As
filed with the Securities and Exchange Commission on April 30, 2010
Registration
No. 333-150878
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
_______________
POST-EFFECTIVE
AMENDMENT NO. 2
to
FORM
S-1
REGISTRATION
STATEMENT UNDER
THE
SECURITIES ACT OF 1933
HEALTH
DISCOVERY CORPORATION
(Exact
Name of Registrant as Specified in Its Charter)
Georgia
(State
or other jurisdiction of
incorporation
or organization)
|
8099
(Primary
Standard Industrial
Classification
Code Number)
|
74-3002154
(I.R.S. Employer
Identification
Number)
|
2
East Bryan Street, Suite #601
Savannah,
GA 31401
(912)
443-1987
(Address,
including zip code, and telephone number, including area code,
of
registrant’s principal executive offices)
_______________
Stephen
D. Barnhill, M.D.
Chief
Executive Officer
Health
Discovery Corporation
2
East Bryan Street, Suite #601
Savannah,
GA 31401
(912)
443-1987
(Name,
address, including zip code, and telephone number, including area
code,
of agent
for service)
_______________
Copies
of Communications to:
Daniel
B. Nunn, Jr.
Fowler
White Boggs P.A.
50
N. Laura Street
Suite
2800
Jacksonville,
FL 32202
(904)
598-3118
_______________
Approximate date of commencement of
proposed sale to the public:
As soon as practicable after the effective
date of this Registration Statement.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, check
the following box.
x
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering.
o
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
o
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definition of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
o
|
Accelerated
filer
o
|
Non-accelerated
filer (Do not check if a smaller reporting company)
o
|
Smaller
reporting company
x
|
CALCULATION
OF REGISTRATION FEE
Title
of Each Class of
Securities
To Be Registered
|
AMOUNT
TO BE
REGISTERED
|
PROPOSED
MAXIMUM
OFFERING
PRICE
PER UNIT
|
Proposed
Maximum
Aggregate
Offering
Price
|
Amount
of
Registration
Fee (2)
|
Common
Stock, no par value, to be issued upon exercise of warrants exercisable at
$0.14 per share
|
35,274,934
|
$0.14(1)
|
$4,938,490.76
|
$283.57
|
Common
Stock, no par value, to be issued upon exercise of warrants exercisable at
$0.19 per share
|
35,274,934
|
$0.19(1)
|
$6,702,237.46
|
$384.84
|
Common
Stock, no par value
|
352,746
|
$0.08(1)
|
$41,230.72
|
$2.38
|
(1)
Estimated solely for the purpose of computing the registration fee pursuant to
Rule 457.
(2)
Previously paid.
The
Registrant hereby amends this Registration Statement on such date or dates as
may be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this Registration Statement
shall hereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
The information in this preliminary prospectus is not complete and may
be changed. These securities may not be sold until the registration
statement filed with the Securities and Exchange Commission is
effective. This preliminary prospectus is not an offer to sell these
securities and is not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
Subject
to Completion, dated April 30, 2010
PROSPECTUS
70,549,868
Shares of Common Stock to be issued upon Exercise of Warrants
352,746
Shares of Common Stock
HEALTH
DISCOVERY CORPORATION
2
East Bryan Street
Suite
#601
Savannah,
GA 31401
(912)
443-1987
This
prospectus relates to the resale of up to 70,549,868
shares of our common
stock, no par value, which may be issued upon the exercise of warrants
previously issued by us and 352,746 shares of our common stock, no par value,
which are being offered for resale from time to time by the shareholders named
in the section entitled “Selling Shareholders” on page 18. The number
of shares the selling shareholders may offer and sell under this prospectus
includes common shares:
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●
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the
selling shareholders currently hold; and
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●
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issuable
to them upon the exercise of warrants previously issued by
us. The selling shareholders may also offer additional shares
of common stock acquired upon the exercise of the warrants and our
issuance of stock as a result of anti-dilution provisions, stock splits,
stock dividends or similar
transactions.
|
We are
registering these shares to satisfy registration rights of the selling
shareholders.
We will
not receive any of the proceeds from any resales by the selling shareholders. We
will, however, receive the proceeds from the exercise of the warrants issued to
the selling shareholders. The selling shareholders may sell the shares of common
stock from time to time in various types of transactions, including on the
Over-the-Counter Bulletin Board and in privately negotiated transactions. For
additional information on methods of sale, you should refer to the section
entitled “Plan of Distribution” on page 19.
On April
28, 2010, the last sales price of the common stock quoted on the
Over-the-Counter Bulletin Board was $0.18 per share. Our company’s common stock
is quoted on the Over-the-Counter Bulletin Board under the symbol
“HDVY.OB.”
Investing
in our common stock involves a high degree of risk. See “Risk Factors” beginning
on page 6.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR
ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date
of this prospectus is April 30, 2010.
TABLE
OF CONTENTS
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Page
#
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PROSPECTUS
SUMMARY
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4
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RISK
FACTORS
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6
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USE
OF PROCEEDS
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17
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PRICE
RANGE OF COMMON STOCK AND DIVIDENDS
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17
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SELLING
SHAREHOLDERS
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17
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PLAN
OF DISTRIBUTION
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20
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BUSINESS
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21
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MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
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36
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DIRECTORS
AND EXECUTIVE OFFICERS
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46
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DESCRIPTION
OF CAPITAL STOCK
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53
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LEGAL
MATTERS
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55
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EXPERTS
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55
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WHERE
YOU CAN FIND MORE INFORMATION
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55
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ABOUT
THIS PROSPECTUS
This
prospectus is a part of a registration statement that we have filed with the
Securities and Exchange Commission. You should read this prospectus
and any accompanying prospectus supplement, as well as any post-effective
amendments to the registration statement of which this prospectus is a part,
together with the additional information described under “Available Information”
before you make any investment decision.
The
terms “Health Discovery,” “Company,” “we,” “our” and “us” refer to Health
Discovery Corporation unless the context suggests otherwise. The term
“you” refers to a prospective purchaser of our common stock.
You
should rely only on the information contained in this prospectus or any
accompanying prospectus supplement. We have not authorized anyone to
provide you with information different from that contained in this prospectus or
any accompanying prospectus supplement. These securities are being
offered for sale and offers to buy these securities are only being solicited in
jurisdictions where offers and sales are permitted. The information
contained in this prospectus and any accompanying prospectus supplement is
accurate only as of the date on their respective covers, regardless of the time
of delivery of this prospectus or any accompanying prospectus supplement or any
sale of the securities.
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this prospectus.
This summary does not contain all of the information you should consider before
investing in our common stock. You should read the entire prospectus carefully,
including “Risk Factors” and the financial statements, before making an
investment decision.
Our
Company Overview
HDC is a
pattern recognition company that uses advanced mathematical techniques to
analyze large amounts of data to uncover patterns that might otherwise be
undetectable. The Company operates primarily in the emerging field of
molecular diagnostics where such tools are critical to scientific
discovery. The terms
artificial intelligence
and
machine learning
are
sometimes used to describe pattern recognition tools.
HDC’s
mission is to use its patents, intellectual prowess, and clinical partnerships
principally to identify patterns that can advance the science of medicine, as
well as to advance the effective use of our technology in other diverse business
disciplines, including the high-tech, financial, and homeland security
markets.
Our
historical foundation lies in the molecular diagnostics field where we have made
a number of important discoveries that may play a critical role in developing
more personalized approaches to the diagnosis and treatment of certain
diseases. However, our SVM assets in particular have broad
applicability in many other fields. Intelligently applied, HDC’s
pattern recognition technology can be a portal between enormous amounts of
otherwise undecipherable data and truly meaningful discovery.
Our
Company’s principal asset is its intellectual property which includes advanced
mathematical algorithms called
Support Vector Machines
(SVM)
and
Fractal Genomic
Modeling
(FGM), as well as
biomarkers
that we discovered
by applying our SVM and FGM techniques to complex genetic and proteomic
data. Biomarkers are biological indicators or genetic expression
signatures of certain disease states. Our intellectual property is
protected by more than 69 patents that have been issued or are currently pending
around the world.
Our
business model has evolved over time to respond to business trends that
intersect with our technological expertise and our capacity to professionally
manage these opportunities. In the beginning, we sought only to use
our SVMs internally in order to discover and license our biomarker signatures to
various diagnostic and pharmaceutical companies. Today, our
commercialization efforts include: utilization of our discoveries and knowledge
to help develop biomarkers for use as companion diagnostics, surrogate
biomarkers, and diagnostic and prognostic predictive tests; licensure of the SVM
and FGM technologies directly to diagnostic and pharmaceutical companies; and,
the formation of new ventures with domain experts in other fields where our
pattern recognition technology holds commercial promise.
Our
Principal Market
The
principal healthcare market for our pattern recognition technology and biomarker
discoveries is medical diagnostics, particularly the rapidly growing field of
molecular diagnostics. The market consists of two basic types of
diagnostic procedures:
in
vitro
tests performed on a patient’s fluid or tissue samples and
in vivo
tests performed
directly on the body, including blood pressure monitoring and imaging analysis
such as x-rays.
In
vitro
diagnostics
(IVD) can be
further divided into several major segments including clinical chemistry,
immunochemistry, hematology/cytometry, microbiology, and molecular
diagnostics.
The IVD
portion of the diagnostics market currently accounts for over $31 billion in
sales worldwide. Today, the molecular diagnostics segment represents
a fraction of the IVD revenues with about $2.5 billion in sales, but it is
widely considered to be the fastest growing segment, estimated at a 20-25%
compounded annual growth rate, mainly in the U.S. and EU markets, versus 6-7%
for IVD as a whole. It is difficult to accurately assess the size of
this segment since many countries do not have reference laboratories external to
hospitals. Areas of particular growth include infectious diseases,
oncology, genetic diseases, and pharmacogenetic analyses. Companies
involved in this space include several major pharmaceutical and diversified
corporations, including Roche Holdings Ltd., Abbott Laboratories, Inc., and
Johnson & Johnson. Siemens AG and General Electric Company
operate medical imaging segments that are expanding in
diagnostics. Other market players include large technology companies
like Becton Dickinson and Company, Beckman Coulter, Inc., and Bio-Rad
Laboratories, Inc.
IVDs have
been established as effective tools for all aspects of disease management,
especially in areas of unmet clinical need. Such tests have been
developed for screening and prognosis as well as for applications, such as
determination of genetic predisposition to disease, detection of presymptomatic
disease, and prediction of individual drug response.
The
Offering
Common
stock offered
upon
exercise of warrants
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70,549,868
Shares
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Common
Stock
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352,746
Shares
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Common
stock to be outstanding after this offering
(1)
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281,273,354
Shares
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Exercise
price of warrants
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35,274,934
at $0.14/share
35,274,934
at $0.19/share
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Net
Proceeds
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The
Company will not receive any proceeds from this offering. The
Company will receive cash upon the exercise of the warrants of up to
$11,640,728.22.
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Use
of proceeds from exercise of warrants
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We
will use the proceeds from the exercise of the warrants for general
corporate purposes, which may include, among other things, our working
capital needs and other general corporate purposes, including research and
product development. See “Use of Proceeds” on page
17.
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Risk
Factors
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See
“Risk Factors” beginning on page 6 and other information included in
this prospectus for a discussion of factors you should consider carefully
before deciding to invest in our common stock.
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Dividend
Policy
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We
have not declared a dividend since our inception and we do not expect to
do so in the foreseeable future. Instead, we anticipate that
all of our earnings, if any, will be used for working capital, to support
our operations and to finance the growth and development of our
business. Any future determination relating to dividend policy
will be made at the discretion of our Board of Directors and will depend
on a number of factors, including our future earnings, capital
requirements, financial condition, future prospects and other factors that
our Board of Directors may deem relevant. If the Company were
to pay dividends, the holders of the shares of Series A Preferred Stock
and the Series B Preferred Stock have a right to first receive, or
simultaneously receive, a dividend on each outstanding share of Series A
Preferred Stock and Series B Preferred Stock on an as if converted to
common stock basis. The holders of the shares of Series B
Preferred Stock also accrue a 10% annual dividend and have a special
dividend right to receive a portion of the Company’s net revenues, subject
to certain limitations. See “Price Range of Our Common Stock and
Dividends” on page 15.
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Over-the-Counter
Bulleting Board Symbol
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Our
common stock is traded on the Over-the-Counter Bulletin Board under the
symbol “HDVY-OB.”
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(1)
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The
number of shares outstanding after this offering is based on the number of
shares outstanding on March 31, 2010 and assumes the issuance of the
Shares upon the exercise of the warrants but excludes 50,077,776
shares issuable
upon the exercise of stock options and other warrants, which are vested
and outstanding as of April 28, 2010 at a weighted average exercise price
of $0.143 per share.
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The
Offering
We are
registering up to 70,549,868
shares of our common
stock that may be issued upon the exercise of warrants and 352,746 shares of our
common stock to enable the sale of such shares by the selling shareholders
identified in the section of this prospectus entitled “Selling
Shareholders.” Information regarding our common stock and the
warrants is included in the section of this prospectus entitled “Description of
Capital Stock.”
RISK
FACTORS
This
document contains certain forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 including, without limitation,
all statements, other than statements of historical facts, that address
activities, events or developments that we expect or anticipate will or may
occur in the future, including but not limited to statements regarding the
successful implementation of our services, business strategies and measures to
implement such strategies, competitive strengths, expansion and growth of our
business and operations, references to future success, the ability of the
Company to utilize its SVM and FGM assets and other intellectual property to
identify biomarkers which can be used in diagnostic tests, the ability to enter
into agreements with strategic partners for the development and
commercialization of diagnostic tests, the ability of the Company to develop a
product line, the ability to achieve profitability, about anticipated size of
the market for diagnostic tests, the capabilities of molecular diagnostic tests,
regarding working with our collaborators resulting in revenue for the Company,
the sufficiency of our liquidity and capital resources, and other such
matters. All such statements are forward-looking statements and are
based on the beliefs of, assumptions made by and information currently available
to our management. The words “expect,” “estimate,” “anticipate,” “believe,”
“intend,” “plan” and similar expressions and variations thereof are intended to
identify forward-looking statements. Such forward-looking statements may involve
uncertainties and other factors that may cause the actual results and
performance of our company to be materially different from future results or
performance expressed or implied by such statements.
The cautionary statements set forth in
this “Risk Factors” section and elsewhere in this annual report identify
important factors with respect to such forward-looking statements, including
certain risks and uncertainties, which could cause actual results to differ
materially from those expressed in or implied by such forward-looking
statements. Among others, factors that could adversely affect actual results and
performance include failure to successfully develop a profitable business,
delays in identifying and enrolling customers, the inability to retain a
significant number of customers, effectiveness and execution of licensing
efforts, our ability to employ and retain key employees and experienced
scientists, our access to tissue samples, loss of the ability to use certain
patent rights, the inability to continue to protect our proprietary information,
competitive conditions, our ability to remain competitive in a rapidly changing
technological environment, acceptance of our products by the market, volatility
in U.S. and global stock markets generally and in our stock price specifically,
potential shareholder claims which could result in substantial dilution to our
shareholders, economic conditions generally, the effect of current difficulties
in the credit markets on our business, factors beyond our control, including,
but not limited to, catastrophes (both natural and man-made), earthquakes,
floods, fires, explosions, acts or terrorism or war, and the risks identified
elsewhere in this report. All written or oral forward-looking statements
attributable to us are expressly qualified in their entirety by the foregoing
cautionary statement. All forward looking statements and cautionary
statements included in this document are made as of the date hereof based on
information available to us, and we assume no obligation to update any forward
looking statement or cautionary statement.
Risks
Related to Our Business
We
are a developing business and a high-risk company.
We are a
high-risk company in a volatile industry. In September 2003, we
completely changed the focus of our business from wireless telecommunications to
biotechnology. Investors should recognize that an investment in our
company is risky and highly speculative. We are a developing
business, and our prospects must be considered in light of the risks,
uncertainties, expenses and difficulties frequently encountered by companies in
their early stages of development. Failure to implement and execute
our business and marketing strategy successfully, to provide superior customer
service, to respond to competitive developments and to integrate, retain and
motivate qualified personnel could have a material adverse effect on our
business, results of operations and financial condition. We must successfully
overcome these and other business risks.
We
may incur future losses, and we may never achieve or sustain
profitability.
While we
expect to continue to maintain a positive cash balance during 2010, our expenses
are expected to exceed our income until we successfully complete transactions
resulting in significant revenue. Accordingly, our capital will be
decreased to pay these operating expenses. If we ever become
profitable, of which there is no assurance that we can, from time to time our
operating expenses could exceed our income and thus our capital will be
decreased to pay these operating expenses. We cannot assure you that
we will ever achieve profitability. Even if we do achieve
profitability, we may not be able to sustain or increase
profitability.
Our
business is difficult to evaluate because we have a limited history of
operations.
Since
reorganizing in 2003, our focus and our business model have been continually
evolving. Accordingly, we have a history of operations in which there
is limited information to identify any historical pattern. Even if we could
discern such a pattern, the rapidly evolving nature of the biotechnology and
pharmaceutical industries would make it very difficult to identify any
meaningful information in such a short history. Therefore, it is also
difficult to make any projections about the future of our
operations. This difficulty may result in our shares trading below or
above their value.
We
may need additional financing.
During
2009, we raised additional capital in the amount of $1,490,015 through the
issuance of Series B Preferred Stock and received proceeds from the exercise of
previously issued warrants to purchase our Common Stock of
$2,450,430. In addition, since January 1, 2010, we have received an
additional $3,039,522 from the exercise of previously issued warrants to acquire
our Common Stock. If we are unable to generate sufficient revenue,
additional proceeds may be required to finance our activities. We cannot assure
prospective investors that we will not need to raise additional capital or that
we would be able to raise sufficient additional capital on favorable terms, if
at all. There can be no assurance that additional financing will be
available, if required, on terms acceptable to us. If we fail to
raise sufficient funds or do not increase our revenues from licensing our
technology or performing services, we may have to cease operations or materially
curtail our business operations. If we raise additional capital by issuing
equity securities, our stockholders may experience dilution. If we raise
additional funds through collaboration and licensing arrangements, we may be
required to relinquish some rights to our technologies or product candidates, or
grant licenses on terms that are not favorable to us.
A
significant portion of our net revenues will be paid as either a Special
Dividend to the holders of the Series B Preferred Stock or to our senior
management in bonuses.
Subject
to the limitations set forth in the Amended and Restated Articles of Amendment
to Articles of Incorporation and applicable law, as long as the Series B
Preferred Stock (the “Series B Preferred Stock”) remain outstanding, the Company
must pay the holders of the Series B Preferred Stock a special
dividend (the “Special Dividend”) equal to 15% of Company “Net
Revenue.” Company Net Revenue will include, but not be limited to,
revenue derived from development fees, license fees and royalties paid to the
Company and revenue collected as a result of the sale of any asset of the
Company or distributions from SVM Capital, LLC, but will not include the
proceeds of any capital infusions from the exercise of outstanding options or
warrants or as a result of any capital raise undertaken by the
Company. At any time following the issuance of the Series B Preferred
Stock, the Company may satisfy the Special Dividend in its entirety if the
aggregate payments made to the Series B Holders is equal to that value which
provides an internal annual rate of return of twenty percent (20%) on the Series
B Preferred Stock. The maximum Special Dividend to be paid each year
shall be the aggregate Series B Original Issue Price, and no amounts in excess
of such amount shall accrue or carry-over to subsequent years. The shares
of our Series B Preferred Stock also accrue dividends at the rate of $0.008 per
year (as adjusted for changes in our capitalization), which must be paid by the
fifth anniversary of the issuance of such shares either by the Company’s
issuance of the number of shares of Common Stock equal to such accrued dividends
divided by the average closing price of the Company’s Common Stock during the
prior ten business days or by the payment of cash, as the Company may determine
in its sole discretion. Further, pursuant to the terms of the employment
agreement with our Chief Executive Officer, a cash bonus (subject to an annual
cap specified in the employment agreement) of 10% of the Company’s Net Revenue
received through August 15, 2010, will be paid as cash bonuses to our Chief
Executive Officer. Additionally, the Company may pay
additional bonuses out of such revenue to other senior
management. See Item 5. - Market for Common Equity, Related
Stockholder Matters, and Issuer Purchases of Equity Securities for further
information on the terms of the Series B Preferred Stock. The payment
of the Special Dividend and any bonuses to management will reduce the amount of
cash able to be used to fund our operations, to pay dividends to holders of our
Common Stock and to otherwise distribute to holders of our Common Stock upon a
sale or liquidation.
A private placement investor has
demanded additional shares of Company Common Stock and if the investor brings
suit against the Company and prevails, it would require the Company to expend
substantial resources and could cause substantial dilution to existing
shareholders.
The
Company has received letters from an investor in the Company’s 2007 private
placement (“2007 Private Placement”), claiming (a) that certain
rights to receive additional common stock of the Company for no additional
consideration have been triggered by certain actions of the Company,
(b) breaches of its contractual rights to approve certain issuances of
derivative securities, (c) breaches of other covenants made by the Company
in the 2007 Private Placement, (d) the Company had violated its SEC
disclosure obligations, and (e) various breaches by the members of the
Board of Directors of their fiduciary duties. The Company denies the
allegations and intends to vigorously defend these claims. However,
due to the uncertainties inherent in litigation, we cannot predict the outcome
of this matter if the investor brings suit against the Company. Such
a lawsuit would be time consuming, distract our management from the business of
the Company and result in substantial expenditures to defend the claim, each of
which could have a material adverse impact on our business, financial condition
and results of operations. Moreover, if we are unsuccessful in
defending against the claims, the Company may be required, among other things,
to issue approximately 146,664,375 shares to such investor, and, if all of the
other investors in the 2007 Private Placement sought the same remedy, the
Company may be required to issue approximately 1,099,494,872 shares in the
aggregate. Issuing any significant portion of such shares of Common
Stock would cause substantial dilution to existing shareholders.
Our
operating results are unpredictable and may fluctuate significantly from period
to period, which may cause our stock price to decline and result in losses to
investors.
Our
operating results may vary from period to period due to numerous factors, many
of which are outside our control, including the number, timing and acceptance of
our services. Factors that may cause our results to vary by period
include:
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payments
of milestones, license fees or research payments under the terms of our
increasing number of external alliances;
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changes
in the demand for our products and services;
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the
nature, pricing and timing of products and services provided to our
collaborators;
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acquisition,
licensing and other costs related to the expansion of our
operations;
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reduced
capital investment for extended periods;
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losses
and expenses related to our investments in joint ventures and
businesses;
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regulatory
developments or changes in public perceptions relating to the use of
genetic information and the diagnosis and treatment of disease based on
genetic information; and
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changes
in intellectual property laws that affect our rights in genetic
information that we sell and
license.
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Advisory
and personnel costs, marketing programs and overhead account for a substantial
portion of our operating expenses. Some of these expenses cannot be adjusted
quickly in the short term. If revenues of the business decline or do
not grow as anticipated, we may not be able to reduce our operating expenses
accordingly. Failure to achieve anticipated levels of revenue could
therefore significantly harm our operating results for a particular
period.
Because
we do not intend to pay dividends on our Common Stock, holders of our Common
Stock will benefit from an investment in our Company only if it
appreciates in value.
We have
never declared or paid any cash dividends on our Common Stock. We currently
intend to retain the Company’s future earnings, if any, to finance the expansion
of the Company’s business and do not expect to pay any cash dividends in the
foreseeable future. As a result, the success of an investment in our
Common Stock will depend entirely upon any future appreciation. There is no
guarantee that our Common Stock will appreciate in value or even maintain the
price at which its investors purchased their shares.
Our stock price has been, and is
likely to continue to be, highly volatile
.
Our stock
price has, since September 1, 2003, traded as high as $0.60 and as low as
$0.03. Our stock price could fluctuate significantly due to a number
of factors beyond our control, including:
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variations
in our actual or anticipated operating results;
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sales
of substantial amounts of our stock;
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announcements
about us or about our competitors, including technological innovation or
new products or services;
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litigation
and other developments related to our patents or other proprietary rights
or those of our competitors;
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litigation
and other developments related to (a) our patents or other proprietary
rights or those of our competitors and (b) claims made by certain
shareholders;
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conditions
in the life sciences, pharmaceuticals or genomics industries;
and
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governmental
regulation and legislation.
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In
addition, the stock market in general, and the market for life sciences and
technology companies in particular, have experienced extreme price and volume
fluctuations historically. These fluctuations often have been unrelated or
disproportionate to the operating performance of these companies. These broad
market and industry factors may decrease the market price of our Common Stock,
regardless of our actual operating performance.
In the
past, companies that have experienced volatility in the market prices of their
stock have been the objects of securities class action litigation. If we became
the object of securities class action litigation, it could result in substantial
costs and a diversion of management’s attention and resources, which could
affect our profitability.
Our
approach of incorporating ideas and methods from mathematics, computer science
and physics into the disciplines of biology, organic chemistry and medicine is
relatively new and may not be accepted by our potential customers or
collaborators.
We intend
to create a fully integrated biomarker discovery company to provide
pharmaceutical and diagnostic companies worldwide with new, clinically relevant
and economically significant biomarkers. Our potential customers and
collaborators may be reluctant to accept our new, unproven technologies, and our
customers may prefer to use traditional services. In addition, our approach may
prove to be ineffective or not as effective as other methods. For
example, our products and technologies may prove to be ineffective if, for
instance, they fail to account for the complexity of the life processes that we
are now attempting to model. If our customers or collaborators do not
accept our products or technologies and/or if our technologies prove to be
ineffective, our business may fail or we may never become
profitable.
Even
if our computational technologies are effective as research tools, our customers
or we may be unable to develop or commercialize new drugs, therapies or other
products based on them.
Even if
our computational technologies perform their intended functions as research
tools, our customers may be unable to use the discoveries resulting from them to
produce new drugs, therapies, diagnostic products or other life science
products. Despite recent scientific advances in the life sciences and
our improved understanding of biology, the roles of genes and proteins and their
involvement in diseases and in other life processes is not well
understood. Only a few therapeutic products based on the study of and
discoveries relating to genes or proteins have been developed and
commercialized. If our customers are unable to use our discoveries to
make new drugs or other life science products, our business may fail or we may
never become profitable.
Our
SVM Portfolio utilizes technology that may be covered by an earlier-issued
patent, and if we lose the rights to use that patent, our ability to exploit
certain aspects of our SVM technology will be impaired.
Our SVM
Portfolio utilizes technology that may be covered by the original hyperplane
patent (Pat. No. 5,649,068) invented by members of our Scientific Advisory Board
and owned by Lucent Technologies, Inc. GRL Corp. (“Lucent”). We
have obtained an assignment of a pre-existing patent license from
Lucent. If Lucent were to terminate the license, it is possible that we
would not be able to use portions of the SVM technology.
The
industries in which we are active are evolving rapidly, and we may be unable to
keep pace with changes in technology.
The
pharmaceutical and biotechnology industries are characterized by rapid
technological change. This is especially true of the data-intensive
areas of such technologies. Our future success will largely depend on
maintaining a competitive position in the field of drug, therapeutics and
diagnostic products discovery. If we fail to keep pace with changes
in technology, our business will be materially harmed. Rapid technological
development may result in our products or technologies becoming obsolete. This
may occur even before we recover the expenses that we incurred in connection
with developing those products and technologies. Products or services
offered by us could become obsolete due to the development of less expensive or
more effective drug or diagnostics discovery technologies. We may not
be able to make the necessary enhancements to our technologies to compete
successfully with newly emerging technologies.
We
face intense competition, and if we are unable to compete successfully we may
never achieve profitability.
