND will require additional funding to
complete the development and launch of its initial
products. 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 the current economic environment and the continuing need to
strengthen our cash position, there is substantial doubt about our ability to
continue as a going concern. We are actively pursuing various funding options,
including licensing opportunities and the sale of investment holdings, as well
as a strategic transaction with our joint venture partner, to obtain additional
funding to continue the development of our products and bring them to commercial
markets. There can be no assurance that we will be successful in our efforts.
Should we be unable to 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:
|
·
|
consummate
a strategic transaction with our joint venture
partner;
|
|
·
|
obtain
adequate sources of funding to pay operating expenses and fund long-term
business operations;
|
|
·
|
manage
or control working capital requirements by reducing operating expenses;
and
|
|
·
|
develop
new and enhance existing relationships with product distributors and other
points of distribution for the Company’s
products.
|
24
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, 2009 and the effect such obligations
are expected to have on our liquidity and cash flows in future periods. At
December 31, 2009, 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
|
$ | 142,991 | $ | 99,116 | $ | 43,875 | $ | - | $ | - |
Off-Balance
Sheet Arrangements
As
described above, on July 30, 2009, QuantRx formed a joint venture with NuRx
Pharmaceuticals, Inc., whereby, pursuant to the terms of the LLC Agreement, each
member will be required to make sustaining capital contributions from time to
time as the Board of the joint venture determines is necessary. At
such time that the Board of the joint venture determines that additional
sustaining cash contributions are required, such sustaining cash contributions
will be made by QuantRx and NuRx on an equal basis provided that QuantRx solely
will be responsible for making a sustaining cash contribution with respect to
the first $700,000 determined to be required by the Board of the joint venture.
Should either party fail to make sustaining contributions as required, such
party would be subject to a reduction in ownership interest and loss of a board
seat.
Moreover,
QuantRx is committed to further capital contributions to QND aggregating
$850,000, comprised of: payment of milestone payments with PRIA Diagnostics in
QuantRx common stock (fair value of $750,000); and a transfer of fixed assets
with a fair value of $100,000 at QND’s discretion.
We have
not entered into any other 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.
25
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. 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 of America
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 differ from
these estimates and assumptions. Additional information on significant
accounting principles is provided in Note 3 of the attached consolidated
financial statements.
26
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 ASC Topic 360-10-35, “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.
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. However, as of the date of this report, March 30, 2010,
management is not aware of any information which would change its analysis of
any possible impairment.
Share-based
Payments
QuantRx
follows the provisions of ASC Topic 718, which establishes the accounting for
transactions in which an entity exchanges equity securities for services and
requires companies to expense the estimated fair value of these awards over the
requisite service period. 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.
The
Company accounts for share-based payments granted to non-employees in accordance
with ASC Topic 505, “Equity Based Payments to Non-Employees.” The Company
determines the fair value of the stock-based payment as either the fair value of
the consideration received or the fair value of the equity instruments issued,
whichever is more reliably measurable. If the fair value of the
equity instruments issued is used, it is measured using the stock price and
other measurement assumptions as of the earlier of either (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 determines the incremental value. 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 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 ASC Topic 470-20, “Debt with Conversion and Other
Options.” When modified in connection with note extensions, the Company
recognized the incremental value as prepaid interest, which is expensed over the
term of the extension.
27
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, 2009
and 2008, 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, 2009 and 2008 and
audited consolidated statements of operations, changes in stockholders’ equity
and cash flows for the years ended December 31, 2009 and 2008 are included
immediately following the signature page to this report, beginning on page F-1.
Audited financial statements for QN Diagnostics, LLC and FluoroPharma, Inc.,
unconsolidated companies in which QuantRx owns 50% or less as of December 31,
2009 which are accounted for under the equity method, are included as
Exhibits.
ITEM
9. CHANGE IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE.
None.
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.
28
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, 2009
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.
29
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, 2009.
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.
30
ITEM
9B. OTHER INFORMATION.
Submission
of Matters to a Vote of Security Holders
During
the quarter ended December 31, 2009, we submitted the following proposals
for approval at the annual meeting of stockholders held on December 3,
2009:
(1)
|
to
consider and vote upon an amendment to our Articles of Incorporation to
effect a reverse stock split of the Common Stock of the Company at a ratio
of not less than one-for-two and not more than one-for-eight at any time
prior to the 2011 annual meeting of stockholders, with the exact ratio to
be set at a whole number within this range to be determined by our board
of directors in its discretion;
|
(2)
|
to
amend our Articles of Incorporation to increase the authorized Common
Shares of the Company to 150,000,000;
and
|
(3)
|
to
ratify the appointment of BehlerMick PS (formerly known as Williams &
Webster, P.S.) as the Company’s independent public accountants for the
year ending December 31, 2009; and
|
(4)
|
to
elect two Class 1 Directors, to hold office until the 2011 annual meeting
or until their respective successors have been duly elected; and to elect
two Class 2 Directors, to hold office until the 2010 annual meeting of
stockholders or until their respective successors have been duly elected,
as set forth below.
|
The
voting results for the proposals were as follows:
For
|
Against
|
Abstain
|
Broker Non-Votes
|
|||||||
Proposal
1
|
27,554,504 | 6,578,210 | 459,152 |
0
|
||||||
Proposal
2
|
27,525,188 | 6,607,566 | 459,112 |
0
|
||||||
Proposal
3
|
32,975,174 | 994,761 | 621,931 |
0
|
||||||
Proposal
4:
|
Nominees
|
For
|
Withheld
|
||||||
Class
1 Directors:
|
||||||||
William
H. Fleming, Ph.D.
|
32,895,427 | 1,696,439 | ||||||
Shalom
Hirschman, M.D.
|
32,902,407 | 1,689,459 | ||||||
Class
2 Directors:
|
||||||||
Walter
W. Witoshkin
|
32,404,468 | 2,187,398 | ||||||
Arthur
Hull Hayes, Jr., M.D.
|
32,883,517 | 1,708,349 |
Each of
the above proposals was passed and all nominated directors were elected.
Additional information regarding the above proposals is set forth in QuantRx’s
definitive proxy statement filed with the SEC on November 5, 2009, which
information is incorporated herein by reference.
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, 2009:
Directors & Executive
Officers
|
Age
|
Position
|
||
Walter
W. Witoshkin(1)
|
65
|
Chairman
& CEO
|
||
William
H. Fleming, Ph.D.(2)
|
63
|
Director,
CSO & President of Diagnostics
|
||
Sasha
Afanassiev
|
42
|
CFO,
Treasurer & VP of Finance
|
||
Dr.
Shalom Hirschman(2)
|
73
|
Director
|
||
Dr.
Arthur Hull Hayes, Jr.(3)
|
76
|
Director
|
(1)
|
Mr.
Witoshkin has been elected/ratified to hold office until the 2010 annual
meeting of stockholders, or until his successor is duly elected or
appointed, unless his office is earlier
vacated.
|
(2)
|
Drs.
Fleming and Hirschman have been elected to hold office until the 2011
annual meeting of stockholders, or until their successor is duly elected
or appointed, unless their office is earlier
vacated.
|
(3)
|
Dr.
Arthur Hull Hayes, Jr. passed away February 11, 2010. The Board is
currently seeking a replacement.
|
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’s affiliate, FluoroPharma,
Inc.
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.
32
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.
Independent
Directors
Shalom
Hirschman, M.D. 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., M.D. served as a Director of QuantRx from September 2006 until
his death in February 2010. 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.
Director
Qualifications
Each of
our directors brings a strong and unique background and set of skills to the
board, providing the board as a whole competence and experience in wide variety
of areas, including finance, accounting, corporate governance, executive
management, medicine, pharmaceuticals, and regulatory affairs. Each of our
directors brings to our board extensive management and leadership experience
gained through their service as executives, and in several cases, chief
executive officers of diverse businesses. In these executive roles, they have
taken hands on, day to day, responsibility for strategy and operations,
including management of capital, risk, and business cycles.
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 2009, (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.
33
Involvement
in Certain Legal Proceedings
QuantRx
is not aware of any events that have occurred during the past ten 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.
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, William Fleming serves on the compensation committee of the
Company’s board of directors. Arthur H. Hayes, Jr. served as the
chairperson of the compensation committee until his death in February 2010. 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 year the compensation committee held no separate
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
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, 2009.
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,
|
2009
|
260,000 | 100,000 |
(1)
|
- | 318,329 |
(4)
|
- | - | - | 678,329 | ||||||||||
CEO
|
2008
|
240,000 | - | - | 415,692 |
(5)
|
- | - | - | 655,692 | |||||||||||
Sasha
Afanassiev,
CFO, Treasurer & |
2009
|
162,500 | 50,000 |
(2)
|
- | 128,500 |
(6)
|
- | - | - | 341,000 | ||||||||||
VP of
Finance
|
2008
|
150,000 | - | - | 94,458 | - | - | - | 244,458 | ||||||||||||
Dr.
William Fleming,
CSO,
President
of
|
2009
|
151,667 | 50,000 |
(3)
|
- | 89,338 | - | - | - | 291,005 | |||||||||||
Diagnostics
|
2008
|
140,000 | - | - | 62,925 | - | - | - | 202,925 |
(1)
|
Bonus
awarded July 2009, unpaid as of March 30,
2010.
|
(2)
|
Bonus
awarded July 2009, unpaid as of March 30,
2010.
|
(3)
|
Includes
$25,000 for bonus awarded July 2009, unpaid as of March 30,
2010.
|
(4)
|
Includes
$28,996 related to the issuance of options from a former
subsidiary.
|
(5)
|
Includes
$16,244 related to the issuance of options from a
subsidiary.
|
(6)
|
Includes
$4,833 related to the issuance of options from a former
subsidiary.
|
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, 2009 and 2008, in accordance with ASC Topic 718 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 2009 and
2008 using the following assumptions: risk-free rate of 3.24% and 5.35%;
volatility of 0.70 and 1.17; actual term and exercise price of options granted.
See Note 16 to the Consolidated Financial Statements for more details on option
issuances.
Employment
Agreements
We have
entered into employment contracts with the above executives that provide for the
continuation of salary to the executives if terminated for reasons other than
cause or in connection with a change in control of QuantRx, as defined in those
agreements. At December 31, 2009, the future employment contract commitment for
such key executives based on these termination clauses was approximately
$636,000, or in the case of a change of control, $1,272,000. In addition, the
agreements state that if QuantRx were to sell all of its shares of capital stock
or assets, or perform a material acquisition of another entity, QuantRx will pay
a completion bonus.
35
Outstanding
Equity Awards at Fiscal Year-End
Option Awards
|
||||||||||
Name
|
Number of Securities
Underlying
Unexercised Options
(#)
Exercisable
|
Number of Securities
Underlying
Unexercised Options
(#)
Unexercisable
|
Equity Incentive Plan
Awards: Number of
Securities Underlying
Unexercised Unearned
Options
(#)
|
Option Exercise
Price
($)
|
Option Expiration
Date
|
|||||
Walter W. Witoshkin,
CEO
& President (1)
|
1,000,000
250,000
350,000
500,000
250,000
350,000
|
-
-
-
-
-
-
|
-
-
-
-
-
-
|
0.50
0.85
0.80
0.31
0.50
0.50
|
05/03/2015
10/08/2017
02/28/2018
01/15/2014
07/24/2014
07/30/2014
|
|||||
Sasha Afanassiev,
CFO,
Treasurer & VP of Finance (2)
|
25,000
75,000
50,000
100,000
150,000
150,000
125,000
|
-
-
-
-
-
-
-
|
-
-
-
-
-
-
-
|
1.60
1.15
0.85
0.80
0.31
0.50
0.50
|
04/03/2016
07/25/2016
10/08/2017
02/28/2018
01/15/2014
07/24/2014
07/30/2014
|
|||||
Dr.
William Fleming,
CSO,
President of Diagnostics(3)
|
-
50,000
110,000
150,000
62,500
|
-
-
-
-
-
|
100,000
-
-
-
62,500
|
1.60
0.85
0.31
0.50
0.50
|
04/03/2016
10/08/2017
01/15/2014
07/24/2014
07/30/2014
|
(1)
|
Options
granted 05/03/2005, which expire 05/03/2015 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.
Warrants granted 01/15/2009 which expire 01/15/2014 vested immediately.
Warrants granted 07/24/2009 which expire 07/24/2014 vested immediately.
Options granted 07/30/2009 which expire 07/30/2014 vested
immediately.
|
(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.
Warrants granted 01/15/2009 which expire 01/15/2014 vested immediately.
Warrants granted 07/24/2009 which expire 07/24/2014 vested immediately.
