Item 1 above and elsewhere) contains
forward-looking statements within the meaning of the Private Securities
Litigation Act of 1995 that involve risks and uncertainties. Some or all of
the
results anticipated by these forward-looking statements may not occur.
Forward-looking statements involve known and unknown risks and uncertainties
including, but not limited to, trends in the biotechnology, healthcare, and
pharmaceutical sectors of the economy; competitive pressures and technological
developments from domestic and foreign genetic research and development
organizations which may affect the nature and potential viability of our
business strategy; and private or public sector demand for products and services
similar to what we plan to commercialize. We disclaim any intention or
obligation to publicly announce the results of any revisions to any of the
forward-looking statements contained herein to reflect future events or
developments.
Unless
otherwise indicated or the context otherwise requires, all references in this
report to “we,” “our,” “ours,” “us,” the “Company,” or similar terms, refer to
QuantRx Biomedical Corporation, a Nevada corporation, and its
subsidiary.
Overview
QuantRx
is a broad-based diagnostics company focused on the development and
commercialization of innovative diagnostic products based on its patented
technology platforms for the worldwide healthcare industry. The Company’s
strategy is to commercialize its products through partners or distributors,
contracting the manufacturing to third party partners while maintaining control
over the manufacturing process. The Company’s 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.
The
Company's technology portfolio, with more than three dozen patents, patents
pending and licensed patents, includes: (1) RapidSense® point-of-care testing
products based on QuantRx core intellectual property related to lateral flow
techniques for the consumer and healthcare professional markets; (2) through
our
affiliate, Genomics USA, Inc., genome-based diagnostic chips for the laboratory
and healthcare professional markets; (3) through FluoroPharma, molecular imaging
agents for positron emission tomography (PET) and fluorescence imaging, with
initial application in cardiovascular disease, addressing significant unmet
medical needs by providing clinicians with important tools for early discovery
and assessment; and (4) PAD technology for diagnosis and treatment of women's
health concerns and other medical needs.
In
April
2007, QuantRx increased its ownership in FluoroPharma, Inc., a development-stage
molecular imaging company, to 57.78% of outstanding capital stock, resulting
in
its consolidation effective April 1, 2007. The investment in FluoroPharma is
intended to strategically expand QuantRx’s diagnostic platforms.
Lateral
Flow Diagnostics
QuantRx
has developed a patented RapidSense® technology - a one-step lateral flow test
with unique features such as: positive read indication for drugs-of-abuse,
improved sensitivity, and the ability to read both large and small molecules.
The rapid, disposable, and point-of-care diagnostic technology is ideal for
collection of either urine or oral fluids. QuantRx also has a patented
technology based on an innovative oral fluid collection device specifically
designed for lateral flow tests – the only
one-step
oral fluid testing device now on the market developed by QuantRx for use with
its patented RapidSense technology. This distinctive collection device has
applications in the growing market of oral sample collections for issues ranging
from drug-abuse testing, gathering biological evidence for criminal
investigation, and screening for numerous communicable diseases including
HIV/AIDS and other STDs.
The
QuantRx device – an industry
first
–
incorporates a removable barrier that prevents test chemicals from washing
into
the oral cavity during the collection process, and allows the controlled start
of the test or tests within the device. Because the QuantRx device is designed
for either single or multiple tests using the same sample, it is ideal for
emerging drugs of abuse analyses and testing for a range of communicable
diseases. The patented technology has a feature that provides a more secure
"chain of custody" system, helping to ensure the identity and integrity of
a
specimen from collection through the reporting of test results.
In
October, 2007, the U.S. Food and Drug Administration (FDA) granted QuantRx
510(k) clearance on its Follicle Stimulating Hormone (FSH) lateral flow
immunoassay test for FSH at 10ng/ml. This female fertility test is a one-step
lateral flow device that determines ovarian reserve indirectly by measuring
FSH
in first morning urine. The Company intends to market this test through third
party distribution. The Company is currently developing a male fertility test
and anticipates introduction of this test in 2008.