The
markets for our products and services are very competitive, and we expect our
competition to increase in the future. Although we have not
identified specific companies that provides the full suite of services that we
do, we compete with entities in the U.S. and worldwide that provide products and
services for the analysis of genomic information and information relating to the
study of proteins (proteomic information) or that commercializes novel genes and
proteins. These include genomics, pharmaceutical and biotechnology
companies, academic and research institutions and government and other publicly
funded agencies. We may not be able to successfully compete with
current and future competitors. Many of our competitors have
substantially greater capital resources, research and development staffs,
facilities, manufacturing and marketing experience, distribution channels and
human resources than we do. This may allow these competitors to
discover or to develop products in advance of us or of our
customers.
Some of
our competitors, especially academic and research institutions and government
and other publicly funded agencies, may provide for free services or data
similar to the services and data that we provide for a fee. Moreover,
our competitors may obtain patent and other intellectual property protection
that would limit our rights or our customers’ and partners’ ability to use or
commercialize our discoveries, products and services. If we are
unable to compete successfully against existing or potential competitors, we may
never achieve profitability.
Our
management may be unable to address future growth.
We
anticipate that if we experience a period of growth in our customer base and
market opportunities, a period of significant expansion of the Company will be
required. This expansion will place a significant strain on our management,
operational and financial resources. To manage future growth of our operations,
if any, we will be required to improve existing and implement new operational
systems, procedures and controls, and to expand, train and manage our employee
base. There can be no assurance that our current and planned personnel, systems,
procedures and controls will be adequate to support our future operations, that
management will be able to hire, train, retain, motivate and manage the required
personnel or that we will be able to identify, manage and exploit existing and
potential strategic relationships and market opportunities. Our failure to
manage growth effectively could have a material adverse effect on our business,
results of operations and financial condition.
If
our business does not keep up with rapid technological change or continue to
introduce new products, we may be unable to maintain market share or recover
investments in our technologies.
Technologies
in the biomarker industry have undergone, and are expected to continue to
undergo, rapid and significant change. We may not be able to keep pace with the
rapid rate of change and introduce new products that will adequately meet the
requirements of the marketplace or achieve market acceptance. If we fail to
introduce new and innovative products, we could lose market share to our
competitors, limit our growth and damage our reputation and
business.
The
future success of our business will depend in large part on our ability to
maintain a competitive position with respect to these technologies. We believe
that successful new product introductions provide a significant competitive
advantage because customers make an investment of time in selecting and learning
to use a new product and are reluctant to switch to a competing product after
making their initial selection. However, our business or others may make rapid
technological developments, which could result in our technologies, products or
services becoming obsolete before we are able to recover the expenses incurred
to develop them.
If
our business cannot enter into strategic alliances or licensing agreements, we
may be unable to develop and commercialize our technologies into new products
and services or continue to commercialize existing products or
services.
We may be
unable to maintain or expand existing strategic alliances or establish
additional alliances or licensing arrangements necessary to continue to develop
and commercialize products, and any of those arrangements may not be on terms
favorable to the business. In addition, current or any future arrangements may
be unsuccessful. If we are unable to obtain or maintain any third party license
required to sell or develop our products or product enhancements, we may choose
to obtain substitute technology either through licensing from another third
party or by developing the necessary technology ourselves. Any substitute
technology may be of lower quality or may involve increased cost, either of
which could adversely affect our ability to provide our products competitively
and harm our business.
We also
depend on collaborators for the development and manufacture of complex
instrument systems and chemicals and other materials that are used in laboratory
experiments. We cannot control the amount and timing of resources our
collaborators devote to our products. We may not be able to enter into or
satisfactorily retain these research, development and manufacturing
collaborations and licensing agreements, which could reduce our growth and harm
our competitive position.
We
may not be able to find business partners to develop and commercialize product
candidates derived from our discovery activities.
Our
strategy for the development and commercialization of diagnostic markers and
therapeutic proteins depends on the formation of collaborations or licensing
relationships with third parties that have complementary capabilities in
relevant fields. Potential third parties include pharmaceutical and
biotechnology companies, diagnostic companies, academic institutions and other
entities. We cannot assure you that we will be able to form these
collaborations or license our discoveries or that these collaborations and
licenses will be successful.
Our
dependence on licensing and other collaboration agreements makes us heavily
dependent on our collaborators.
We may
not be able to enter into licensing or other collaboration agreements on terms
favorable to us. Even if we do enter into an acceptable agreement,
collaborators typically may be afforded significant discretion in electing
whether to pursue any of the planned activities. In most cases, our
collaborators will have responsibility for formulating and implementing key
strategic or operational plans. Decisions by our collaborators on these key
plans, which may include development, clinical, regulatory, marketing (including
pricing), inventory management and other issues, may prevent successful
commercialization of the product or otherwise affect our
profitability.
In
addition, we may not be able to control the amount and timing of resources our
collaborators devote to the product candidates, and collaborators may not
perform their obligations as expected. Additionally, business combinations or
changes in a collaborator’s business strategy may negatively affect its
willingness or ability to complete its obligations under the arrangement with
us. Furthermore, our rights in any intellectual property or products
that may result from our collaborations may depend on additional investment of
money that we may not be able or willing to make.
Potential
or future collaborators may also pursue alternative technologies, including
those of our competitors. Disputes may arise with respect to the
ownership of rights to any technology or product developed with any future
collaborator. Lengthy negotiations with potential collaborators or disagreements
between us and our collaborators may lead to delays or termination in the
research, development or commercialization of product candidates or result in
time-consuming and expensive litigation or arbitration. If our collaborators
pursue alternative technologies or fail to develop or commercialize successfully
any product candidate to which they have obtained rights from us, our business,
financial condition and results of operations may be significantly
harmed.
If
we are unable to hire or retain key personnel or sufficient qualified employees,
we may be unable to successfully operate our business.
Our
business is highly dependent upon the continued services of our Chief Executive
Officer, Board of Directors, and Scientific Advisory Board. While
certain members of our senior management are parties to employment or consulting
agreements and non-competition and non-disclosure agreements, we cannot assure
you that these key personnel and others will not leave us or compete with us,
which could materially harm our financial results and our ability to
compete. The loss, incapacity or unavailability for any reason of any
of these individuals could have a material adverse effect upon our business, as
well as our relationships with our potential customers. We do not
carry key person life insurance on any member of our senior
management. Furthermore, competition for highly qualified personnel
in our industry and geographic locations is intense. Our business
would be seriously harmed if we were unable to retain our key employees, or to
attract, integrate or retain other highly qualified personnel in the
future.
We
may not be able to employ and retain experienced scientists, mathematicians and
management.
Technologies
in our industry have undergone, and are expected to continue to undergo, rapid
and significant change. A highly skilled staff is integral to developing,
marketing and supporting new products that will meet or exceed the expectations
of the marketplace and achieve market acceptance. Without experienced staff, our
business may be unable to maintain or grow market share, which could result in
lower than expected revenues and earnings.
If
our access to tissue samples or to genomic data or other information is
restricted, or if this data is faulty, our business may suffer.
To
continue to build our technologies and related products and services, we need
access to third parties’ scientific and other data and
information. We also need access to normal and diseased human and
other tissue samples and biological materials. We may not be able to
obtain or maintain such access on commercially acceptable terms. Some
of our suppliers could become our competitors and discontinue selling supplies
to us. Information and data from these suppliers could contain errors
or defects that could corrupt our databases or the results of our analysis of
the information and data. In addition, government regulation in the
United States and other countries could result in restricted access to, or use
of, human and other tissue samples. Although currently we do not face
significant problems in obtaining access to tissues, if we lose access to
sufficient numbers or sources of tissue samples, or if tighter restrictions are
imposed on our use of the information generated from tissue samples, our
business may suffer.
The
sales cycle for some of our products and services is lengthy. We
expend substantial funds and management effort with no assurance of successfully
selling our products or services.
Our
ability to obtain customers for our platforms, tools and services depends in
large part upon the perception that our technologies can help accelerate their
efforts in drug and diagnostics discovery. Our ability to obtain
customers for our therapeutic or diagnostic product candidates significantly
depends on our ability to validate and prove that each such product candidate is
suitable for our claimed therapeutic or diagnostic purposes. Our
ability to obtain customers will also depend on our ability to successfully
negotiate terms and conditions for such arrangements. The sales cycle for our
therapeutic and diagnostic product candidates is typically lengthy and may take
more than 12 months.
An
inability to protect our proprietary data, technology or products may harm our
competitive position.
If we do
not adequately protect the intellectual property underlying our products and
services, competitors may be able to develop and market the same or similar
products and services. This would erode our competitive advantage. In
addition, the laws of some countries do not protect or enable the enforcement of
intellectual property to the same extent as the laws of the United
States.
We use
contractual obligations to protect a significant portion of our confidential and
proprietary information and know-how. This includes a substantial
portion of the knowledge base from which we develop a large portion of our
proprietary products and services. However, these measures may not
provide adequate protection for our trade secrets or other proprietary
information and know-how. Customers, employees, scientific advisors,
collaborators or consultants may still disclose our proprietary information in
violation of their agreements with us, and we may not be able to meaningfully
protect our trade secrets against this disclosure.
In
addition, we have applied for patents covering some aspects of some of our
technologies and biomarker subsets of genes and proteins we have discovered
using these technologies. We plan to continue to apply for patents
covering parts of our technologies and discoveries as we deem appropriate, but
cannot assure you that we will be able to obtain any patents or that the patents
will be upheld if challenged. The patent positions of biotechnology
related companies are generally uncertain and involve complex legal and factual
questions. Legislative changes and/or changes in the examination
guidelines of governmental patents offices may negatively affect our ability to
obtain patent protection for certain aspects of our intellectual property,
especially with respect to genetic discoveries, and may negatively impact the
enforceability of one or more of our patents. In contrast to recent court
decisions invalidating claims directed to individual human genes and proteins,
our focus has been directed to identifying relationships between small groups of
genes and proteins that are useful for diagnosing, treating and prognosing
diseases and other conditions.
Our
success depends in large part on our ability to patent our
discoveries.
Our
success depends, in large part, on our ability to obtain patents on biomarkers
and pathways that we have discovered and are attempting to
commercialize. We face intense competition from other biotechnology
and pharmaceutical companies. These include customers who use our products and
technologies and are pursuing patent protection for discoveries, which may be
similar or identical to our discoveries. We cannot assure you that
other parties have not sought patent protection relating to the biomarkers and
pathways that we discovered or may discover in the future. Our patent
applications may conflict with prior applications of third parties or with prior
publications. They may not result in issued patents and, even if
issued, our patents could be invalidated or may not be sufficiently broad to
provide us with any competitive advantages. U.S. and other patent
applications ordinarily remain confidential for 18 months from the date of
filing. As a result, patent applications that we file which we
believe are novel at the time of filing may be determined at a later stage to be
inconsistent with earlier applications. Additionally, the scope of
patents we receive may not provide us with adequate protection of our
intellectual property, which would harm our competitive position. Any
issued patents that cover our proprietary technologies may not provide us with
substantial protection or be commercially beneficial to the
business. The issuance of a patent is not conclusive as to its
validity or its enforceability. Federal courts may invalidate these
patents or find them unenforceable. Competitors may also be able to
design around our patents. If we are unable to protect our patented
technologies, we may not be able to commercialize our technologies, products or
services and our competitors could commercialize our technologies. Any of these
events could materially harm our business or financial results.
Litigation
or other proceedings or third party claims of intellectual property infringement
could prevent us, or our customers or collaborators, from using our discoveries
or require us to spend time and money to modify our operations.
The
technology that we use to develop our products, and the technology that we
incorporate in our products, may be subject to claims that they infringe the
patents or proprietary rights of others. The risk of this occurring will tend to
increase as the genomics, biotechnology and software industries expand, more
patents are issued and other companies engage in other genomic-related
businesses. If we infringe patents or proprietary rights of third
parties, or breach licenses that we have entered into with regard to our
technologies and products, we could experience serious harm. If litigation is
commenced against us alleging intellectual property rights infringement or if we
initiate a lawsuit to assert claims of infringement, protect or trade secrets or
know-how or to determine the enforceability, scope and validity of the
proprietary rights of others, we may incur significant costs in litigating,
whether or not we prevail in such litigation. Regardless of the
outcome, litigation can be very costly. These costs would also
include diversion of management and technical personnel to defend us against
third parties or to enforce our patents (once issued) or other rights against
others. In addition, parties making claims against us may be able to
obtain injunctive or other equitable relief that could prevent us from being
able to further develop or commercialize. Further, these lawsuits
could result in the invalidation or limitation of the scope of our patents or
the forfeiture of the rights associated with these patents. This
could also result in the award of substantial damages against us. In
the event of a successful claim of infringement against us, we may be required
to pay damages and obtain one or more licenses from third parties. If
we are not able to obtain these licenses at a reasonable cost, if at all, we
could encounter delays in product introductions while we attempt to develop
alternative methods or products. Defense of any lawsuit or failure to obtain any
of these licenses could prevent us from commercializing available products, all
of which could negatively impact our business, financial condition or results of
operations. Moreover, during the course of these suits, there may be
public announcements of the results of hearings, motions and other interim
proceedings or developments in the litigation. Securities analysts or investors
may perceive these announcements to be negative, which could cause the market
price of our Common Stock to decline.
Many of
our services will be based on complex, rapidly developing technologies. Although
we will try to identify all relevant third party patents, these products could
be developed by the business without knowledge of published or unpublished
patent applications that cover some aspect of these technologies. The biomarker
industry has experienced intensive enforcement of intellectual property rights
by litigation and licensing. If we are found to be infringing the
intellectual property of others, we could be required to stop the infringing
activity, or we may be required to design around or license the intellectual
property in question. If we are unable to obtain a required license
on acceptable terms, or are unable to design around any third party patent, we
may be unable to sell some of our services, which could result in reduced
revenue.
We
may acquire or make strategic investments in other businesses and technologies
in the future, and these could prove difficult to integrate, disrupt our
business, dilute stockholder value and adversely affect our operating
results.
If
opportunities arise, we may consider making acquisitions of or investments in
businesses, technologies, services or products. These activities may
involve significant cash expenditures, debt incurrence, additional operating
losses and expenses that may have a material adverse effect on the operating
results of our business. Moreover, even if we acquire complementary
businesses or technologies, we may be unable to successfully integrate any
additional personnel, operations or acquired technologies into our
business.
Difficulties
in integrating an acquired business or managing an investment could disrupt our
business, distract our management and employees and increase our
expenses. Future acquisitions could expose us to unforeseen
liabilities and result in significant charges relating to intangible
assets. Sizable acquisitions or investments may also divert senior
management from focusing on our existing business plan. Finally, if
we make acquisitions using convertible debt or equity securities, existing
stockholders may be diluted, which could affect the market price of our
stock.
Risks Related to Our
Industry
There
are many risks of failure in the development of drugs, therapies, diagnostic
products and other life science products. These risks are inherent to the
development and commercialization of these types of products.
Risks of
failure are inseparable from the process of developing and commercializing
drugs, therapies, diagnostic products and other life science products. These
risks include the possibility that any of these products will:
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be
found to be toxic or ineffective;
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fail
to receive necessary regulatory approvals;
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be
difficult or impossible to manufacture on a large
scale;
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be
uneconomical to market;
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fail
to be developed prior to the successful marketing of similar products by
competitors; or
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be
impossible to market because they infringe on the proprietary rights of
third parties or compete with superior products marketed by third
parties.
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We are
dependent on our customers’ commercialization of our discoveries. Any
of these risks could materially harm our business and financial
results.
The
trend towards consolidation in the pharmaceutical and biotechnology industries
may adversely affect us.
The trend
towards consolidation in the pharmaceutical and biotechnology industries may
negatively affect us in several ways. These consolidations usually
involve larger companies acquiring smaller companies, which results in the
remaining companies having greater financial resources and technological
capabilities, thus strengthening competition in the industry. In
addition, continued consolidation may result in fewer customers for our products
and services.
We
may be subject to product liability claims if products derived from our products
or services harm people.
We may be
held liable if any product that is made with the use, or incorporation of, any
of our technologies or data causes harm or is found otherwise
unsuitable. These risks are inherent in the development of genomics,
functional genomics and pharmaceutical products. If we are sued for
any harm or injury caused by products derived from our services or products, our
liability could exceed our total assets. In addition, such claims
could cause us to incur substantial costs, divert management’s attention from
executing the Company’s business plan and subject us to negative publicity even
if we prevail in our defense of such claims.
Our
business and the products developed by our collaborators may be subject to
governmental regulation.
New
therapeutic or diagnostic products that may be developed by our collaborators
will have to undergo a lengthy and expensive regulatory review process in the
United States and other countries before it can be marketed. It may
be several years, or longer, before any therapy or diagnostic product that is
developed by using our technologies, will be sold or will provide us with any
revenues. This may delay or prevent us from becoming
profitable. Changes in policies of regulatory bodies in the United
States and in other countries could increase the delay for each new therapy and
diagnostic products.
Even if
regulatory approval is obtained, a product on the market and its manufacturer
are subject to continuing review. Discovery of previously unknown
problems with a product may result in withdrawal of the product from the
market.
Although
we intend to become involved in the clinical phases in the future, we still
expect to rely mainly on collaborators of our discovery activities to file
regulatory approval applications and generally direct the regulatory review
process. We cannot be certain whether they will be able to obtain
marketing clearance for any product that may be developed on a timely basis, if
at all. If they fail to obtain required governmental clearances, it
will prevent them from marketing therapeutic or diagnostic products until
clearance can be obtained, if at all. This will in turn reduce our
chances of receiving various forms of payments, including those relating to
sales of marketed therapeutic or diagnostic products by them.
The
law applicable to us may change in a manner that negatively affects our
prospects.
We must
comply with various legal requirements, including requirements imposed by
federal and state securities and tax laws. Should any of those laws change over
the term of our existence, the legal requirements to which we may be subject
could differ materially from current requirements, which could increase the cost
of doing business or preclude us from undertaking certain parts of our business
plan, would result in adverse consequences.
If
ethical and other concerns surrounding the use of genetic information become
widespread, there may be less demand for our products and services.
Genetic
testing has raised ethical issues regarding confidentiality and the appropriate
uses of the resulting information. For these reasons, governmental
authorities may call for limits on or regulation of the use of genetic testing
or prohibit testing for genetic predisposition to various conditions,
particularly for those that have no known cure. Any of these
scenarios could reduce the potential markets for our technologies in the field
of predictive drug response, which could materially harm our business and
financial results.
Risks
Related to This Offering
The
so-called “penny stock rule” could make it cumbersome for brokers and dealers to
trade in our common stock, making the market for our common stock less liquid
which could cause the price of our stock to decline.
Trading of our common stock on the OTC
Bulletin Board may be subject to certain provisions of the Securities Exchange
Act of 1934, commonly referred to as the “penny stock” rule. A penny
stock is generally defined to be any equity security that has a market price
less than $5.00 per share, subject to certain exceptions. If our
stock is deemed to be a penny stock, trading in our stock will be subject to
additional sales practice requirements on broker-dealers. These may
require a broker-dealer to:
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make
a special suitability determination for purchasers of our
shares;
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receive
the purchaser’s written consent to the transaction prior to the purchase;
and
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deliver
to a prospective purchaser of our stock, prior to the first transaction, a
risk disclosure document relating to the penny stock
market.
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Consequently,
penny stock rules may restrict the ability of broker-dealers to trade and/or
maintain a market in our common stock. Also, prospective investors
may not want to get involved with the additional administrative requirements,
which may have a material adverse effect on the trading of our
shares.
Any
projections and forecasts included in this prospectus were prepared based on
assumptions regarding facts and future events which may or may not
materialize.
Many
factors influencing the operation of our business are beyond our and our
management’s control. There can be no assurance that the actual operation of our
company’s business will correspond with any projections and the forecasts
included in this prospectus. No representation or warranty of any
kind is made by us, management, our accountant, attorneys or any other person
associated with our company, that the projections made by us will correspond
with future events.
Investors must rely on our
management
.
Holders
of the common stock will have very limited rights or powers to participate in
the management of Health Discovery. Accordingly, no potential investor should
purchase the common stock unless he or she is willing to entrust all aspects of
day-to-day management and operations to our management. Investors will be
relying on the expertise and experience of our management to identify and
administer the business. Past experience and performance by our Board of
Directors, Scientific Advisory Board and employees provides no assurance of
future results.
USE
OF PROCEEDS
We will not receive any proceeds from
the sale of the shares in this offering by the selling
shareholders. We will, however, receive proceeds from the exercise of
warrants held by the selling shareholders. We expect to use any
proceeds we receive for working capital and for other general corporate
purposes, including research and product development.
PRICE
RANGE OF COMMON STOCK AND DIVIDENDS
Our common stock is traded on the OTC
Bulletin Board under the symbol HDVY. The range of closing prices for
our common stock, as reported on Bloomberg.com during each quarter of the last
two fiscal years was as follows. These quotations reflect
inter-dealer prices, without retail mark-up, mark-down or commission and may not
represent actual transactions.
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High
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Low
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First
Quarter 2008
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$
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0.08
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$
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0.03
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Second
Quarter 2008
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$
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0.08
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$
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0.03
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Third
Quarter 2008
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$
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0.09
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|
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$
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0.03
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Fourth
Quarter 2008
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$
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0.07
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$
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0.04
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High
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Low
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First
Quarter 2009
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$
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0.09
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$
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0.04
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Second
Quarter 2009
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$
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0.08
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$
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0.03
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Third
Quarter 2009
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$
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0.13
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|
$
|
0.03
|
|
Fourth
Quarter 2009
|
|
$
|
0.40
|
|
|
$
|
0.09
|
|
As of March 22, 2010, there were
approximately 319 holders of record of our common stock.
We have not paid any cash dividends
since inception, and we do not anticipate paying any in the foreseeable
future. We intend to retain future earnings, if any, to support the
development and growth or our business. Payment of future dividends,
if any, will be at the discretion of our board of directors after taking into
account various factors, including our financial condition, operating results,
current and anticipated cash needs and plans for expansion. Under the
Georgia Business Corporation Act, a company is prohibited from paying a dividend
if, after giving effect to that dividend, either the company would not be able
to pay its debts as they become due in the usual course of business or the
company’s total assets would be less than the sum of its total liabilities plus
the amount that would be needed if the company were to be dissolved at the time
of the dividend to satisfy the preferential rights upon dissolution of
shareholders whose preferential rights are superior to those receiving the
dividends. The Company has had limited revenue since inception, has
incurred recurring losses from operations, and has had to continually seek
additional capital investment in order to fund operations. The
Company’s auditors have concluded that these factors, among others, raise
substantial doubt about the Company’s ability to continue as a going
concern. As a result, the Company may be unable to pay any dividend
until the Company achieves a level of revenue that provides sufficient resources
to pay its debts as they become due and to continue as a going
concern. If the Company were to pay dividends, the holders of the
shares of Series A Preferred Stock and the Series B Preferred Stock have a right
to first receive, or simultaneously receive, a dividend on each outstanding
share of Series A Preferred Stock and Series B Preferred Stock on an as if
converted to Common Stock basis. The holders of the shares of Series
B Preferred Stock also accrue a 10% annual dividend and have a special dividend
right to receive a portion of the Company’s net revenues, subject to certain
limitations.
SELLING
SHAREHOLDERS
In
connection with the Securities Purchase Agreement by and among the Company and
the selling shareholders dated August 16, 2007 (the “Private Placement”), a copy
of which is attached as Exhibit 10.8, the Company issued 51,538,822 shares of
restricted common stock at $0.08 per share in exchange for $2.55 million in cash
and conversion of approximately $1.5 million in debt to common
shares. In addition, each of the selling shareholders acquired a
warrant to purchase shares equivalent to its investment, with an aggregate of
warrants to purchase 51,538,822 shares of Company common stock issued at an
exercise price of $0.14 and a warrant to purchase shares equivalent to its
investment, with an aggregate of warrants to purchase 51,538,822 shares of
Company common stock issued at an exercise price of $0.19. A form of
warrant is attached here to as Exhibit 10.9. There was no private
placement agent in connection with the Private Placement.
Certain
of our shares of common stock which may be issued to the selling shareholders
upon the exercise of warrants acquired by the selling shareholders in the
Private Placement are being registered for resale by the selling shareholders.
Certain of our shares of common stock, which were issued to the selling
shareholders pursuant to the terms of the securities purchase agreement as a
result of this registration statement not having been declared effective by
August 28, 2008, are also being registered for resale by the selling
shareholders. The table below shows the name and number of shares of our
common stock owned by the selling shareholders who may sell shares covered by
this prospectus.
The
selling shareholders may resell all, a portion or none of such shares of common
stock, whether previously issued or which may be issued upon the exercise of
warrants from time to time. The table below sets forth with respect to each
selling shareholder, based upon information available to us as the date of this
prospectus, the number of shares of common stock beneficially owned, the number
of shares of common stock registered by this prospectus and the number and
percent of outstanding common stock that will be owned after the sale of the
registered shares of common stock assuming the sale of all of the registered
shares of common stock under this prospectus and all other currently effective
prospectuses. Because the selling shareholders may offer all, some or none of
their respective shares of common stock, no definitive estimate as to the number
of shares thereof that will be held by the selling shareholders after such
offering can be provided. Therefore, we have prepared the table below
on the assumption that the selling shareholders will sell all shares covered by
this prospectus. Except as noted below by footnote, none of the
selling shareholders are affiliates of Health Discovery, have had a material
relationship with Health Discovery during the past three years or are or were
affiliates with registered broker-dealers.
Name
|
|
Beneficially
Owned
Before Offering
(1)
|
|
|
Number
of Shares
Being Offered
(2)
|
|
|
Number
of Shares
Beneficially
Owned
After
Offering
(3)
|
|
|
Percentage
of Class
Owned
After
Offering
(3)
|
|
Curtis
G. Anderson
|
|
|
14,248,915
|
(6)
|
|
|
9,515,056
|
|
|
|
4,733,859
|
|
|
|
2.76
|
%
|
Athena
Venture Partners, L.P.
(4)
|
|
|
9,406,250
|
(6)
|
|
|
6,281,250
|
|
|
|
3,125,000
|
|
|
|
1.84
|
%
|
Bloom
Investment Co.
(5)
|
|
|
940,625
|
(6)
|
|
|
628,125
|
|
|
|
312,500
|
|
|
|
*
|
|
William
M. Goldstein
(7)
|
|
|
2,313,125
|
(8)
|
|
|
125,625
|
|
|
|
2,187,500
|
|
|
|
1.29
|
%
|
Stephen
M. Grosberg
|
|
|
12,040,000
|
(6)
|
|
|
8,040,000
|
|
|
|
4,000,000
|
|
|
|
2.36
|
%
|
John
A. Landsberger
|
|
|
5,450,000
|
(9)
|
|
|
2,512,500
|
|
|
|
2,937,500
|
|
|
|
1.73
|
%
|
John
and Laura Maring
|
|
|
940,625
|
(6)
|
|
|
628,125
|
|
|
|
312,500
|
|
|
|
*
|
|
Joseph
McKenzie
|
|
|
5,556,295
|
(10)
|
|
|
3,456,800
|
|
|
|
2,099,495
|
|
|
|
1.24
|
%
|
MicroCapital
Fund LP
(11)
|
|
|
10,299,843
|
(6)
|
|
|
6,877,968
|
|
|
|
3,421,875
|
|
|
|
2.02
|
%
|
MicroCapital
Fund Ltd.
(12)
|
|
|
3,433,281
|
(6)
|
|
|
2,292,656
|
|
|
|
1,140,625
|
|
|
|
*
|
|
Molly
Murphy Crowley Revocable
Trust
UTD April 1991
(13)
|
|
|
1,128,750
|
(6)
|
|
|
753,750
|
|
|
|
375,000
|
|
|
|
*
|
|
Frank
T. Nickell
|
|
|
9,406,250
|
(6)
|
|
|
6,281,250
|
|
|
|
3,125,000
|
|
|
|
1.84
|
%
|
Jules
Paderewski
|
|
|
3,400,222
|
(14)
|
|
|
1,738,623
|
|
|
|
1,661,599
|
|
|
|
*
|
|
Prime
Mover Capital Partners, L.P.