Options granted 07/30/2009 which expire 07/30/2014 vested
immediately.
|
(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. Warrants
granted 01/15/2009 which expire 01/15/2014 vested immediately. Warrants
granted 07/24/2009 which expire 07/24/2014 half vested immediately;
remaining half vested with achievement of development milestone in
November 2009. Options granted 07/30/2009 which expire 07/30/2014 half
vested with achievement of development milestone in November 2009;
remaining half vest upon achievement of development milestone which has
not yet been met.
|
There are
no outstanding stock awards as of December 31, 2009. 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 2009 and 2008 using the following assumptions: risk-free rate of
3.24% and 5.35%; volatility of 0.70 and 1.17; actual term and exercise price of
options granted. See Note 16 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
$5,000 and 6,250 stock options per Board meeting attended in person; up to a
maximum of four meetings per year. All options are granted at year end and have
a term of five years and an exercise price equal to the closing stock price on
date of grant.
36
The
following table summarizes Director Compensation for the year ended December 31,
2009.
Name
|
Fees
Earned
or
Paid in
Cash ($)
|
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)
|
$ | 10,000 | (2) | - | $ | 2,875 | - | - | - | $ | 12,875 | |||||||||||||||||
Dr.
Arthur Hull Hayes, Jr. (1)
|
$ | 10,000 | (2) | - | $ | 2,875 | - | - | - | $ | 12,875 |
(1)
|
On
December 31, 2009, Dr. Shalom Hirschman and Dr. Arthur H. Hayes, Jr. were
granted options to purchase 12,500 shares of common stock for an exercise
price of $0.38. The options have a five year term. As of December 31,
2009, Dr. Hirschman and Dr. Hayes had options to purchase 18,750 and
31,250 shares of common stock outstanding,
respectively.
|
(2)
|
Director
fees include $5,000 unpaid as of March 30,
2010.
|
The
Company used the Black-Scholes option price calculation to value the options
granted in 2009 using the following assumptions: risk-free rate of 3.24%;
volatility of 0.70; 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 22, 2010, 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 22, 2010; 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 22, 2010
|
Percentage of Class (2)
|
|||
Walter
W. Witoshkin (3)
|
2,600,000 | 5.53 | % | ||
William
H. Fleming (4)
|
864,534 | 1.93 | % | ||
Sasha
Afanassiev (5)
|
675,000 | 1.50 | % | ||
Shalom
Hirschman (6)
|
518,750 | 1.17 | % | ||
Arthur
Hull Hayes, Jr. (7)
|
31,250 | 0.07 | % | ||
Evan
Levine (8)
6725
Mesa Ridge Road, Suite 100
San
Diego, CA 92121
|
3,163,800 | 7.12 | % | ||
Matthew
Balk (9)
570
Lexington Avenue
New
York, NY 10021
|
2,830,255 | 6.37 | % | ||
Mark
Capital, LLC
6725
Mesa Ridge Road, Suite 100
San
Diego, CA 92121
|
2,375,000 | 5.35 | % | ||
Sherbrooke
Partners, LLC
570
Lexington Avenue
New
York, NY 10021
|
2,830,255 | 6.37 | % |
(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 44,427,630
shares of common stock outstanding as of March 22, 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 22, 2010.
|
(3)
|
Ownership
is based upon 1,850,000 common stock options currently exercisable and
common stock warrants currently exercisable for 750,000 common
shares.
|
(4)
|
Ownership
includes beneficial ownership of 1,000 shares of common stock held by the
executive’s father, 112,500 common stock options currently exercisable,
and common stock warrants currently exercisable for 260,000 common
shares.
|
(5)
|
Ownership
is based on 375,000 common stock options currently exercisable and common
stock warrants currently exercisable for 300,000 common
shares.
|
(6)
|
Ownership
includes 18,750 common stock options currently
exercisable.
|
(7)
|
Ownership
is based on 31,250 common stock options currently
exercisable.
|
(8)
|
Includes
2,375,000 shares of common stock held by Mark Capital, LLC of which Evan
Levine is the managing member; 727,400 shares of common stock held by Mr.
Levine as custodian for his minor children; and 61,400 shares of common
stock held by Mr. Levine in an IRA.
|
(9)
|
Represents
2,830,255 shares of common stock held by Sherbrooke Partners, LLC, of
which Matthew Balk is the sole
member.
|
38
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
Transactions
with Related Parties
In the
fourth quarter of 2009, warrants to purchase 1,750,000 shares of common stock
were granted in settlement of $195,000 in outstanding accounts payable and a six
month financial advisory services contract with Burnham Hill Partners, of which
Matthew Balk, a beneficial owner of more than 5% of QuantRx common stock, is a
managing member. The warrants have an exercise price of $0.55 and a term of five
years.
In August
2008, in connection with a debt financing, QuantRx incurred cash commissions of
$50,000 to Burnham Hill Partners. Burnham Hill Partners was the placement agent
for the debt financing. These commissions payable were settled in connection
with a financial advisory services contract in the fourth quarter of
2009.
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 were due to Burnham Hill Partners for its role as placement agent in
the transaction as of December 31, 2008 and were settled in connection with a
financial advisory services contract in the fourth quarter of 2009.
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 were due to Burnham Hill Partners for
its role as placement agent in the transaction as of December 31, 2008, and were
settled in connection with a financial advisory services contract in the fourth
quarter of 2009.
Director
Independence
The
Company has determined that two of the four Directors serving at December 31,
2009 (Dr. Shalom Hirschman and Dr. Arthur Hull Hayes, Jr.), were
independent under
Rule 10A-3(b)(1) of the Securities Exchange Act of 1934 adopted pursuant to the
Sarbanes-Oxley Act.
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
Audit
Fees
The
aggregate fees billed for professional services rendered by BehlerMick PS
(formerly known as Williams & Webster, P.S.) for the audit of our annual
financial statements and the reviews of financial statements included in our
Forms 10-Q for years 2009 and 2008 were $30,849 and $72,714,
respectively.
39
Audit-Related
Fees
During
the years ended December 31, 2009 and 2008, no assurance or related
services were performed by BehlerMick PS that were reasonably related to the
performance of the audit or review of our financial statements.
Tax
Fees
During
the years ended December 31, 2009 and 2008, $2,302 and $2,392 in fees were
billed by BehlerMick PS for tax compliance, tax advice or tax planning
services.
All
Other Fees
During
the years ended December 31, 2009 and 2008, no fees were billed by
BehlerMick PS other than the fees set forth under the captions “Audit Fees” and
“Tax Fees” above.
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 BehlerMick PS were pre-approved by the Audit Committee.
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
Exhibit
No.
|
Description
|
|
2.1
|
Contribution
Agreement, dated July 30, 2009, by and among QuantRx, QN Diagnostics, LLC
and NuRx* (incorporated by reference to Exhibit 2.1 filed with Form 8-K on
August 5, 2009)
|
|
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)
|
|
3.5
|
Certificate
of Designation for Series A-1 Preferred Stock (incorporated by reference
to Exhibit 3.1 filed with Form 8-K on August 5, 2009)
|
|
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)
|
40
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).
|
|
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)
|
|
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).
|
41
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).
|
|
10.26
|
Asset
Purchase Agreement, dated July 30, 2009, by and between QuantRx and PRIA
(incorporated by reference to Exhibit 10.1 filed with Form 8-K on August
5, 2009)
|
|
10.27
|
Development
and Services Agreement, dated July 30, 2009, by and between QuantRx and QN
Diagnostics, LLC* (incorporated by reference to Exhibit 10.2 filed with
Form 8-K on August 5, 2009)
|
|
10.28
|
LLC
Agreement, dated July 30, 2009, by and between QuantRx and NuRx
(incorporated by reference to Exhibit 10.3 filed with Form 8-K on August
5, 2009)
|
|
10.29
|
Warrant
to Purchase 2,000,000 Shares of Common Stock of QuantRx, dated July 30,
2009, issued by QuantRx in favor of NuRx (incorporated by reference to
Exhibit 10.4 filed with Form 8-K on August 5, 2009)
|
|
10.30
|
Warrant
to Purchase 2,000,000 Shares of Common Stock of QuantRx, dated July 30,
2009, issued by QuantRx in favor of NuRx (incorporated by reference to
Exhibit 10.5 filed with Form 8-K on August 5, 2009)
|
|
10.31
|
Employment
Agreement, dated July 30, 2009, by and between QuantRx and Walter
Witoshkin (incorporated by reference to Exhibit 10.6 filed with Form 8-K
on August 5, 2009)
|
|
10.32
|
Employment
Agreement, dated July 30, 2009, by and between QuantRx and Sasha
Afanassiev (incorporated by reference to Exhibit 10.7 filed with Form 8-K
on August 5, 2009)
|
|
10.33
|
Employment
Agreement, dated July 30, 2009, by and between QuantRx and William Fleming
(incorporated by reference to Exhibit 10.8 filed with Form 8-K on August
5, 2009)
|
|
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)
|
|
23.1
|
Consent of BehlerMick PS | |
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
|
|
99.1
|
Audited
financial statements of QN Diagnostics, LLC, a 50% or less owned person
accounted for by the equity method
|
|
99.2
|
Audited
financial statements of FluoroPharma, Inc., a 50% or less owned person
accounted for by the equity
method
|
* Certain
exhibits and schedules are omitted but will be furnished to the Commission
supplementally upon request.
**
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.
42
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: March
31, 2010
|
By:
|
/s/ Walter W. Witoshkin
|
|
Walter
W. Witoshkin, Chairman & CEO
|
|||
Date: March
31, 2010
|
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: March
31, 2010
|
By:
|
/s/
Walter W. Witoshkin
|
|
|
Walter
W. Witoshkin, Director
|
||
|
|||
Date:
March 31, 2010
|
By:
|
/s/
William H. Fleming
|
|
|
William H. Fleming, Director | ||
|
|||
Date: March
31, 2010
|
By: |
/s/
Shalom Hirschman
|
|
|
Shalom
Hirschman, Director
|
43
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, 2009 and 2008, the
consolidated results of operations for the years ended December 31, 2009 and
2008, consolidated cash flows for the years ended December 31, 2009 and 2008,
and Consolidated Statement of Stockholders’ Equity for the years ended December
31, 2009 and 2008. These results have been determined on the basis of generally
accepted accounting principles and practices applied consistently.