QuantRx
intends to file over a half a dozen new 510(k) applications for its lateral
flow
tests for drugs-of-abuse and menopause over the next 12 months. Additionally,
feasibility for development of lateral flow tests for infectious disease and
cardiac markers is currently being explored.
The
technology has strong potential and numerous possible applications. For this
reason, QuantRx is pursuing collaborative research and development and original
equipment manufacturer (OEM) relationships with companies and organizations
interested in exploring new and existing analytes to drive the development
of
new products for the diagnostic marketplace to advance healthcare
worldwide.
In
the
fourth quarter 2007, QuantRx intends to introduce its Affirm® drugs-of-abuse
product line in the U.S. and European markets. This OEM product line is intended
to develop distribution channels, complement its RapidSense line expected to
be
introduced in 2008, and enable QuantRx to offer a complete spectrum of
drugs-of-abuse test product lines.
Genome-based
Diagnostic Microarray Chips
Forming
the basis of our next-generation point-of-care diagnostic technology is the
clinically optimized microarray technology of the QuantRx affiliate company,
Genomics USA. This technology platform is based on the non-covalent attachment
of DNA probes to a surface which allows for cost-effective fabrication and
manufacturing. This novel technology produces the only microarrays for analyzing
intermediate numbers of genes.
The
initial function for this technology is "The HLA Chip," which is based on Human
Leukocyte Antigen (HLA) typing. Population-scale typing of HLA, a substrate
of
the genome, is the initial focus, resulting in the ability to detect disorders
related to the immune system. An initial application for this HLA-based
“laboratory on a chip” is in vaccine development and personalized vaccine
delivery; essentially determining a vaccine’s effectiveness for a particular
individual. Additional market applications include population scale testing
for
Human Papilloma Virus (HPV) and other infectious diseases, tissue
transplantation, stem cell therapeutics, personalized treatment for autoimmune
diseases such as arthritis and multiple sclerosis, and personalized treatment
of
microbial infections.
Importantly,
the biophysical properties of these "self-assembling" DNA microarrays allow
Single Nucleotide Polymorphism (SNP)-based hybridizations simply and directly,
without the need to perform single-base extension or any other secondary
biochemical treatment. This simplification reduces the cost of the product,
increases signal quality, and allows the product to be used by non-experts,
especially in field-testing or small-clinic environments.
Follow-on
products in the personalized medicine market will service chemical therapeutics,
especially those applications in which personal genetic variation at a number
of
gene sites can cooperate to alter treatment responsiveness for conditions such
as obesity, depression, cardiovascular risk, and others.
Development
of this critical test has been accelerated by the infusion of approximately
$3
million via a Department of Defense sponsored grant, with the focus being to
provide the military with information necessary to determine who would benefit
from various vaccines, in the event of a biowarfare release. A prototype of
this
test is anticipated in 2008.
Initial
commercialization of the HLA micorarray chip for its initial application in
vaccine development and personalized vaccine development is expected in early
2009.
Molecular
Imaging
The
Company, through FluoroPharma,
is
developing proprietary diagnostic imaging products, with initial focus on the
development
of novel positron emission tomography (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
is a novel metabolic agent in development for the following intended uses:
(a)
detection of ischemic and infarcted tissue in patients with suspected or proven
forms of acute and chronic CAD, particularly in those patients that cannot
undergo stress-testing; and, (b) Cardiac Viability Assessment (CVA), for the
prediction of functional improvement prior to, or following revascularization
in
patients with acute CAD, including myocardial infarction.
CardioPET
represents a potentially highly sensitive means of detecting ischemia at rest,
because it can detect subtle metabolic insufficiency in myocardium. Thus a
primary application of CardioPET is its use in the assessment of patients with
acute and chronic CAD that cannot undergo stress-testing.