(15)
|
|
|
20,693,750
|
(6)
|
|
|
13,818,750
|
|
|
|
6,875,000
|
|
|
|
4.06
|
%
|
James
Tobey Roberts
|
|
|
6,473,390
|
(6)
|
|
|
4,322,762
|
|
|
|
2,150,628
|
|
|
|
1.27
|
%
|
Julian
Stern
|
|
|
4,118,158
|
(6)
|
|
|
2,749,999
|
|
|
|
1,368,159
|
|
|
|
*
|
|
Manish
Vora
(16)
|
|
|
376,250
|
(6)
|
|
|
251,250
|
|
|
|
125,000
|
|
|
|
*
|
|
Jimmy
Woodward
(17)
|
|
|
940,625
|
(6)
|
|
|
628,125
|
|
|
|
312,500
|
|
|
|
*
|
|
|
*
represents less than 1%
|
|
(1)
|
The
number of shares beneficially owned is determined in accordance with Rule
13(d)-3 of the Securities Exchange Act of 1934, and the information is not
necessarily indicative of beneficial ownership for any other
purpose. Under such rule, beneficial ownership includes any
shares as to which each selling shareholder has sole or shared voting
power or investment power and also any shares that the selling shareholder
has the right to acquire within 60 days.
|
|
(2)
|
Represents
the number of shares of company common stock that may be issued to the
selling shareholders upon the exercise of warrants plus the number of
shares of common stock issued to the selling shareholders (1% of the
number of shares initially purchased by the selling
shareholders). The warrants were issued to the selling
shareholders in connection with the Private Placement described
above.
|
|
(3)
|
Assumes
that 169,522,590 shares are outstanding and that all common shares and
shares issued upon the exercise of warrants will be resold by the selling
shareholders in this offering. On September 8, 2008, the
Company received notice, claiming that certain anti-dilution rights had
been triggered under the terms of the private placement. See
Item 15, Recent Sales of Unregistered Securities on page
II-1.
|
|
(4)
|
A
limited partnership in which the children of Dr. Richard Caruso, one
of the Company’s former directors, are limited partners. Voting
and dispositive power are vested in Richard E. Caruso, Gary R. DiLella and
Gerald N. Holtz.
|
|
(5)
|
Voting
and dispositive power vested in Harold S. Bloom.
|
|
(6)
|
Includes
warrants to acquire one-third the number of shares initially purchased by
the selling shareholder at an exercise price of $0.14 per share and
expiring on September 7, 2010, and warrants to acquire one-third the
number of shares initially purchased by the selling shareholder at an
exercise price of $0.19 per share and expiring on September 7,
2010. Includes the number of shares of common stock issued to
the selling shareholders (1% of the number of shares initially purchased
by the selling shareholder).
|
|
(7)
|
Resigned
as a director on April 11, 2008.
|
|
(8)
|
Includes warrants to acquire
62,500
shares at an exercise price of
$0.14 per share and expiring on September 7, 2010, and warrants to acquire
62,500
shares at an exercise price of
$0.19 per share and expiring on September 7, 2010. Includes
warrants to acquire 312,500 shares at an exercise price of $0.24 per share
and expiring December 31, 2008. Includes warrants to acquire
1,500,000 shares at an exercise price of $0.13 per share and expiring on
January 31, 2012.
Includes the number of shares of
common stock issued to the selling shareholders (1% of the number of
shares initially purchased by the selling
shareholder).
|
|
(9)
|
Includes warrants to acquire
1,250,000
shares at an exercise price of
$0.14 per share and expiring on September 7, 2010, and warrants to acquire
1,250,000
shares at an exercise price of
$0.19 per share and expiring on September 7, 2010. Includes
warrants to acquire 1,687,500 shares at an exercise price of $0.24 per
share and expiring on December 31, 2008.
Includes the number of shares of
common stock issued to the selling shareholders (1% of the number of
shares initially purchased by the selling
shareholder).
|
|
(10)
|
Includes warrants to acquire
1,719,801
shares at an exercise price of
$0.14 per share and expiring on September 7, 2010, and warrants to acquire
1,719,801
shares at an
exercise price of $0.19 per share and expiring on September 7,
2010.
Includes the number of shares of
common stock issued to the selling shareholders (1% of the number of
shares initially purchased by the selling
shareholder).
|
|
(11)
|
Voting
and dispositive power vested in Ian Ellis and Tim Creutz.
|
|
(12)
|
Voting
and dispositive power vested in John Ivanac.
|
|
(13)
|
Voting
and dispositive power vested in Molly Crowley.
|
|
(14)
|
Includes
warrants to acquire 864,987 shares at an exercise price of $0.14 per share
and expiring on September 7, 2010, and warrants to acquire 864,987
shares at an exercise price of $0.19 per share and expiring on
September 7, 2010. Includes the number of shares of common
stock issued to the selling shareholders (1% of the number of shares
initially purchased by the selling shareholder).
|
|
(15)
|
Voting
and dispositive power vested in Peter Belton.
|
|
(16)
|
Affiliated
with registered broker dealer. Vora purchased the securities in
his individual capacity and at the time of the purchase of the securities
to be resold, he had no agreements or understandings, directly or
indirectly, with any person to distribute the
securities.
|
|
(17)
|
Resigned
as a director on November 13, 2007.
|
PLAN
OF DISTRIBUTION
We are registering the shares of common
stock to be issued upon the exercise of warrants on behalf of the selling
shareholders. We are also registering certain of our shares of common
stock which were issued to the selling shareholders pursuant to the terms of the
securities purchase agreement on behalf of the selling
shareholders. All costs, expenses and fees in connection with the
registration of the shares offered by this prospectus will be borne by us, other
than brokerage commissions and similar selling expenses, if any, attributable to
the sale of shares which will be borne by the selling shareholders. We have
agreed to indemnify the selling shareholders against certain losses, claims,
damages and liabilities, including liabilities under the Securities
Act. Sales of shares may be effected by selling shareholders from
time to time in one or more types of transactions (which may include block
transactions) in the over-the-counter market, any exchange or quotation system,
in negotiated transactions, through put or call options transactions relating to
the shares, through short sales of shares, or a combination of any such methods
of sale, and any other method permitted pursuant to applicable law, at market
prices prevailing at the time of sale, or at negotiated prices. Such
transactions may or may not involve brokers or dealers.
The
selling shareholders may enter into hedging transactions with broker-dealers or
other financial institutions. In connection with such transactions,
broker-dealers or other financial institutions may engage in short sales of the
shares or of securities convertible into or exchangeable for the shares in the
course of hedging positions they assume with selling shareholders. The selling
shareholders may also enter into options or other transactions with
broker-dealers or other financial institutions which require the delivery to
such broker-dealers or other financial institutions of shares offered by this
prospectus, which shares such broker-dealer or other financial institution may
resell pursuant to this prospectus (as amended or supplemented to reflect such
transaction). The selling shareholders may pledge and/or loan these shares to
broker-dealers who may borrow the shares against their hedging short position
and in turn sell these shares under the prospectus to cover such short
position.
The
selling shareholders may make these transactions by selling shares directly to
purchasers or to or through broker-dealers, which may act as agents or
principals. Such broker-dealers may receive compensation in the form of
discounts, concessions or commissions from selling shareholders and/or the
purchasers of shares for whom such broker-dealers may act as agents or to whom
they sell as principal, or both (which compensation as to a particular
broker-dealer is not expected to be in excess of customary
commissions).
The
selling shareholders and any broker-dealers that act in connection with the sale
of shares may be deemed to be “underwriters” within the meaning of Section 2(11)
of the Securities Act, and any commissions received by such broker-dealers or
any profit on the resale of the shares sold by them while acting as principals
might be deemed to be underwriting discounts or commissions under the Securities
Act. The selling shareholders may agree to indemnify any agent, dealer or
broker-dealer that participates in transactions involving sales of the shares
against certain liabilities, including liabilities arising under the Securities
Act.
Because
selling shareholders may be deemed “underwriters” within the meaning of Section
2(11) of the Securities Act, the selling shareholders may be subject to the
prospectus delivery requirements of the Securities Act. We have informed the
selling shareholders that the anti-manipulative provisions of Regulation M
promulgated under the Exchange Act may apply to their sales in the
market.
Selling
shareholders also may resell all or a portion of the shares in open market
transactions in reliance upon Rule 144 under the Securities Act provided they
meet the criteria and conform to the requirements of Rule 144.
BUSINESS
Our
History
We were
organized under the name Direct Wireless Communications, Inc. in April 2001 by
Direct Wireless Corporation, which licensed to us its technology for a wireless
telephone. In October 2001, Direct Wireless Corporation, then our
sole stockholder, pursuant to an effective registration statement under the
Securities Act of 1933, distributed its entire holdings of our common stock as a
stock dividend to its stockholders. As a result of the dividend,
Direct Wireless Corporation ceased to own any of our equity
securities. The negative events that occurred over the next several
years in the communications industry made it difficult for us to fund the
advancement of our communication platform. As a result, we made the
decision to strategically change the overall direction of our intended business
activities.
On August
26, 2003, we acquired all of the assets of The Barnhill Group, LLC, which was
owned by Stephen D. Barnhill, M.D. Dr. Barnhill is a physician
trained in laboratory medicine and clinical pathology. He developed
artificial intelligence and pattern recognition computational techniques today
used in medicine, genomics, proteomics, diagnostics, drug discovery and other
fields of scientific endeavor. Following the acquisition, Dr.
Barnhill became our Chief Executive Officer and Chairman of our Board of
Directors. Also, immediately following our acquisition of the assets
of The Barnhill Group, LLC and the change in strategic direction of the Company,
our licensing rights to the telecommunications technology previously granted by
Direct Wireless Corporation were terminated and all payment obligations to
Direct Wireless Corporation were terminated.
Subsequently,
we amended our charter to change our name to Health Discovery Corporation (“HDC”
or the “Company”) on November 6, 2003, at which time the new trading symbol
(HDVY) became effective.
On
December 30, 2003, we acquired the assets of Fractal Genomics, LLC, a company
with patented Fractal Genomics Modeling (“FGM”) software, through the issuance
of 3,825,000 common shares of the Company and the issuance of a $500,000 note
payable, all of which has been paid.
On July
30, 2004, we began purchasing rights to a portfolio of 71 patents and pending
patent applications, including patents on the use of Support Vector Machines, or
SVMs, and other machine learning tools useful for diagnostic and drug discovery
(the “SVM Portfolio”). On May 6, 2005, we acquired the remaining
interest in the SVM Portfolio from a group of unrelated third
parties.
Effective
September 26, 2004, we were assigned a patent license agreement with Lucent
Technologies GRL Corporation (“Lucent”). The patent license agreement is
associated with the SVM Portfolio. We agreed to pay minimum royalty fees to
Lucent, which increases based on the revenue of each licensed product that is
sold, leased, or put into use by the Company. The license granted will continue
for the entire unexpired term of Lucent’s patents.
On July
12, 2007, we completed our reincorporation in Georgia by effecting a conversion
in our legal domicile from Texas to Georgia. Our business, assets,
liabilities, net worth and headquarters were unchanged as a result of the
conversion, and our directors and officers prior to the conversion continued to
serve after the conversion. In connection with the conversion, the
Company’s shares were converted on a one-for-one basis.
On
October 9, 2007, we amended our Articles of Incorporation to set forth the
rights and preferences of the Series A Preferred Stock. All
outstanding shares of Series A Preferred Stock were converted on a one-for-one
basis into shares of our Common Stock, no par value (the “Common Stock”) on
November 4, 2009.
On March
4, 2008, we formed two wholly owned subsidiaries, SVM Technology Inc., a Georgia
corporation, and SVM Technology Inc., a Delaware corporation. We
anticipate that we will use each of these subsidiaries to expand our business
model by applying SVM technology outside of scientific discovery in the
healthcare arena.
On
March 30, 2009, we amended our Articles of Incorporation to provide the
rights and preferences of the Series B Preferred Stock, including the right to
receive dividends, including special dividends, the right to vote on matters
presented to holders of Common Stock, a preference right in the event of
liquidation, and the right to convert the Series B Preferred Stock into Common
Stock. On November 13, 2009 we further amended and restated our
Articles of Incorporation to provide for the rights and preferences of the
Series B Preferred Stock as more fully described on the Amended and Restated
Articles of Amendment to Articles of Incorporation attached to the 2009 Form
10-K as Exhibit 3.1(c).
Our
Company Overview
HDC is a
pattern recognition company that uses advanced mathematical techniques to
analyze large amounts of data to uncover patterns that might otherwise be
undetectable. The Company operates primarily in the emerging field of
molecular diagnostics where such tools are critical to scientific
discovery. The terms
artificial intelligence
and
machine learning
are
sometimes used to describe pattern recognition tools. With our
historical foundation in the molecular diagnostics field, we have made a number
of important discoveries that may play a critical role in developing more
personalized approaches to the diagnosis and treatment of certain
diseases. However, our SVM assets in particular, have broad
applicability in many other fields. HDC’s assets, the pattern
recognition technology can be a portal between enormous amounts of otherwise
undecipherable data and truly meaningful discovery.
HDC’s
mission is to use its patents, intellectual prowess, and clinical partnerships
principally to identify patterns that can advance the science of medicine, as
well as to advance the effective use of our technology in other diverse business
disciplines, including the high-tech, financial, and homeland security
markets.
Our
Company’s principal asset is its intellectual property, which includes advanced
mathematical algorithms called Support Vector Machines (SVM) and Fractal Genomic
Modeling (FGM), as well as biomarkers that we discovered by applying our SVM and
FGM techniques to complex genetic and proteomic data. Biomarkers are
biological indicators or genetic expression signatures of certain disease
states. Our intellectual property is protected by more than 71
patents that have been issued or are currently pending around the
world.
Our
business model has evolved over time to respond to business trends that
intersect with our technological expertise and our capacity to professionally
manage these opportunities. In the beginning, we sought only to use
our SVMs internally in order to discover and license our biomarker signatures to
various diagnostic and pharmaceutical companies. Today, our
commercialization efforts include: utilization of our discoveries and knowledge
to help develop biomarkers for use as companion diagnostics, surrogate
biomarkers, and diagnostic and prognostic predictive tests; licensure of the SVM
and FGM technologies directly to diagnostic and pharmaceutical companies; and,
the formation of new ventures with domain experts in other fields where our
pattern recognition technology holds commercial promise.
Our
Principal Market
The
principal healthcare market for our pattern recognition technology and biomarker
discoveries is medical diagnostics, particularly the rapidly growing field of
molecular diagnostics. The market consists of two basic types of
diagnostic procedures:
in
vitro
tests performed on a patient’s fluid or tissue samples and
in vivo
tests performed
directly on the body, including blood pressure monitoring and imaging analysis
such as x-rays.
In
vitro
diagnostics
(IVD) can be
further divided into several major segments, including clinical chemistry,
immunochemistry, hematology/cytometry, microbiology, and molecular
diagnostics.
The IVD
portion of the diagnostics market currently accounts for over $31 billion in
sales worldwide. Today, the molecular diagnostics segment represents
a fraction of the IVD revenues with about $2.5 billion in sales, but it is
widely considered to be the fastest growing segment, estimated at a 20-25%
compounded annual growth rate, mainly in the U.S. and EU markets, versus 6-7%
for IVD as a whole. It is difficult to accurately assess the size of
this segment since many countries do not have reference laboratories external to
hospitals. Areas of particular growth include infectious diseases,
oncology, genetic diseases, and pharmacogenetic analyses. Companies
involved in this space include several major pharmaceutical and diversified
corporations, including Roche Holdings Ltd., Abbott Laboratories, Inc., and
Johnson & Johnson. Siemens AG and General Electric Company
operate medical imaging segments that are expanding in
diagnostics. Other market players include large technology companies
like Becton, Dickinson and Company, Beckman Coulter, Inc. and Bio-Rad
Laboratories, Inc.
IVDs have
been established as effective tools for all aspects of disease management,
especially in areas of unmet clinical need. Such tests have been
developed for screening and prognosis as well as for applications, such as
determination of genetic predisposition to disease, detection of presymptomatic
disease, and prediction of individual drug response.
Molecular
Diagnostics
Within
the overall IVD market, the molecular diagnostics segment is expected to expand
dramatically, largely attributable to advances in genomics and proteomics.
Primary market drivers
include the addition of new diagnostic tests in high volume testing areas
coupled with the introduction of new instrumentation that provide greater ease,
speed, and quality in test performance. Given its annualized growth
rate, the potential for molecular diagnostics is particularly impressive in the
U.S., which represents the largest commercial market with the most favorable
conditions for entry and marketing.
Borrowing
from the two disciplines of genomics and proteomics, molecular diagnostics
categorizes cancer and other diseases using technology such as mass spectrometry
and gene chips. Genomics is the study of all the genes in a cell or
organism, and proteomics is the study of all the proteins in a cell or
organism. Molecular diagnostics determines how these genes and
proteins interact in patients by focusing on patterns in different types of
healthy and diseased patient cells. Molecular diagnostics uncover
these genomic and proteomic changes and capture this information as expression
patterns. Also called
molecular signatures
, these
expression patterns improve clinicians' ability to diagnose cancer when it is
less advanced, predict which patients will respond to certain treatments,
predict cancer recurrence risk, and select appropriate treatment for individual
patients.
Molecular
diagnostics can facilitate early, accurate screening and prediction of diseases
in their asymptomatic stages, years before symptoms manifest or diseases
actually begin. This allows intervention to begin earlier, perhaps
preventing the disease entirely. Early intervention will allow the
healthcare system to encompass both preventative and reactive medicine,
improving overall healthcare efficiency and possibly reducing systemic
healthcare expenditures.
The
molecular diagnostics industry is an increasingly powerful healthcare
participant with tremendous potential. It is characterized by a very
diverse, constantly changing technology base that continuously produces new
opportunities and applications. Advances in polymerase chain reaction
(“PCR”), multiplexing, sequencing and other technologies are propelling both new
and old companies forward with novel capabilities.
Similarly, a growing
understanding of the molecular basis of cancer and other chronic diseases has
awakened new realms of medicine to the possibilities of molecular diagnostic
testing.
Clinicians
have discovered that molecular diagnostics have many uses beyond just the
creation of new screening and diagnostic tools. Expression patterns
can also provide information for the design of new cancer treatments, monitor
the treatment’s effectiveness as it is studied in a clinical trial, and even
predict the patient’s response to a new treatment. In addition to its
importance in addressing the many kinds of cancer, molecular diagnostics will
likely become an important technology for detecting resistance to antibiotics, a
major hazard in the hospital setting. In the future, molecular tests
should be able to determine within two to three hours not only the nature of an
infection, but also therapeutic selection and any potential
resistance.
The
molecular diagnostics market as a whole is experiencing growth, rapidly changing
technology and intense competition. New tests and new instruments to
perform automated analysis continue to expand the capabilities of companies in
this industry. The identification and validation of novel genes, gene
products, and biomarkers results in a potential market for diagnostic tests to
identify such genes, gene products and biomarkers. The market
includes sales of reagents, instruments, and kits to clinical laboratories and
research reagents that can be used by labs to develop their own in-house
diagnostic tests. It also includes testing services by those clinical
labs that have developed their own products, plus diagnostics companies that
operate their own branded, certified testing services.
Molecular
diagnostic tests typically analyze DNA, RNA, or protein biomarkers (analytes) to
identify a disease, determine its course, evaluate response to therapy, or
predict individual predisposition to a disease. The techniques
applied involve analysis of DNA sequences, DNA methylation patterns, gene
expression profiles, proteins, protein expression, or combinations of these
biomarkers. Such biomarkers provide direct information about
genotypic and/or phenotypic changes associated with specific diseases or
responses to treatment. Biomarker analysis has also become an
important tool in drug discovery, preclinical drug development, and patient
monitoring during clinical trials.
Most
molecular diagnostics currently on the market are primarily single-analyte tests
involving the detection of a single gene or protein. However, many
disease-related processes are multifactorial, involving the abnormal expression
of multiple genes or proteins. Second-generation molecular
diagnostics are anticipated to utilize novel detection technologies and
multiplexing platforms to allow the measurement of a large number of analytes
simultaneously. These innovations within the industry will
increasingly utilize multiplexing platforms such as DNA microarrays that perform
parallel biomarker analysis.
The
market has been driven by transition to fully automated systems, real time
amplification, and growing development of point-of-care
platforms. Industry experts estimate that future growth will stem
from emerging applications like genotyping for identifying drug resistant
strains; bioterrorism testing applications within infectious disease; disease
diagnostics and prognostic assays for disease applications like sepsis and
nosocomial infections, such as MRSA, cancer, cardiovascular disease, and
Alzheimer’s disease; diagnosis of inherited disorders; and theranostics
companion diagnostics.
Genomic
testing to determine diagnosis, therapeutic selection and response, and
preventative measures is an important segment of the overall IVD
market. Although this segment is small today, it is an extremely
fast-growing component.
Using
companion diagnostics in patient care can substantially improve patient outcomes
and pave the way for more personalized, targeted medicine by reducing both
misdiagnoses and adverse reactions, and by eliminating unnecessary and expensive
downstream tests. Today, patient dosage levels are based on age, sex,
and weight, as determined by empirical studies. However, specific drug
metabolism may be as individualized as one’s fingerprint. In the
future, molecular diagnostics may be able to direct physicians to the right
drugs for every patient, no matter what the illness.
This
trend towards personalized medicine may ultimately lead to the reduction of
overall healthcare expenditures. What is known as a
surrogate
molecular marker
may now be
substituted for the lengthy process of comparing the effects of a prospective
new drug versus a placebo on the ultimate outcome of a disease. As a
result, a drug’s effectiveness against the disease process in question may be
monitored more efficiently by evaluating the presence or absence of a specific
biomarker, thereby avoiding failures late in the research and development
process as well as the threat of recalls. One example of the
successful application of biomarker data to therapeutic evaluation is the use of
blood cholesterol levels to evaluate the effectiveness of cholesterol lowering
drugs.
This
approach has the potential for creating a revolutionary new paradigm in the
conduct of clinical trials worldwide.
From a
demographic standpoint, 12% of the U.S. population was 65 years old or older in
2000. By 2030, that portion of the population is anticipated to grow to 20%,
burdening the healthcare system with increased numbers of cardiovascular,
neurological, and other age-related diseases. Age-related
conditions are expected to contribute to the health care market that may provide
an opportunity to market greater product development and molecular
tests.
Demand
for diagnostics addressing the pharmacogenetic testing segment (i.e. companion
diagnostics and surrogate biomarkers) are expected to drive market growth in the
years ahead. Pharmacogenetics broadly relates to the study of genetic
variations and their application to drug discovery to provide personalized
therapy. Currently the second largest market sector behind
diagnostics for infectious diseases, the pharmacogenetic sector of the molecular
diagnostics market is projected to grow rapidly.
The
Role of HDC’s Technology in Molecular Diagnostics
Our
pattern recognition technology offers pharmaceutical companies a key tool as
they approach drug discovery in this new era of personalized
medicine. Accordingly, our marketing efforts are focused on utilizing
our technology in partnership with many of the world’s leading pharmaceutical
and life-sciences companies. Our primary commercialization strategy
for our technology and discoveries is to enter into both licensing agreements
and joint development opportunities that feature up-front license fees,
fee-for-service development revenue, milestone payments, and royalty
streams. We believe the pharmaceutical market offers us a promising
commercial opportunity for the application of our technology, as the
pharmaceutical industry is characterized by costly R&D efforts to create new
patent-protected products.
The use
of HDC’s SVM technology and our discovered biomarkers may help pharmaceutical
companies develop and evaluate new drugs and medical therapies in less time and
at lower cost. According to the lobby group PhRMA, only 1 of every
10,000 potential medicines investigated by America's drug companies survives the
research and development process and is approved for patient use by the U.S.
Food and Drug Administration (FDA). On average, the drug
developmental process can take up to 15 years in research and development, with
costs approaching many hundreds of millions of dollars. This extended timeframe
and enormous expense has led to an emphasis on the development of “blockbuster”
drugs.
Within
the drug discovery R&D process, biomarkers like ours can help pharmaceutical
companies identify disease targets and pathways and validate mechanisms of drug
action. They may also serve as pharmacodynamic indicators of drug
activity, drug response, and drug toxicity in clinical
development. Biomarkers may also be used to help avoid new drug
failures in late stage trials. Outside of the pharmaceutical market,
the use of biomarkers can result in earlier detection of disease, and improved
prognosis of therapeutic outcome.
We
consistently work to influence the evolving relationship between diagnostics and
monitoring patients for therapeutic outcome. In February 2007, the
FDA provided 510(k) clearance for
MammoPrint
, Agendia B.V.’s
multi-gene expression breast cancer prognosis test. We believe this
indicates the acceptance of the field of molecular diagnostics and highlighted
the growing importance of personalized medicine. In particular, the
advent of molecular diagnostics has led to the possibility of a completely new
paradigm in the care of patients suffering from cancer and other
diseases.
Current
diagnostic tools, such as blood marker-based immunoassays, imaging techniques,
and biopsy analyses, provide valuable information and have played an important
role in the successful treatment of cancer patients but are not without
limitations. We believe there is a market for advanced diagnostic and
prognostic tests that can provide meaningful information, screen for cancer,
detect early recurrence, and monitor progression and therapeutic response in
real time. HDC’s pattern recognition technology can play a critical
role in the development of these tests because an advanced pattern recognition
technique such as SVM technology
is required
for this type of
discovery.
Working
with recognized diagnostic and pharmaceutical partners, our goal is to develop a
product line of newly discovered biomarker signatures and pathways that can be
found in human genes and genetic variations, as well as gene, protein and
metabolite expression differences. In addition, we market our
expertise in the design of clinical trials for companion diagnostics to
substantiate the clinical validity and commercial utility of those
biomarkers. We also market the potent combination of our intellectual
property and intellectual prowess to our prospective collaborative
partners. As inventors of the SVM technology, our world renowned
mathematicians offer these companies the strongest possible development team for
their drug discovery, diagnostic test or other applications.
Our
Technologies and Discoveries
HDC owns
a patent portfolio of machine learning technology, including certain pioneer
patents on SVM. We also consult with many of the physicians, clinical
specialists and mathematicians responsible for developing and filing the pioneer
neural network and SVM patents for the analysis of clinical data.
The
Company’s SVM technology is commonly considered within the context of
artificial
intelligence
. This is a branch of computer science concerned
with giving computers the ability to perform functions normally associated with
human intelligence, such as reasoning and optimization through experience.
Machine learning is a type of artificial intelligence that enables the
development of algorithms and techniques that allow computers to
learn. Pattern recognition is machine learning with a wide spectrum
of applications including medical diagnosis, bioinformatics, classifying DNA
sequences, detecting credit card fraud, stock market analysis, object
recognition in computer vision, and robot locomotion.
SVM
Overview
SVMs are
mathematical algorithms that allow computers to sift through large, complex
datasets to identify patterns. SVMs are widely acknowledged for their
ability to discover hidden relationships in these complex
datasets. With the ability to handle what is known as
infinite dimensional space
,
SVMs are broadly considered to be superior to neural networks and other
mathematical techniques. SVM is a core machine learning technology
with strong theoretical foundations and excellent empirical
successes.