44
QUANTRX
BIOMEDICAL CORPORATION
FINANCIAL
STATEMENTS
Table
of Contents
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
Consolidated
Balance Sheets as of December 31, 2009 and 2008
|
F-3
|
|
Consolidated
Statements of Operations for the Years Ended December 31, 2009 and
2008
|
F-4
|
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2009 and
2008
|
F-5
|
|
Consolidated
Statement of Stockholders’ Equity for the Years Ended December 31, 2009
and 2008
|
F-6
|
|
Notes
to Consolidated Financial Statements
|
F-7
|
F-1
To the
Board of Directors and Shareholders
QuantRx
Biomedical Corporation
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
We have
audited the accompanying consolidated balance sheets of QuantRx Biomedical
Corporation as of December 31, 2009 and 2008 and the related consolidated
statements of operations, stockholders’ equity and cash flows for the years then
ended. These consolidated financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on these
consolidated financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the 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 audits 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 audits
provide a reasonable basis for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of QuantRx Biomedical
Corporation as of December 31, 2009 and 2008, and the results of its operations
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 that
the Company will continue as a going concern. As discussed in Note 2 to the
consolidated financial statements, the Company’s accumulated deficit and lack of
revenues raise substantial doubt about its ability to continue as a going
concern. Management’s plans regarding the resolution of this issue are also
discussed in Note 2. The consolidated financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/
BehlerMick PS
BehlerMick
PS
Spokane,
Washington
March 30,
2010
F-2
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
BALANCE SHEETS
December
31, 2009
|
December
31, 2008
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ | 376,211 | $ | 66,226 | ||||
Accounts
receivable
|
41,128 | 45,760 | ||||||
Accounts
receivable – related party
|
31,500 | - | ||||||
Interest
receivable – related party
|
47,689 | 31,689 | ||||||
Inventories
|
4,681 | 40,138 | ||||||
Prepaid
expenses
|
128,228 | 189,049 | ||||||
Note
receivable – related party
|
200,000 | 200,000 | ||||||
Deferred
finance costs, net
|
- | 8,693 | ||||||
Deposits
|
- | 104,146 | ||||||
Total
Current Assets
|
829,437 | 685,701 | ||||||
Investments
|
200,000 | 200,000 | ||||||
Investment
in joint venture
|
63,601 | - | ||||||
Property
and equipment, net
|
179,590 | 496,206 | ||||||
Intangible
assets, net
|
59,780 | 2,012,097 | ||||||
Security
deposits
|
11,093 | 10,667 | ||||||
Total
Assets
|
$ | 1,343,501 | $ | 3,404,671 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 749,225 | $ | 2,205,661 | ||||
Accrued
expenses
|
233,000 | 298,692 | ||||||
Deferred
revenue
|
- | 58,781 | ||||||
Deferred
revenue – related party
|
337,160 | - | ||||||
Short-term
convertible notes payable, net of discount
|
- | 2,510,054 | ||||||
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
|
- | 5,731 | ||||||
Total
Current Liabilities
|
1,321,385 | 6,492,197 | ||||||
Notes
payable, long-term
|
44,000 | 44,000 | ||||||
Total
Liabilities
|
1,365,385 | 6,536,197 | ||||||
Commitments
and Contingencies
|
- | - | ||||||
Stockholders’
Equity (Deficit):
|
||||||||
Preferred
stock; $0.01 par value, 25,000,000 authorized Series A-1 convertible
preferred shares 10,000,000 designated; 4,060,397 and 0 shares issued and
outstanding
|
40,604 | - | ||||||
Common
stock; $0.01 par value, 75,000,000 authorized; 44,427,630 and 42,886,380
shares issued and outstanding
|
444,276 | 428,863 | ||||||
Additional
paid-in capital
|
47,756,355 | 41,549,234 | ||||||
Accumulated
deficit
|
(48,263,119 | ) | (45,109,623 | ) | ||||
Total
Stockholders’ Equity (Deficit)
|
(21,884 | ) | (3,131,526 | ) | ||||
Total
Liabilities and Stockholders’ Equity (Deficit)
|
$ | 1,343,501 | $ | 3,404,671 |
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,
|
||||||||
2009
|
2008
|
|||||||
Revenues:
|
||||||||
Revenues
|
$ | 486,005 | $ | 624,495 | ||||
Revenues
– related party
|
2,065,264 | - | ||||||
Total
Revenues
|
2,551,269 | 624,495 | ||||||
Costs
and Operating Expenses:
|
||||||||
Cost
of goods sold (excluding depreciation and amortization)
|
27,853 | 61,896 | ||||||
Sales
and marketing
|
10,118 | 94,603 | ||||||
General
and administrative
|
2,002,964 | 2,894,432 | ||||||
Professional
fees
|
497,582 | 957,135 | ||||||
Research
and development
|
2,324,286 | 2,032,677 | ||||||
Amortization
|
22,402 | 179,444 | ||||||
Depreciation
|
70,082 | 103,992 | ||||||
Total
Costs and Operating Expenses
|
4,955,287 | 6,324,179 | ||||||
Loss
from Operations
|
(2,404,018 | ) | (5,699,684 | ) | ||||
Other
Income (Expense):
|
||||||||
Interest
and dividend income
|
40,095 | 22,622 | ||||||
Interest
expense
|
(465,027 | ) | (369,895 | ) | ||||
Rental
income
|
20,798 | 23,373 | ||||||
Amortization
of debt discount to interest expense
|
(361,666 | ) | (1,148,512 | ) | ||||
Amortization
of deferred financing costs to interest expense
|
(8,693 | ) | (309,164 | ) | ||||
Loss
from deconsolidation of subsidiary
|
(43,286 | ) | - | |||||
Loss
from deconsolidated subsidiary
|
(272,579 | ) | - | |||||
Loss
from joint venture
|
(1,022,760 | ) | - | |||||
Loss
on extinguishment of debt
|
- | (439,445 | ) | |||||
Gain
(loss) on disposition of assets
|
1,363,640 | (8,029 | ) | |||||
Total
Other Income (Expense), net
|
(749,478 | ) | (2,229,050 | ) | ||||
Loss
before Taxes
|
(3,153,496 | ) | (7,928,734 | ) | ||||
Provision
for Income Taxes
|
- | - | ||||||
Net
Loss
|
(3,153,496 | ) | (7,928,734 | ) | ||||
Losses
Attributable to Noncontrolling Interest in Subsidiary
|
- | 207,333 | ||||||
Net
Loss Attributable to QuantRx
|
$ | (3,153,496 | ) | $ | (7,721,401 | ) | ||
Basic
and Diluted Net Loss per Common Share
|
$ | (0.07 | ) | $ | (0.18 | ) | ||
Basic
and Diluted Weighted Average Shares Used in per Share
Calculation
|
43,676,575 | 42,133,840 |
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,
|
||||||||
2009
|
2008
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (3,153,496 | ) | $ | (7,721,401 | ) | ||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||
Depreciation
and amortization
|
92,484 | 283,436 | ||||||
Interest
expense related to amortization of non-cash discount, non-cash beneficial
conversion feature and deferred financing costs
|
370,359 | 1,457,676 | ||||||
Expenses
related to employee stock based compensation
|
582,792 | 947,322 | ||||||
Expenses
related to options issued to non-employees
|
4,083 | 6,667 | ||||||
Expenses
related to common stock warrants issued for consulting
|
7,499 | 39,437 | ||||||
Expenses
related to common stock issued for consulting
|
69,000 | - | ||||||
Non-cash
fair value of warrants and options issued for consulting
|
100,050 | 255,429 | ||||||
Non-cash
incremental fair value of modified warrants issued for
interest
|
6,250 | 400 | ||||||
Non-cash
fair value of warrants issued for interest
|
72,075 | 17,301 | ||||||
Non-cash
fair value of common stock issued for interest
|
78,000 | 125,225 | ||||||
Loss
from deconsolidation of subsidiary
|
43,286 | - | ||||||
Loss
from deconsolidated subsidiary
|
272,579 | - | ||||||
Loss
from joint venture
|
1,022,760 | - | ||||||
Interest
income settled in common stock of former subsidiary
|
(18,000 | ) | - | |||||
Loss
on extinguishment of debt
|
- | 439,445 | ||||||
Gain
(loss) on disposition of assets
|
(1,363,640 | ) | 8,029 | |||||
Issuance
of convertible notes for accrued interest
|
175,895 | 164,924 | ||||||
Issuance
of preferred stock for accrued interest
|
60,823 | - | ||||||
Noncontrolling
interest
|
- | (207,333 | ) | |||||
(Increase)
decrease in:
|
||||||||
Accounts
receivable
|
(26,868 | ) | 34,998 | |||||
Interest
receivable
|
(16,000 | ) | (16,040 | ) | ||||
Inventories
|
35,457 | (2,825 | ) | |||||
Prepaid
expenses
|
(43,685 | ) | 37,974 | |||||
Deposits
|
581 | 302 | ||||||
Security
deposits
|
(426 | ) | - | |||||
Increase
(decrease) in:
|
||||||||
Accounts
payable
|
84,206 | 1,203,535 | ||||||
Accrued
expenses
|
149,358 | 65,410 | ||||||
Deferred
revenue
|
278,379 | 58,781 | ||||||
Net
Cash Used by Operating Activities
|
(1,116,199 | ) | (2,801,308 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Cash
paid for purchases of fixed assets
|
(27,870 | ) | (73,992 | ) | ||||
Cash
paid for intangible assets
|
(250,000 | ) | (75,000 | ) | ||||
Advances
to subsidiary prior to deconsolidation
|
(13,800 | ) | - | |||||
Cash
paid for licensing agreements
|
- | (28,715 | ) | |||||
Cash
paid for capitalized website development costs
|
- | (600 | ) | |||||
Net
Cash Used by Investing Activities
|
(291,670 | ) | (178,307 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from issuance of promissory notes, net of issuance costs of $0 and
$57,500
|
430,000 | 1,042,500 | ||||||
Proceeds
from issuance of senior secured convertible notes, net of legal fees of $0
and $7,500
|
425,000 | 1,292,500 | ||||||
Proceeds
from issuance of short-term secured promissory notes
|
250,000 | 550,000 | ||||||
Proceeds
from exercise of common stock warrants
|
- | 169,189 | ||||||
Repayment
of short-term debt
|
(1,347,199 | ) | (200,000 | ) | ||||
Distribution
from joint venture
|
2,000,000 | - | ||||||
Payments
on loan payable used to finance equipment purchase
|
(5,731 | ) | (10,882 | ) | ||||
Payment
of payables related to asset acquisition deposit
|
(25,000 | ) | - | |||||
Payment
of payables related to fixed asset purchases
|
(8,803 | ) | (10,798 | ) | ||||
Net
Cash Provided by Financing Activities
|
1,718,267 | 2,832,509 | ||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
310,398 | (147,106 | ) | |||||
Net
Cash of Deconsolidated Subsidiary
|
(413 | ) | - | |||||
Cash
and Cash Equivalents, Beginning of Period
|
66,226 | 213,332 | ||||||
Cash
and Cash Equivalents, End of Period
|
$ | 376,211 | $ | 66,226 | ||||
Supplemental
Cash Flow Disclosures:
|
||||||||
Interest
expense paid in cash
|
$ | 71,634 | $ | 58,577 | ||||
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 | ||||
Fair
value of common stock issued with senior secured convertible
notes
|
85,803 | 7,816 | ||||||
Fair
value of warrants issued with senior secured convertible
notes
|
33,487 | 140,955 | ||||||
Fair
value of beneficial conversion feature embedded in senior secured
convertible notes
|
6,325 | 649,187 | ||||||
Incremental
fair value of modified warrants issued pursuant to debt
financing
|
- | 30,132 | ||||||
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 common stock issued with promissory notes
|
51,848 | 203,523 | ||||||
Fair
value of warrants issued with promissory notes
|
39,666 | 108,159 | ||||||
Fair
value of warrants issued in conjunction with joint venture
formation
|
1,000,000 | - | ||||||
Issuance
of preferred stock to settle short-term debt
|
3,999,565 | - | ||||||
Fair
value of common stock warrants issued to settle accounts
payable
|
195,000 | - | ||||||
Increase
in payables related to purchase of fixed assets
|
- | 142,516 | ||||||
Increase
in payables for debt financing costs
|
- | 125,000 | ||||||
Increase
in payables related to asset acquisition deposit
|
- | 25,000 | ||||||
Decrease
in deposits related to asset acquisition
|
100,000 | - | ||||||
Issuance
of common stock for asset acquisition
|
350,000 | - | ||||||
Decrease
in intangible assets related to joint venture contribution
|
722,722 | - | ||||||
Exchange
of promissory note for senior secured convertible note
|
707,890 | - | ||||||
Elimination
of deconsolidated subsidiary accounts:
|
||||||||
Prepaid
expenses
|
104,506 | - | ||||||
Property
and equipment, net
|
274,404 | - | ||||||
Intangible
assets, net
|
1,907,193 | - | ||||||
Deposits
|
3,565 | - | ||||||
Accounts
payable (includes $133,713 for fixed assets A/P)
|
1,311,839 | - | ||||||
Accrued
expenses
|
215,050 | - | ||||||
Additional
paid-in capital
|
479,129 | - |
The
accompanying notes are an integral part of these financial
statements.
F-5
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
Preferred
Stock
|
Common
Stock
|
Total
|
||||||||||||||||||||||||||
Number
of Shares
|
Amount
|
Number
of
Shares
|
Amount
|
Additional
Paid-in Capital |
Accumulated
Deficit
|
Stockholders’
Equity
|
||||||||||||||||||||||
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 | ) | |||||||||||||||||||
|
||||||||||||||||||||||||||||
Fair
value of employee stock based compensation for options
issued
|
- | - | - | - | 263,892 | - | 263,892 | |||||||||||||||||||||
Fair
value of employee stock based compensation for common stock warrants
issued
|
- | - | - | - | 318,900 | - | 318,900 | |||||||||||||||||||||
Fair
value of options issued to non-employees
|
- | - | - | - | 4,083 | - | 4,083 | |||||||||||||||||||||
Fair
value of common stock issued for consulting
|
- | - | 150,000 | 1,500 | 67,500 | - | 69,000 | |||||||||||||||||||||
Fair
value of common stock warrants issued to non-employees for
consulting
|
- | - | - | - | 107,549 | - | 107,549 | |||||||||||||||||||||
Fair
value of common stock warrants issued to settle accounts
payable
|
- | - | - | - | 195,000 | - | 195,000 | |||||||||||||||||||||
Incremental
fair value of modified warrants for interest
|
- | - | - | - | 6,250 | - | 6,250 | |||||||||||||||||||||
Fair
value of warrants issued for interest
|
- | - | - | - | 72,075 | - | 72,075 | |||||||||||||||||||||
Fair
value of common stock issued for interest
|
- | - | 200,000 | 2,000 | 76,000 | - | 78,000 | |||||||||||||||||||||
Fair
value of common stock issued with senior secured convertible
notes
|
- | - | 306,250 | 3,063 | 82,740 | - | 85,803 | |||||||||||||||||||||
Fair
value of warrants issued with senior secured convertible
notes
|
- | - | - | - | 33,487 | - | 33,487 | |||||||||||||||||||||
Fair
value of embedded beneficial conversion feature of convertible
notes
|
- | - | - | - | 6,325 | - | 6,325 | |||||||||||||||||||||
Fair
value of common stock issued with promissory notes
|
- | - | 185,000 | 1,850 | 49,998 | - | 51,848 | |||||||||||||||||||||
Fair
value of warrants issued with promissory notes
|
- | - | - | - | 39,666 | - | 39,666 | |||||||||||||||||||||
Issuance
of preferred stock to settle short-term debt and accrued
interest
|
4,060,397 | 40,604 | - | - | 4,019,785 | - | 4,060,389 | |||||||||||||||||||||
Issuance
of common stock for asset acquisition - PRIA
|
- | - | 700,000 | 7,000 | 343,000 | - | 350,000 | |||||||||||||||||||||
Fair
value of warrants issued in conjunction with joint venture
formation
|
- | - | - | - | 1,000,000 | - | 1,000,000 | |||||||||||||||||||||
Elimination
of deconsolidated subsidiary additional paid in capital
|
- | - | - | - | (479,129 | ) | - | (479,129 | ) | |||||||||||||||||||
Net
loss for the year ended December 31, 2009
|
- | - | - | - | - | (3,153,496 | ) | (3,153,496 | ) | |||||||||||||||||||
BALANCE,
DECEMBER 31, 2009
|
4,060,397 | $ | 40,604 | 44,427,630 | $ | 444,276 | $ | 47,756,355 | $ | (48,263,119 | ) | $ | (21,884 | ) |
The
accompanying notes are an integral part of these financial
statements
F-6
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 for the Point-of-Care (POC)
markets based on its patented technology platforms for the worldwide healthcare
industry. These platforms include: RapidSense® and Q-Reader™ point-of-care
testing products based on QuantRx core intellectual property related to lateral
flow techniques for the consumer and healthcare professional markets (through
our joint venture QN Diagnostics) and PAD technology for the consumer markets
for the treatment of hemorrhoids, minor vaginal infection, urinary incontinence,
and other medical needs. Additionally, the Company has made significant
investments in a company developing Single Nucleotide Polymorphism (SNP) chips,
genome-based diagnostic chips for the next generation of genomic and proteomic
diagnostic markets and in its formerly majority-owned subsidiary, FluoroPharma,
Inc., a company developing molecular imaging agents for Positron Emission
Tomography (PET) and fluorescence imaging with initial application in
cardiovascular disease, to provide clinical support for the Company’s POC
cardiac diagnostics.