CardioPET
may also be ideal as the metabolic component in CVA due to its ability to
specifically identify damaged but viable myocardial tissue. In contrast to
non-viable scar tissue, viable myocardial tissue can undergo revascularization,
which has been documented to improve left ventricular function and increase
survival.
CardioPET
will address two separate populations: (1) the estimated 1.75 million patients
with chronic forms of CAD in the U.S. that undergo pharmacologic stress-testing
due to stress-test contraindication; and, (2) the 350,000 patients with
presumptive hibernating or stunned myocardium. For at-rest
assessment of the former population, we believe CardioPET may be readily adopted
by the cardiology community for the assessment of this patient pool. For CVA
testing, we believe that CardioPET’s “first mover” advantage, when combined with
the favorable technical parameters relative to currently available glucose-based
agents such as fluorodeoxyglucose (FDG), should result in favorable market
adoption. Another potential application for CardioPET is as a substitute for
regular stress testing, as physicians see the benefit of fewer total scans
and
potentially faster diagnoses.
Following
the filing of an Investigational New Drug (IND) application with the FDA, a
Phase I clinical trial for CardioPET commenced in 2006 and is nearing
completion. The Phase I trial is a single center, open label study, designed
to
evaluate safety, distribution and dosimetry of CardioPET as a PET tracer for
myocardial imaging in healthy subjects. All primary study and safety endpoints
were achieved; the drug and treatment were exceedingly well-tolerated.
Evaluation of the safety and distribution of the agent in subjects with known
CAD is ongoing. The Company expects to initiate a limited Phase II study in
late
2007 focused on evaluation of cardiac ischemia in subjects with chronic and
acute forms of CAD.
BFPET
is
a blood flow imaging being developed for use as a myocardial perfusion agent
in
conjunction with stress-testing for the detection of ischemic and infarcted
myocardial tissue in patients with suspected or proven chronic CAD.
BFPET
has
been designed to enter the myocardial cells of the heart muscle in direct
proportion to blood flow and membrane potential—the two most important
physiological indicators of adequate blood supply to the heart. BFPET
effectively differentiates between those cells of the myocardium that are
ischemic (reversibly damaged), infarcted (irreversibly damaged), and those
that
are healthy. Because ischemic and infarcted cells take up significantly less
BFPET than normal healthy myocardial cells, the signal emitted by the tracer
attached to BFPET is inversely proportional to the extent of myocardial injury,
the result of which can be visualized with PET imaging
technologies.
Currently,
it is estimated that approximately 80% of the 7 million patients with suspected
acute and chronic forms of CAD in the U.S. are evaluated using the combination
of blood flow imaging agents (blood flow agents) and stress-testing. An
additional 350,000 patients undergo CVA in which a blood flow agent, such as
BFPET, is used in combination with a metabolic imaging agent such as FDG or
FluoroPharma’s CardioPET. We believe that BFPET may represent the first
commercially feasible cardiovascular blood flow agent for the PET market.
VasoPET
is a novel imaging agent for the detection of inflamed and/or coronary artery
plaque formation in patients with CAD. VasoPET, if approved, would represent
the
first cardiovascular PET product to reliably differentiate between vulnerable
and stable coronary artery plaque.
Coronary
artery plaques grow over time and progressively narrow the lumen of the coronary
artery until blood flow to the heart diminishes to a critical level. The rupture
of atherosclerotic plaque and the subsequent formation of clots overlying the
plaque are currently recognized as the primary mechanisms of myocardial and
cerebral infarctions. Therefore, the detection of vulnerable plaque in
atherosclerotic lesions is a highly desirable goal; and to this date remains
both a significant clinical objective and large unaddressed market opportunity.
VasoPET
is positioned to capture a small percentage of the entire atherosclerosis
scanning market, which represents more than 50 million Americans. Preliminary
estimates for the VasoPET market are a direct function of the more than 100
thousand patients that undergo carotid artery procedures annually. There is
a
significant need to follow up after treatment to track the success of these
procedures. We conservatively estimate that VasoPET will gradually become the
standard follow up for carotid artery procedures and that 75% of patients will
be scanned with VasoPET one year post-surgery.