Since
their introduction in 1992, SVMs marked the beginning of a new era in the
learning from examples
paradigm in artificial intelligence. Rooted in the Statistical Learning Theory
developed by Professor Vladimir Vapnik, a member of HDC’s Scientific Advisory
Board, SVMs quickly gained attention from the math and science communities due
to a number of theoretical and computational merits. This development
advanced a new framework for modeling learning algorithms. Within
this framework, the fields of machine learning and statistics were merged,
introducing powerful algorithms designed to handle the difficulties of prior
computational techniques.
The new
generation of learning algorithms that were developed based on this theory has
proved to be remarkably resistant to the problems imposed by noisy data and high
dimensionality. They are computationally efficient, have an inherent modular
design that simplifies their implementation and analysis and allows the
insertion of domain knowledge, and, more importantly, they have theoretical
guarantees about their generalization ability. SVMs have been
validated in hundreds of independent academic publications and
presentations. In recognition for his work, Professor Vapnik received
the prestigious Alexander von Humboldt Prize from the German government honoring
foreign scientists and scholars for lifetime achievement.
SVMs have
become widely established as one of the leading approaches to pattern
recognition and machine learning worldwide and are replacing neural networks in
a variety of fields, including engineering, information retrieval and
bioinformatics. This technology has been incorporated into product
and research applications by many biomedical, pharmaceutical, software, computer
and financial companies. Educational and research institutions
throughout the world have successfully applied SVMs to a wide array of
applications, including gene and protein expression analysis, medical image
analysis, flow cytometry, and mass spectrometry.
Recursive
Feature Elimination - Support Vector Machine Overview
Recursive
Feature Elimination (RFE-SVM) is an application of SVM that was created by HDC’s
Chief Executive Officer and members of its Scientific Advisory Board to find
discriminate relationships within clinical datasets, as well as within gene
expression and proteomic datasets created from micro-arrays of tumor versus
normal tissues. In general, SVMs identify patterns – for instance, a
biomarker/genetic expression signature of a disease. The RFE-SVM
utilizes this pattern recognition capability to identify and rank order the data
points that contribute most to the desired results. The Company
believes that its four RFE-SVM patents are currently the only RFE patents issued
in the world.
Using
RFE-SVM, we have been able to access information in micro-array datasets that
the most advanced bioinformatics techniques missed. In one
micro-array experiment, RFE-SVMs were able to filter irrelevant tissue-specific
genes from those related to the malignancy. RFE-SVM has also been used to
determine gene expression patterns that correlate to the severity of a disease,
not just its existence. It has been shown to improve both diagnosis
and prognosis by providing physicians with an enhanced decision
tool. HDC’s scientists believe that these analytic methods are
effective for finding genes and proteins implicated in several cancers, as well
as in assisting with the pharmacogenetic and toxicological profiling of
patients. The RFE-SVM method is also capable of finding those
specific genes and proteins that are unhindered by ever-increasing patent
protection.
Fractal
Genomic Modeling Overview
On
September 30, 2003, we acquired the assets of Fractal Genomics, LLC, a company
with patented FGM software. The fractal technology is used to find
discriminate relationships within clinical datasets as well as within gene
expression datasets created from micro-arrays of disease versus normal
tissues.
The
Fractal Genomic Modeling (“FGM”) data analysis technique has been shown to
improve the mapping of genetic pathways involved in the diagnosis and prevention
of certain diseases. HDC scientists believe that these analytic methods are
effective for finding genes implicated in several cancers, HIV infection,
lymphedema, Down's syndrome, and a host of other diseases, as well as the
pharmacogenetic profiling of patients.
FGM
technology is designed to study complex networks. A complex network can be made
up of genes inside a living organism, web pages on the Internet, stocks within a
financial market, or any group of objects or processes that appear to be
connected together in some intricate way. FGM uses a new approach toward
modeling network behavior to rapidly generate diagrams and software simulations
that facilitate prediction and analysis of whatever process is the particular
object of study. Two important concepts behind FGM technology are the notions of
scale-free networks and self-similarity.
Our
Scientific Advisory Board
Our
Scientific Advisory Board is comprised of scientists with vast experience in the
fields of mathematics and medicine. The members of the Scientific
Advisory Board are Kary Mullis, Ph.D., winner of the Nobel Prize for Chemistry
for discovering PCR (1993), Vladmir Vapnik, Ph.D., creator of SVMs and winner of
the Humboldt Research Award, Isabelle Guyon, Ph.D., co-inventor of the first
patent for SVMs, Nitesh Chawla, Ph.D., Assistant Professor in the Department of
Computer Science and Engineering and Co-Director of the Interdisciplinary Center
for Network Science and Applications at the University of Notre Dame, Ramananda
K. Madyastha, M.D., Ph.D, recipient of the Raja Ravi Sher Singh of Kalsia
Memorial Cancer Research Prize for outstanding contributions in the field of
cancer research, and Bernhard Scholköpf, Ph.D., director at the Max Plank
Institute for Biological Cybernetics in Tubingen, Germany and an elected member
of the Max Plank Society.
Our
Scientific Achievements
Our Chief
Executive Officer and members of our Scientific Advisory Board are experienced
in the design, analysis and application of machine learning technology, having
invented many of the concepts and methodologies used to exploit domain
knowledge. In addition, through pattern recognition, our Chief
Executive Officer and members of our Scientific Advisory Board have identified
and patent-protected biomarkers as possible treatment advances for several
diseases, including Benign Prostatic Hyperplasia (BPH), prostate cancer,
leukemia, colon cancer, and breast cancer.
Benign
Prostatic Hyperplasia (BPH)
HDC has identified and
patent-protected
a subset of genes that separates benign prostatic
hyperplasia (BPH) from prostate cancer with a high degree of
accuracy. This same set of genes also separated BPH from normal
tissue patterns, indicating that BPH is a disease with molecular characteristics
of its own. This discovery could be used to develop a new
non-invasive diagnostic test for BPH, which does not currently exist, as well as
a completely new type of therapy for patients with this disease. This
patent-protected gene set was developed in association with an international
pharmaceutical company to be used as a surrogate biomarker for their clinical
trial evaluating a new BPH drug.
BPH is a
non-cancerous enlargement of the prostate gland that occurs as men
age. The enlargement often leads to obstruction in the flow of urine
through the urethra that passes through the prostate gland. BPH is a common
condition, representing a global treatment market of almost $4 billion annually
growing by 12% per year in fixed-rate US dollar terms. According to
the National Institutes of Health (NIH), BPH affects more than 50% of men over
age 60 and as many as 90% of men over the age of 70. While BPH does
not cause prostate cancer, both may be found together.
Prostate
Cancer
HDC has identified, patent-protected
and recently licensed
a genetic biomarker signature that identifies
clinically significant high grade prostate cancer cells based on analysis of
tissue samples. Upon the achievement of successful validation, the
Company’s test may be used to analyze patients with elevated PSA or abnormal
rectal exams, with negative biopsy results to determine if there is genomic
evidence of grade three or higher cancer cells present in biopsy tissue,
indicating the presence of a cancer potentially missed by the
biopsy. In 2008 we, Clarient, Inc. and an internationally renowned US
academic cancer center successfully completed all phases of the clinical trial
process with the hope of achieving the statistical significance necessary to
validate the ability to commercialize a test. We were very pleased
with the results of the clinical trial and our results were recently published
in the respected peer-reviewed journal UroToday International, and based on
these results, the tissue-based prostate cancer test was made commercially
available at Clarient. For additional developments on the prostate
cancer test, see Item 7 – Management’s Discussion and Analysis of Financial
Condition and Results of Operation, Operational Activities.
The
National Cancer Institute (NCI) estimates that more than 186,000 new cases of
prostate cancer will be diagnosed in the U.S. in 2008, with more than 28,660
deaths. There are approximately 50 million PSA tests performed
worldwide each year, half of which are performed in the U.S. The PSA
test sells in the U.S. national clinical laboratories for approximately $100 per
test. In a peer-reviewed paper recently published in the New England
Journal of Medicine, the PSA test was shown to be an ineffective prostate cancer
screening test, leaving open the opportunity for a better test to replace the
PSA test as a screening tool for prostate cancer. The Company’s
prostate cancer test was the subject of a peer-reviewed paper published in the
August 2009 edition of UroToday International, a respected international urology
journal.
Leukemia
HDC has identified and
patent-protected
a set of leukemia genes that can separate ALL-T-cell
leukemia from ALL-B-cell leukemia with a high degree of accuracy. The
Company collaborated with a prominent cancer research hospital to analyze a gene
expression database to identify new biomarkers and pathways involved in
leukemia. The Company intends to further validate this finding in
anticipation of developing a molecular diagnostic product for
commercialization. The Company hopes to complete validation of its
test for leukemia in 2010.
Leukemia
is a type of cancer that originates in the bone marrow. The accumulation of
malignant cells interferes with the body's production of healthy blood cells and
makes the body unable to protect itself against infections. The National Cancer
Institute (NCI) estimates that more than 44,000 new cases will be diagnosed in
the U.S. in 2008, with almost 22,000 deaths.
Colon
Cancer
HDC has identified and
patent-protected
colon cancer-specific biomarkers that can be used in the
development of diagnostic assays for cancer detection, disease discrimination,
and even a potential vaccine. The aim of this early biomarker
discovery project was to define the gene expression patterns associated with
colon cancer. Our RFE-SVM served as an effective tool for sifting
through the voluminous data of thousands of measurements to highlight only those
genes that optimally contributed to the study focus. The Company is
currently validating these findings with tissues from St. Vincent's Medical
Center in New York City in anticipation of developing a molecular diagnostic
product for commercialization in the near future.
In the
United States, colorectal cancer is the third most common cancer in men and
women. The National Cancer Institute (NCI) estimates that more than
108,000 new cases of colon and rectal cancer will be diagnosed in the U.S. in
2008, with nearly 50,000 deaths.
Breast
Cancer
HDC
licensed its two breast cancer diagnostic technologies (
MammoSIGHT,
for detecting
malignancy in mammograms and
MetastaSIGHT,
for identifying
circulating tumor cells in the blood) to Smart Personalized Medicine, LLC
pursuant to an amended license agreement in exchange for a 20% ownership
position in Smart Personalized Medicine, LLC and a per test royalty up to 7.5%
based on net proceeds received from the sale of the new breast cancer prognostic
test other than by Quest Diagnostics Incorporated. The detection
component of these technologies finds the areas of particular interest in the
image and separates these objects from the background. The feature
extraction component formulates numerical values relevant to the classification
task from the segmented objects. HDC’s patented technology can be
used within all diagnostic imaging radiology techniques, including PET scans, CT
scans, and MRIs.
See Item 7 –
Management’s Discussion and Analysis of Financial Condition and Results of
Operations, Operational Activities for additional information regarding recent
developments with Smart Personalized Medicine and Quest.
For
women, breast cancer is the most common non-skin cancer and the second leading
cause of cancer-related death in the United States. An estimated
221,000 women are diagnosed with breast cancer in the United States each year,
and one in eight U.S. women will have breast cancer in her
lifetime. However, death rates from breast cancer have been declining
since 1990, and these decreases are believed to be the result, in part, of
earlier detection and improved treatment. Mammography remains the
best method of early breast cancer detection. According to studies
cited by the National Cancer Institute, 10-20% of breast cancers detected by a
physical exam were missed by a film mammogram. For this reason, there
have been extensive research efforts to improve mammography.
The FDA
reports that there are about 33.5 million mammography procedures performed each
year in the United States. Data from 2000-2002 show that about 70
percent of all mammograms that are performed annually are for screening purposes
(to detect cancer as opposed to following cancer once it has been diagnosed).
This translates to about 23.5 million screening procedures every
year. Currently, the breast cancer prognostic market is projected to
be about $300 to $400 million.
Detecting
malignancy in mammograms can be very difficult. Individual mammograms are unique
and there can be great variation within “normal” images. Unlike CT
scans and MRIs, mammograms are not cross-sectional images. Basically,
a mammogram produces a two-dimensional picture of a three-dimensional
object. The projection from 3D to 2D and the resulting overlaps on
the images may interfere with the recognition of the distinguishing features,
which are often very subtle. The rules for differentiating the benign
and malignant cases are vague and not easily formulated.
One way
to reduce reading errors is to have two radiologists read the same mammograms
independently. However, in most health care systems, it is not feasible to
implement such a two-radiologist reading process. A computer-assisted
detection (CAD) system serving as a second reader is therefore an attractive
option, and CAD is currently reimbursed by both insurance companies and
Medicare.
Both
digital and film mammography use X-rays to produce an image of the
breast. In film mammography, which has been used for over thirty-five
years, the image is created directly on a film. While standard film
mammography is very good, it is less sensitive for women who have dense
breasts. A major limitation of film mammography is the film
itself. Once a film mammogram is obtained, it cannot be significantly
altered; if the film is underexposed, for example, contrast is lost and cannot
be regained.
Digital
mammography takes an electronic image of the breast and stores it directly in a
computer. Digital mammography uses less radiation than film mammography and
allows for improvement in image storage and transmission because images can be
stored and sent electronically. Radiologists can use software to help
interpret digital mammograms.
MammoSIGHT
HDC’s
MammoSIGHT
technology
introduces the use of SVMs in detecting malignancy in mammograms. The SVM
classifier produces an index discriminating between the benign and malignant
cases. The individual components can be developed in parallel because of the
modular structure. In developing the calcification segmentation component, a
selected set of malignant, benign and normal cases representing a wide range of
images was used to guide and test the design in order to produce a general,
robust and accurate algorithm. At the same time, the SVM classifier was
developed and tested with manually prepared input data. A set of 300 images (150
benign and 150 malignant cases) was used in training the SVM. An independent set
of 328 images was used for testing. High dimensional input features were used to
ensure a sufficient capacity for automatically extracted features.
Clusters
of micro calcifications are characterized by their relatively small sizes and
high densities. The algorithm combines a recursive peak seeking technique with
morphological operations to achieve a highly accurate calcification detection
and segmentation.
MetastaSIGHT
Cancer
cells have the ability to migrate from the organ of its origin to any distant
organ throughout the body. This is known as metastasis, the hallmark of
malignant cancers. During metastasis, cancerous cells break through barriers to
travel through the body's circulatory system to invade other organs. These cells
form new cells in vital organs throughout the body, becoming secondary tumors
that destroy normal cells by depriving them of nutrition.
Even with
today’s best treatment when the cancer is forced into remission, metastasis will
not necessarily leave the body. Metastasis cannot be eliminated by surgery.
Often, malignant cells circulate in the blood before detection by clinical
examination.
MetastaSIGHT
uses an
SVM-based approach to introduce new cellular imaging technology that identifies
circulating tumor cells in the blood. By identifying circulating
tumor cells, patients and their doctors can take proactive measures to address
therapeutic decisions.
HIV/AIDS
HDC identified and
patent-protected
an AIDS expression signature that separated AIDS brain
cells from non-AIDS brain cells with a high degree of accuracy. This
biomarker discovery was accomplished in conjunction with Dr. Paul Shapshak,
Director of the Dementia/HIV Laboratory at the University of Miami Medical
School, and a group of leading scientists using HDC's proprietary FGM analysis
technique. HDC sold the biomarker discovery to the University of
Miami in November 2005.
Employees
On
December 31, 2009, we had 6 full time employees.
Website
Address
Our
corporate website address is www.HealthDiscoveryCorp.com. To view our
public filings from the home page, select the “Display SEC Filings” tab followed
by “SEC Filings.” This is a direct link to our filings with the
Securities and Exchange Commission (“SEC”), including but not limited to our
Annual Report of Form 10-K, quarterly reports on Form 10-Q and current reports
on Form 8-K, and any amendments to these reports. These reports are
accessible soon after we file them with the SEC.
Governmental
Regulation
Our
business plan involves
Biomarker Discovery
in the
field of molecular diagnostics. This early discovery process does not
involve any governmental regulations or approvals. If we are
successful in licensing our discoveries to other companies, FDA approvals may be
required before the ultimate product may be sold to consumers. Our
current plan is to require the companies licensing our discoveries or
technologies to be responsible for the costs involved in such
approvals. If we are not successful in licensing these discoveries on
these terms or choose to take these discoveries to market ourselves, we may then
be subject to applicable FDA regulations and would then bear the costs of such
approvals.
We know
of no governmental regulations that will materially affect the Company’s current
operations or products.
Intellectual
Property
In
connection with the SVM Acquisition, we obtained rights to the intellectual
property within the “SVM Portfolio” that currently consists of thirty-eight
patents which were or have since issued as well as thirty-one other patent
applications that are pending in the U.S. and elsewhere in the
world. The issued patents and pending applications in the SVM
portfolio to date, including new applications that we have filed since acquiring
the original SVM Portfolio, HDC are:
Patent/Application
No.
|
|
Title
|
|
|
|
|
|
|
|
U.S.
Patent No. 6,128,608
|
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Enhancing
Knowledge Discovery Using Multiple Support Vector Machines
|
|
05/01/2019
|
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|
U.S.
Patent No. 6,157,921
|
|
Enhancing
Knowledge Discovery Using Support Vector Machines in a Distributed Network
Environment
|
05/01/2019
|
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U.S.
Patent No. 6,427,141
|
|
Enhancing
Knowledge Discovery Using Multiple Support Vector
Machines.
|
|
05/01/2019
|
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|
U.S.
Patent No. 6,658,395
|
|
Enhancing
Knowledge Discovery from Multiple Data Sets Using Multiple Support Vector
Machines.
|
|
05/01/2019
|
|
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|
U.S.
Patent No. 6,714,925
|
|
System
for Identifying Patterns in Biological Data Using a Distributed
Network.
|
|
05/01/2019
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U.S.
Patent No. 6,760,715
|
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Enhancing
Biological Knowledge Discovery Using Multiple Support Vector
Machines.
|
|
05/01/2019
|
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U.S.
Patent No. 6,789,069
|
|
Method
of Identifying Patterns in Biological Systems and Method of
Uses.
|
|
05/01/2019
|
|
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U.S.
Patent No. 6,882,990
|
|
Method
of Identifying Biological Patterns Using Multiple Data
Sets.
|
|
05/01/2019
|
|
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U.S.
Patent No. 6,944,602
|
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Spectral
Kernels for Learning Machines
|
|
02/19/2023
|
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U.S.
Patent No. 6,996,542
|
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Computer-Aided
Image Analysis
|
|
04/21/2021
|
Patent/Application
No.
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Title
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Expiration
Date
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U.S.
Patent No. 7,117,188
|
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Methods
of Identifying Patterns in Biological Systems and Uses
Thereof
|
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05/01/2019
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U.S.
Patent No. 7,299,213
|
|
Method
of Using Kernel Alignment to Extract Significant Features from a Large
Dataset
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Enhancing
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Enhancing
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Enhancing
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Enhancing
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Enhancing
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Method
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Computer
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European
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Computer
Aided Image Analysis
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Japanese
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Computer
Aided Image Analysis
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Methods
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Methods
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Canadian
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Pre-Processing
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Pre-Processing
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Enhancing
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Enhancing
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Method
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Method
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Method
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Colon
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System
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Methods
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Methods
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Kernels
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Canadian
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Computer
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Method
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U.S.
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Remote
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HDC also
owns intellectual property rights in U.S. and foreign patents and pending patent
applications covering the FGM technology. The FGM portfolio includes
three issued patents, which are:
Patent/Application
No.
|
|
Title
|
|
Expiration
Date
|
|
|
|
|
|
U.S.
Patent No. 6,920,451
|
|
Method
for the Manipulation, Storage, Modeling, Visualization and Quantification
of Datasets.
|
|
01/19/2021
|
|
|
|
|
|
U.S.
Patent No. 7,366,719
|
|
Method
for the Manipulation, Storage, Modeling, Visualization and Quantification
of Datasets
|
|
01/19/2021
|
|
|
|
|
|
European
Patent No. 1252588
|
|
Method
for the Manipulation, Storage, Modeling, Visualization and Quantification
of Datasets.
|
|
01/19/2021
|
Our
Competition
HDC
conducts its business principally in the diagnostics industry in the field of
Biomarker Discovery and image
analysis
. The diagnostics industry is highly fragmented,
competitive and evolving. There is intense competition among countless
healthcare, biotechnology and diagnostics companies attempting to discover
potential new diagnostic products. These companies may:
|
●
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develop
new diagnostic products before we or our collaborators;
|
|
|
|
|
●
|
develop
diagnostic products that are more effective or cost-effective than those
developed by us or our collaborators; or
|
|
|
|
|
●
|
obtain
patent protection or other intellectual property rights that would limit
the ability to develop and commercialize, or a customers’ ability to use,
our or our collaborators’ diagnostic
products.
|
The
Company competes with companies in the United States and abroad that are engaged
in the development and commercialization of diagnostic tests that utilize
biomarker discovery and CAD image analysis techniques. These companies may
develop products that are competitive with and/or perform the same or similar to
the products offered by us or our collaborators. Also, clinical laboratories may
offer testing services that are competitive with the products sold by us or our
collaborators. The testing services offered by clinical laboratories may be
easier to develop and market than test kits developed by us or our collaborators
because the testing services are not subject to the same clinical validation
requirements that are applicable to FDA-cleared or approved diagnostic test
kits.
While a
number of companies perform biomarker discovery, we believe that our SVM and FGM
technologies give us a distinct advantage over competing
technologies. Neither classical statistical analysis nor neural
networks (the competing technologies) can effectively handle the large amounts
of inputs necessary to produce fully validated biomarkers like the Company's
technology.
Customers
and Licensees
We have
produced sales, licensing, and developmental revenue since 2005 through
agreements with a few customers and licensees. We have a strategic alliance and
licensing agreement with Clarient, Inc. for commercialization of a new molecular
diagnostic test for prostate cancer based on our discovered prostate cancer
biomarker signature. Pursuant to our agreement, as amended, Clarient,
Inc. obtained a non-exclusive license to the prostate cancer test in exchange
for our 10% royalty interest from all reimbursements of the test once
commercialized. We and Clarient have successfully completed all
phases of the clinical trial process with the hope of achieving the statistical
significance necessary to validate the ability to commercialize a
test. Results from both the Phase I, Phase II and Phase III
double-blinded clinical validation studies now completed at Clarient
demonstrated a very high success rate for identifying the presence of
Grade 3 or higher prostate cancer cells (clinically significant cancer), as
well as normal BPH (benign prostatic hyperplasia) cells. With the
completion of the clinical trial, HDC’s new gene-based molecular diagnostic test
is now being commercialized to be used by physicians on their patients at risk
of having prostate cancer. The new prostate cancer test will be performed at
Clarient’s Clinical Laboratory in Aliso Viejo, CA. HDC will receive 10% royalty
on each test performed.
In July
2008, we entered into a development and license agreement with DCL Medical
Laboratories LLC, a full-service clinical laboratory focused on women’s health,
for the collaborative development and commercialization of SVM-based computer
assisted diagnostic tests for the independent detection of ovarian, cervical and
endometrial cancers. Pursuant to the development and license
agreement, we will own any developed intellectual property and DCL will
have a sole use license relating to applications and new mathematical tools
developed during the course of the development and license agreement. Images and
interpretative data from this new SVM-based system may now be transmitted
electronically, thus allowing remote review and collaborative interpretation.
Dr. Hanbury, one of our directors, is currently President, CEO and a shareholder
of DCL.
In August
2008, we entered into a licensing agreement with Smart Personalized Medicine,
LLC, a company founded by our former director, Dr. Richard
Caruso. Under the terms of this agreement, we will work to develop a
superior breast cancer prognostic test using our SVM technology in collaboration
with a prominent cancer research hospital. In exchange for a license
to use our SVM technology, we received a 15% equity position in Smart
Personalized Medicine, LLC (which will remain undiluted until there is at least
$5 million in investment from investors in Smart Personalized Medicine,
LLC) and a per test royalty up to 7.5% based on net proceeds received from the
sale of the new breast cancer prognostic test.
In
September 2008, we received royalty proceeds related to our licensing agreement
with Bruker Daltonics, which was originally announced in August,
2006. The royalties relate to Bruker Daltonics’ sales of its
ClinProTools
TM
clinical proteomics product line for its mass spectrometers, which contains
HDC’s SVM technology. Bruker launched its ClinProTools
TM
at
approximately the same time as the license with our Company. While
this royalty was relatively small, it represents additional royalty payments
from this relationship and offers the opportunity of future royalties for the
life of the patents related to future sales of the Bruker product.
On
January 30, 2009, we entered into a license agreement with Abbott Molecular Inc.
(“Abbott”), pursuant to which the Company granted Abbott a worldwide, exclusive,
royalty-bearing license for in-vitro diagnostic rights to develop and
commercialize reagent test kits for the Company’s prostate cancer molecular
diagnostic tests in both biopsy tissue and urine. Upon regulatory
approval, these individual test kits could be sold to national, regional and
local clinical laboratories, as well as hospital, academic and physician
laboratories around the world.
We also
granted Abbott a worldwide, royalty bearing, co-exclusive license (co-exclusive
with Quest) for developing and commercializing a “laboratory developed” urine
based molecular diagnostic test for clinically significant prostate cancer which
could be commercialized and sold directly to physicians for their patients in a
clinical laboratory.
We also
granted Abbott a worldwide, royalty bearing, co-exclusive license (co-exclusive
with Clarient, Inc.) for developing and commercializing a “laboratory developed”
biopsy tissue based molecular diagnostic test for clinically significant
prostate cancer which could be commercialized and sold directly to physicians
for their patients in a clinical laboratory.
In
February 2009, Abbott paid to us a one-time initial signing fee of
$100,000. In addition, with respect to the products subject to the
license (the “Products”), Abbott will pay milestone payments to us upon
achievement of the following events: $250,000 upon completion of
Phase 1 and 2 as described in the FDA Submission Plan; $250,000 upon completion
of Phase 3 and 4 as described in the FDA Submission Plan; $500,000 upon
submission of either a 510(k) or Pre Market Approval (“PMA”) submission to the
FDA; and $500,000 upon the receipt of a written notification by the FDA of the
approval of the applicable 510(k) or PMA submission. We will also
receive royalty payments of 10% of Abbott’s Net Sales for the Products with
medical utility claims for use on prostate biopsy tissue samples, and 5% of
Abbott’s Net Sales for the Products with medical utility claims for use on urine
samples. We will also receive royalty payments on the “Laboratory
Developed Tests” equal to 10% of Abbott’s Net Sales for the tests performed on
prostate biopsy tissue and 5% of Abbott’s Net Sales for tests performed on urine
samples. In addition to the royalty payments, with respect to the
urine based Products, Abbott will also pay us certain amounts upon the
achievement of certain milestones as follows: after the sale of
50,000 tests in a calendar year, a milestone payment of $200,000; after a sale
of 200,000 tests in a calendar year, a milestone payment of $750,000; and after
a sale of 500,000 tests in a calendar year, a milestone payment of
$1,500,000. “Net Sales” is equal to Abbott’s gross revenue less 5%
subject to adjustments as described in the license.
On
January 30, 2009, we entered into a license agreement with Quest Diagnostics
Incorporated (“Quest”), pursuant to which the Company granted to Quest a
non-exclusive, royalty bearing license for developing and commercializing a
“laboratory developed” urine based molecular diagnostic test for clinically
significant prostate cancer which could be commercialized and sold by Quest’s
clinical laboratories directly to physicians for their patients. In
consideration of granting the license to Quest, Quest paid a license fee to the
Company and will pay running royalty payments, certain milestone payments, and
development fees.
Research
and Development
Our past
Research and Development costs have been minimal due to the unique relationships
we have maintained with the members of our scientific team and their
institutions. Our total R&D costs have consisted solely of the
consultant fees paid to Dr. Stamey, Dr. Vapnik, and Dr. Guyon. These
fees consisted of $13,697 for 2009 and $14,160 for 2008.