The
Company’s overall growth strategy is to: (i) leverage its broad-based
intellectual property (IP) and patent portfolio to develop new and innovative
diagnostic products; (ii) commercialize products through corporate partners and
distributors; and (iii) contract manufacturing to third parties while
maintaining control over the manufacturing process.
On July
30, 2009, QuantRx and NuRx Pharmaceuticals, Inc. jointly formed QN Diagnostics,
LLC (QND), a Delaware limited liability company, with each company owning 50% of
the joint venture. The purpose of the joint venture is to develop and
commercialize products incorporating our lateral flow strip technology and
related lateral flow strip readers.
The joint
venture is managed by a board consisting of two QuantRx designees, two NuRx
designees and an independent designee mutually selected by QuantRx and
NuRx. Subject to certain exceptions, board decisions are made by
majority vote, provided that QuantRx and NuRx have veto rights with respect to
certain matters. Since QuantRx does not have control of the joint venture,
QuantRx accounts for the investment in QND utilizing the equity method of
accounting. See Note 4.
These
consolidated financial statements include the accounts of the Company and,
through December 31, 2008, its formerly majority-owned subsidiary,
FluoroPharma. FluoroPharma 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.
Effective May 5, 2009, QuantRx and FluoroPharma executed transactions that
resulted in QuantRx no longer having a controlling ownership interest, resulting
in the deconsolidation of FluoroPharma. QuantRx has restated its financial
statements as of January 1, 2009, to reflect the results of its former
subsidiary as a one-line item, and effective May 5, 2009, our financial
statements reflect our investment in FluoroPharma under the equity method of
accounting. See Note 8 for additional information. When used in these notes, the
terms “Company,” “we,” “our,” “ours,” or “us” mean QuantRx Biomedical
Corporation, a Nevada corporation.
F-7
2.
|
MANAGEMENT
STATEMENT REGARDING GOING CONCERN
|
The Company and QND have not generated
sufficient revenues from operations to meet its operating expenses. In addition, QND will require additional funding to
complete the development and launch of its initial
products. 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 the current economic environment and the continuing need to
strengthen our cash position, there is still doubt about our ability to continue
as a going concern. We are actively pursuing various funding options, including
licensing opportunities and the sale of investment holdings, as well as a
strategic transaction with our joint venture partner, to obtain additional
funding to continue the development of our products and bring them to commercial
markets. There can be no assurance that we will be successful in our efforts.
Should we be unable to 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:
|
·
|
consummate
a strategic transaction with our joint venture partner;
|
|
·
|
obtain
adequate sources of funding to pay unfunded operating expenses and fund
long-term business operations;
|
|
·
|
manage
or control working capital requirements by reducing operating expenses;
and
|
|
·
|
develop
new and enhance existing relationships with product distributors and other
points of distribution for the Company’s
products.
|
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 (GAAP) and have been consistently applied in the preparation
of the financial statements.
The
Financial Accounting Standards Board (FASB) issued the FASB Accounting Standards
Codification (the Codification or ASC), which is an aggregation of previously
issued authoritative GAAP in one comprehensive set of guidance, effective for
reporting in the third quarter of 2009. In accordance with the Codification,
references to previously issued accounting standards have been replaced by ASC
references. Subsequent revisions to GAAP will be incorporated into the ASC
through Accounting Standards Updates (ASU).
F-8
Accounting for Share-Based
Payments
QuantRx
follows the provisions of ASC Topic 718, which establishes the accounting for
transactions in which an entity exchanges equity securities for services and
requires companies to expense the estimated fair value of these awards over the
requisite service period. 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,
which resulted in employee stock-based compensation expense for the year ended
December 31, 2009 and 2008 of $582,792 and $947,322, respectively (including
$274,299 relating to subsidiary options in 2008).
The
Company accounts for share-based payments granted to non-employees in accordance
with ASC Topic 505, “Equity Based Payments to Non-Employees.” The Company
determines the fair value of the stock-based payment as either the fair value of
the consideration received or the fair value of the equity instruments issued,
whichever is more reliably measurable. If the fair value of the
equity instruments issued is used, it is measured using the stock price and
other measurement assumptions as of the earlier of either (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 determines the incremental value. QuantRx has modified warrants in
connection with the issuance of certain notes and note extensions. These
modified warrants were originally issued in connection with previous private
placement investments. In the case of debt issuances, the warrants were
accounted for as original issuance discount based on their relative fair values.
When modified in connection with a note issuance, QuantRx recognizes the
incremental value as a part of the debt discount calculation, using its relative
fair value in accordance with ASC Topic 470-20, “Debt with Conversion and Other
Options.” When modified in connection with note extensions, the Company
recognized the incremental value as prepaid interest, which is expensed over the
term of the extension.
The fair
value of each share based payment is estimated on the measurement date using the
Black-Scholes model with the following assumptions, which are determined at the
beginning of each year and utilized in all calculations for that
year:
2009
|
2008
|
|||||||
Risk-free
interest rate
|
3.24 | % | 5.35 | % | ||||
Expected
volatility
|
70 | % | 117 | % | ||||
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.
F-9
Expected Term. For options,
the Company has no history of employee exercise patterns; therefore, uses the
option term as the expected term. For warrants, the Company uses the actual term
of the warrant.
Pre-Vesting Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience. The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future
periods.
Accounts, Notes and Interest
Receivable and Allowance for Bad Debts
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. Notes receivable of $200,000 and related interest receivable of
$14,000 were fully allowed for as of December 31, 2008 and were written off in
2009.
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,
2009 and 2008.
Concentration of
Risks
Financial
instruments that potentially expose the Company to concentrations of credit risk
consist primarily of cash and cash equivalents. The Company primarily maintains
its cash balances with financial institutions in federally insured accounts. At
times, such balances may exceed federally insured limits. The Company has not
experienced any losses to date resulting from this practice. At December 31,
2009 and 2008, our cash was not in excess of these limits.
QuantRx
has contributed substantially all of its intellectual property assets relating
to lateral flow diagnostic testing to QND, a joint venture which we do not
control. The operations of QND have a significant impact on QuantRx’s financial
statements.
Earnings per
Share
The
Company computes net income (loss) per common share in accordance with ASC Topic
260. Net income (loss) per share is based upon the weighted average number of
outstanding common shares and the dilutive effect of common share equivalents,
such as options and warrants to purchase common stock, convertible preferred
stock and convertible notes, if applicable, that are outstanding each year.
Basic and diluted earnings per share were the same at the reporting dates of the
accompanying financial statements, as including common stock equivalents in the
calculation of diluted earnings per share would have been
antidilutive.
F-10
As of
December 31, 2009, the Company had outstanding options exercisable for 2,855,500
shares of its common stock, warrants exercisable for 14,784,347 shares of its
common stock, and preferred shares convertible into 8,120,794 shares of its
common stock. The above options, warrants, and preferred shares were deemed to
be antidilutive for the year ended December 31, 2009.
As of
December 31, 2008, the Company had outstanding options exercisable for 2,238,000
shares of its common stock, warrants exercisable for 7,926,684 shares of its
common stock, and convertible debt subject to conversion into 5,215,959 shares.
The above options, warrants and convertible debt were deemed to be antidilutive
for the year ended December 31, 2008.
Fair Value of Financial
Instruments
Effective
January 1, 2008, the Company adopted ASC Topic 820, “Fair Value
Measurements and Disclosures” for financial assets and liabilities. On
January 1, 2009, the Company adopted ASC Topic 820 for nonfinancial assets
and liabilities. We have not elected the fair value option for any of our assets
or liabilities.
The
Company's financial instruments primarily consist of cash and cash equivalents,
short-term accounts and notes receivable, and accounts payable. All instruments
are accounted for on the 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.
ASC Topic
820 establishes a fair value hierarchy that prioritizes the inputs to valuation
techniques used to measure fair value into three levels as follows:
Level 1:
Quoted prices for identical instruments in active markets accessible at the
measurement date.
Level 2:
Quoted prices for similar instruments in active markets; quoted prices for
identical or similar instruments in markets that are not active; and
model-derived valuations whose inputs are observable or whose significant value
drivers are observable.
Level 3:
Unobservable inputs for the instrument are only used when there is little, if
any, market activity for the instrument at the measurement date. Prices or
valuation techniques that require inputs that are both significant to the fair
value measurement and unobservable (i.e. supported by little or no market
activity).
Fair Value Measurements
Using
|
||||||||||||||||
Description
|
Year
Ended 12/31/2009 |
Significant Other
Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
Total Gains
(Losses) |
||||||||||||
Investment
in FluoroPharma
|
$ | - | - | $ | - | $ | (43,286 | ) | ||||||||
Investment
and Note Receivable from GUSA
|
$ | 400,000 | - | $ | 400,000 | - | ||||||||||
Recognized
in earnings
|
$ | (43,286 | ) |
F-11
At the
time of FluoroPharma’s deconsolidation, the fair market value of QuantRx’s
remaining noncontrolling interest was $842,876, based on the third party
investment; however, FluoroPharma had a deficit equity balance, which resulted
in QuantRx writing off the remaining basis in the investment of $43,286 and
recording a loss from deconsolidation of $43,286 in accordance with ASC Topic
810. In determining fair value of our investment and note receivable from GUSA,
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.
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 ASC Topic 360-10-35, “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.
Management
has determined that no impairments were required during the years ended December
31, 2009 and 2008.
Income
Taxes
The
Company accounts for income taxes and the related accounts under the liability
method. Deferred tax assets and liabilities are determined based on the
differences between the financial statement carrying amounts and the income tax
bases of assets and liabilities. A valuation allowance is applied against any
net deferred tax asset if, based on available evidence, it is more likely than
not that some or all of the deferred tax assets will not be
realized.
Our
policy is to recognize interest and/or penalties related to income tax matters
in income tax expense. We had no accrual for interest or penalties on our
consolidated balance sheets at December 31, 2009 or 2008, and have not
recognized interest and/or penalties in the consolidated statement of operations
for the years ended December 31, 2009 or 2008. See Note 13, Income
Taxes.
Intangible
Assets
The
Company’s intangible assets consist of patents, licensed patents and patent
rights, and website development costs, and are carried at the legal cost to
obtain them. Costs to renew or extend the term of intangible assets are expensed
when incurred. In 2008, through our formerly majority owned subsidiary, the
Company also held technology licenses and other acquired intangibles. Intangible
assets are amortized using the straight line method over the estimated useful
life. Useful lives are as follows: patents, 17 years; patents under licensing,
10 years; website development costs, three years, and in 2008, acquired
intangibles had a weighted average life of 15 years. Amortization expense for
the years ended December 31, 2009 and 2008, totaled $22,402 and $179,444
(including $152,060 for the acquired intangibles of FluoroPharma). The estimated
aggregate amortization expense for 2010 through 2014 is $12,976; and $7,412 for
each year thereafter.
F-12
Noncontrolling
Interest
In
January 2009, we adopted an amendment to ASC Topic 810 “Consolidation”, which
required us to make certain changes to the presentation of our financial
statements. This amendment requires noncontrolling interests to be treated as a
separate component of equity, not as a liability or other item outside of
permanent equity. Upon a loss of control, the interest sold, as well as any
interest retained, is required to be measured at fair value, with any gain or
loss recognized in earnings. The statement 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. As of January 1, 2009, the Company presented its financial statements
in accordance with this statement.