The
Company has completed the studies necessary for the filing of INDs for the
myocardial perfusion imaging agent, BFPET and atherosclerotic plaque imaging
agent, VasoPET. Single-dose preclinical toxicology studies revealed no untoward
effects of either compound when they were administered in doses up to one
million times the anticipated clinical dose. Submission of the IND and
commencement of Phase I clinical trial to evaluate safety and dosimetry in
healthy subjects is expected in late 2007 or early 2008.
We
anticipate that our first New Drug Application will be filed with the U.S.
FDA
in 2010.
Miniform
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 for
diagnostic testing.
The
QuantRx Miniform PAD is fully biodegradable and flushable, making it safe,
convenient, and easy to use, addressing the growing trend in medicine to turn
to
products that seek to improve health and treat disease chiefly by assisting
the
body’s innate capacity to recover from illness and injury.
The
Company plans to market its initial PAD-based products under the QuantRx Unique®
and Unique-T® brands through various distribution arrangements. Additionally,
the Company expects to introduce the Unique line via the internet in the fourth
quarter of 2007. Addressing the over-the-counter market for temporary hemorrhoid
pain relief medication and supplies, the Unique line incorporates technology
licensed from the Procter & Gamble Company. The proprietary Unique and
Unique-T are intended for treatment and daily care of hemorrhoids and minor
vaginal infections. They are distinctive in that they are the only PAD-based
hemorrhoid-treatment product in a segment of the healthcare market that has
experienced little or no innovation in decades.
The
QuantRx PadKit® was developed on the basis of clinical research indicating that
the miniform may also be an ideal diagnostic sample collection device. When
coupled with a simple transport kit, it allows patients to take their own
samples which are sent to a laboratory for analysis and diagnosis, providing
a
sample for drug use screening, genetic conditions, and disease. QuantRx holds
several patents covering this application and plans to commercialize products
it
may develop under these patents under the QuantRx PadKit trademark.
Commercialization will likely require extensive clinical testing and submission
to the FDA for marketing approval.
The
Company is exploring the potential combination of the miniform PAD
sample-collection capability with the microarray technology of its affiliate
company, Genomics USA, to bring to market a diagnostic tool for female tissue
sampling, specifically testing for colon cancer and HPV, a virus that has been
shown to cause cervical cancer. In addition, QuantRx is exploring clinical
validation for the use of its PAD technology for application in therapeutic
transdermal drug delivery, based on results of preclinical vaginal drug-delivery
research conducted at the University of Belfast and Oxford University.
Consolidated
Results of Operations
Net
operating revenues for the three months ended September 30, 2007 and 2006,
were
$85,518 and $32,106, respectively. Net operating revenues for the nine months
ended September 30, 2007 and 2006, were $256,169 and $57,788, respectively.
The
increase in revenues of $53,412 for the quarter and $198,381 for the nine months
is due to revenues of $51,844 and $155,145 related to short-term research and
development agreements, and an increase of $1,568 and $43,236 accreted from
deferred revenue.
Other
revenues in the three and nine months ended September 30, 2007, included rental
income of $6,224 and $14,509, respectively, for the subleasing of research
and
development laboratory space at our research facility and, in the first quarter,
a $14,000 governmental grant for qualified expenditures at our research
facility.
Sales
and
marketing expense for the three months ended September 30, 2007 and 2006, was
$78,243 and $67,468, respectively, and for the nine months ended September
30,
2007 and 2006, was $173,524 and $229,911. The increase of $10,775 for the
quarter primarily reflects an increase in business development costs offset
by a
decrease in personnel and related expenses. The decrease of $56,387 for the
nine
months primarily reflects a decrease in personnel and related expenses, offset
by increased business development costs.