Description
of Property
We do not
own any real property. We lease 908 square feet of office space in
Savannah, Georgia, pursuant to a three year lease dated July 1, 2007 with an
initial cost of $1,678 per month. We currently pay $1,741 per month due to
subsequent contractual increases. Our principal executive office is located at 2
East Bryan Street, Suite #601, Savannah, Georgia 31401, and our telephone number
is (912) 443-1987. Our principal executive office is well maintained
and suitable for the business conducted in it.
Legal
Proceedings
None.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Corporate
Overview
Our
Company is a pattern recognition company that uses advanced mathematical
techniques to analyze large amounts of data to uncover patterns that might
otherwise be undetectable. Our Company operates primarily in the
emerging field of molecular diagnostics and imaging where such tools greatly
enhance scientific discovery. Our primary business consists of
licensing our intellectual property and working with prospective customers on
the development of varied products that utilize pattern recognition
tools. We also endeavor to develop our own product line of newly
discovered biomarkers and pathways that include human genes and genetic
variations, as well as gene, protein, metabolite expression differences and
image analysis techniques. In drug discovery, biomarkers can help
elicit disease targets and pathways and validate mechanisms of drug
action. They may also be pharmacodynamic indicators of drug activity,
response and toxicity for use in clinical development.
We
partnered and intend to continue partnering with clinical laboratories to
commercialize our clinical diagnostic tests and to provide pharmaceutical and
diagnostic companies with all aspects of diagnostic and drug discovery, from
expert assessment of the clinical dilemma through proper selection and
procurement of high quality specimens. We will then apply our
proprietary analytical evaluation methods and state-of-the-art computational
analysis to derive relevant and accurate clinical data, with the goal of
producing new diagnostic and prognostic tests as well as image analysis
techniques.
Our
business is based on the belief that in order to discover the most clinically
relevant biomarkers, the computational component must begin at the inception of
the clinical dilemma to be solved. This process includes several
critical levels of decision-making - all of which are part of our business
strategy. We intend to produce more relevant and predictable
biomarkers for drug discovery so that new and better medicines and diagnostic
markers can be developed for patients worldwide.
Operational
Activities
The
Company actively markets its technology and related developmental expertise to
several prospects in the healthcare field, including some of the world’s largest
corporations in the pharmaceutical, biotech, and life sciences
industries. Given the scope of some of these prospects, the sales
cycle can be quite long, but management believes that these marketing efforts
will produce favorable results in the future. In 2010, we plan to
focus on the development, consulting and licensing of our technology in various
fields of use.
Licensing
and Commercialization Developments
We
previously announced that the RT-PCR assay for the four genes comprising the
Company’s recently commercialized gene-based molecular diagnostic test for
prostate cancer can be successfully used in urine samples for gene
testing. The study, completed in collaboration with a world renowned
academic cancer research hospital, demonstrated that the gene expression of all
four genes comprising the molecular signature for clinically significant
prostate cancer could be detected in urine samples spiked with as few as 50
prostate cancer cells.
On
January 30, 2009, we entered into a license agreement with Abbott Molecular Inc.
(“Abbott”), pursuant to which, among other things, the Company granted Abbott a
worldwide, exclusive, royalty-bearing license for in-vitro diagnostic rights to
develop and commercialize reagent test kits for the Company’s prostate cancer
molecular diagnostic tests in both biopsy tissue and urine. We also
granted Abbott a worldwide royalty bearing, co-exclusive license (co-exclusive
with Quest) for developing and commercializing a Laboratory Developed urine
based molecular diagnostic test (“LDT”) for clinically significant prostate
cancer, which could be commercialized in a clinical laboratory and sold directly
to physicians for their patients. Abbott paid to us a one-time
initial signing fee of $100,000 and then reimbursed us $100,000 in development
costs as required by the license agreement. In addition, with respect
to products subject to the license (the “Products”), Abbott will pay milestone
payments to us upon achievement of the following events: $250,000
upon completion of Phases 1 and 2 as described in the FDA Submission Plan;
$250,000 upon completion of Phases
3 and 4 as described in
the FDA
Submission
Plan; $500,000 upon submission of either a 510(k) or Pre Market Approval (“PMA”)
submission to the FDA; and $500,000 upon the receipt of a written notification
by the FDA of the approval of the applicable 510(k) or PMA submission. We will
also receive royalty payments of 10% of Abbott’s Net Sales for the Products with
medical utility claims for use on prostate biopsy tissue samples, and 5% of
Abbott’s Net Sales for the Products with medical utility claims for use on urine
samples. In addition to the royalty payments, with respect to the urine based
products, Abbott will also pay us certain amounts upon the achievement of
certain milestones as follows: after the sale of 50,000 tests in a
calendar year, a milestone payment of $200,000; after a sale of 200,000 tests in
a calendar year, a milestone payment of $750,000; and after a sale of 500,000
tests in a calendar year, a milestone payment of $1,500,000. “Net
Sales” is equal to Abbott’s gross revenue less 5%, subject to adjustments as
described in the license.
On
January 30, 2009, we entered into a license agreement with Quest, pursuant to
which the Company granted to Quest a non-exclusive, royalty bearing license for
developing and commercializing a urine-based LDT for clinically significant
prostate cancer which could be commercialized and sold by Quest’s clinical
laboratories directly to physicians for their patients. In
consideration of granting the license to Quest, Quest paid a license fee to the
Company and will pay running royalty payments, certain milestone payments, and
development fees.
The
Company is continuing to advance the development of the urine based prostate
cancer test. The Company is pleased with the data and results completed to
date. We continue to progress towards the goal of commercialization
of the urine-based prostate cancer test at Quest and with Abbott as laboratory
developed tests in the near future, as well as an
in-vitro
diagnostic test (IVD
test kits) offered for sale by Abbott upon FDA approval of the test
kits.
Upon regulatory
approval, Abbott could begin commercialization and sale of the individual
in-vitro
diagnostic test kits
to additional national, regional and local clinical laboratories, as well as
hospital, academic and physician laboratories around the world.
On March
11, 2010, the Company, Quest Diagnostics Incorporated (“Quest”) and Smart
Personalized Medicine, LLC (“SPM”) entered into a Development Agreement (the
“Quest Development Agreement”) pursuant to which the Company and SPM will assist
Quest in the development of new laboratory tests for aiding in the selection of
breast cancer therapies. The Company, SPM and Quest also entered a related
Licensing Agreement (the “Quest License”).
Pursuant
to the Quest License, SPM granted a co-exclusive (with SPM) sublicense to
utilize the Licensed Patent Rights to the extent necessary to enable Quest to
develop Products and perform the Validation Work under the Quest Development
Agreement. Quest has the right to use SPM’s Breast Cancer Database developed in
association with a world renowned academic cancer center (the
“Database”). In consideration for the license, Quest will separately
make payments to SPM and us. Such payments to us will include a $500,000 up
front “Development License Fee,” monthly “License Maintenance Fees” equal to
$8,750 for the first year and $17,500 for each year thereafter (with such fees
being credited against the “Royalty Payments” described below), upon the
publication of a study performed for the Validation Work an “Initial Product
License Fee” of $125,000 for each of the first two Products, and “Royalty
Payments” equal to 2.45% of the Net Sales of each Licensed Product (i.e., each
breast cancer test) sold by Quest. Quest will reimburse SPM and us for costs
incurred related to any Validation Work done with respect to a
Product.
Pursuant
to the Quest Development Agreement, we are required to use the support vector
machine technology and other intellectual property licensed to SPM to analyze
data for the development and/or validation of applications of clinical
laboratory services, In Vitro Diagnostic kits, clinical trial services and the
other elements of “Field” (collectively, the “Products”). In
consideration for our efforts under the Quest Development Agreement, Quest will
pay us $375,000 (in addition to the $500,000 described above), which payments
shall be made in equal monthly installments over the next nine
months.
Effective
March 11, 2010, the Company and SPM amended (the “Amendment”) the original
License Agreement, dated August 22, 2008 (the “SPM License Agreement”), pursuant
to which we had licensed our intellectual property to SPM for use in the
development of breast cancer products. As amended, we will receive all payments
under the Quest Development Agreement and License Agreement directly from Quest,
and SPM will not be required to make any additional payments to the Company
related to either such agreement. With respect to SPM proceeds
received unrelated to the arrangement with Quest, we will receive a per test
royalty up to 7.5% based on net proceeds received from a Test (as defined in the
SPM License Agreement) and such additional allocation and distribution of
license fees and royalties received from future sublicenses with third parties
as may be agreed. In addition, our equity percentage interest in SPM
was increased from 15% to 20%, and such equity percentage interest may be
diluted only to the same extent and in the same manner as each other initial
equity percentage interest holder; provided, however, that when raising
additional equity, SPM must obtain our prior written approval of the terms and
conditions of such equity offering. SPM expects that once the
laboratory test is developed with Quest, it can provide physicians and their
patients a way to better determine the probability of relapse, allowing patients
with good prognosis results an opportunity to avoid unnecessary expensive and
traumatic chemotherapy treatments.
On July
31, 2007, we announced our alliance and licensing agreement with Clarient, Inc.
for development of a new molecular diagnostic test for prostate cancer based on
our discovered prostate cancer biomarker signature. During 2008, we
and Clarient successfully completed all phases of the clinical trial process
with the hope of achieving the statistical significance necessary to validate
the ability to commercialize a test. Results from both the Phase I,
Phase II and Phase III double-blinded clinical validation studies now completed
at Clarient demonstrated a very high success rate for identifying the presence
of Grade 3 or higher prostate cancer cells (clinically significant cancer), as
well as normal BPH (benign prostatic hyperplasia) cells. Although
Clarient has not yet reported any commercial sales to us, the prostate gene
expression test is available through Clarient’s PATHSiTETM virtual reporting
tool and accessible to Clarient’s entire pathology network.
In July
2008, the Company and DCL Medical Laboratories LLC (“DCL”) entered into a
development and license agreement for the collaborative development and
commercialization of SVM-based computer assisted diagnostic tests for the
independent detection of ovarian, cervical and endometrial
cancers. Due to a change in the strategic direction involving DCL, we
mutually terminated the development and license agreement in January 2010.
The Company is pleased with the development progress to date of its Pap
Smear image analysis technique and is currently seeking a strategic partnership
with a clinical laboratory capable of completing development, final validation
and commercialization of this computer assisted diagnostic (CAD)
test.
In
January 2007, SVM Capital, LLC was formed as a joint venture between HDC and
Atlantic Alpha Strategies, LLC (“Atlantic Alpha”) to explore and exploit the
potential applicability of our SVM technology to quantitative investment
management techniques. Atlantic Alpha’s management has over thirty
years of experience in commodity and futures trading. SVM Capital has
made significant progress since the formation of the joint
venture. Atlantic Alpha reports that the SVM technology is now
working well with dynamic time series for S&P data accumulated over the past
fifty-eight years as well as a limited pilot program of real-time trading
activity, and that the latest SVM-derived models generated by SVM Capital have
successfully outperformed the static
buy-and-hold
model both in
increased returns as well as in reduced risk. Once the stability of
these models is confirmed, SVM Capital intends to apply the models to a wide
range of financial asset classes such as interest rates, currencies, metals and
petroleum products. SVM Capital plans to apply the investment model
either in a single fund or a series of related funds. SVM Capital
expects to charge a management fee and a performance fee related to its
investment activities. HDC owns a 45% equity position in SVM
Capital.
In August
2008, we entered into an agreement with Patent Profit International, a Silicon
Valley-based patent brokerage firm, with the goal of marketing our patent
portfolio and exclusive rights to SVM techniques and applications outside of
biomarker discovery and the healthcare field, to prospective
buyers/licensees. In December 2009, the Company terminated the
arrangement in favor of establishing internal resources to pursue the
monetization of our intellectual property portfolio in non-healthcare fields
using our own resources, including the hiring of our Executive Vice President
and Managing Director of Global IP Strategies. Our goal remains to
monetize our significant intellectual property through non-medical licenses and
development agreements such as we have accomplished in the healthcare
space.
Management
believes that our research agreement with a leading biotech company to develop
an SVM-based diagnostic test to help interpret flow cell cytometry data for
myelodysplastic syndrome (pre-leukemia) has resulted in a successful proof of
concept The Company is pleased with the development progress to date, and the
Company is now seeking a strategic partnership with a clinical laboratory
capable of completing development, final validation and commercialization of the
new diagnostic test for the interpretation of flow cytometry data.
We have
developed, in association with a large international pharmaceutical company, a
diagnostic test for use as a surrogate biomarker to determine treatment success
in the clinical trial for its new drug to treat BPH (enlarged
prostate). This international pharmaceutical company was acquired by
a larger pharmaceutical company during our final contract discussions, and the
acquiring company has now subsequently been acquired by an even larger
international pharmaceutical company. After the successful integration of these
companies, we hope to renew interest in the BPH test that we developed for them.
If the new pharmaceutical company chooses not to continue development of its BPH
drug, then we intend to seek another strategic pharmaceutical partner, which has
BPH drugs either in the market currently or under development to finish
development, final validation and commercialization of our new molecular
diagnostic test for BPH.
We have
advanced our dialogue with other important industry players in the healthcare
field and, in certain situations, related to the field of molecular
diagnostics. We will also continue to pursue development
opportunities with our existing licensing customers.
While we
have a number of negotiations in process with potential licensing partners,
there is a possibility that we will be unable to reach agreement with any party,
that the negotiations continue but are not finalized, or that those that may be
finalized do not provide the economic returns that we expect.
Intellectual
Property Developments
The U.S.
Patent and Trademark Office issued a new patent to the Company in January 2009,
which covers a feature ranking technique for use with support vector
machines. In June 2009, the U.S. Patent and Trademark Office issued
two new patents to the Company, one of which includes expanded claims to the
Company’s proprietary RFE-SVM method for feature selection. The
second patent covers a web-based data mining system that utilizes multiple
support vector machine models to analyze combinations of biological data of many
different types, for example, genomic, proteomic, and clinical data, from many
different sources, including measurement instruments, clinical databases,
on-line databases and on-line journals to produce ranked lists of genes or
proteins that may be used as biomarkers.. The U.S. Patent and
Trademark Office issued another new patent to the Company in November 2009
covering an alternative method of feature selection that reduces the number of
support vectors to create a sparse-SVM that can be used to generate a codebook
for identifying patterns in data, including applications to signal compression.
Also in November 2009, the U.S. Patent and Trademark Office issued the Company’s
first patent covering a pre-processing method to greatly improve the
effectiveness of SVMs for the analysis of mass spectrometry data for protein
biomarker discovery. Finally, in December 2009, the European Patent
Office granted a patent on the Company’s claims covering the use of SVMs for
computer-aided analysis of digitized images. With the issuance of
these patents, the Company now holds the exclusive rights to 41 issued U.S. and
foreign patents covering uses of SVM and FGM technology for discovery of
knowledge from large data sets.
In
December 2009, the decision was made to allow the two remaining pending patent
applications covering methods using Fractal Genomic Modeling to be abandoned
following repeated rejections by the U.S. Patent and Trademark
Office. These rejections were based on a change in patentability
criteria that was set forth in a 2008 decision by the U.S. Supreme Court in a
case known as
In re
Bilski
. The applications, which had been filed prior to the
ruling, did not contain certain descriptive material that would have been
necessary to overcome a patentable subject matter rejection pursuant to
Bilski
.
On
October 16, 2009, the U.S. Patent and Trademark Office issued a notice of
allowance for the Company’s pending patent application entitled “Kernels and
Kernel Methods for Spectral Data.” This application includes claims
covering an alternative pre-processing method for enhancing the analysis of
protein expression data obtained using a mass spectrometer. In
December 2009, the Company filed a provisional application covering its new
smart phone application for melanoma screening. Also in
December 2009, the Company filed an international patent application through the
World Intellectual Property Organization (WIPO) with claims covering the four
gene prostate cancer test and algorithm using tissue or urine
specimens. This application will allow further coverage of the
prostate cancer test to be sought via foreign patent offices including Europe,
China and Japan, among over one hundred other countries.
In
October 2008, an Indian patent was issued to the Company covering the use of
SVMs for knowledge discovery from multiple data sets. Also that
month, the U.S. Patent and Trademark Office issued a new patent to the Company
covering a data mining platform with multiple SVM modules for use in analyzing
bioinformatics data.
In August
2008, the U.S. Patent and Trademark Office granted a patent to us covering the
use of SVMs in computer-aided image analysis of digitized microscopic images of
medical specimens. This patent focuses on a method and computer
system for analyzing medical images generated during microscopic evaluation of
cytology specimens and tissue samples. SVM-aided image analysis using
this patented method could permit automated and rapid analysis of a series of
sample images that are typically examined visually by a technologist or
pathologist, greatly increasing the sensitivity and accuracy of
tests.
The U.S.
Patent and Trademark Office issued a new patent to the Company in June 2008,
which covers the use of SVMs for computer-aided analysis of medical images, with
particular applications in cytology and pathology. Also in June 2008,
the Company was issued a patent in Japan, which covers recursive feature
elimination (RFE) using SVMs for selection and ranking of the most important
features within large datasets. In May 2008, the U.S. Patent and Trademark
Office issued two new patents to the Company, one of which claims a method for
analysis of any type of data that has a structure. The second patent
covers additional feature selection techniques that can be used to successfully
identify the most important pieces of information needed to solve complex
pattern-recognition problems. The U.S. Patent and Trademark Office
issued one new patent to the Company in April 2008, which covers the use of FGM
technology for visualization of data patterns.
Year
Ended December 31, 2009 Compared with Year Ended December 31, 2008
Revenue
Since
December 31, 2005, the Company has received cash from operating activities
totaling $1,157,263, which consists of recorded revenue of $613,328 through
December 31, 2009 and has deferred revenue yet to be recognized of $543,935 at
December 31, 2009.
For the
year ended December 31, 2009, revenue was $61,803 compared with $65,731 in
revenue for the year ended December 31, 2008. Revenue is recognized
for licensing and development fees over the period earned, which in most cases
is the length of the license. The revenue recognized in 2009 was
primarily the recognition of deferred revenue. As of December 31,
2009, the Company had deferred revenue of $543,935, which includes $431,435 of
cash received but not yet recognized as revenue and $112,500 in accounts
receivable. Deferred revenue was $453,715 at December 31, 2008, which
has been reduced because we recognize the revenue over the life of the
contract.
Operating
and Other Expenses
Amortization
expense, which is the amortization of costs of acquiring or filing of patents
over their estimated useful lives, was $262,719 for the twelve months ended
December 31, 2009 and 2008.
Professional
and consulting fees totaled $406,786 for 2009 compared with $757,748 for
2008. These fees, related primarily to legal, accounting, and
scientific activities, decreased principally due to the change in accounting
estimate related to equity grants for Scientific Advisory Board
members. A credit of $325,676 was recorded to reflect this
change.
Compensation
expense of $939,029 for the twelve months ended December 31, 2009 was higher
than the $745,918 reported for the comparable period of 2008. This increase is
due to additional compensation expense related to employees hired in 2009 to
manage the business and to develop and nurture new strategic partnerships and
the charge for employee options granted in 2009.
Other
general and administrative expenses decreased from $484,806 in 2008 to $461,257
in 2009. This decrease principally was due to reduced costs related
to options granted to directors. A charge of $49,375 was recorded in
2008 related to vesting of a director’s warrants. No similar charge
occurred in 2009.
Loss
from Operations
The loss
from operations for the twelve months ended December 31, 2009 was $2,007,988
compared to a loss from operations of $2,185,460 for the prior
year. The decreased loss was due to the decrease in expenses as
previously discussed.
Other
Income and Expense
Interest
income was $6,393 for the twelve months ended December 31, 2009 compared to
$39,160 in 2008. Decreased interest income was due to the lower
average cash available to invest throughout 2009 and the decreasing interest
rates available.
Interest
expense was $15,276 in 2009 compared with $1,161 in 2008. This
increase relates to the $14,437 in interest paid to the holder of the $500,000
promissory note in 2009. See Liquidity and Capital Resources – Cash
Flow from Financing Activities for additional information regarding the issuance
of the promissory note.
Net
Loss
The net
loss for the twelve months ended December 31, 2009 was $2,016,871 compared to a
net loss of $2,147,460 for the twelve months ended December 31,
2008. The decreased loss was due to the overall decrease in expenses
as previously discussed.
Net loss
per share attributable to common shareholders was $0.01 for both the twelve
months ended December 31, 2009 and 2008.
Liquidity
and Capital Resources
At
December 31, 2009, the Company had $2,951,270 in cash and cash equivalents and
total current liabilities of $824,334. Additionally, during the first
quarter of 2010, we received approximately $3,150,000 in cash from the exercise
of warrants and from the receipt of a final payment under the settlement
agreement with Vermillion. On March 29, 2010, our total cash and cash
equivalents was approximately $5,200,000. As a result of the proceeds
from the exercise of our warrants and the sale of the Series B Preferred Stock,
we believe we have sufficient resources to meet all of our current
obligations. Our net loss for the twelve months ended December 31,
2009 was $2,016,871. However, cash used by operating activities for
the twelve months ended December 31, 2009 was $1,298,940. The net loss is
favorably offset by net non-cash charges to operations and adjustments of
$717,931, which did not require the use of cash. Cash used by
investment activities was $638,480 due to the acquisition of fixed assets and
the addition of $622,358 in certificates of deposit.
Cash provided by
financing activities was $3,940,445, comprised of the sale of Series B Preferred
Stock for $1,490,015 and $2,450,430 from the issuance of Common Stock as a
result of warrant exercises.
The
Company has no future commitments for capital expenditures and anticipates no
changes of circumstances likely to require material demands on
liquidity.
Cash
Flow from Operating Activities
In
February 2009 in connection with the licensing agreement, Abbott paid to us a
one-time initial signing fee of $100,000. In addition, with respect
to the Products, Abbott may be obligated to pay milestone payments outlined
above if certain targets are met. On August 7, 2009, Abbott
reimbursed the Company $100,000 in development costs as required by the license
agreement.
On
January 30, 2009, we entered into a license agreement with Quest, pursuant to
which the Company granted to Quest a non-exclusive, royalty bearing license for
developing and commercializing a urine-based LDT for clinically significant
prostate cancer which could be commercialized and sold by Quest’s clinical
laboratories directly to physicians for their patients. In
consideration of granting the license to Quest, Quest paid a license fee to the
Company and will pay running royalty payments, and certain milestone
payments.
In
September 2009 and September 2008, we received royalty proceeds related to our
licensing agreement with Bruker Daltonics. The royalties relate to
Bruker Daltonics’ sales of its ClinProTools™ clinical proteomics product line
for its mass spectrometers, which contains HDC’s SVM technology.
Cash
Flow from Financing Activities
Pursuant
to the Company’s rights under certain warrants to acquire shares of Company
Common Stock at an exercise price of $0.19 (the “Tranche 2 Warrants”), as a
result of the Company’s stock achieving minimum trading price thresholds, in
March 2010 the Company elected to require the exercise or forfeiture of certain
of the Tranche 2 Warrants (the “Tranche 2 Call Right”). As a result
of the Company’s election with respect to its Tranche 2 Call Right and other
voluntary exercises by holders of the Tranche 2 Warrants, the Company issued
11,729,390 shares of Common Stock for gross proceeds of $2,228,584 and warrants
to acquire 3,001,827 shares were forfeited. See Note L – Subsequent
Events to our financial statement for the fiscal year ended December 31, 2009
for further information on the Company’s call of the Tranche 2
Warrants.
Pursuant
to the Company’s rights under certain warrants to acquire shares of Company
Common Stock at an exercise price of $0.14 (the “Tranche 1 Warrants”), as a
result of the Company’s stock achieving minimum trading price thresholds, in
November 2009, the Company elected to require the exercise or forfeiture of
certain of the Tranche 1 Warrants (the “Tranche 1 Call Right”). As a
result of the Company’s election with respect to its Tranche 1 Call Right and
other voluntary exercises by holders of the Tranche 1 Warrants, the Company
issued 15,878,073 shares of Common Stock for gross proceeds of $2,222,930 and
warrants to acquire 1,759,394 shares were forfeited.
In 2009,
the Company, pursuant to the Purchase Agreement, sold 19,402,675 shares of
Series B Preferred Stock for an aggregate purchase price of $1,490,015, net of
associated expenses.
On June
30, 2009, we issued a promissory note for $500,000 to a director and long-term
shareholder. The promissory note contained an 8% annual interest rate
and was due on January 4, 2010. The promissory note was secured by
certain intellectual property and other assets of the Company. The
proceeds from the promissory note were used for general working capital
purposes. This short term debt financing was intended to serve as a
bridge to anticipated future licensing revenues in a manner which is not
dilutive to shareholders. On November 11, 2009, the Company paid in
full the outstanding balance of $500,000, with a total payment, including
interest, of $514,437, thus eliminating this debt and any collateral obligations
on the Company’s intellectual property or other assets.
The
Company continues to incur maintenance fees (fees to various governmental patent
offices on previously filed patents) for its patent portfolio and expects those
fees to be approximately $250,000 during 2010.
The
Company has relied primarily on equity funding plus debt financing for
liquidity. While the Company has produced limited revenue, it must
continue to do so in order to generate sufficient cash to continue
operations. The Company believes it currently has sufficient cash to
support operations until it is able to generate revenue through royalty payments
from the molecular diagnostic deals signed, revenue generation from the melanoma
risk assessment and additional new licensing fees from its significant patent
portfolio and development fees for providing services related to those
patents. The Company expects to receive the $500,000 License Fee and
additional the $375,000 development fees from Quest this year from the breast
cancer molecular diagnostic test. In addition, the Company has been
and continues to be in meaningful discussions with a variety of parties related
to the commercialization efforts discussed above, which if successful, may
result in significant revenue. Should it prove necessary, the Company
may also consider such alternatives as raising additional equity through private
placements and/or debt offerings.
Subsequent
Events
On March
11, 2010, the Company, SPM and Quest entered into a Development Agreement (the
“Quest Development Agreement and related License Agreement related to the
development of new laboratory tests for aiding in the selection of breast cancer
therapies. In consideration for the license, Quest will separately
make payments to SPM and us. Such payments to us will include a $500,000 up
front “Development License Fee,” monthly “License Maintenance Fees” equal to
$8,750 for the first year and $17,500 for each year thereafter (with such fees
being credited against the “Royalty Payments” described below), upon the
publication of a study performed for the Validation Work an “Initial Product
License Fee” of $125,000 for each of the first two Products, and “Royalty
Payments” equal to 2.45% of the Net Sales of each Licensed Product (i.e., each
breast cancer test) sold by Quest. Quest will reimburse SPM and us for costs
incurred related to any Validation Work done with respect to a
Product. Pursuant to the Quest Development Agreement, we are required
to use the support vector machine technology and other intellectual property
licensed to SPM to analyze data for the development and/or validation of
applications of clinical laboratory services, In Vitro Diagnostic kits, clinical
trial services and the other elements of “Field” (collectively, the
“Products”). In consideration for our efforts under the Quest
Development Agreement, Quest will pay us $375,000 (in addition to the $500,000
described above), which payments shall be made in equal monthly installments
over the next nine months.
In
February 2010, we announced that we are developing a melanoma/skin cancer mobile
phone application which will enable customers to take a picture of a mole,
lesion or birthmark, send it to us, and receive a risk assessment for melanoma
and other skin cancer on their mobile phone. This first-ever
melanoma/skin cancer mobile phone application using our SVM technology will
employ sophisticated image analysis techniques using patent protected algorithms
for evaluating moles, lesions and birthmarks. Since mid-February
2010, Health Discovery Corporation has made significant progress on our melanoma
risk management mobile phone application. We have selected Apple’s
iPhone as our initial mobile platform and have been focused on tuning image
capture and analysis capabilities for skin lesions and moles for that
platform. In addition, we have initiated discussions with potential
U.S. and non-U.S. laboratory partners, dermatologists and marketing
partners. Discussions have also begun with the research arm of a
major medical center expert in skin cancer for joint research
opportunities. We anticipate a limited beta release of the iPhone
application around Memorial Day, 2010. This release will enable us to
optimize and refine the application prior to a subsequent public launch of the
risk assessment tool. The application will combine free skin health educational
and research services with the melanoma risk assessment available for a
charge. The retail price for a melanoma risk assessment will be
competitive and reasonable for the service provided. We expect
to generate revenues from the iPhone application and website services in the
third quarter 2010.