On May 5,
2009, QuantRx and FluoroPharma reorganized their relationship by terminating
their investment agreement and related agreements. The termination of these
investment agreements, which were originally executed on March 10, 2006, allowed
FluoroPharma to close an equity financing with third party
investors. In conjunction with the termination of these agreements
and the additional investment in FluoroPharma by third parties, QuantRx agreed
to convert all outstanding receivables from FluoroPharma into common stock of
FluoroPharma. As a result of these transactions and the third party investment,
QuantRx’s ownership interest in FluoroPharma’s issued and outstanding capital
stock was reduced to a noncontrolling interest, which resulted in
deconsolidation and a loss at deconsolidation in accordance with ASC
810. See Note 8 for additional details.
Principles of
Consolidation
These
consolidated financial statements include the accounts of the Company and,
through December 31, 2008, its formerly majority-owned subsidiary,
FluoroPharma. Effective May 5, 2009, QuantRx and FluoroPharma
executed transactions that resulted in QuantRx no longer having a controlling
ownership interest, resulting in the deconsolidation of FluoroPharma. QuantRx
has restated its financial statements as of January 1, 2009, to reflect the
results of its former subsidiary as a one-line item, and effective May 5, 2009
our financial statements reflect our investment in FluoroPharma under the equity
method of accounting. All significant intercompany accounts and transactions
have been eliminated in consolidation. See Note 8 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, 2009 and 2008 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 $70,082 and $103,992 for the years ended December 31,
2009 and 2008. Expenditures for repairs and maintenance are expensed as
incurred. See Note 6.
Recent Accounting
Pronouncements
In
January 2010, the FASB issued ASU No. 2010-06, “Fair Value Measurements and
Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements.”
This ASU requires additional disclosures about significant unobservable inputs
and transfers within Level 1 and 2 measurements. Adoption of this update is
required for interim periods beginning in 2010 and is not expected to have any
impact on the Company’s consolidated results of operation or financial
position.
F-13
In
October 2009, the FASB issued ASU No. 2009-13, “Revenue Recognition (ASC 605)
Multiple-Deliverable Revenue Arrangements.” The guidance modifies the
fair value requirements of ASC 605-25 by providing principles for allocation of
consideration among its multiple elements, allowing more flexibility in
identifying and accounting for separate deliverables under an
arrangement. This guidance will be effective for revenue arrangements
entered into or materially modified during 2010. We do not expect the
adoption of this guidance to have any impact on our consolidated financial
statements.
Certain
reclassifications have been made in the presentation of the financial statements
for the year ended December 31, 2008 to conform to the presentation of the
financial statements for the year ended December 31, 2009. The reclassifications
were to reflect the retrospective adoption of ASC Topic 810.
Research and Development
Costs
Research
and development costs are expensed as incurred. The cost of intellectual
property purchased from others that is immediately marketable or that has an
alternative future use is capitalized and amortized as intangible assets.
Capitalized costs are amortized using the straight-line method over the
estimated economic life of the related asset.
Revenue
Recognition
The
Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
Topic 13 when persuasive evidence of an arrangement exists and delivery or
performance has occurred, provided the fee is fixed or determinable and
collection is probable. The Company assesses whether the fee is fixed and
determinable based on the payment terms associated with the transaction. If a
fee is based upon a variable such as acceptance by the customer, the Company
accounts for the fee as not being fixed and determinable. In these cases, the
Company defers revenue and recognizes it when it becomes due and payable.
Up-front engagement fees are recorded as deferred revenue and amortized to
income on a straight-line basis over the term of the agreement, although the fee
is due and payable at the time the agreement is signed or upon annual renewal.
Payments related to substantive, performance-based milestones in an agreement
are recognized as revenue upon the achievement of the milestones as specified in
the underlying agreement when they represent the culmination of the earnings
process. The Company assesses the probability of collection based on a number of
factors, including past transaction history with the customer and the current
financial condition of the customer. If the Company determines that collection
of a fee is not reasonably assured, revenue is deferred until the time
collection becomes reasonably assured.
The
Company recognizes revenue from nonrefundable minimum royalty agreements from
distributors or resellers upon delivery of product to the distributor or
reseller, provided no significant obligations remain outstanding, the fee is
fixed and determinable, and collection is probable. Once minimum royalties have
been received, additional royalties are recognized as revenue when earned based
on the distributor’s or reseller’s contractual reporting
obligations.
F-14
The
Company’s strategy includes entering into collaborative agreements with
strategic partners for the development, commercialization and distribution of
its product candidates. Such collaborative agreements may have multiple
deliverables. The Company evaluates multiple deliverable arrangements pursuant
to ASC Topic 605-25, “Revenue Recognition: Multiple-Element
Arrangements.” Pursuant to this Topic, in arrangements with multiple
deliverables where the Company has continuing performance obligations, contract,
milestone and license fees are recognized together with any up-front payments
over the term of the arrangement as performance obligations are completed,
unless the deliverable has standalone value and there is objective, reliable
evidence of fair value of the undelivered element in the arrangement. In the
case of an arrangement where it is determined there is a single unit of
accounting, all cash flows from the arrangement are considered in the
determination of all revenue to be recognized. Cash received in advance of
revenue recognition is recorded as deferred revenue.
QN
Diagnostics, LLC
On July
30, 2009, QuantRx and QN Diagnostics entered into a Development and Services
Agreement, pursuant to which QND pays a monthly fee to QuantRx in exchange for
QuantRx providing all services related to the development, regulatory approval
and commercialization of lateral flow products. The revenue recognized by
QuantRx associated with the QND Development and Services Agreement in 2009 was
$2,065,264, and the expenses related to this agreement for 2009 were $2,065,264.
Expenses are included in each appropriate expense category. As of December 31,
2009, deferred revenue consisted of $337,160 of prepaid service fees related to
its development and services agreement with QND, which was recognized in the
first quarter of 2010, and accounts receivable from QND was $31,500. See Note
4.
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
specified 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 was amortized into revenue over the expected
development period of the agreement, estimated as 18 months. QuantRx recognized
revenue of $119,897 and $80,111 in the years ended December 31, 2009 and 2008
related to this agreement.
Development
Agreements and Royalties
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 2009 and 2008, QuantRx recognized
revenues of approximately $180,000 and $420,000 related to these development
agreements in accordance with its revenue recognition policies, and costs of
approximately $100,000 and $290,000.
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. Effective August 1, 2009, QuantRx is providing the
development service to ALT through QN Diagnostics, LLC under the terms of its
operating agreement with QN Diagnostics, and as such, these revenues were
recognized by QND.
F-15
The
Church & Dwight agreement included 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 received royalties on net sales of the
product of $81,426 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.
|
INVESTMENT
IN JOINT VENTURE - QN DIAGNOSTICS,
LLC
|
On July
30, 2009, QuantRx and NuRx Pharmaceuticals, Inc. (NuRx) entered into
agreements to form QN Diagnostics, LLC (QND), a Delaware limited liability
company. Pursuant to the agreements, QuantRx contributed certain intellectual
property and other assets related to its lateral flow strip technology and
related lateral flow strip reader technology with a fair value of
$5,450,000, and NuRx contributed $5,000,000 in cash to QND. Following
the respective contributions by NuRx and QuantRx to the joint venture, NuRx and
QuantRx each own a 50% interest in QND. The purpose of the joint
venture is to develop and commercialize products incorporating the lateral flow
strip technology and related lateral flow strip readers.
The joint
venture is managed by a board consisting of two QuantRx designees, two NuRx
designees and an independent designee mutually selected by QuantRx and
NuRx. Subject to certain exceptions, board decisions are made by
majority vote, provided that QuantRx and NuRx have veto rights with respect to
certain matters. Since QuantRx does not have control of the joint venture,
QuantRx accounts for the investment in QND utilizing the equity method of
accounting.
Under the
terms of the agreements, QND made a $2,000,000 cash distribution to QuantRx.
QuantRx is committed to further capital contributions aggregating $1.55 million,
comprised of: payment of milestone payments with PRIA Diagnostics (see Note 5)
in QuantRx common stock (fair value of $750,000); transfer of fixed assets with
a fair value of $100,000 at QND’s discretion; and a $700,000 sustaining capital
contribution as required by QND. Subsequent sustaining capital contributions
will be made by QuantRx and NuRx on an equal basis.
QuantRx
and QND also entered into a Development and Services Agreement, pursuant to
which QND shall pay a monthly fee to QuantRx in exchange for QuantRx providing
all services related to the development, regulatory approval and
commercialization of lateral flow products.
In
connection with these transactions, NuRx received two warrants to purchase
2,000,000 shares of QuantRx common stock each, for an aggregate of 4,000,000
shares of QuantRx common stock (fair value $1,000,000). The warrants
expire on July 30, 2014 and have an exercise price of $0.50 and $1.25,
respectively.
F-16
QuantRx
recognized a gain on the contribution of the intellectual property of $1.36
million, representing the net gain of $4.72 million from the disposition,
reduced by the fair value of warrants issued to NuRx ($1.0 million) and the
elimination of the portion of the intercompany gain associated with QuantRx’s
50% interest in QND ($2.36 million).
Summarized
financial information of QND for July 30, 2009 (inception) through December 31,
2009, is as follows: current assets: $1,064,000; noncurrent assets: $5,251,000;
total assets: $6,315,000; current liabilities: $97,000; revenues and gross
profit: $125,000; net loss: $2,232,000. QuantRx recorded losses from
QND under the equity method of $1,023,000, representing the Company’s 50%
portion of QND’s net loss, adjusted for an amortization modification based upon
QuantRx’s basis in the contributed assets. There were no other
intercompany profits to eliminate.
5.
|
PRIA
ASSET PURCHASE AGREEMENT
|
On July
30, 2009, the Company executed an asset purchase agreement with PRIA
Diagnostics, LLC, pursuant to which PRIA agreed to sell to QuantRx certain of
PRIA’s patents, trademarks, other intellectual property assets and certain fixed
assets. The aggregate purchase price for such assets was $725,000, comprised of
cash and shares of QuantRx common stock.
Under the
asset purchase agreement, QuantRx is required to make additional contingent
payments, in the form of cash and common stock, upon the occurrence of certain
milestone events. Such cash milestone payments will be made by QN
Diagnostics (see Note 4). In addition, QND is required to pay
royalties to PRIA on a quarterly basis upon the commercialization of a product
utilizing the acquired technologies for five years from the initial sales date
of the first such product sold. QuantRx also agreed under the asset
purchase agreement to offer to PRIA the first opportunity to manufacture certain
products utilizing the acquired technologies before entering into any agreement
or arrangement with a third party to manufacture such products.
F-17
6.
|
OTHER
BALANCE SHEET INFORMATION
|
Components
of selected captions in the accompanying balance sheets as of December 31, 2009
and 2008 consist of:
2009
|
2008
|
|||||||
Prepaid
expenses:
|
||||||||
Prepaid
consulting
|
$ | - | $ | 92,649 | ||||
Prepaid
consulting – related party (See Note 17)
|
83,375 | 4,674 | ||||||
Prepaid
insurance
|
22,960 | 37,473 | ||||||
Prepaid
interest
|
- | 44,426 | ||||||
Prepaid
rent
|
16,533 | 5,310 | ||||||
Other
|
5,360 | 4,517 | ||||||
Prepaid
expenses
|
$ | 128,228 | $ | 189,049 | ||||
Deferred
financing costs:
|
||||||||
Deferred
financing costs
|
$ | - | $ | 133,250 | ||||
Less:
accumulated amortization
|
- | (124,557 | ) | |||||
Deferred
financing costs, net
|
$ | - | $ | 8,693 | ||||
Property
and equipment:
|
||||||||
Computers
and office furniture, fixtures and equipment
|
$ | 124,877 | $ | 136,690 | ||||
Machinery
and equipment
|
181,347 | 466,338 | ||||||
Leasehold
improvements
|
92,233 | 92,233 | ||||||
Less:
accumulated depreciation
|
(218,867 | ) | (199,055 | ) | ||||
Property
and equipment, net
|
$ | 179,590 | $ | 496,206 | ||||
Accrued
expenses:
|
||||||||
Payroll
and related
|
$ | 175,000 | $ | 156,750 | ||||
Professional
fees
|
41,500 | 43,800 | ||||||
Accrued
interest
|
- | 41,142 | ||||||
Other
|
16,500 | 57,000 | ||||||
Accrued
expenses
|
$ | 233,000 | $ | 298,692 |
7.
|
NOTES
RECEIVABLE
|
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. QuantRx
continues to explore the possibility of further investment, and has postponed
settlement of the note during this exploratory period, during which the note
continues to accrue interest. QuantRx accrued interest of $16,000 and $16,040 on
this note for the years ended December 31, 2009 and 2008. 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 8 for additional information on
GUSA.