General
and administrative expense, including professional fees, for the three months
ended September 30, 2007 and 2006, was $864,917 and $477,436, respectively,
and
for the nine months ended September 30, 2007 and 2006, was $3,220,441 and
$1,470,513, respectively. The increase of $387,481 for the quarter is primarily
attributable to the consolidation of FluoroPharma’s financial results and
increased personnel and related expenses. The increase of $1,749,928 for the
nine months is primarily attributed to an increase in professional fees and
the
consolidation of FluoroPharma’s financial results and, to a lesser extent,
increased personnel expenses.
Research
and development expense for the three months ended September 30, 2007 and 2006,
was $462,740 and $176,488, respectively, and for the nine months ended September
30, 2007 and 2006, was $1,464,873 and $436,778, respectively. The increase
of
$286,252 and $1,028,095 for the three and nine months is primarily attributable
to the consolidation of FluoroPharma’s financial results and their expenses
related to clinical trials, as well as the hiring of additional research and
development personnel and increased expenses associated with occupying a new
research and development facility beginning in the fourth quarter of 2006.
The
Company’s net loss for the three months ended September 30, 2007 and 2006, was
$1,327,357 and $1,960,676, respectively, and for the nine months ended September
30, 2007 and 2006, was $4,797,193 and $5,558,135, respectively. The decreased
net loss for the quarter of $633,319 is primarily due to a reduction in interest
expense of $1,279,104 related to convertible promissory notes which were
converted to common stock in December 2006, partially offset by the effects
of
the 2007 consolidation of FluoroPharma. The decreased net loss for the nine
months of $760,942 primarily relates to a reduction in interest expense of
$3,502,537, partially offset by the effects of the 2007 consolidation of
FluoroPharma and an increase in professional fees of $634,041.
Liquidity
and Capital Resources
As
of
September 30, 2007, the Company had cash and cash equivalents of $184,670,
as
compared to cash and cash equivalents of $1,256,912 as of December 31, 2006.
The
net decrease in cash of $1,072,242 for the nine months ended September 30,
2007,
is primarily attributable to net operating cash used of $3,933,690, the issuance
of a $200,000 8% convertible promissory note to Genomics USA, Inc., and $253,689
for purchased fixed assets, primarily offset by the private placement of
3,532,500 shares of common stock and warrants to accredited investors for gross
proceeds of $3,532,500 and gross proceeds from warrant exercises of
$584,206.
QuantRx
has used its financing proceeds, as well as its revenues, to fund current
operating expenses and investments intended to strategically expand our
platforms and technologies.
In
the
future, QuantRx expects to expand operations with the use of additional
financing and increased revenues from operations with the introduction of
several products in late 2007 and early 2008. On October 16, 2007, QuantRx
completed the first tranche of a private placement of 10% senior secured
convertible promissory notes and warrants to purchase shares of QuantRx common
stock. The private placement may be completed in multiple tranches until
$2,000,000 in aggregate notional amount of Notes have been issued. In connection
with the private placement, QuantRx issued Notes in the aggregate principal
amount of $1,000,000 and Warrants to purchase 250,000 shares of QuantRx' common
stock. It is anticipated that an additional $1,000,000 will be raised through
the issuance of 10% senior secured convertible promissory notes and warrants
to
purchase shares of QuantRx common stock in the fourth quarter of
2007.
Off-Balance
Sheet Arrangements
We
have
not entered into any transactions with unconsolidated entities in which we
have
financial guarantees, subordinated retained interests, derivative instruments
or
other contingent arrangements that expose us to material continuing risks,
contingent liabilities or any other obligations under a variable interest in
an
unconsolidated entity that provides us with financing, liquidity, market risk,
or credit risk support.
Critical
Accounting Policies
Revenue
Recognition
The
Company recognizes revenue in accordance with the SEC’s Staff Accounting
Bulletin Topic 13, “Revenue Recognition” (“Topic
13”) and EITF No. 00-21, “Revenue Arrangements with Multiple Deliverables.”