In
February 2010, the Company entered into an exclusive agreement with the
Pancreas, Biliary and Liver Surgery Center of New York at Saint Vincent Catholic
Medical Centers in New York City to develop new molecular diagnostic tests for
the early detection of pancreatic cancer. The Pancreas, Biliary and Liver
Surgery Center is under the leadership of Drs. Michael Wayne, Franklin Kassim
and Avram Cooperman. Under the terms of the agreement, the Pancreas,
Biliary and Liver Surgery Center will provide all specimens from their collected
specimen banks, specimens on all new patients and all associated clinical and
outcomes data. The specimens will include tissue, blood and
urine. The Company will use its patent protected SVM-based discovery
technology and science team in an attempt to develop these new molecular
diagnostic tests for pancreatic cancer in a similar fashion to the urine-based
prostate cancer test developed by the Company and licensed for development and
commercialization to Quest Diagnostics and Abbott on a royalty-based, world-wide
co-exclusive basis. The Company will own all of the intellectual
property and commercialization rights to these newly discovered molecular
diagnostic tests for pancreatic cancer, and the Company intends to partner with
a large clinical laboratory for development, marketing and commercialization of
these new pancreatic cancer tests.
Also in
February 2010, the Company entered into an exclusive agreement with the
Pancreas, Biliary and Liver Surgery Center of New York to provide clinical
specimens to be utilized to complete the final validation of HDC's molecular
diagnostic test for colon cancer. Under the terms of the agreement, the
Pancreas, Biliary and Liver Surgery Center of New York will provide specimens
from its collected specimen banks, as well as blood and tissue specimens on all
new patients along with all associated clinical and outcomes
data. The Company owns all of the intellectual property and
commercialization rights to this molecular diagnostic test for colon cancer, and
HDC intends to partner with a large clinical laboratory for development,
marketing and commercialization of this new colon cancer test.
In
January 2010, the Company received the final payment of $150,000 that was due
under an agreement that settled the Company’s patent infringement lawsuit
against Vermillion, Inc. (formerly known as Ciphergen Biosystems,
Inc.).
In
February 2010, the Company appointed D. Paul Graham to the Board to fill the
vacancy created by the resignation of Dr. Michael Hanbury, who resigned due to
his acceptance of new senior executive responsibilities with Spectrum Laboratory
Network in Greensboro, North Carolina. Dr. Hanbury will continue to
assist the Company as an unpaid advisor.
On
January 11, February 15 and February 26, 2010, three new provisional
applications were filed in the U.S. Patent and Trademark Office covering stages
in the Company’s development of the smart phone application for melanoma
screening. Also in January 2010, a new continuation application was
filed in the U.S. Patent and Trademark Office seeking expanded claims covering
the use of SVMs for analysis of spectral data. With these new
filings, the Company now has 33 pending U.S. and foreign patent
applications.
In March
2010, the U.S. Patent and Trademark Office issued the Company’s second patent
covering the use of SVMs for analysis of protein mass spectrometry data for
using in biomarker discovery. With the issuance of this patent, the Company now
holds the exclusive rights to 42 issued U.S. and foreign patents.
The
Company has been selected by MDB Capital Group as one of its Top 50 “Best and
Brightest” companies that will present at the invitation-only, 1
st
Annual Bright Lights Conference on May 10-12, 2010. This will be the
first public company conference to focus exclusively on companies with
disruptive and market changing intellectual property. The
Company was selected to present on the basis of ranking in the top 10th
percentile for IP leadership from over 1,600 small cap companies with U.S.
patents granted, as rated by
PatentVest
, MDB Capital
Group’s proprietary IP intelligence platform. In addition, The
Company is a nominee for MDB Capital Group’s first-ever “Provectus Award” to be
handed-out at the conference. The term “provectus” is Latin for “most
advanced.” This award will be presented to the top 5 companies across
all industries with the highest combined Tech Score, Patent Application CAGR and
number of patent grants. The Provectus Award will recognize the
strength of IP process and given to the “Best of the Best”.
Critical
Accounting Policies, Estimates and Assumptions
We
consider our accounting policies related to revenue recognition, impairment of
intangible assets and stock based compensation to be critical accounting
policies. A number of significant estimates, assumptions, and judgments are
inherent in our determination of when to recognize revenue, how to evaluate our
intangible assets, and stock-based compensation expense. These estimates,
assumptions and judgments include deciding whether the elements required to
recognize revenue from a particular arrangement are present, estimating the fair
value of an intangible asset, which represents the future undiscounted cash
flows to be derived from the intangible asset, and estimating the useful life
and volatility of stock awards granted. We base our estimates and judgments on
historical experience and on various other assumptions that we believe to be
reasonable under the circumstances. Actual results could differ materially from
these estimates.
Valuation
of intangible and other long-lived assets.
We assess
the carrying value of intangible and other long-lived assets at least annually,
which requires us to make assumptions and judgments regarding the future cash
flows related to these assets. The assets are considered to be
impaired if we determine that the carrying value may not be recoverable based
upon our assessment of events or changes in circumstances such as:
|
§
|
the
asset’s ability to continue to generate income from operations and
positive cash flow in future periods;
|
|
|
|
|
§
|
loss
of legal ownership or title to the asset;
|
|
|
|
|
§
|
significant
changes in our strategic business objectives and utilization of the
asset(s); and
|
|
|
|
|
§
|
the
impact of significant negative industry or economic
trends.
|
If the
assets are considered to be impaired, the impairment we recognize is the amount
by which the carrying value of the assets exceeds the fair value of the assets.
In addition, we base the useful lives and related amortization or depreciation
expense on our estimate of the period that the assets will generate revenues or
otherwise be used by us. We also periodically review the lives assigned to our
intangible assets to ensure that our initial estimates do not exceed any revised
estimated periods from which we expect to realize cash flows from the
technologies. If a change were to occur in any of the above-mentioned factors or
estimates, the likelihood of a material change in our reported results would
increase.
Revenue
Recognition
We
recognize revenue principally from license and royalty fees for intellectual
property and from development agreements with research partners. Each element of
revenue recognition requires a certain amount of judgment to determine if the
following criteria have been met: (i) persuasive evidence of an arrangement
exists; (ii) delivery has occurred or services have been rendered; (iii) the
seller’s price to the buyer is fixed or determinable; (iv) collectability is
reasonably assured, and (v) both title and the risks and rewards of ownership
are transferred to the buyer. We are required to make significant estimates
involving our recognition of revenue from license and royalty fees. Our license
and royalty fees revenue estimates depend upon our interpretation of the
specific terms of each individual arrangement and our judgment to determine if
the arrangement has more than one deliverable and how each of these deliverables
should be measured and allocated to revenue. In addition, we have to make
significant estimates about the useful life of the technology transferred to
determine when the risk and rewards of ownership have transferred to the buyer
to decide the period of time to recognize revenue. In certain circumstances we
are required to make judgments about the reliability of third party sales
information and recognition of royalty revenue before actual cash payments for
these royalties have been received. Changes to these assumptions or
market conditions could cause changes in revenues.
Share-Based
Compensation
Share-based
compensation expense is significant to our financial position and results of
operations, even though no cash is used for such expense. In determining the
period expense associated with unvested options, we estimate the fair value of
each option at the date of grant. We believe it is important for investors to be
aware of the high degree of subjectivity involved when using option pricing
models to estimate share-based compensation. The determination of the fair value
of share-based payment awards on the date of grant using an option-pricing 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 valuation methodology, the expected term, expected stock price
volatility over the term of the awards, the risk-free interest rate, expected
dividends and pre-vesting forfeitures. If any one of these factors changes and
we employ different assumptions in future periods, the compensation expense that
we record could differ significantly from what we have recorded in the current
period.
For
share-based awards, we estimated the expected term by considering various
factors including the vesting period of options granted, employees’ historical
exercise and post-employment termination behavior; however, due to the limited
history of our Company, such data is limited. We estimated the expected
life will be substantially longer than the vesting period given the early
stage
nature of our
operations and accordingly have used the contractual life as the expected term.
Our estimated volatility was derived using our historical stock price
volatility. We have never declared or paid any cash dividends on our Common
Stock and currently do not anticipate paying such cash dividends. The risk-free
interest rate is based upon U.S. Treasury securities with remaining terms
similar to the expected term of the share-based awards.
Off-Balance
Sheet Arrangements
We have
no off-balance sheet arrangements that provide financing, liquidity, market or
credit risk support or involve leasing, hedging or research and development
services for our business or other similar arrangements that may expose us to
liability that is not expressly reflected in the financial
statements.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Our
executive officers, directors and significant employees are:
Name
|
Age
|
Position
|
Stephen
D. Barnhill, M.D.
|
51
|
Chief
Executive Officer and Chairman of the Board
|
R.
Scott Tobin
|
55
|
President,
General Counsel, Principal Financial Officer and
Director
|
Thomas
L. Gallagher
|
47
|
Executive
Vice President and Managing Director of Global IP
Strategies
|
D.
Paul Graham
|
47
|
Director
|
Joseph
McKenzie
|
60
|
Director
|
Ramananda
K. Madyastha, M.D., Ph.D
|
73
|
Senior
Vice President
|
John
A. Norris
|
63
|
Chief
Operating Officer
|
Hong
Zhang, Ph.D.
|
48
|
Senior
Vice President
|
In
addition to the information presented in the biographical details below
regarding each director’s specific experience, qualifications, attributes and
skills that led us to conclude that he should serve as a director, we also
believe that all of our directors have a reputation for integrity, honesty and
adherence to high ethical standards. They each have demonstrated
business acumen and an ability to exercise sound judgment, as well as a
commitment of service to the Company and our Board.
Stephen D.
Barnhill, M.D.,
is currently our Chief
Executive Officer and has been since September 2003
.
He also serves as our
Chairman of the Board and has been a member of the Board of Directors since
November 2003. He is a physician trained in laboratory medicine and
clinical pathology. He has developed and used artificial intelligence,
pattern-recognition, and computational techniques in Medicine, Genomics,
Proteomics, Diagnostics and Drug Discovery.
Dr.
Barnhill is or has been a Fellow of the American College of Physician Inventors,
the American College of International Physicians, the American Medical
Association, the American College of Physician Executives, the American
Association of Artificial Intelligence, the American College of Managed Care
Medicine, the Association of Clinical Scientists, the American Society of
Contemporary Medicine and Surgery, the American Society of Law, Medicine and
Ethics, the Southern Medical
Society, the American
Federation for Clinical Research, and the National Federation of Catholic
Physicians.
Dr.
Barnhill founded the Barnhill Clinical Laboratories in 1988 and served as
Chairman, CEO, President and Medical Director. This laboratory was later
acquired by Corning-Metpath in 1989 and after the acquisition he served as
Medical Director of this clinical laboratory until 1992.
In 1992,
Dr. Barnhill founded National Medical Specialty Laboratories and served as
Chairman, CEO, President, and Medical Director. This research laboratory was
founded to utilize pattern-recognition mathematics and artificial intelligence
techniques in cancer diagnosis. Dr. Barnhill is an inventor on the
very first patents issued by the United States Patent and Trademark Office for
the use of neural networks in medicine. This company was acquired by Horus
Therapeutics, a New York based pharmaceutical company. Dr. Barnhill
served as Executive Vice-President and Chairman of the Scientific Advisory Board
for Horus Therapeutics until 1998. Johnson & Johnson later acquired the
Horus patents invented by Dr. Barnhill.
In 1999,
Dr. Barnhill founded and served as Chairman, President and CEO of Barnhill
BioInformatics, Inc., which later became Barnhill Genomics, Inc. and BioWulf
Technologies, LLC and raised over $13.5 million in private placement
funding. The primary focus of these companies was to utilize
the next generation of artificial intelligence and pattern-recognition
techniques, known as support vector machines, to identify genes that cause
cancer. Dr. Barnhill is the sole inventor on the very first patents issued by
the United States Patent and Trademark Office for the use of support vector
machines in medicine. From the summer of 2000 until he organized The
Barnhill Group L.L.C. in the summer of 2003, Dr. Barnhill was not engaged in any
professional activities as the result of a non-compete agreement signed by Dr.
Barnhill when he left the employment of Barnhill Genomics, Inc.
D. Paul Graham
has been a member of the Board of Directors since February
2010. In 1997, after a successful 12-year career with one of Canada’s
premier transportation companies, Mr. Graham opened offices in Toronto, Canada
to bring M&A experience and value to what he considered the underserviced
sector of the small to middle market. In 2002, he added offices in
Atlanta, Georgia and in 2005 opened offices in Savannah, Georgia, which is now
his principal office.
As CEO of
Graham Capital Partners, LLC (“GCP”), Mr. Graham fuels the Company’s strategic
direction. GCP provides investment banking and business advisory
services to the small and middle markets for companies achieving revenues
between $10 million and $100 million.
GCP
undertakes multi-industry transactions and mandates with an emphasis on
transportation, logistics, distribution, manufacturing, and business
services. Mr. Graham has been involved in acquisitions, divestitures,
and financings totaling over $200,000,000 in transaction value in North America
and abroad.
Leveraging
his multifaceted experience gained in over two decades of day to day operations
and finance of privately held companies, Mr. Graham leads GCP in M&A and
advisory services in North America, Europe and North Africa.
Mr.
Graham was educated at Lakehead University and York University in the
disciplines of accounting and finance. Mr. Graham serves in an
advisory capacity and as a director for a number of privately held corporations
and is a member of the Atlanta chapter of the Association for Corporate
Growth.
Joseph McKenzie,
D.V.M.,
has been a member of the Board of Directors since April 2009. Dr.
McKenzie practices veterinary medicine, having founded and managed the
multi-million dollar growth of multiple veterinary practices in Georgia, South
Carolina and Florida. He also created and built the community “drug dog”
program, which over the years and across the nation has become a generally
accepted and highly successful weapon against drug smuggling at the port of
Savannah as well as in the community at large. Dr. McKenzie has also been
honored for his years of valuable service on the Board of Directors of the
Georgia Veterinary Medical Association. Dr. McKenzie holds a degree in chemistry
from Armstrong Atlantic State University, where he was recently honored as its
most outstanding alumnus. He also holds a doctorate in veterinary science from
the University of Georgia’s College of Veterinary Medicine.
R. Scott Tobin
is our
President,
General Counsel and Director and has been since April 2009. Mr. Tobin
brings over twenty-five years of corporate law experience. During his
legal practice, Mr. Tobin primarily focused on mergers and acquisitions,
corporate governance and finance. He most recently practiced with the
Savannah, Georgia, law firm of Hunter Maclean. In addition, he has
enjoyed success as a senior executive, entrepreneur and venture
capitalist. Mr. Tobin also served as Executive Vice President for
Global Strategies at a publicly traded technology company, CEO of a North
Carolina manufacturer, General Counsel to a global software firm, Managing
Partner of the Atlanta office of a European law firm and an Assistant Attorney
General for the State of Georgia. A graduate of the University of North Carolina
at Chapel Hill and its School of Law, he now serves as President and Chairman of
the law school’s foundation. Mr. Tobin also has served as the
founding director of the UNC School of Law Initiative for Corporate Governance
and as a member of the UNC School of Law Council for Entrepreneurial Law. He was
recognized in 2003 as one of the Top 10 business people in the Triad Region of
North Carolina.
The
following sets forth the biographical information for our executive officers and
significant employees:
Thomas L.
Gallagher
has served as our Executive Vice President, Managing Director
of Global IP Strategies and Associate General Counsel since December
2009. Mr. Gallagher spent almost fifteen years on Wall Street as a
securities and business transaction lawyer, as well as an assistant general
counsel managing risk on a transaction and policy basis for a then-$9 billion
publicly traded company. He went on to become a Vice President at Goldman, Sachs
Co. (NYSE: GS - News), New York, NY, where he helped co-lead the restricted
stock desk on the equity trading floor. He pioneered the use of
10b5-1 selling plans, working with CEOs and other corporate executives to manage
their large, single stock risk. He also assisted numerous companies in strategic
buy backs of their stock. Subsequently, Mr. Gallagher was also a member of an
investment management team at Goldman Sachs that advised clients with
approximately $1.5 billion in assets. In addition to his Wall Street
experience, among other activities, Gallagher spent three years working on a
pro bono
basis
for Mother Teresa’s
religious order, the Missionaries of Charity, developing and administering the
Mother Teresa of Calcutta Center, Inc., and traveling to Calcutta, India, among
other locations. He spent a year working for a Jesuit-affiliated not-for-profit
organization supporting
Fe y
Alegria
, a network of 2,600 schools for the poor serving 1.3 million
students in Latin America and the Caribbean.
Ramananda K.
Madyastha, M.D., Ph.D
, has served as our Senior Vice President of
Research and Development since 2003. Dr. Madyastha is the Recipient
of the Raja Ravi Sher Singh of Kalsia Memorial Cancer Research Prize for
outstanding contributions in the field of cancer research. He served on the
Faculty of the Basic and Clinical Immunology and Microbiology Department at the
Medical University of South Carolina. Dr. Madyastha has been an active member of
the American Association of Cancer Research for more than 20 years. In addition,
he is Board Certified by the American Board of Managed Care Medicine and is a
licensed Clinical Laboratory Director. Dr. Madyastha was involved in the
development of the first neural network based diagnostic tests for prostate and
ovarian cancer.
John A. Norris
has served as our Chief Operating Officer since September
2009. Mr. Norris also serves as Chairman of Norris
Capital. From March 2007 to November 2008, Mr. Norris served as the
Chairman and CEO of Needlebot, Inc. From May 1999 to June 2005 Mr.
Norris served as the Chairman and CEO of Coprindm Corporation (now Decision
View).
Mr. Norris
is a Former Principal Deputy Commissioner and COO of the US FDA in Washington,
DC, where he led the last major FDA-reform initiative, from May 1984 to May
1988. This work was performed under the overall leadership and
guidance of President Ronald Reagan, HHS Secretaries Margaret Heckler and Dr.
Otis Bowen, FDA Commissioner Dr. Frank Young, Senator Orrin Hatch, and
Congressman Paul Rogers. Until recently, he also taught healthcare
policy and management (including healthcare-reform, Medicare-reform,
healthcare-IT-reform, personalized-medicine-reform, and FDA-reform) at Harvard
University, and was Founder and Faculty-Editor-in-Chief of the
American Journal of Law, Medicine,
and Ethics
, a leading academic publication covering healthcare policy,
law, regulation, management, finance, and ethics. Mr. Norris has been
the CEO to a significant number of successful life-sciences and healthcare-IT
companies and has served on the boards of and/or consulted with dozens
more. For example, he helped champion the billion dollar turn-around
of the laser eye surgery company, Summit Technology, and he was Chairman of the
Board of the American Society of Law, Medicine, and
Ethics. Additionally, he has consulted with senior executives of
leading companies, including Pfizer, Merck, J&J, and Glaxo, among
others.
Hong Zhang, Ph.D.
has been our
Senior
Vice President, Computational Medicine since 2004. As visiting
faculty at Johns Hopkins University, Dr. Zhang lectured at the Center for
Biomarker Discovery on Bioinformatics: Peak Detection Methods for Mass Spectral
Data. Currently a Yamacraw Associate Professor at Armstrong Atlantic
University, Dr. Zhang was the Vice President and CIO for a neural network and
computer assisted medical diagnostic systems company that employs neural network
and mathematical/statistical preprocessing techniques. In this
position, Dr. Zhang was involved in digital image processing and pattern
recognition for medical image processing as well as software design and
programming for support vector machine applications. Dr. Zhang was a
professor in the Department of Mathematical Sciences at Purdue University from
1989 to 1996. He has held numerous academic positions, including
Adjunct Associate Professor, Associate Professor with Tenure, and Assistant
Professor. He was a visiting Associate Professor in 1995 in the
Department of Biometry at the Medical University of South Carolina.
Throughout
his academic career, Dr. Zhang has consulted on many software and analytical
development projects for Union Switch and Signal, Inc., General Electric
Company, and the Department of Pharmacology at the University of
Pittsburgh. Dr. Zhang has published numerous articles on the use of
neural networks in the detection of cancers. He has been published in
more than twenty medical and technical journals. Dr. Zhang received a
Ph.D., Mathematics at the University of Pittsburgh, 1989, M.A., Mathematics,
University of Pittsburgh, 1986, M.S.E.E., Electrical Engineering, University of
Pittsburgh, 1984, B.S., Computer Science, Fudan University, 1982. Dr.
Zhang’s numerous awards and honors include: National Cancer Institute SBIR
Grant, 1999, 2000; Purdue Research Foundation Summer Faculty Grant, 1993; IPFW
Summer Research Grant, 1992; Andrew Mellon Fellowship, 1986-1987; Andrew Mellon
Fellowship, 1985-1986; First Place, Fudan University Mathematics Competition,
1979.
The
directors named above will serve until the next annual meeting of our
stockholders. Absent an employment agreement, officers hold their
positions at the pleasure of the Board of Directors.
Audit
Committee
We do not
have a separately designated standing audit committee. The entire
board of directors is acting as our audit committee. Given the size
of the Company and the difficulty in attracting additional directors, the Board
has not designated an audit committee financial expert.
Audit
Report
The Board
of Directors oversees the Company’s accounting and reporting practices,
financial reports, internal controls and audit functions. Management is
responsible for the preparation and integrity of the Company’s consolidated
financial statements, accounting and financial reporting principles, disclosure
controls and procedures, internal control over financial reporting, and
procedures designed to assure compliance with accounting standards and
applicable laws and regulations. The Company’s independent registered public
accounting firm (the “independent auditors”) is responsible for performing an
independent audit of the consolidated financial statements and expressing an
opinion on the conformity of those consolidated financial statements with
generally accepted accounting principles, as well as performing an independent
audit and expressing an opinion on the effectiveness of internal control over
financial reporting.
The
Board, in overseeing the audit function, provides advice, counsel and direction
to management and the Company’s independent auditors on the basis of the
information it receives, through discussions with management and the independent
auditors, and the experience of the Board in business, financial and accounting
matters. The Board’s audit functions are not intended to duplicate or certify
the activities of management or the independent auditors. The Board meets with
management and the independent auditors to review the Company’s financial
statements and discuss various topics and events, including, but not limited to,
items related to the Company’s internal control over financial reporting,
critical accounting policies and the adequacy of disclosure in the Company’s
consolidated financial statements. In accordance with law, the Board has also
established procedures for the receipt, retention and treatment of complaints
received by the Company regarding accounting, internal controls, or auditing
matters, including the confidential, anonymous submission of concerns regarding
questionable accounting and auditing matters.
The Board
reports as follows with respect to the audit of the Company’s 2009 consolidated
financial statements:
|
●
|
The
Board has reviewed and discussed the Company’s 2009 audited consolidated
financial statements with its management, including the reasonableness of
significant estimates and judgments and the clarity of disclosure in the
Company’s financial statements, including the disclosures related to the
Company’s critical accounting policies;
|
|
●
|
The
Board has discussed with Hancock Askew & Co LLP, the matters required
to be discussed by SAS 61, which include, among other items, matters
related to the conduct of the audit of the Company’s consolidated
financial statements;
|
|
●
|
The
Board has received written disclosures and the letter from the independent
auditors required by the applicable requirements of the Public Company
Accounting Oversight Board regarding the independent auditor’s
communications with the Board concerning independence;
and
|
|
●
|
Based
on review and discussions of the Company’s 2009 audited consolidated
financial statements with management and discussions with Hancock Askew
& Co LLP, the Board recommended that the Company’s 2009 audited
consolidated financial statements be included in its Annual Report on Form
10-K.
|
This
report is provided by the entire Board of Directors.
Nominees
for Directors
In
filling vacancies and otherwise identifying candidates for our Board of
Directors, we seek individuals
who will be able to
guide our operations based on their business experience,
both past and present,
or their education. Responsibility for our operations is
centralized within
management.
Shareholder
Nomination of Candidates for Board of Directors
We have
not made any material changes to the procedures by which our shareholders may
recommend nominees to the Board of Directors. Nominations of persons
for election to the Board of Directors may be made by any shareholder who
complies with the notice provisions set forth in Section 3.8 of the Bylaws,
which provides that a shareholder’s notice must be delivered or mailed and
received at the principal executive office of the Company not less than thirty
days before the date of the meeting; provided, however, that in the event that
less than forty days’ notice or prior public disclosure of the date is given,
notice by the shareholder to be timely must be so received not later than the
close of business on the tenth day following the day on which the public
announcement of the meeting date was made. Such shareholder's notice
shall set forth (i) as to each person whom the shareholder proposes to nominate
for election or reelection as a Director, all information relating to such
person as required to be disclosed in solicitation of proxies for election of
Directors made in compliance with Regulation 14A under the Securities and
Exchange Act of 1934, as amended (including such person's written consent to
being named in a proxy statement as a nominee and to serving as a Director if
elected); and (ii) as to the shareholder giving the notice (A) the name and
address, as they appear on the books of the Company, of such shareholder and (B)
the class and number of shares of the Company's capital stock that are
beneficially owned by such shareholder. At the request of the Board
of Directors, any person nominated by the Board of Directors for election as a
Director shall furnish to the Secretary of the Company that information required
to be set forth in a shareholder's notice of nomination which pertains to the
nominee. No person shall be eligible for election as a Director of
the Company unless nominated in accordance with the provisions of Section 3.8 of
the Company’s Bylaws.
Code
of Ethics
The
Company has adopted a Code of Ethics applicable to our Chief Executive Officer
and Principal Financial Officer. This Code of Ethics is posted on our
website at www.healthdiscoverycorp.com. The Code of Ethics is also
available without charge upon request directed to Investor Relations, Health
Discovery Corporation, 2 East Bryan Street, Suite #601, Savannah,
GA 31401. The Company intends to disclose amendments or
waivers of the Code of Ethics required to be disclosed by posting such
information on its website.
Summary
Compensation Table
The
following table sets forth various elements of compensation for our Named
Executive Officers for each of the last two calendar years:
Name
and Principal
Position
|
|
|
Year
|
|
|
Salary
($)
|
|
|
Bonus
($)
|
|
|
Option
Awards
($)
|
|
|
All
Other Compensation
($)
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephen
D. Barnhill, M.D.
|
|
|
2009
|
|
|
$
|
300,000
|
|
|
$
|
8,508
|
|
|
$
|
—
|
(1)
|
|
$
|
31,855
|
(2)
|
|
$
|
340,363
|
|
Chief
Executive Officer
|
|
|
2008
|
|
|
$
|
300,000
|
|
|
$
|
50,000
|
|
|
$
|
172,485
|
(1)
|
|
$
|
38,291
|
(2)
|
|
$
|
560,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R.