F-18
8.
|
INVESTMENTS
|
FluoroPharma,
Inc.
On May 5,
2009, QuantRx and FluoroPharma reorganized their relationship by terminating
their investment agreement and related agreements. The termination of these
agreements, which were originally executed on March 10, 2006, allowed
FluoroPharma to close an equity financing with third party
investors. In conjunction with the termination of these agreements
and the additional investment in FluoroPharma, QuantRx agreed to convert all
outstanding receivables from FluoroPharma, consisting of previously issued notes
and related accrued interest and advances in the aggregate amount of $1,568,567,
into 1,148,275 shares of common stock of FluoroPharma. As a result of these
transactions and the third party investment, QuantRx’s ownership interest in
FluoroPharma’s issued and outstanding capital stock was reduced to a
noncontrolling interest, which resulted in deconsolidation. Subsequent to the
termination of the agreements between QuantRx and FluoroPharma, QuantRx has no
continuing obligations or commitments to FluoroPharma.
At May 5,
2009, QuantRx’s remaining net basis of the investment in FluoroPharma, inclusive
of receivables from FluoroPharma, was $43,286, after taking into account
previously recorded losses of $5,056,304 ($272,579 in 2009) related to the
consolidated results of FluoroPharma. These losses have been included in our
consolidated financial statements commencing April 1, 2007, the original date of
consolidation, through May 4, 2009, and are net of losses allocated to the then
noncontrolling (formerly minority) interests as applicable. On May 5, subsequent
to the execution of the aforementioned transactions which led to the
deconsolidation of FluoroPharma, QuantRx’s ownership of the outstanding capital
stock of FluoroPharma was reduced to a noncontrolling interest of approximately
45.55%. At deconsolidation the fair market value of QuantRx’s remaining
noncontrolling interest in FluoroPharma was $842,876, based on the third party
investment; however, FluoroPharma had a deficit equity balance, which resulted
in QuantRx writing off the remaining basis in the investment of $43,286 and
recording a loss from deconsolidation of $43,286 in accordance with ASC Topic
810.
Effective
May 5, 2009, our financial statements reflect our investment in FluoroPharma
under the equity method of accounting. As of December 31, 2009 and December 31,
2008, QuantRx owned 39.81% and 57.78%, respectively, of the issued and
outstanding capital stock of FluoroPharma. However, at December 31, 2009, due to
FluoroPharma’s issuance of a separate class of common stock in 2009, QuantRx
held 17.53% of the voting rights of FluoroPharma.
At
December 31, 2009, FluoroPharma’s summarized financial information was estimated
as follows: current assets: $62,000; noncurrent assets: $130,000; total assets:
$192,000; current and total liabilities $1,255,000; expenses and net losses for
the period of May 5 through December 31, 2009 were $748,000. QuantRx’s
allocation of FluoroPharma’s net loss for the period commencing May 5 through
December 31, 2009, was not recorded ($314,000), since the remaining investment
in FluoroPharma had a carrying value of $0 as of the deconsolidation of
FluoroPharma at May 5, 2009.
As of
December 31, 2008, the portion of FluoroPharma’s losses attributable to the
noncontrolling interest have been recorded, reducing the noncontrolling interest
to zero.
As of
December 31, 2008, QuantRx advanced $900,000 to FluoroPharma through short-term
convertible promissory notes. Additionally, QuantRx advanced $553,700 as of
December 31, 2008. These advances, notes and accrued interest of
$83,067 were eliminated in the consolidation of the year ended December 31,
2008.
F-19
Genomics USA,
Inc.
In May
2006, QuantRx purchased 144,024 shares of GUSA common stock for $200,000. As of
December 31, 2009 and 2008, QuantRx owned approximately 10% of the issued and
outstanding capital stock of GUSA.
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.
9.
|
INTANGIBLE
ASSETS
|
Intangible
assets as of December 31, 2009 and 2008 consisted of the following:
2009
|
2008
|
|||||||
Licensed
patents and patent rights
|
$ | 50,000 | $ | 2,197,020 | ||||
Patents
|
41,004 | 82,008 | ||||||
Technology
license
|
- | 22,517 | ||||||
Website
development
|
40,750 | 49,711 | ||||||
Less:
accumulated amortization
|
(71,974 | ) | (339,159 | ) | ||||
Intangibles,
net
|
$ | 59,780 | $ | 2,012,097 |
At
December 31, 2008, the Company’s consolidated financial statements included the
accounts of its formerly majority-owned subsidiary. Effective May 5, 2009 the
Company no longer held a controlling interest, which resulted in the
deconsolidation and the elimination of the former subsidiary’s accounts; which
included the elimination of intangible assets with a net carrying amount of
$1,907,193. See Note 8 for additional details.
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 pays royalties based on net sales of such licensed
products.
The
Company has capitalized this engagement fee and amortizes 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, 2009 and 2008. 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,
2009 or 2008.
F-20
10.
|
SHORT-TERM
NOTES PAYABLE
|
In July
2009, QuantRx made full settlement with all holders of QuantRx convertible and
promissory notes, and obtained the release of all security interests in QuantRx
assets granted to those note holders. In connection with the full
settlement of these notes and the release of all liens in favor of such note
holders, each note holder received either cash in an amount equal to the
outstanding principal and accrued interest, shares of the newly created Series
A-1 convertible preferred stock (see Note 14), or a combination of both. In the
aggregate, $1,335,156 was paid and 4,060,397 shares of Series A-1 convertible
preferred stock with a fair value of $4,060,397 were issued to the note holders
to settle the outstanding $5,281,765 in convertible and promissory notes and
$113,778 in related accrued interest.
Notes
payable as of December 31, 2009 and 2008 were comprised of the
following:
2009
|
2008
|
|||||||
Short-term
convertible notes payable, net:
|
||||||||
Senior
secured convertible notes payable
|
$ | - | $ | 2,607,979 | ||||
Less:
discount for common stock, warrants and conversion feature,
net
|
- | (97,925 | ) | |||||
Short-term
convertible notes payable, net
|
$ | - | $ | 2,510,054 | ||||
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 |
The
following describes the convertible and promissory notes. QuantRx used the net
proceeds from each offering for product development, working capital and general
corporate purposes. The Black-Scholes option pricing model was used to calculate
the fair values of all warrants issued or modified in connection with these
notes. See Note 3.
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.
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 January 23, 2009. All holders extended this
maturity date to July 31, 2009. Interest on the outstanding principal amount of
the 2008 Notes was 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. In connection with the financing and in
accordance with the terms of the convertible promissory notes issued in 2007
(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.
F-21
QuantRx
determined that the terms of the 2008 Notes were “substantially different” 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. 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 2008 of
$1,000,000 were allocated between the notes and the warrants on a relative fair
value basis. 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.
The
conversion option embedded in the 2008 Notes described above was not considered
a derivative instrument and was not required to be bifurcated since it is
indexed to QuantRx’s stock and is classified as stockholders’ equity. Equity
classification of the embedded conversion option is met. QuantRx also concluded
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 as the
allocated proceeds divided by the number of shares to be received on conversion.
This amount was recorded as original issue discount.
In
association with the issuance of the 2008 Notes, 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 and the first quarter of 2009, the Company issued
additional 2008 Notes maturing July 31, 2009 aggregating $625,000 ($325,000 in
2009 and $300,000 in 2008) with substantially the same terms as the original
2008 Notes. In connection with these note issuances, warrants with a five-year
term to purchase 156,250 shares of common stock at an exercise price of $0.55
(fair value of $41,563; relative fair value of $34,567) and 106,250 shares of
common stock (fair value of $43,063; relative fair value of $36,922) were also
issued. Certain warrants that were previously issued to the holders through
previous financing transactions were modified by reducing their exercise prices
to $0.55 (fair value of $37,900; relative fair value of
$30,131). Additionally, there was a beneficial conversion feature on
one note issued in the fourth quarter of 2008 ($1,427) and one note issued in
the first quarter of 2009 ($6,325). No deferred finance costs were incurred on
these additional 2008 Notes.
F-22
In the
second quarter of 2009, QuantRx issued additional 2008 Notes maturing July 31,
2009 aggregating $835,672 with substantially the same terms as the original 2008
Notes. The notes were issued to one holder of “2008 Promissory Notes” (see
below) in full settlement of $707,890 in 2008 Promissory Notes due to mature in
the second quarter of 2009, and related accrued interest of $27,782, as well as
additional principal of $100,000. In connection with the issuance of these
notes, QuantRx granted 225,000 shares of common stock (fair value of $63,000;
relative fair value of $56,698) and warrants with a five year term to purchase
150,000 shares of common stock at an exercise price of $0.55 (fair value of
$19,500; relative fair value of $17,839). There was no calculated beneficial
conversion feature and there were no deferred finance costs for these
notes.
The
accounting for the additional 2008 Notes is consistent with the original 2008
Notes. The cash proceeds from these additional 2008 Notes of $725,000 were
allocated between the notes, common stock, new and modified warrants, as
applicable, on a relative fair value basis. QuantRx allocated the relative fair
values of the common stock ($93,620), new warrants ($52,406), and modified
warrants ($30,131) at the date of issuance to original issue discount.
Additionally, the beneficial conversion feature of $7,752 associated with the
additional 2008 Notes was accounted for as original issue discount.
In the
aggregate for all 2008 Notes, the fair value of the warrants issued to placement
agents and the cash commissions and legal fees, if any, were recorded as
deferred financing costs. The total original issue discount related to the
common stock, warrants, and modified warrants issued to the investors, the
beneficial conversion feature, and the deferred financing costs were amortized
to interest expense over the original term of each 2008 Note. Interest expense,
including amortization of original issue discount and deferred financing costs,
related to the 2008 Notes was $419,777 and $ 1,060,435 for the years ended
December 31, 2009 and 2008. The Company issued 10% convertible notes in the
aggregate amount of $148,114 for quarterly interest in the form of paid-in-kind
notes in the first half of 2009, and $150,733 in 2008.
2008 Secured Promissory
Notes Payable
In the
second quarter of 2008, the Company issued to certain accredited investors 8%
senior secured promissory notes (the “2008 Secured Promissory 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. 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.
F-23
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 and an exercise price of $0.85
(fair value $9,000) 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 and an exercise price of
$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 was 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 was recorded as prepaid interest and was being expensed over the
term of the extension, with the remaining balance expensed at settlement in July
2009.
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 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 was expensed over the term of the
extension.
In the
second quarter of 2009, QuantRx issued an additional $250,000 2008 Secured
Promissory Note with substantially the same terms as the original 2008 Secured
Promissory Notes and a maturity date of August 10, 2009. The note was issued to
NuRx Pharmaceuticals, Inc. in contemplation of a strategic transaction. There
were no deferred finance fees incurred and no original issue
discount.
In the
aggregate, QuantRx recorded $55,447 and $321,001 in interest expense, including
amortization of original issue discount, deferred financing costs and prepaid
interest, for the years ended December 31, 2009 and 2008.
2008 Unsecured Promissory
Notes Payable
In August
2008, the Company issued to certain accredited investors 8% promissory notes
(the “2008 Promissory 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 an 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
originally due on October 31, 2008, along with all accrued and unpaid interest.
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.
F-24
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 original
maturity date was 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 was amortized over the original term of
the new note. In the second quarter of 2009, this 2008 Promissory Note and
additional 2008 Promissory Notes issued in the second quarter of 2009 held by
this note holder, in the aggregate principal amount of $707,890, together with
accrued interest of $27,782 related to these 2008 Promissory Notes, were settled
through the issuance of a 2008 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, which was expensed over the
term of the extension. After making a principal payment of $15,000,
QuantRx executed a further extension with this holder as of January 31, 2009,
extending the maturity date to May 31, 2009 for the remaining principal amount
of $485,000. In consideration for this extension, QuantRx granted
100,000 shares of common stock (fair value $39,000) and warrants to purchase
100,000 shares of common stock with a five year term and an exercise price of
$0.55 (fair value $21,000). Additionally, warrants to purchase
125,000 shares of common stock were modified, reducing the exercise price from
$0.85 to $0.55 (incremental fair value $3,750). The fair value of the
consideration was expensed over the term of the extension. At May 31, 2009,
QuantRx executed an additional extension with this holder extending the maturity
date to July 31, 2009. In consideration for this additional extension, QuantRx
granted 100,000 shares of common stock (fair value $39,000) and warrants to
purchase 100,000 shares of common stock with a five year term and an exercise
price of $0.55 (fair value $21,000), which was expensed over the term of the
additional extension.
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;
relative fair value of $23,054). The relative fair value of the
warrants was recorded as debt discount and was amortized over the original term
of the notes. As of March 31, 2009, the holders agreed to extend the maturity
date to June 30, 2009. In consideration for this extension, in April 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 (aggregate fair value
$12,075). The fair value of the consideration was expensed over the term of the
extension.