Revenue is recognized when all of the following criteria are met:
(1) persuasive evidence of an arrangement exists; (2) delivery has
occurred or services have been rendered; (3) the seller’s price to the
buyer is fixed and determinable; and (4) collectibility is reasonably
assured.
Revenue
from licensing agreements is recognized based on the performance requirements
of
the agreement. Revenue is deferred for fees received before earned.
Nonrefundable upfront fees that are not contingent on any future performance
by
us are recognized as revenue when revenue recognition criteria under Topic
13
and EITF 00-21 are met and the license term commences. Nonrefundable upfront
fees, where we have an ongoing involvement or performance obligations, are
recorded as deferred revenue and recognized as revenue over the life of the
contract, the period of the performance obligation or the development period,
whichever is appropriate in light of the circumstances.
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 agreements when they represent the culmination of the earnings
process. Royalty revenue from licensed products will be recognized when earned
in accordance with the terms of the license agreements.
Use
of Estimates
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the reported amounts
of
assets and liabilities, revenues and expenses, and related disclosures of
contingent assets and liabilities in the financial statements and accompanying
notes. The accounting policies discussed below are considered by management
to
be the most important to the Company’s financial condition and results of
operations, and require management to make its most difficult and subjective
judgments due to the inherent uncertainty associated with these matters.
All
significant estimates and assumptions are developed based on the best
information available to us at the time made and are regularly reviewed and
adjusted when necessary. We
believe that our estimates and assumptions are reasonable under the
circumstances; however, actual results may vary from these estimates and
assumptions.
Impairment
of Assets
We
assess
the impairment of long-lived assets whenever events or changes in circumstances
indicate that their carrying value may not be recoverable. The determination
of
related estimated useful lives, and whether or not these assets are impaired,
involves significant judgments related primarily to the future profitability
and/or future value of the assets. Changes in our strategic plan and/or market
conditions could significantly impact these judgments and could require
adjustments to recorded asset balances. We hold minority interests 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.
We
perform annual impairment tests of our equity method goodwill and other
intangible assets in accordance with SFAS No. 142, “Goodwill and Other
Intangible Assets.” Under SFAS No. 142, goodwill is not amortized but is
subject to impairment tests based upon a comparison of the fair value of the
entity and the carrying value of the entity’s net assets. SFAS No. 142
requires a review of goodwill and other intangible assets for impairment at
least annually or when circumstances exist that would indicate an impairment
of
such goodwill or other intangible assets. We determine whether the equity method
goodwill and other intangible assets are impaired by comparing the respective
fair values of the equity method goodwill and/or other intangible assets to
their respective carrying values.
In
determining fair value of assets, QuantRx bases estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about carrying values of assets that are not readily apparent from
other sources. Actual fair value may differ from management estimates resulting
in potential impairments causing material changes to certain assets and results
of operations.
Share-based
Payments
We
grant
options to purchase our common stock to our employees and directors under our
stock option plan subject to the provisions of SFAS No. 123 (R), “Share-Based
Payments.” Effective January 1, 2005, we use the fair value method to apply
the provisions of SFAS No. 123 (R) with a modified prospective application
which provides for certain changes to the method for valuing share-based
compensation. The valuation provisions of SFAS No. 123 (R) apply to new
awards and to awards that are outstanding on the effective date and subsequently
modified or cancelled. Under the modified prospective application, prior periods
are not revised for comparative purposes.
Upon
adoption of SFAS No. 123 (R), we began estimating the value of stock option
awards on the date of grant using a Black-Scholes pricing model (Black-Scholes
model). The determination of the fair value of share-based payment awards on
the
date of grant using the Black-Scholes model is affected by our stock price,
as
well as assumptions regarding a number of complex and subjective variables.
These variables include, but are not limited to, our expected stock price
volatility over the term of the awards, actual and projected employee stock
option exercise behaviors, and risk-free interest rate. If factors change and
we
employ different assumptions in the application of SFAS No. 123 (R) in
future periods, the compensation expense that we record under SFAS No. 123
(R) may differ significantly from what we have recorded in the current period.