Scott Tobin
|
|
|
2009
|
|
|
$
|
84,461
|
|
|
—
|
|
|
$
|
175,331
|
(1)
|
|
$
|
8,752
|
(2)
|
|
$
|
268,544
|
|
President
& General Counsel
|
|
|
2008
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1)
|
See
Note I –Stock Compensation, to the Company’s Financial Statements for the
fiscal year ended December 31, 2009 for disclosure of assumptions made in
the valuation of options.
|
|
(2)
|
Represents
health insurance premiums and reimbursed healthcare
costs.
|
Employment
Agreements
On August
15, 2008, the Company entered into an employment agreement with Dr. Stephen
Barnhill for his employment as Chief Executive Officer. The
employment agreement has a term of two years. Under the terms of the
employment agreement, Dr. Barnhill received a one-time retention signing bonus
of $50,000 and his annual base salary is $300,000. Dr. Barnhill will
also be eligible to receive a cash bonus equal to 10% of the Company’s revenue
received during the term of the employment agreement; but such cash bonus cannot
exceed 300% of his annual base salary. Dr. Barnhill was also granted
an option to purchase an aggregate of 6,000,000 shares of the Company’s Common
Stock at an exercise price of $0.08; 5,000,000 of which have vested with the
remaining 1,000,000 vesting upon the Company’s Common Stock achieving a minimum
share price. Dr. Barnhill is eligible to be reimbursed monthly for
reasonable and necessary business expenses and to receive health insurance
benefits and other benefits maintained by us for our executives. Dr.
Barnhill will be entitled to twenty paid vacation days during the calendar
year. If Dr. Barnhill’s employment is terminated for Cause, as that
term is defined in the employment agreement, or if Dr. Barnhill terminates the
employment agreement for Good Reason, as that term is defined in the employment
agreement, then Dr. Barnhill will receive as severance the amount of his base
salary for the remainder of the term and an amount equal to the actual cost of
ninety days of his COBRA premium payments. If the employment
agreement is terminated for any other reason than for Cause or for Good Reason,
Dr. Barnhill is not eligible to receive severance. The employment
agreement also generally provides that Dr. Barnhill will keep confidential
information confidential and that he will not compete with us in our business
nor solicit our customers or employees for a period of 12 months following
termination of employment.
We
entered into an employment agreement with Mr. R. Scott
Tobin effective April 15, 2009. The employment agreement has an
initial term of eighteen (18) months, beginning April 15, 2009, and will
automatically renew and continue for successive twelve (12) month periods unless
otherwise terminated. Mr. Tobin will receive an annual base salary
of $120,000 and will also be eligible to receive a bonus, which may be paid in
cash, stock, enhanced employee benefits or a combination thereof as determined
by the Company, of up to one hundred percent (100%) of his salary, based on
objectives jointly determined by Mr. Tobin and the Chairman and CEO.
Mr. Tobin was also granted an option to purchase an aggregate of 4,500,000
shares of the Company’s Common Stock at an exercise price of $0.08, which vest
over an eighteen (18) month period, and with respect to a portion of the
options, the Company attaining certain performance metrics, since achieved.
Mr. Tobin is eligible to receive health insurance benefits and other
benefits maintained by us for our executives. If Mr. Tobin’s
employment is terminated without Cause, as defined in the employment agreement,
or if Mr. Tobin terminates the employment agreement for Good Reason, as defined
in the employment agreement, then Mr. Tobin will receive as severance (i) the
maximum incentive bonus he would have received had he remained employed by the
Company the later of the entire calendar year in which the termination occurs or
the end of the term, (ii) the amount of his base salary for the remainder of the
term of the agreement plus ninety (90) days, and (iii) an amount equal to the
actual cost of ninety (90) days of his COBRA premium payments. If the
employment agreement is otherwise terminated, Mr. Tobin is not eligible to
receive severance, and will only receive his base salary accrued up to the
effective date of the termination, any unpaid earned and accrued incentive
bonus, payment for accrued and unused vacation, and reimbursement of expenses,
if any. The employment agreement also generally provides that Mr.
Tobin will keep confidential information confidential and that he will not
compete with us in our business nor solicit our customers or employees for a
period of twelve (12) months following termination of employment.
On
September 15, 2009, we entered into an employment agreement with Mr. John A.
Norris for his employment as Chief Operating Officer. In connection
with his service as Chief Operating Officer, Mr. Norris is responsible for
business development, primarily creating new strategic partnerships, licenses
and contracts to complement the Company’s existing agreements. The
employment agreement with Mr. Norris had an initial term of four months,
effective September 1, 2009, and the parties are continuing to perform under the
current agreement on a month to month basis. Mr. Norris receives a monthly
salary of $10,000. If Mr. Norris’ employment is terminated without Cause, as
defined in the employment agreement, or if Mr. Norris terminates the employment
agreement for Good Reason, as defined in the employment agreement, then Mr.
Norris will receive as severance the amount of his base salary for the remainder
of the term of the agreement. If the employment agreement is otherwise
terminated, Mr. Norris is not eligible to receive severance, and will only
receive his base salary accrued up to the effective date of the termination and
reimbursement of expenses, if any. The employment agreement also generally
provides that Mr. Norris will keep confidential information confidential and
that he will not compete with us in our business nor solicit our customers or
employees for a period of ninety days following termination of
employment.
Effective
December 1, 2009, we entered into an employment agreement with Mr. Thomas L.
Gallagher for his employment as Managing Director, SVM Diversified
Strategies. In connection with his service, Mr. Gallagher’s
responsibilities include executing on new licensing opportunities for the
Company’s SVM technology in the non-medical space. Mr. Gallagher
receives a monthly salary of $10,000.
Outstanding
Equity Awards at Fiscal Year-End
|
|
|
Option
Awards
|
Name
|
|
|
Number
of
Securities
Underlying
Unexercised
Options
(#) Exercisable
|
|
|
Number
of
Securities
Underlying
Unexercised
Options
(#) Unexercisable
|
|
|
Option
Exercise
Price
|
|
|
Option
Expiration
Date
|
Stephen
Barnhill M.D.
|
|
|
|
3,000,000
|
|
|
|
3,000,000
|
(1)
|
|
$
|
0.08
|
|
|
August
15, 2018
|
R.
Scott Tobin
|
|
|
|
1,000,000
|
|
|
|
3,500,000
|
(2)
|
|
$
|
0.08
|
|
|
April
29, 2019
|
(1) The
options vest according to the following vesting schedule: 2,000,000
vest on January 1, 2010 and upon the Company’s Common Stock’s closing price for
any 20 consecutive trading days achieving a minimum share price of $0.20 (which
occurred on December 1, 2009); and 1,000,000 vest on January 1, 2010 and upon
the Company’s Common Stock’s closing price for any 20 consecutive trading days
achieving a minimum share price of $0.25.
(2) The
options vest according to the following vesting schedule: On the
designated vesting dates, January 1, 2010 (1,500,000 vest) and September 15,
2010 (2,000,000 vest), based upon the Company’s having achieved during the term
of the agreement cash on hand in excess of $800,000 or a positive trailing
90-day EBITDA or raising an additional $1,000,000 in capital from new investors
excluding the exercise of warrants and options.
Director
Compensation
Outside
directors are paid $1.00 each year. Each outside director is awarded
options to purchase shares of Company Common Stock as described
below.
Name
|
|
Fees
Earned or
Paid
in Cash
($)
|
|
|
Option
Awards
($)
|
|
|
Total
($)
|
|
Stephen
D. Barnhill, M.D.
|
|
$
|
0.00
|
|
|
$
|
0.00
|
|
|
$
|
0.00
|
|
R.
Scott Tobin
|
|
$
|
0.00
|
|
|
$
|
0.00
|
|
|
$
|
0.00
|
|
Michael
Hanbury (1)
|
|
$
|
1.00
|
|
|
$
|
28,400
|
|
|
$
|
28,401
|
|
Joseph
McKenzie (2)
|
|
$
|
1.00
|
|
|
$
|
21,206
|
|
|
$
|
21,207
|
|
|
(1)
|
1,500,000
warrants granted in 2008. 750,000 remain outstanding as of
March 30, 2010 and 750,000 were forfeited upon Dr. Hanbury’s resignation
from the Board.
|
|
|
|
|
(2)
|
500,000
options granted in 2009 and remaining outstanding as of December 31,
2009.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS.
The
following table sets forth information concerning the beneficial ownership of
our Common Stock as of March 22, 2010 by (i) each of our directors, (ii) each of
our executive officers, (iii) each person who is known to us to be the
beneficial owner of more than five percent of our Common Stock, and (iv) all of
our executive officers and directors as a group. At March 22, 2010,
there were 210,723,486 shares of Common Stock outstanding and 19,402,675
shares of Series B
Preferred Stock outstanding. At March 22, 2010 there were no shares
of Series A Preferred Stock outstanding.
Name
and Address of Beneficial Owner
|
|
|
Amount
and Nature of
Beneficial
Owner
|
|
|
Percent
of
Class
(1)
|
Dr.
Stephen D. Barnhill
Chairman
of the Board, Chief Executive Officer and Director
2
East Bryan Street, Suite #601
Savannah,
GA 31401
|
|
|
24,855,722
(2)
|
|
|
11.58%
|
R.
Scott Tobin
President
& General Counsel, Director
2
East Bryan Street, Suite #601
Savannah,
GA. 31401
|
|
|
2,500,000
(3)
|
|
|
1.17%
|
D.
Paul Graham
Director
2
East Bryan Street, Suite #601
Savannah,
GA. 31401
|
|
|
0
(4)
|
|
|
0%
|
Joseph
McKenzie
Director
2
East Bryan Street, Suite #601
Savannah,
GA. 31401
|
|
|
6,056,225
(5)
|
|
|
2.84%
|
William
Quirk
2
East Bryan Street, Suite #601
Savannah,
GA 31401
|
|
|
55,461,664
(6)
|
|
|
22.71%
|
All
executive officers and directors as a
group (4 persons)
|
|
|
33,411,947
|
|
|
11.99%
|
|
(1)
|
The
percentage assumes the exercise by the stockholder or group named in each
row of all options or warrants for the purchase of our Common Stock held
by such stockholder or group and exercisable within 60 days as of March
31, 2010.
|
|
(2)
|
Includes
5,000,000 of vested options. The shares are held by The Barnhill Group
LLC, which is wholly owned by Dr. Barnhill.
|
|
(3)
|
Consists
of vested options.
|
|
(4)
|
None
of Mr. Graham’s options are exercisable within the next 60
days.
|
|
(5)
|
Includes
2,219,802 vested options.
|
|
(6)
|
Includes
33,527,778 vested warrants.
|
For
Equity Compensation Plan Information Table, see Item 5 – Market for Registrant’s
Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
On June
30, 2009, we issued a promissory note for $500,000 to Joseph McKenzie, a
director and long term shareholder. The promissory note contained an
8% annual interest rate and was due on January 4, 2010. The
promissory note was secured by certain intellectual property and other assets of
the Company. The proceeds from the promissory note were used for
general working capital purposes. This short term debt financing was
intended to serve as a bridge to anticipated future licensing revenues in a
manner which is not dilutive to shareholders. On November 11, 2009,
the Company paid in full the outstanding balance of $500,000, with a total
payment, including interest, of $514,437, thus eliminating this debt and any
collateral obligations on the Company’s intellectual property or other
assets.
In July
2008, the Company and DCL Medical Laboratories LLC (“DCL”) entered into a
development and license agreement for the collaborative development and
commercialization of SVM-based computer assisted diagnostic tests for the
independent detection of ovarian, cervical and endometrial
cancers. Due to a change in strategic direction involving DCL, we
mutually terminated the development and license agreement in January
2010. At the time we entered into the development and license
agreement,
Dr.
Hanbury, our former director, was President, CEO and a shareholder of DCL
Medical Laboratories.
The
Company has adopted the independence standards promulgated by the New York Stock
Exchange and has made a determination that, as of March 30, 2010, the
following directors are independent according to those
standards: Joseph McKenzie and Paul Graham.
DESCRIPTION
OF CAPITAL STOCK
The
following information concerning our capital stock summarizes certain provisions
of our Articles of Incorporation, commonly referred to as our Charter, and
Bylaws, as well as certain statutes regulating the rights of holders of our
common stock. The information does not purport to be a complete description of
such matters and is qualified in all respects by the provisions of the Charter,
the Bylaws and the Georgia Business Corporation Code.
Common
Stock
General.
We
are authorized to issue 300,000,000 shares of common stock, no par
value. As of
[March
22, 2010]
, there were
[210,732,486]
shares of common
stock outstanding. Holders of the common stock are entitled to one vote per
share for the election of directors and on all other matters submitted to a vote
of shareholders. Subject to any preferences for preferred shares then
outstanding, they are also entitled to dividends declared by the directors out
of funds legally available for payment of dividends. Holders of the common stock
do not have any cumulative voting rights or any preemptive or similar
rights. On September 8, 2008, the Company received notice,
claiming that certain anti-dilution rights had been triggered under the terms of
the Private Placement. See Item 15, Recent Sales of Unregistered
Securities on page II-1.
Assessment and
Redemption.
The shares of common stock presently
outstanding are, and the shares that will be issued in connection with this
offering will be, fully paid and non-assessable. There is no provision for
redemption or conversion of our common stock.
Liquidation
Rights.
In the event of our liquidation,
dissolution or winding up, whether voluntarily or involuntarily, the holders of
our common stock (and the holders of any class or series of preferred stock
entitled to participate with our common stock in the distribution of assets)
will be entitled to share ratably in any of the net assets or funds which are
available for distribution to shareholders, after the satisfaction of all
liabilities or after adequate provision is made therefor and after distribution
to holders of any class of stock having preference over our common stock in the
case of liquidation.
Our Transfer Agent is Corporate Stock
Transfer, 3200 Cherry Creek Drive South, Denver, Colorado 80209; telephone (303)
282-4800.
Preferred
Stock
We are
authorized to issue 30,000,000 shares of preferred stock. The Board
of Directors has the authority to issue classes or series of preferred stock in
the future having designations, rights, preferences and relative, participating,
option or other special rights of the shares of each such class or series,
including such things as voting rights, dividend rights, redemption rights, and
other restrictions and features. In November of 2007, the Company
issued 7,437,184 shares of Series A Preferred Stock in a conversion of $594,975
of secured debt to equity. On November 4, 2009, as a result of the
trading value of the Common Stock exceeding $0.12 per share for a period of 30
consecutive calendar days, all shares of Series A Preferred Stock converted by
its terms into 7,437,184 shares of Common Stock.
During
the first quarter of 2009 the Board of Directors authorized the designation of
Series B Preferred Stock. The number of shares originally constituting the
Series B Preferred Stock was 13,750,000, however, during the fourth quarter of
2009 the Board of Directors authorized the increase in the number of shares
constituting the Series B Preferred Stock to 20,625,000. The Company sold to
individual investors a total of 19,402,675 shares of Series B Preferred
Stock for $1,490,015, net of associated expenses, in 2009. The
Series B Preferred Stock has not been registered under either federal or state
securities laws and must be held until a registration statement covering such
securities is declared effective by the Securities and Exchange Commission or an
applicable exemption applies.
The
Series B Preferred Stock may be converted into Common Stock of the Company at
the option of the holder, without the payment of additional consideration by the
holder, so long as the Company has a sufficient number of authorized shares to
allow for the exercise of all of its outstanding warrants and options. The
Shares of Series B Preferred Stock must be converted into Common Stock of the
Company upon the demand by the Company after the fifth anniversary of the date
of issuance.
The
Series B Preferred Stock accrues dividends at the rate of 10% of the
Series B Original Issue Price per year, which shall be satisfied by the fifth
anniversary of the issuance of such shares of the Series B Preferred Stock
(the “Original Issue Date”) by the Companys issuance of the number of shares of
Common Stock equal to such accrued dividends divided by the average closing
price of the Company’s Common Stock as reported on the Over-the-Counter-Bulletin
Board or other exchange on which the Company’s Common Stock trades during the
prior ten business days or by the payment of cash, as the Company may determine
in its sole discretion. Dividends in the amount of $14,993 have been accrued for
Series B Preferred stock as of December 31, 2009.
Subject
to the limitations set forth in the Amended and Restated Articles of Amendment
to Articles of Incorporation and applicable law, as long as the Series B
Preferred Stock remain outstanding, the Company pay the holders of the Series B
Preferred Stock a special dividend equal to 15% of Company Net Revenue collected
beginning with the Original Issue Date and ending on the date the Series B
Preferred Stock cease to be outstanding (the “Cash Bonus”). Company
Net Revenue will include, but not be limited to, revenue derived from
development fees, license fees and royalties paid to the Company and revenue
collected as a result of the sale of any asset of the Company or distributions
from SVM Capital, LLC (each a “Revenue Contract”), reduced by the amount of any
out-of-pocket costs or expenses that are directly related to obtaining,
negotiating or documenting the Revenue Contracts and the performance of such
Revenue Contracts, but shall not include the proceeds of any capital infusions
from the exercise of outstanding options or warrants or as a result of any
capital raise undertaken by the Company. At any time following the
Original Issue Date, the Company may satisfy the special dividend right in its
entirety if the aggregate payments made to the Series B Holders is equal to that
value which provides an internal annual rate of return of twenty percent (20%)
on the Series B Preferred Stock. The maximum Cash Bonus to be paid
each year shall be the aggregate Series B Original Issue Price, and no amounts
in excess of such amount shall accrue or carry-over to subsequent
years.
No
dividend payment will be made if, after the payment of such dividend, the
Company would not be able to pay its debts as they become due in the usual
course of business, or the Company’s total assets would be less than the sum of
its total liabilities plus the amount that would be needed, if the Company were
to be dissolved, to satisfy the preferential rights upon the dissolution to
shareholders whose preferential rights are superior to those receiving the
dividend.
Any
amendment to the Charter authorizing an increase in the number of authorized
shares of preferred stock will require the prior approval of the holders of a
majority of our common stock, Series A Preferred Stock, and Series B Preferred
Stock then issued and outstanding. Although we do not have any present plans to
issue any additional preferred stock, the ownership and control of Health
Discovery Corporation by the holders of our common stock and Series A Preferred
Stock would be diluted if we were to issue additional preferred stock that had
voting rights.
Private
Placement Warrants
In 2007, the Company issued
51,538,822 shares of restricted Common Stock in return for $2.55 million in cash
and the conversion of approximately $1.6 million in debt. Proceeds
from the private placement were used for general working capital
purposes. Each purchaser of Common Stock also received one warrant to
acquire an equal number of shares at $0.14 (the “Tranche 1 Warrants”) and one
warrant to acquire an equal number of shares at $0.19 (the “Tranche 2
Warrants”). As a result of the Company’s Common Stock achieving
minimum trading price thresholds, the Company elected to require the exercise or
forfeiture of certain of the Tranche 1 Warrants in November, 2009, and of the
Tranche 2 Warrants in March 2010. As a result of the Company’s
election of its rights and other voluntary exercises by the holders of the
warrants, the Company issued 33,763,712 shares of Common Stock for gross
proceeds of $5,489,952 and warrants to acquire 4,761,222 shares were
forfeited. Warrants to purchase 31,276,358 shares at $0.14 and
33,276,355 shares at $0.19 remain outstanding.
Certain
Takeover Considerations
If the
Company were to pursue a merger or share exchange of the Company with or into
any other corporation, or any sale, lease, exchange or other disposition of all
or substantially all of the assets of the Company to any other corporation,
person or other entity, the Articles of Incorporation of the Company require
that the Board of Directors recommend the plan of merger, plan of conversion or
share exchange to the shareholders, unless the Board of Directors elects,
because of conflict of interest or other special circumstances, to make no
recommendation to the shareholder, and that two-thirds of all of the votes
entitled to be cast on the plan approve such plan.
Change in Number
of Directors.
Our bylaws provide that any change in the number
of directors requires the affirmative vote of at least a majority of the entire
Board of Directors or the affirmative vote of the holders of at least a majority
of the outstanding shares of common stock.
LEGAL
MATTERS
Certain
legal matters in connection with this offering have been passed upon for us by
Powell Goldstein LLP, Atlanta, Georgia.
EXPERTS
The
balance sheets as of December 31, 2009 and 2008 and the related statements of
operations, changes in stockholders’ equity, and cash flows for the years then
ended in this prospectus and registration statement have been audited by Hancock
Askew & Co., LLP, independent registered public accounting firm, as stated
in their report thereon included herein, and are included in reliance upon such
report given upon their authority as experts in accounting and
auditing.
WHERE
YOU CAN FIND MORE INFORMATION
HEALTH
DISCOVERY CORPORATION
|
1
|
PROSPECTUS
SUMMARY
|
4
|
RISK
FACTORS
|
6
|
USE
OF PROCEEDS
|
17
|
PRICE
RANGE OF COMMON STOCK AND DIVIDENDS
|
17
|
SELLING
SHAREHOLDERS
|
17
|
PLAN
OF DISTRIBUTION
|
20
|
PLAN
OF DISTRIBUTION
|
20
|
BUSINESS
|
21
|
BUSINESS
|
21
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
36
|
DIRECTORS
AND EXECUTIVE OFFICERS
|
46
|
DESCRIPTION
OF CAPITAL STOCK
|
53
|
LEGAL
MATTERS
|
55
|
EXPERTS
|
55
|
WHERE
YOU CAN FIND MORE INFORMATION
|
55
|
We file reports, proxy statements and
other information with the SEC pursuant to the information requirements of the
Securities Exchange Act of 1934. You can read and copy these reports, proxy
statements and other information concerning us at the SEC’s Public Reference
Room at 100 F Street, N.E, Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330
for further
information on the Public Reference Room. You can review our electronically
filed reports, proxy and information statements on the SEC’s Internet site at
http://www.sec.gov.
We have
filed with the SEC, Washington, D.C. 20549, a registration statement on Form S-1
under the Securities Act of 1933, as amended, with respect to our common stock
issuable upon the exercise of warrants offered hereby. This prospectus does not
contain all of the information set forth in the registration statement and the
exhibits and schedules to the registration statement. Certain items are omitted
in accordance with the rules and regulations of the SEC. For further information
with respect to our company and our common stock, reference is made to the
registration statement and the exhibits and any schedules filed with the
registration statement. Statements contained in this prospectus as to the
contents of any contract or other document referred to are not necessarily
complete and in each instance, if such contract or document is filed as an
exhibit, reference is made to the copy of such contract or other documents filed
as an exhibit to the registration statement, each statement being qualified in
all respects by such reference. You can obtain a copy of the full registration
statement, including the exhibits and schedules thereto, from the SEC as
indicated above.
Hancock
Askew & Co LLP
100
Riverview Drive
Savannah,
GA 31404
Report of
Independent Registered Public Accounting Firm
Board of
Directors
Health
Discovery Corporation
Savannah,
Georgia
We have
audited the accompanying balance sheets of Health Discovery Corporation as of
December 31, 2009 and 2008, the related statements of operations, changes in
stockholders' equity, and cash flows for each of the two years in the period
ended December 31, 2009. These financial statements are the responsibility
of the management of Health Discovery Corporation. Our responsibility is
to express an opinion on these 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 audits 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 expressed no such opinion. An audit also
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, 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 financial statements referred to above present fairly, in all
material respects, the financial position of Health Discovery Corporation as of
December 31, 2009 and 2008 and the results of its operations and its cash flows
for each of the two years in the period ended December 31, 2009 in conformity
with accounting principles generally accepted in the United States of
America.
/s/
Hancock Askew & Co., LLP
Savannah,
Georgia
March 30,
2010
HEALTH
DISCOVERY CORPORATION
Balance
Sheets
December
31, 2009 and 2008
Assets
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
Cash
|
|
$
|
2,328,912
|
|
|
|
325,887
|
|
Certificates
of Deposit
|
|
|
622,358
|
|
|
|
-
|
|
Accounts
Receivable
|
|
|
112,500
|
|
|
|
112,500
|
|
Prepaid
Expense and Other Current Assets
|
|
|
15,569
|
|
|
|
34,355
|
|
|
|
|
|
|
|
|
|
|
Total
Current Assets
|
|
|
3,079,339
|
|
|
|
472,742
|
|
|
|
|
|
|
|
|
|
|
Equipment,
Less Accumulated Depreciation of $19,251 and $25,947
|
|
|
24,667
|
|
|
|
14,888
|
|
|
|
|
|
|
|
|
|
|
Other
Assets
|
|
|
|
|
|
|
|
|
Deferred Charges
|
|
|
10,336
|
|
|
|
-
|
|
Patents,
Less Accumulated Amortization of $1,468,412 and $1,205,693
|
|
|
2,517,382
|
|
|
|
2,780,101
|
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
$
|
5,631,724
|
|
|
|
3,267,731
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
Current
Liabilities
|
|
|
|
|
|
|
Accounts
Payable – Trade
|
|
$
|
570,837
|
|
|
|
220,972
|
|
Accrued
Liabilities
|
|
|
214,122
|
|
|
|
245,742
|
|
Deferred
Revenue
|
|
|
39,375
|
|
|
|
57,153
|
|
|
|
|
|
|
|
|
|
|
Total
Current Liabilities
|
|
|
824,334
|
|
|
|
523,867
|
|
|
|
|
|
|
|
|
|
|
Deferred
Revenue – Long Term
|
|
|
504,560
|
|
|
|
396,562
|
|
|
|
|
|
|
|
|
|
|
Dividends
Payable
|
|
|
14,993
|
|
|
|
-
|
|
Total
Liabilities
|
|
|
1,343,887
|
|
|
|
920,429
|
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
Equity
|
|
|
|
|
|
|
|
|
Series
A Preferred Stock, Convertible, Stated Value of $0.08 per
Share,
|
|
|
|
|
|
|
|
|
7,437,184
Authorized, Issued and Outstanding 0 and 7,437,184
respectively
|
|
|
-
|
|
|
|
594,975
|
|
Series
B Preferred Stock, Convertible, 20,625,000 Shares
Authorized, Issued
|
|
|
|
|
|
|
|
|
and
Outstanding 19,402,675 and 0 Shares, respectively
|
|
|
1,490,015
|
|
|
|
-
|
|
Common
Stock, No Par Value, 300,000,000 Shares Authorized,
|
|
|
|
|
|
|
|
|
Issued
and Outstanding 194,462,847 and 169,522,590 Shares,
respectively
|
|
|
18,807,239
|
|
|
|
15,744,873
|
|
Accumulated
Deficit
|
|
|
(16,009,417
|
)
|
|
|
(13,992,546
|
)
|
|
|
|
|
|
|
|
|
|
Total
Stockholders' Equity
|
|
|
4,287,837
|
|
|
|
2,347,302
|
|
|
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
|
$
|
5,631,724
|
|
|
|
3,267,731
|
|
See
accompanying notes to financial statements.
HEALTH
DISCOVERY CORPORATION
Statements
of Operations
For the
Years Ended December 31, 2009 and 2008
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
Licensing
and Development
|
|
$
|
61,803
|
|
|
|
65,731
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
262,719
|
|
|
|
262,719
|
|
Professional
and Consulting Fees
|
|
|
406,786
|
|
|
|
757,748
|
|
Compensation
|
|
|
939,029
|
|
|
|
745,918
|
|
Other
General and Administrative Expenses
|
|
|
461,257
|
|
|
|
484,806
|
|
Total
Expenses
|
|
|
2,069,791
|
|
|
|
2,251,191
|
|
Net
Loss from Operations
|
|
|
(2,007,988
|
)
|
|
|
(2,185,460
|
)
|
|
|
|
|
|
|
|
|
|
Other
Income (Expense):
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
|
6,393
|
|
|
|
39,160
|
|
Interest
Expense
|
|
|
(15,276
|
)
|
|
|
(1,161
|
)
|
Total
Other Income (Expense)
|
|
|
(8,883
|
)
|
|
|
37,999
|
|
Net
Loss
|
|
$
|
(2,016,871
|
)
|
|
|
(2,147,461
|
)
|
|
|
|
|
|
|
|
|
|
Preferred
stock dividends
|
|
|
14,993
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Loss
attributable to common shareholders (Basic and Diluted)
|
|
$
|
(2,031,864
|
)
|
|
|
(2,147,461
|
)
|
|
|
|
|
|
|
|
|
|
Weighted
Average Outstanding Shares (Basic and Diluted)
|
|
|
173,418,302
|
|
|
|
169,165,786
|
|
|
|
|
|
|
|
|
|
|
Loss
Per Share (Basic and Diluted)
|
|
$
|
(.01
|
)
|
|
|
(.01
|
)
|
See
accompanying notes to financial statements.