In the
second quarter of 2009, the Company issued a $50,000 8% Promissory Note maturing
May 31, 2009 (settled prior to maturity with the issuance of a 2008 Note) and
$185,000 8% Promissory Notes maturing June 30, 2009 and July 31, 2009. In
connection with these issuances, QuantRx issued 105,000 shares of common stock
(fair value $39,150; relative fair value of $28,488) and warrants to purchase an
aggregate of 130,000 shares of common stock with a five year term and an
exercise price of $0.55 (fair value $19,050; relative fair value of
$16,611). The relative fair value of the common stock and warrants
was recorded as debt discount and was amortized over the original term of the
notes.
F-25
In the
third quarter of 2009, the Company issued an aggregate of $80,000 8% Promissory
Notes maturing July 31, 2009. In connection with these issuances, QuantRx issued
80,000 shares of common stock (fair value $33,000; relative fair value of
$23,360). The relative fair value of the common stock was recorded as
debt discount and was expensed over the original term of the notes.
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 terms of the 2008 Promissory Notes. In the aggregate, QuantRx
recorded $353,951 and $410,274 in interest expense, including amortization of
original issue discount, prepaid interest, and deferred financing costs, related
to the 2008 Promissory Notes for the years ended December 31, 2009 and 2008. No
deferred finance costs were incurred on these Promissory Notes issued in
2009.
11.
|
LONG-TERM
NOTES PAYABLE
|
QuantRx
received a $44,000 loan from the Portland Development Commission in 2007. The
loan matures in 20 years and was interest free through February 2010. The terms
of the note stipulate monthly interest only payments from April 2010 through
December 2014, at a 5% annual rate.
12.
|
COMMITMENTS
AND CONTINGENCIES
|
QN Diagnostics and PRIA
Diagnostics
QuantRx
is committed to further capital contributions to QN Diagnostics aggregating
$1.55 million, comprised of: payment of milestone payments with PRIA Diagnostics
in QuantRx common stock (fair value of $750,000); transfer of fixed assets with
a fair value of $100,000 at QND’s discretion; and a $700,000 sustaining capital
contribution as required by QND. Subsequent sustaining capital contributions
will be made by QuantRx and NuRx on an equal basis. Should either party fail to
make sustaining contributions as required, such party would be subject to a
reduction in ownership interest and loss of a board seat. See Notes 4
and 5.
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 $132,775 and $174,099 for the years ended December
31, 2009 and 2008, respectively. Minimum lease payments for the years 2010
through 2014 are as follows: $99,116; $43,875; and $0 thereafter; and in the
aggregate is $142,991. Sublease income relating to our operating leases was
$20,798 and $23,373 for the years ending December 31, 2009 and 2008, and is
recorded in other income.
F-26
Executive Employment
Agreements
We have
entered into employment contracts with key executives that provide for the
continuation of salary to the executives if terminated for reasons other than
cause or in connection with a change in control of QuantRx, as defined in those
agreements. At December 31, 2009, the future employment contract commitment for
such key executives based on these termination clauses was approximately
$636,000, or in the case of a change of control, $1,272,000. In addition, the
agreement states that if QuantRx were to sell all of its shares of capital stock
or assets, or perform a material acquisition of another entity, QuantRx will pay
a completion bonus.
Legal
Contingencies
We may
occasionally become subject to legal proceedings and claims that arise in the
ordinary course of our business. It is impossible for us to predict
with any certainty the outcome of any disputes that may arise, and we cannot
predict whether any liability arising from claims and litigation will be
material in relation to our financial position or results of
operations.
13.
|
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 2004.
At
December 31, 2009 and 2008, the Company had gross deferred tax assets calculated
at an expected blended rate of 38% of approximately $15,540,955 and $16,085,386,
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 $15,537,251 and $16,065,431 has been
established at December 31, 2009 and 2008, 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.
There is
no unrecognized tax benefit included in the balance sheet that would, if
recognized, affect the effective tax rate.
F-27
The
significant components of the Company’s net deferred tax assets (liabilities) at
December 31, 2009 and 2008 are as follows:
2009
|
2008
|
|||||||
Gross
deferred tax assets:
|
||||||||
Net
operating loss carryforwards
|
$ | 11,638,561 | $ | 14,040,021 | ||||
Difference
between book and tax basis of former subsidiary stock held
|
1,937,844 | - | ||||||
Stock
based expenses
|
1,108,159 | 1,590,554 | ||||||
Tax
credit carryforwards
|
292,999 | 358,869 | ||||||
All
others
|
563,392 | 95,942 | ||||||
15,540,955 | 16,085,386 | |||||||
Gross
deferred tax liabilities:
|
||||||||
Difference
between book and tax bases of tangible and intangible
assets
|
(3,704 | ) | (19,955 | ) | ||||
Deferred
tax asset valuation allowance
|
(15,537,251 | ) | (16,065,431 | ) | ||||
Net
deferred tax asset (liability)
|
$ | - | $ | - |
At
December 31, 2009, the Company has net operating loss carryforwards of
approximately $30,627,791, which expire in the years 2010 through 2029. The net
change in the allowance account was a decrease of $528,180 for the year ended
December 31, 2009.
14.
|
CAPITAL
STOCK
|
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, and
10,000,000 are designated Series A-1 convertible preferred stock, $0.01 par
value. The remaining 5,250,000 authorized preferred shares have not been
designated by the Company as of December 31, 2009. At December 31, 2009,
4,060,397 shares of Series A-1 preferred stock were outstanding. The Company had
no issued and outstanding preferred stock at December 31, 2008.
The
Series A-1 preferred stock ranks prior to the common stock for purposes of
liquidation preference, and to all other classes and series of equity securities
of the Company that by their terms do not rank senior to the Series A-1
preferred stock. Holders of the Series A-1 preferred stock shares are entitled
to receive, when, as and if declared by the Board of Directors, preferential
dividends which shall accrue at the rate of 8% per annum to be paid at the
option of the Company, either in cash or by the issuance of additional shares of
Series A-1 preferred stock. The Company may, at its option, redeem shares of the
Series A-1 preferred stock, in whole or in part, out of funds legally available,
by action of the Board of Directors, at any time after the issuance of such
Series A-1 preferred stock, at a redemption price equal to the face amount plus
all accrued and unpaid dividends on such Series A-1 preferred stock. At any time
on or after the issuance date, the Series A-1 preferred stock may be converted
by the holder of any such shares subject to certain limitations into a number of
fully paid and nonassessable shares of common stock at a conversion rate of two
shares of common stock for each one share of Series A-1 preferred
stock.
In the
third quarter of 2009, the Company issued 4,060,397 shares of Series A-1
preferred stock to certain holders of the Company’s promissory notes in exchange
for the cancellation of their respective notes and the releases of any security
interests.
F-28
Common
Stock
The
Company has authorized 75,000,000 shares of its common stock, $0.01 par value.
The Company had issued and outstanding 44,427,630 and 42,886,380 shares of its
common stock at December 31, 2009 and 2008, respectively. In December 2009, the
shareholders of the Company approved an increase to authorized common stock to
150,000,000 shares. The increase took effect in January 2010 with the filing of
the amendment to the articles of incorporation with the state of
Nevada.
In the
fourth quarter of 2009, 150,000 shares of common stock were granted in
consideration of investor relations services. The fair value of $69,000 was
expensed in the year ended December 31, 2009.
In the
third quarter of 2009, in connection with an asset purchase, QuantRx issued
700,000 shares of common stock (fair value of $350,000). See Note
5.
In the
third quarter of 2009, in connection with the issuance of $80,000 8% unsecured
promissory notes, the Company issued an aggregate of 80,000 shares of common
stock (fair value $33,000; relative fair value of $23,360).
In the
second quarter of 2009, in connection with the issuance of $835,672 10% senior
secured convertible promissory notes, the Company issued an aggregate 225,000
shares of common stock (fair value of $63,000; relative fair value of $56,698)
and warrants with a five year term to purchase 150,000 shares of common stock at
an exercise price of $0.55 (fair value of $19,500; relative fair value of
$17,839).
In the
second quarter of 2009, in connection with the issuance of $235,000 8%
promissory notes, the Company issued an aggregate of 105,000 shares of common
stock (fair value of $39,150; relative fair value of $28,488) and warrants to
purchase an aggregate of 130,000 shares of common stock with a five year term
and an exercise price of $0.55 (fair value of $19,050; relative fair value of
$16,611).
In the
second quarter of 2009, in connection with an extension of a 2008 Promissory
Note, the Company issued 100,000 shares of common stock (fair value $39,000) and
warrants to purchase 100,000 shares of common stock with a five year term and an
exercise price of $0.55 (fair value $21,000).
In the
first quarter of 2009, in connection with the issuance of $300,000 10% senior
secured convertible promissory notes, the Company issued an aggregate of 81,250
shares of common stock (fair value of $33,813; relative fair value of $29,105)
and warrants to purchase 81,250 shares of common stock with a five year term and
an exercise price of $0.55 (fair value of $18,188; relative fair value of
$15,648).
In the
first quarter of 2009, in connection with an extension of a 2008 Promissory
Note, QuantRx granted 100,000 shares of common stock with a fair value of
$39,000 and warrants to purchase 100,000 shares of common stock with a five year
term and an exercise price of $0.55 (fair value
$21,000). Additionally, warrants to purchase 125,000 shares of common
stock were modified, reducing the exercise price from $0.85 to
$0.55.
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.
F-29
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.
15.
|
STOCK
PURCHASE WARRANTS
|
Common Stock
Warrants
In the
fourth quarter of 2009, warrants to purchase 1,750,000 shares of common stock
(fair value of $295,050) were granted in settlement of $195,000 in outstanding
accounts payable and a six month financial advisory services contract. The
warrants have an exercise price of $0.55 and a term of five years. $16,675 was
expensed as consulting expense in 2009 for this contract.
In the
fourth quarter of 2009, a warrant to purchase 25,000 shares of common stock
(fair value of $6,000) was granted to a consultant in connection with the
successful completion of a development milestone. The warrants have a five year
term and an exercise price of $0.40 and were expensed on the grant
date.
F-30
In the
fourth quarter of 2009, warrants to purchase an aggregate of 200,000 shares of
common stock (fair value of $29,000) were granted in consideration of investor
relations services. Warrants to purchase 100,000 shares of common stock were
issued with an exercise price of $0.50 and have a term of five years. Warrants
to purchase 100,000 shares of common stock were issued with an exercise price of
$1.25 and have a term of five years. The warrants vest over one year, and will
be remeasured during the vesting term as required. $8,000 was expensed in 2009
related to these issuances.
In the
third quarter of 2009, in connection with the establishment of a joint venture,
QuantRx issued two warrants to purchase 2,000,000 shares (4,000,000 in the
aggregate) of QuantRx common stock with a fair value of
$1,000,000. The warrants expire on July 30, 2014 and have an exercise
price of $0.50 and $1.25, respectively. See Note 4.
In the
third quarter of 2009, warrants to purchase an aggregate of 550,000 shares of
common stock were granted to certain executives. The warrants were issued with
an exercise price of $0.50, have a term of five years and were fully vested at
December 31, 2009. The aggregate fair value of $165,000 was recognized as stock
based compensation expense in 2009.
In the
second quarter of 2009, in connection with the issuance of $835,672 10% senior
secured convertible promissory notes, the Company issued an aggregate 225,000
shares of common stock (fair value of $63,000; relative fair value of $56,698)
and warrants with a five year term to purchase 150,000 shares of common stock at
an exercise price of $0.55 (fair value of $19,500; relative fair value of
$17,839).
In the
second quarter of 2009, in connection with the issuance of $235,000 8%
promissory notes, the Company issued an aggregate of 105,000 shares of common
stock (fair value of $39,150; relative fair value of $28,488) and warrants to
purchase an aggregate of 130,000 shares of common stock with a five year term
and an exercise price of $0.55 (fair value of $19,050; relative fair value of
$16,611).
In the
second quarter of 2009, in connection with extensions of certain 2008 Promissory
Notes, the Company issued 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 these issuances was recognized as
interest expense in 2009.
In the
second quarter of 2009, in connection with an extension of a 2008 Promissory
Note, the Company issued 100,000 shares of common stock (fair value $39,000) and
warrants to purchase 100,000 shares of common stock with a five year term and an
exercise price of $0.55 (fair value $21,000). The fair value of these issuances
was recognized as interest expense in 2009.
In the
first quarter of 2009, in connection with the issuance of $300,000 10% senior
secured convertible promissory notes, the Company issued an aggregate of 81,250
shares of common stock (fair value of $33,813; relative fair value of $29,105)
and warrants to purchase 81,250 shares of common stock with a five year term and
an exercise price of $0.55 (fair value of $18,188; relative fair value of
$15,648).
In the
first quarter of 2009, in connection with an extension of a 2008 Promissory
Note, QuantRx granted 100,000 shares of common stock with a fair value of
$39,000 and warrants to purchase 100,000 shares of common stock with a five year
term and an exercise price of $0.55 (fair value
$21,000). 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 these issuances and modifications was
recognized as interest expense in 2009.