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.
ITEM
3. Controls
and Procedures
(a) Evaluation
of Disclosure Controls and Procedures
The
Company maintains disclosure controls and procedures that are designed to ensure
that information required to be disclosed in our SEC reports is recorded,
processed, summarized, and reported within the time periods specified in the
SEC’s rules and forms, and that such information is communicated to our
management including our Chief Executive Officer and Chief Financial Officer
as
appropriate. With the supervision and with the participation of our management,
including the Chief Executive Officer and Chief Financial Officer, we have
evaluated the effectiveness of our disclosure controls and procedures (as
defined under Exchange Act Rules 13a-15(e) and 15(d)-15(e)), as of the end
of the period covered by this report. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer have concluded that these
disclosure controls and procedures were effective as of September 30,
2007.
(b) Changes
in Internal Control over Financial Reporting
During
the period covered by this Quarterly Report on Form 10-QSB, there were no
changes in our internal control over financial reporting that have materially
affected, or are reasonably likely to affect, our internal control over
financial reporting.
Given
the
inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that misstatements due to error or fraud will not
occur or that all control issues and instances of fraud, if any, will 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. Further, the design of a control system must reflect the
fact
that there are resource constraints, and that the benefits of a control system
must be considered relative to its cost. The design of any system of controls
is
also based in part on certain assumptions regarding 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.
PART
II - OTHER INFORMATION
ITEM
1. Legal
Proceedings.
As
of the
date hereof, the Company has no pending or threatened litigation.
ITEM
2. Unregistered
Sales of Equity Securities, and Use of Proceeds
In
the
third quarter 2007, QuantRx initiated a limited warrant exercise inducement
targeting certain large warrant holders. The inducement was a reduction in
the
exercise price from $1.50 to $0.75 to a limited number of accredited investors
holding warrants acquired in conjunction with prior common stock purchases.
As a
result of this inducement, 751,001 common stock warrants were exercised and
exchanged for 751,001 shares of our common stock, $0.01 par value, for aggregate
gross proceeds of $563,251. In connection with the exercise of these warrants,
QuantRx paid cash commissions to Legend Merchant, Inc., of $16,429.
In
August
2007, 38,100 common stock warrants were exercised and exchanged for 38,100
shares of our common stock, $0.01 par value, resulting in proceeds to the
Company of $20,955. The exercise price for these warrants was
$0.55.
On
September 4 and June 1, 2007, the Company issued 2,000 and 6,000 common stock
warrants with five-year terms and exercise prices of $0.87 and $1.15,
respectively, in consideration of business development consulting services.
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.
All
proceeds will be used for general corporate purposes.
There
were no additional sales of unregistered securities other than as reported
in
prior reports on Form 8-K.
ITEM
3. Defaults
on Senior Securities
None.
ITEM
4. Submission
of Matters to a Vote of Security Holders
None.
ITEM
5. Other
Information
None.
ITEM
6. Exhibits
Exhibit
Index
|
Exhibit
|
Description
|
|
|
31.1
|
|
Certification
of Chief Executive Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended.
|
|
31.2
|
|
Certification
of Chief Financial Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended.
|
|
32.1*
|
|
Certification
of Chief Executive Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350.
|
|
32.2*
|
|
Certification
of Chief Financial Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350.
|
*The
certifications attached as Exhibits 32.1 and 32.2 accompany this Quarterly
Report on Form 10-QSB 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.
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:
November 12, 2007
|
By:
|
/s/
Walter Witoshkin
|
|
|
|
|
Walter
Witoshkin
|
|||
|
|
Chairman
& CEO
|
|||
|
|
|
|||
|
Date:
November 12, 2007
|
By:
|
/s/
Sasha Afanassiev
|
|
|
|
|
Sasha
Afanassiev
|
|||
|
|
CFO,
Treasurer & VP of Finance
|
|||