F-31
In the
first quarter 2009, in connection with the issuance of $325,000 8% promissory
notes, the Company issued 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; relative fair value of $23,054).
In the
first quarter of 2009, warrants to purchase an aggregate of 810,000 shares of
common stock were granted to employees and warrants to purchase an aggregate of
50,000 shares of common stock were granted to certain consultants. The warrants
were issued with an exercise price of $0.31, have a term of five years and vest
immediately, and have a fair value of $163,400.
In
January 2009, in connection with an extension of a maturity date on a 2008
Secured Promissory Note, QuantRx granted a warrant 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 these
issuances and modifications was recognized as interest expense in
2009.
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 was 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 was 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.
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). The fair value of these issuances was recorded as prepaid
interest and amortized over the terms of the extensions as interest
expense.
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.
F-32
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 was 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 had 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 was remeasured during the vesting term as required, with a final fair value
measurement of $18,000. Consulting expense related to the issuance of these
warrants was $34,000 for the year ended December 31, 2008 and a reduction of
$16,000 for the year ended December 31, 2009.
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 (fair value of $16,250).
The warrants were issued to an executive officer of our former majority-owned
subsidiary as payment for a one year contract for technical advisory services
related to medical diagnostics. Consulting expense related to the issuance of
these warrants was $4,674 and $11,576 for the years ended December 31, 2009 and
2008. At December 31, 2008, $4,674 was recorded as prepaid consulting related to
this contract.
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.
F-33
The
following is a summary of all common stock warrant activity during the two years
ended December 31, 2009:
Number of Shares
Under Warrants
|
Exercise Price Per
Share
|
Weighted Average
Exercise Price
|
|||||||||
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 | |||||||
Warrants
granted
|
8,241,750 |
$0.31
- $ 1.25
|
$ | 0.68 | |||||||
Warrants
expired
|
(1,384,087 | ) |
$1.50
|
$ | 1.50 | ||||||
Warrants
exercised
|
- |
-
|
- | ||||||||
Warrants
issued and exercisable at December 31, 2009
|
14,784,347 |
$0.31 - $ 2.00
|
$ | 0.81 |
The
following represents additional information related to common stock warrants
outstanding and exercisable at December 31, 2009:
Exercise
Price
|
Number of Shares Under
Warrants |
Weighted Average
Remaining
Contract Life in Years |
Weighted
Average
Exercise Price |
|||||||||||
$ | 0.31 | 860,000 | 4.04 | $ | 0.31 | |||||||||
$ | 0.40 | 25,000 | 4.88 | $ | 0.40 | |||||||||
$ | 0.42 | 182,065 | 1.40 | $ | 0.42 | |||||||||
$ | 0.50 | 3,706,873 | 3.79 | $ | 0.50 | |||||||||
$ | 0.55 | 3,848,348 | 3.86 | $ | 0.55 | |||||||||
$ | 0.61 | 4,000 | 2.88 | $ | 0.61 | |||||||||
$ | 0.75 | 2,000 | 2.75 | $ | 0.75 | |||||||||
$ | 0.85 | 1,153,131 | 1.21 | $ | 0.85 | |||||||||
$ | 0.87 | 2,000 | 2.68 | $ | 0.87 | |||||||||
$ | 0.89 | 200,000 | 3.29 | $ | 0.89 | |||||||||
$ | 0.95 | 150,000 | 2.29 | $ | 0.95 | |||||||||
$ | 1.00 | 325,750 | 4.07 | $ | 1.00 | |||||||||
$ | 1.10 | 200,000 | 2.95 | $ | 1.10 | |||||||||
$ | 1.15 | 6,000 | 2.42 | $ | 1.15 | |||||||||
$ | 1.20 | 30,000 | 2.33 | $ | 1.20 | |||||||||
$ | 1.25 | 2,177,500 | 4.55 | $ | 1.25 | |||||||||
$ | 1.35 | 75,000 | 2.29 | $ | 1.35 | |||||||||
$ | 1.50 | 1,518,180 | 0.84 | $ | 1.50 | |||||||||
$ | 2.00 | 318,500 | 1.23 | $ | 2.00 | |||||||||
14,784,347 | 3.31 | $ | 0.81 |
The
Company used the Black-Scholes option price calculation to value the warrants
granted in 2009 and 2008 using the following assumptions: risk-free rate of
3.24% and 5.35%; volatility of 0.70 and 1.17; actual term and exercise price of
warrants granted. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share-Based Payments.”
16.
|
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.
F-34
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 2009, 25,000 non-qualified common stock options were granted
to members 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 $0.38, have a term of five years and vested immediately. The fair value of
these options is $5,750.
In the
fourth quarter of 2009, qualified stock options to purchase an aggregate of
50,000 shares of common stock were granted and issued from the Company’s 2007
Incentive and Non-Qualified Stock Option Plan to employees in accordance with
employment agreements and the successful completion of development milestones.
The options were fully vested, have a five year term and an exercise price of
$0.40. The fair value of these options is $12,000.
In the
third quarter of 2009, non-qualified stock options to purchase an aggregate of
500,000 shares of common stock were granted and issued from the Company’s 2007
Incentive and Non-Qualified Stock Option Plan to executives in accordance with
employment agreements executed July 30, 2009. The options were issued with an
exercise price of $0.50, have a term of five years, and at December 31, 2009,
options to purchase 437,500 shares of common stock are vested, with the
remainder vesting with the successful completion of development milestones. The
fair value of these options is $150,000.
In the
first quarter of 2009, qualified stock options to purchase an aggregate of
130,000 shares of common stock were granted to 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, and have a term of five years. The
options vest monthly over one year. The fair value of these options is
$24,700.
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.
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.
F-35
The
following is a summary of all common stock option activity during the two years
ended December 31, 2009:
Shares Under
Options
Outstanding |
Weighted Average
Exercise
Price |
|||||||
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
granted
|
705,000 | $ | 0.45 | |||||
Options
forfeited
|
(87,500 | ) | $ | 0.83 | ||||
Options
exercised
|
- | - | ||||||
Outstanding
at December 31, 2009
|
2,855,500 | $ | 0.66 |
Options Exercisable
|
Weighted Average Exercise
Price Per Share |
|||||||
Exercisable
at December 31, 2008
|
2,048,000 | $ | 0.69 | |||||
Exercisable
at December 31, 2009
|
2,687,583 | $ | 0.63 |
The
following represents additional information related to common stock options
outstanding and exercisable at December 31, 2009:
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
|
|||||||||||||||||
$ | 0.31 | 130,000 | 4.04 | $ | 0.31 | 124,583 | $ | 0.31 | ||||||||||||||
$ | 0.35 | 6,250 | 4.00 | $ | 0.35 | 6,250 | $ | 0.35 | ||||||||||||||
$ | 0.38 | 25,000 | 5.00 | $ | 0.38 | 25,000 | $ | 0.38 | ||||||||||||||
$ | 0.40 | 50,000 | 4.88 | $ | 0.40 | 50,000 | $ | 0.40 | ||||||||||||||
$ | 0.50 | 1,500,000 | 5.09 | $ | 0.50 | 1,437,500 | $ | 0.50 | ||||||||||||||
$ | 0.69 | 6,250 | 3.00 | $ | 0.69 | 6,250 | $ | 0.69 | ||||||||||||||
$ | 0.80 | 502,500 | 8.17 | $ | 0.80 | 502,500 | $ | 0.80 | ||||||||||||||
$ | 0.85 | 363,000 | 7.78 | $ | 0.85 | 363,000 | $ | 0.85 | ||||||||||||||
$ | 1.00 | 60,000 | 0.18 | $ | 1.00 | 60,000 | $ | 1.00 | ||||||||||||||
$ | 1.15 | 75,000 | 6.57 | $ | 1.15 | 75,000 | $ | 1.15 | ||||||||||||||
$ | 1.17 | 12,500 | 2.00 | $ | 1.17 | 12,500 | $ | 1.17 | ||||||||||||||
$ | 1.60 | 125,000 | 6.26 | $ | 1.60 | 25,000 | $ | 1.60 | ||||||||||||||
2,855,500 | 5.89 | $ | 0.66 | 2,687,583 | $ | 0.63 |
The
weighted average remaining contractual term for both fully vested share options
(exercisable, above) and options expected to vest (outstanding, above) is 5.9
years. The aggregate intrinsic value of all of QuantRx’s options is
$9,288.
The
weighted-average grant-date fair value of options granted during 2009 and 2008
was $0.27 and $0.75, respectively. There were no options exercised during 2009
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
2009 and 2008 was $236,321 and $621,695, respectively.
F-36
A summary
of the status of the Company’s nonvested stock options as of December 31, 2009
and changes during the year ended December 31, 2009 is presented
below:
Nonvested Stock Options
|
Shares
|
Weighted Average
Grant Date Fair Value
|
||||||
Nonvested
at December 31, 2008
|
190,000 | $ | 1.20 | |||||
Options
granted
|
705,000 | $ | 0.27 | |||||
Options
vested
|
(720,833 | ) | $ | 0.33 | ||||
Options
forfeited
|
(6,250 | ) | $ | 0.76 | ||||
Nonvested
at December 31, 2009
|
167,917 | $ | 1.06 |
As of
December 31, 2009, there was approximately $54,842 of unrecognized compensation
cost related to nonvested options. Weighted average period of nonvested stock
options was 5.6 years as of December 31, 2009.
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
3.24% and 5.35%; volatility of 0.70 and 1.17; actual term and exercise price of
options granted. See Note 3, Summary of Significant Accounting Policies,
“Accounting for Share-Based Payments.”
17.
|
RELATED
PARTY TRANSACTIONS
|
In the
fourth quarter of 2009, warrants to purchase 1,750,000 shares of common stock
(fair value of $295,050) were granted in settlement of $195,000 in outstanding
accounts payable and a six month financial advisory services contract with
Burnham Hill Partners, of which a beneficial owner of more than 5% of QuantRx
common stock is a managing member. The warrants have an exercise price of $0.55
and a term of five years. Of the $100,050 allocated to the financial advisory
services contract, $16,675 was expensed as consulting expense in 2009, and as of
December 31, 2009, $83,375 was recorded as prepaid consulting.
In August
2008, in connection with a debt financing, QuantRx incurred cash commissions of
$50,000 to Burnham Hill Partners. Burnham Hill Partners was the placement agent
for the debt financing. These commissions payable were settled in connection
with a financial advisory services contract in the fourth quarter of
2009.
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 were due to Burnham Hill Partners for its role as placement agent in
the transaction as of December 31, 2008 and were settled in connection with a
financial advisory services contract in the fourth quarter of 2009.
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 were due to Burnham Hill Partners for
its role as placement agent in the transaction as of December 31, 2008, and were
settled in connection with a financial advisory services contract in the fourth
quarter of 2009.
An
executive officer of our former majority-owned subsidiary, who is also a
beneficial owner of approximately 25% of the former majority-owned 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.
F-37
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 (fair value of $16,250).
The warrants were issued to an executive officer of our former majority-owned
subsidiary as payment for a one year contract for technical advisory services
related to medical diagnostics. Consulting expense related to the issuance of
these warrants was $4,674 and $11,576 for the years ended December 31, 2009 and
2008. At December 31, 2008, $4,674 was recorded as prepaid consulting related to
this contract.
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 this agreement during the year
ended December 31, 2008 were $20,000.
18.
|
SUBSEQUENT
EVENTS
|
In
December 2009, the shareholders of the Company approved an increase to
authorized common stock to 150,000,000 shares. The increase took effect in
January 2010 with the filing of the amendment to the articles of incorporation
with the state of Nevada.
On
January 29, 2010, QuantRx entered into an Agreement and Plan of Merger (the
“Merger Agreement”) with NuRx Pharmaceuticals, Inc. (NuRx) and NP Acquisition
Corporation, a wholly-owned subsidiary of QuantRx (“Merger Sub”). The Merger
Agreement provides that at the effective time (the “Effective Time”), Merger Sub
will be merged with and into NuRx, with NuRx continuing as the surviving
corporation and a wholly-owned subsidiary of QuantRx.
Under the
terms of the Merger Agreement, at the Effective Time, each outstanding share of
NuRx’s common stock (other than shares held by NuRx or any wholly-owned
subsidiary of NuRx or by QuantRx or Merger Sub or any of their respective
subsidiaries, or by stockholders of NuRx who have properly demanded appraisal
rights for their shares in accordance with Nevada law) will be converted into
the right to receive approximately 1.54 shares of QuantRx common
stock. All options and warrants of NuRx outstanding at the Effective
Time will be assumed by QuantRx and converted into rights with respect to
QuantRx’s common stock.
On March
26, 2010, QuantRx entered into a Security Purchase Agreement with a qualified
institutional buyer in which QuantRx sold 333,333 shares of FluoroPharma, Inc.
class A common stock at a price of $0.75 per share for an aggregate amount of
$250,000. Subsequent to this transaction, QuantRx’s ownership interest in
FluoroPharma was reduced to approximately 36%.
F-38