HEALTH
DISCOVERY CORPORATION
Statements
of Changes in Stockholders’ Equity
For
the Year Ended December 31, 2009 and 2008
|
|
Issued
and Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
A
Preferred
Shares
|
|
|
B
Preferred
Shares
|
|
|
Common
Shares
|
|
|
A
Preferred
Amount
|
|
|
B
Preferred
Amount
|
|
|
Common
Amount
|
|
|
Accumulated
Deficit
|
|
|
Total
Stockholders'
Equity
|
|
Balance
– January 1, 2008
|
|
|
7,437,184
|
|
|
|
-
|
|
|
|
169,007,206
|
|
|
$
|
594,975
|
|
|
$
|
-
|
|
|
$
|
15,390,609
|
|
|
$
|
(11,845,085
|
)
|
|
$
|
4,140,499
|
|
Shares
issued pursuant to the terms of the Securities Purchase Agreement for no
additional consideration
|
|
|
-
|
|
|
|
|
|
|
|
515,384
|
|
|
|
-
|
|
|
|
-
|
|
|
|
36,077
|
|
|
|
-
|
|
|
|
36,077
|
|
Share-based
Compensation and Expense
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
318,187
|
|
|
|
-
|
|
|
|
318,187
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,147,461
|
)
|
|
|
(2,147,461
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
- December 31, 2008
|
|
|
7,437,184
|
|
|
|
-
|
|
|
|
169,522,590
|
|
|
$
|
594,975
|
|
|
$
|
-
|
|
|
$
|
15,744,873
|
|
|
$
|
(13,992,546
|
)
|
|
$
|
2,347,302
|
|
Shares
issued pursuant upon the exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
17,503,073
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,450,430
|
|
|
|
-
|
|
|
|
2,450,430
|
|
Stock
issued in connection with sales of Series B Preferred
Stock
|
|
|
-
|
|
|
|
19,402,675
|
|
|
|
|
|
|
|
|
|
|
|
1,490,015
|
|
|
|
|
|
|
|
|
|
|
|
1,490,015
|
|
Share-based
Compensation and Expense
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
31,954
|
|
|
|
-
|
|
|
|
31,954
|
|
Series
A Preferred Stock Exchanged for Common Stock
|
|
|
(7,437,184
|
)
|
|
|
|
|
|
|
7,437,184
|
|
|
|
(594,975
|
)
|
|
|
-
|
|
|
|
594,975
|
|
|
|
-
|
|
|
|
-
|
|
Series
B Preferred Stock Dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14,993
|
)
|
|
|
|
|
|
|
(14,993
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,016,871
|
)
|
|
|
(2,016,871
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
- December 31, 2009
|
|
|
-
|
|
|
|
19,402,675
|
|
|
|
194,462,847
|
|
|
$
|
-
|
|
|
|
1,490,015
|
|
|
$
|
18,807,239
|
|
|
$
|
(16,009,417
|
)
|
|
$
|
4,287,837
|
|
See
accompanying notes to financial statements.
HEALTH
DISCOVERY CORPORATION
Statements
of Cash Flows
For the
Years Ended December 31, 2009 and 2008
|
|
2009
|
|
|
2008
|
|
Cash
Flows From Operating Activities:
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(2,016,871
|
)
|
|
$
|
(2,147,461
|
)
|
Adjustments
to Reconcile Net Loss to Net Cash
|
|
|
|
|
|
|
|
|
Used
by Operating Activities:
|
|
|
|
|
|
|
|
|
Stock
Issued Pursuant to Shareholder Agreement
|
|
|
-
|
|
|
|
36,077
|
|
Share-based
Compensation and Expense
|
|
|
31,954
|
|
|
|
318,187
|
|
Depreciation
and Amortization
|
|
|
269,062
|
|
|
|
268,147
|
|
|
|
|
|
|
|
|
|
|
Changes
in Assets and Liabilities:
|
|
|
|
|
|
|
|
|
Decrease
(Increase) in Accounts Receivable
|
|
|
-
|
|
|
|
112,500
|
|
(Increase)
Decrease in Prepaid Expense & Other Assets
|
|
|
8,448
|
|
|
|
(526
|
)
|
Increase
(Decrease)in Accounts Payable – Trade
|
|
|
349,865
|
|
|
|
159,799
|
|
(Decrease)
Increase in Deferred Revenue
|
|
|
90,220
|
|
|
|
(62,708
|
)
|
(Decrease)
Increase in Accrued Liabilities
|
|
|
(31,618
|
)
|
|
|
6,153
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Used by Operating Activities
|
|
|
(1,298,940
|
)
|
|
|
(1,309,832
|
)
|
|
|
|
|
|
|
|
|
|
Cash
Flows From Investing Activities:
|
|
|
|
|
|
|
|
|
Purchase
of Equipment
|
|
|
(16,122
|
)
|
|
|
(12,720
|
)
|
Purchase
of Certificates of Deposits
|
|
|
(622,358
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Used by Investing Activities
|
|
|
(638,480
|
)
|
|
|
(12,720
|
)
|
|
|
|
|
|
|
|
|
|
Cash
Flows From Financing Activities:
|
|
|
|
|
|
|
|
|
Proceeds
from Related Party Note Payable
|
|
|
500,000
|
|
|
|
-
|
|
Repayment
of Related Party Note Payable
|
|
|
(500,000
|
)
|
|
|
-
|
|
Proceeds
from Warrant Exercise
|
|
|
2,450,430
|
|
|
|
-
|
|
Proceeds
from Issuance of Preferred B Stock
|
|
|
1,490,015
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Provided by Financing Activities
|
|
|
3,940,445
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net
Increase (Decrease) in Cash
|
|
|
2,003,025
|
|
|
|
(1,322,552
|
)
|
|
|
|
|
|
|
|
|
|
Cash,
at Beginning of Period
|
|
|
325,887
|
|
|
|
1,648,439
|
|
|
|
|
|
|
|
|
|
|
Cash,
at End of Period
|
|
$
|
2,328,912
|
|
|
$
|
325,887
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosures of Cash Flow Information:
|
|
|
|
|
|
|
|
|
Cash
Paid for Interest
|
|
$
|
15,276
|
|
|
$
|
1,161
|
|
See
accompanying notes to financial statements.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements
Note
A - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
DESCRIPTION
OF BUSINESS
Health
Discovery Corporation (the “Company”) is a biotechnology-oriented company that
has acquired patents and has patent pending applications for certain machine
learning tools, primarily pattern recognition techniques using advanced
mathematical algorithms to analyze large amounts of data thereby uncovering
patterns that might otherwise be undetectable. Such machine learning
tools are currently in use for diagnostics and drug discovery, but are also
marketed for other applications. The Company licenses the use of its
patented protected technology and may provide services to develop specific
learning tools under development agreements or to sell to third
parties.
USE
OF ESTIMATES
The
preparation of financial statements 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, disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during
the period. Accordingly, actual results could differ from those
estimates. Significant estimates that are particularly susceptible to
change in the near-term include the valuation of share-based compensation and
consideration for services and the recoverability of the patents.
RECLASSIFICATIONS
Certain
amounts from 2008 have been reclassified to conform to the presentation used in
2009. Items previously classified as cost of revenues have been
reclassified to operating expenses.
REVENUE
RECOGNITION
Revenue
is generated through the sale or license of patented technology and processes
and from services provided through development agreements. These
arrangements are generally governed by contracts that dictate responsibilities
and payment terms. The Company recognizes revenues as they are earned
over the duration of a license agreement or upon the sale of any owned patent
once all contractual obligations have been fulfilled. Revenue is
recognized under development agreements in the period the services are
performed.
CASH
AND CASH EQUIVALENTS
Cash and
cash equivalents include cash and monies invested in overnight funds with
financial institutions.
ACCOUNTS
RECEIVABLE
Trade
accounts receivable for licensing fees and development services are recorded at
net contract value based upon the written agreement with the customer. In
certain cases, accounts receivable may include royalties receivable from
customers based upon those customers estimated sales of the products or
diagnostic tests containing patented processes and technologies. The Company
considers amounts past due based on the related terms of the agreement and
reviews its exposure to amounts receivable based upon collection history and
specific customer credit analysis. The Company provides an allowance for
doubtful amounts if collectability is no longer reasonably assured. As of
December 31, 2009 and 2008, all amounts receivable were from a single customer
and considered fully collectable.
PROPERTY
AND EQUIPMENT
Property
and equipment, which consists of office furniture, computer equipment and
leasehold improvements, are stated at cost. Depreciation is calculated using the
straight-line method over the estimated useful lives of the assets, which range
from 3 to 10 years. Leasehold improvements are amortized using the
straight-line method over the estimated useful lives of the assets or the term
of the lease, whichever is shorter.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
A - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, continued
PATENTS
Initial
costs paid to purchase patents are capitalized and amortized using the straight
line method over the remaining life of the patent. The Company capitalizes the
external and in-house legal costs and filing fees associated with obtaining
patents on its new discoveries and amortizes these costs using the straight-line
method over the shorter of the legal life of the patent or its economic life,
generally 17 years, beginning on the date the patent is issued. If the
applied for patents are abandoned or are not issued, the Company will expense
the capitalized costs to date in the period of abandonment or earlier if
abandonment appears probable. The carrying value of patents is reviewed
for impairment whenever events or changes in circumstances indicate that the
carrying amount may not be recoverable. As of December 31, 2009, the Company
does not believe there has been any impairment of its intangible
assets.
INVESTMENTS
The
Company uses the equity method to account for its equity investments in ventures
for which it has 50% or less ownership and the ability to exercise significant
influence over operating and financial policies, but does not control. The
Company uses the cost method to account for its investments in companies that it
does not control and for which it does not have the ability to exercise
significant influence over operating and financial policies.
INCOME
TAXES
The
Company accounts for income taxes using the asset and liability method. Deferred
tax assets and liabilities are recognized for future tax benefits and expenses
or consequences attributable to temporary differences between the financial
statement carrying amounts of existing assets and liabilities and their
respective tax bases. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income for the
years in which those temporary differences are expected to be recovered or
settled.
In the
event the future tax consequences of differences between the financial reporting
bases and tax bases of the Company’s assets and liabilities result in deferred
tax assets, an evaluation of the probability of being able to realize the future
benefits indicated by such assets is made. A valuation allowance is provided for
the portion of the deferred tax asset when it is more likely than not that some
portion or all of the deferred tax asset will not be realized. In assessing the
realizability of the deferred tax assets, management considers the scheduled
reversals of deferred tax liabilities, projected future taxable income and tax
planning strategies.
STOCK-BASED
COMPENSATION
Stock-based
compensation cost is measured at grant date, based on the fair value of the
award, and is recognized as expense over the requisite service
period.
Valuation and Amortization
Method
– The fair value awards of stock which do not contain a market
condition target are estimated on the grant date using the Black-Scholes
option-pricing model. The fair value of options which contain a market
condition, such as a specified hurdle price, is estimated on the grant date
using a probability weighted fair value model similar to a lattice valuation
model. Both the Black-Scholes and the probability weighted valuation
models require assumptions and estimates to determine expected volatility,
expected life, expected dividend yield and expected risk-free interest
rates.
Expected Term
– The expected
term of the award represents the period that the Company’s stock-based awards
are expected to be outstanding and was determined based on historical
experience, giving consideration to the contractual terms of the stock-based
awards, vesting schedules and expectations of future employee
behavior. Given the lack of historical data and early-stage nature of
the Company's operations, the expected term is estimated as the contractual
term.
Expected Volatility –
Volatility is a measure of the amounts by which a financial variable such
as stock price has fluctuated (historical volatility) or is expected to
fluctuate (expected volatility) during a period. The Company uses the historical
volatility, employing prior period equivalent to the expected term to estimate
expected volatility.
Risk-Free Interest Rate
– The
Company bases the risk-free interest rate used in the Black-Scholes valuation
method on the implied yield currently available on U.S. Treasury
zero-coupon issues with a remaining term equivalent to the expected term of a
stock award.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
A - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, continued
RESEARCH
AND DEVELOPMENT EXPENSE
The
Company’s past research and development costs have been minimal due to the
unique relationships we have maintained with the members of our scientific team
and their institutions. Our total R&D costs have
consisted primarily of the consultant fees paid to members of our
scientific advisory board
.
The consultant fees consisted of $13,697 for 2009 and $14,160 for
2008.
FAIR
VALUE OF FINANCIAL INSTRUMENTS
The
Company’s financial instruments consist of cash, accounts receivable, accounts
payable and accrued expenses. The Company considers the carrying
values of its financial instruments in the financial statements to approximate
their fair value due to the short term nature of such items.
NET
LOSS PER SHARE
Basic
Earnings Per Share (“EPS”) includes no dilution and is computed by dividing
income or loss available to common shareholders by the weighted average number
of common shares outstanding for the period. Diluted EPS reflects the
potential dilution of securities that could share in the earnings or losses of
the entity. Due to the net loss in all periods presented, the calculation of
diluted per share amounts would cause an anti-dilutive result and therefore is
not presented. Potentially dilutive shares at December 31, 2009 and 2008 include
options and warrants outstanding of 100,615,177 and 128,777,644 at December 31,
2009 and 2008, respectively.
CONCENTRATIONS
OF CREDIT RISK
The
Company maintains its cash balances at financial institutions that are insured
by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per
account. From time-to-time, the Company’s cash balances exceed the
amount insured by the FDIC. Management believes the risk of loss of
cash balances in excess of the insured limit to be low.
NEW
ACCOUNTING PRONOUNCEMENTS
ASC Topic
105 incorporates the July 2009, FASB issuance of SFAS No. 168,
Codification and the Hierarchy of
Generally Accepted Accounting Principles,
which establishes the FASB
Accounting Standards Codification (the “Codification” or “ASC”) and supersedes
all existing accounting standards as the single source of authoritative
non-governmental U.S. GAAP. All other accounting literature not included
in the Codification is considered non-authoritative, except for additional
authoritative rules and interpretive releases of the SEC and applicable only to
SEC registrants. The Codification is organized by topic, subtopic,
section, and paragraph, each of which is identified by a numerical
designation. This statement applied beginning in the third quarter
2009. All accounting references have been updated, and therefore SFAS
references have been replaced with ASC references.
In
November 2008, the FASB issued Codification No. 323, Equity Method Investment
Accounting Considerations ("ASC 323"). ASC 323 clarifies accounting for certain
transactions and impairment considerations involving the equity method,
including initial measurement, decrease in investment value and change in level
of ownership or degree of influence. ASC 323 is effective on a prospective basis
for fiscal years beginning on or after December 15, 2008. We adopted ASC 323 on
January 1, 2009, and the adoption did not have an impact on our financial
statements.
In
June 2009, the FASB issued ASC 810,
Consolidations
, to improve
financial reporting by enterprises involved with variable interest entities by
addressing (1) the elimination of the qualifying special-purpose
entity concept and (2) constituent concerns about the application
of accounting and disclosures which do not provide timely and useful
information about an enterprise’s involvement in a variable interest entity.
This statement is effective for financial statements issued for fiscal years
beginning after November 15, 2009, with earlier adoption prohibited. We are
currently assessing the potential impacts, if any, on our consolidated financial
statements.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Deferred
revenue represents the unearned portion of payments received in advance for
licensing or service agreements.
The
Company received $150,000 in cash in February 2009 in connection with two
licensing agreements completed in the first quarter of 2009. Deferred revenue of
$150,000 was recorded and will be recognized as income over the estimated
remaining term of the underlying patents of approximately 15 years, subject to
the terms of the license agreement.
The
Company treats the incremental direct cost of revenue arrangements, which
consists principally of employee bonuses, as deferred charges and such
incremental direct costs are amortized to expense using the straight-line method
over the same term, subject to the terms of the license agreement.
The
Company had total unearned revenue of $543,935 as of December 31, 2009. The long
term portion of unearned revenue represents the remaining term of the agreements
or the remaining lives of the underlying patents, as appropriate, and ranges
from one to sixteen years.
The
expected future annual recognition of revenue is as follows:
For the Year Ending December 31,
|
|
|
|
|
|
2010
|
|
$
|
39,375
|
|
2011
|
|
|
39,375
|
|
2012
|
|
|
39,375
|
|
2013
|
|
|
39,375
|
|
2014
|
|
|
39,375
|
|
Thereafter
|
|
|
347,060
|
|
Total
expected future annual amortization
|
|
$
|
543,935
|
|
Note
C – PATENTS
The
Company has acquired a group of patents related to biotechnology and certain
machine learning tools used for diagnostic and drug discovery.
The cost
and accumulated amortization for 2009 and 2008 are as follows:
|
|
2009
|
|
|
2008
|
|
Cost
of Patents
|
|
$
|
3,985,794
|
|
|
$
|
3,985,794
|
|
Accumulated
Amortization
|
|
|
(1,468,412
|
)
|
|
|
(1,205,693
|
)
|
Patents,
net of Amortization
|
|
$
|
2,517,382
|
|
|
$
|
2,780,101
|
|
Amortization
charged to operations for each of the years ended December 31, 2009 and 2008 was
$262,719. The weighted average amortization period for patents is 14
years. Estimated amortization expense for the next five years is
$262,719 per year.
Note
D – INVESTMENTS
At
December 31, 2009 the Company had certificates of deposit at a financial
institution with maturities ranging from 3 months to 9 months. These
certificates of deposits bear interest at rates from 1.00% to
1.39%. The fair value of the certificates of deposit approximate the
carrying value due to the short maturity on the investment and comparison to
similar instructions.
On March
27, 2007, the Company and an investment partner formed SVM Capital LLC as an
equity investment for purposes of utilizing SVMs as a quantitative investment
management technique. The Company owns 45% of the membership interest
and has significant influence with the operation of the entity but does not have
control over the entity and is not considered the primary
beneficiary. Accordingly, the investment is accounted for using the
equity method of accounting. The Company’s initial investment was
$5,000 and the license to use the SVM technology applied to financial
markets. The carrying value of this investment was zero as of
December 31, 2009 and December 31, 2008.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
D – INVESTMENTS- continued
In August
2008, pursuant to a license agreement, as amended, we contributed a license to
Smart Personalized Medicine, LLC (“SPM”) in return for a 20% equity
interest. SPM is a company founded by a former director and current
senior advisor to attempt to develop a breast cancer prognostic test using our
SVM technology in collaboration with a prominent cancer research hospital. There
was no financial activity in this entity in 2008 or 2009. In March
2010, the Company announced a deal with Quest Diagnostics and SPM to develop
breast cancer products. See Note L for additional detail regarding
the transaction with Quest Diagnostics. With respect to SPM revenues
received unrelated to the arrangement with Quest Diagnostics, we will receive a
per test royalty up to 7.5% based on net proceeds received from the sale of the
new breast cancer prognostic test. The Company has no
contractual obligation to provide any funds to this
venture. The net value of the investment was zero as of
December 31, 2009 and December 31, 2008.
Note
E – LICENSE FEES EXPENSE - LICENSE AGREEMENT
Effective
September 26, 2004, the Company was assigned a patent license agreement with
Lucent Technologies GRL Corporation (“Lucent”). The patent license
agreement was associated with the patents acquired July 30, 2004. The Company
agreed to pay royalty fees to Lucent in the amount of the greater of an annual
fee of $10,000 or at the rate of five percent (5%) on each licensed product
which is sold, leased, or put into use by the Company, until cumulative
royalties equal $40,000 and at the rate of one percent (1%)
subsequently. The license granted will continue for the entire
unexpired term of Lucent’s patents. During both 2009 and 2008, the
Company paid $10,000 in royalty fees to Lucent.
Note
F – INCOME TAXES
The
Company has incurred net losses since inception, and we have determined that it
is more likely than not we will be unable to benefit in the future from the
accumulated net operating loss. Consequently, we have not
recorded any U.S. federal or state income tax expense or benefit. We
have no recorded income tax provision or benefit for the fiscal years ending
December 31, 2009 or 2008.
The
following items comprise the Company’s net deferred tax assets (liabilities) as
of December 31, 2009 and 2008.
|
|
2009
|
|
|
2008
|
|
Deferred
tax assets:
|
|
|
|
|
|
|
Net
operating loss carry-forward
|
|
$
|
4,305,217
|
|
|
$
|
3,655,365
|
|
Deferred
revenue
|
|
|
184,938
|
|
|
|
154,263
|
|
Contributions
|
|
|
3,341
|
|
|
|
2,491
|
|
Depreciation
and amortization
|
|
|
894
|
|
|
|
1,148
|
|
Warrants
and options granted
|
|
|
272,026
|
|
|
|
560,136
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
4,766,415
|
|
|
|
4,373,403
|
|
Less
valuation allowance
|
|
|
(4,766,415
|
)
|
|
|
(4,373,403
|
)
|
|
|
|
|
|
|
|
|
|
Net
deferred taxes
|
|
|
-
|
|
|
|
-
|
|
As of
December 31, 2009, an increase in the valuation allowance of $393,013 has been
recorded for the deferred tax asset, as management has determined that it is
more likely than not that the deferred tax asset will not be
realized.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
F – INCOME TAXES - continued
Total
income tax expense (benefit) differed from the amounts computed by applying the
U.S. Federal statutory tax rates to pre-tax loss for the fiscal years ending
December 31, 2009 and 2008 as follows:
|
|
2009
|
|
|
2008
|
|
Total
expense (benefit) computed by:
|
|
|
|
|
|
|
Applying
the U.S. Federal statutory rate
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
State
income taxes, net of federal tax benefit
|
|
|
(3.0
|
)
|
|
|
(3.0
|
)
|
Valuation
allowance
|
|
|
37.0
|
|
|
|
37.0
|
|
Effective
tax rate (benefit)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
The
Company has unused net operating loss carry-forwards of approximately $12.6
million that are available to offset future income taxes payable. The net
operating losses will expire beginning in 2021.
Based in
its evaluation of tax positions, the Company has concluded that there are no
significant uncertain tax positions requiring recognition in its financial
statements. The Company’s evaluation was performed for all tax years which
remain subject to examination and adjustment by major tax jurisdictions as of
December 31, 2009.
Note
G – NOTES PAYABLE AND CONVERTIBLE NOTES PAYABLE
On
June 30, 2009, the Company issued a secured promissory note to a director
of the Company in the amount of $500,000. The note contained an 8%
annual interest rate and was due on January 4, 2010. The note was
completely repayable by the Company at any time without any related fees or
penalties. The holder had the right to demand payment of the note
upon certain Events of Default (as defined in the note). The note was
secured by certain intellectual property and other assets of the
Company. On November 11, 2009, the Company paid in full the outstanding
balance of this $500,000 secured promissory note with a total payment, including
interest, of $514,437, thus eliminating all Company debt under the note and any
collateral obligations on the Company's intellectual property or other
assets.
Note
H – COMMITMENTS
The
Company is a party to a three year lease for the corporate
office. The Company currently pays $1,741 per month. The lease is
considered an operating lease and terminates June 30, 2010. Future
lease payments under the term of the lease will be $10,446 in 2010.
Note
I – STOCK COMPENSATION AND OTHER DERIVATIVE SECURITIES
Information
about options and warrants outstanding for 2009 and 2008 is summarized
below:
Number
of Derivative
Securities
Issued
|
|
2009
|
|
|
Weighted
Average
Exercise
Price
|
|
|
2008
|
|
|
Weighted
Average
Exercise
Price
|
|
Outstanding
beginning of year
|
|
|
128,777,644
|
|
|
$
|
0.16
|
|
|
|
162,599,644
|
|
|
$
|
0.17
|
|
Granted
|
|
|
5,000,000
|
|
|
$
|
0.08
|
|
|
|
8,750,000
|
|
|
$
|
0.08
|
|
Exercised
|
|
|
(17,503,073
|
)
|
|
$
|
0.14
|
|
|
|
0
|
|
|
|
|
|
Expired
un-exercised
|
|
|
(15,659,394
|
)
|
|
$
|
0.15
|
|
|
|
(42,572,000
|
)
|
|
$
|
0.21
|
|
Outstanding
end of the year
|
|
|
100,615,177
|
|
|
$
|
0.16
|
|
|
|
128,777,644
|
|
|
$
|
0.16
|
|
Exercisable December
31
|
|
|
92,615,177
|
|
|
$
|
0.16
|
|
|
|
120,527,644
|
|
|
$
|
0.16
|
|
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
I – STOCK COMPENSATION AND OTHER DERIVATIVE SECURITIES, continued
December
31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
Prices
|
|
|
Number
Outstanding
|
|
|
Weighted-
Average
Remaining
Contractual
Life (years)
|
|
|
Number
Exercisable
|
|
|
Weighted
Average
Remaining
Contractual
Life
(years)
of
Exercisable
Warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.08
|
|
|
|
14,300,000
|
|
|
7.75
|
|
|
|
6,300,000
|
|
|
7.03
|
|
$0.13
|
|
|
|
2,500,000
|
|
|
2.0
|
|
|
|
2,500,000
|
|
|
2.0
|
|
$0.14
|
|
|
|
32,276,355
|
|
|
0.75
|
|
|
|
32,276,355
|
|
|
0.75
|
|
$0.19
|
|
|
|
51,538,822
|
|
|
0.75
|
|
|
|
51,538,822
|
|
|
0.75
|
|
Total
|
|
|
|
100,615,177
|
|
|
1.8
|
|
|
|
92,615,177
|
|
|
1.3
|
|
As of
December 31, 2009, there was approximately $126,017 of unrecognized cost related
to stock option and warrant grants. The cost is to be recognized over
the remaining vesting periods that average approximately 1 year. The
aggregate intrinsic value of all options and warrants outstanding and
exercisable as of December 31, 2009 was $8,013,729.
In the
first quarter of 2008, the Company fully vested a 1,500,000 warrant grant for a
retiring director by accelerating the vesting of 375,000 warrant shares
exercisable at $0.13. A charge of $44,438 was recorded as directors’
fees.
In June
2008, a warrant to purchase 1,500,000 shares of Company common stock at an
exercise price of $0.08, vesting over three years and expiring in six years, was
issued by the Company to a new director. The value of $85,200 has
been charged as directors’ fees over the vesting period. See
Note L – Subsequent Events, regarding the forfeiture of a portion of the warrant
shares.
The
Company granted 1,250,000 options to an advisor during the third quarter of
2008. The fair value of each option granted was $0.06 and was
estimated on the date of grant using the Black-Scholes pricing model with the
following assumptions: dividend yield at 0%, risk-free interest rate of 2.62%,
an expected life of 5 years, and volatility of 98.61%. The
aggregate computed value of these options was $74,693, and this amount will be
charged as expense over the two-year vesting period.
The
Company entered into an award agreement on August 15, 2008 with the Chief
Executive Officer granting 6,000,000 stock options. The options vest in
the following increments once both the service condition, indicated by the
applicable Vesting Date, and the market condition, indicated by attaining the
minimum share price for any 20 consecutive trading days, are
satisfied.
Vesting
Date
|
|
Minimum
Share
Price
|
|
Number
of Options
|
|
|
|
|
|
|
August
15, 2008
|
|
$
|
0.10
|
|
1,000,000
|
|
|
|
|
|
|
January
1, 2009
|
|
$
|
0.15
|
|
2,000,000
|
|
|
|
|
|
|
January
1, 2010
|
|
$
|
0.20
|
|
2,000,000
|
|
|
|
|
|
|
January
1, 2010
|
|
$
|
0.25
|
|
1,000,000
|
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
I – STOCK COMPENSATION AND OTHER DERIVATIVE SECURITIES, continued
The
August 15, 2008, January 1, 2009 and January 1, 2010 conditions have been
satisfied with respect to 5,000,000 of these stock options.
The fair
value of each option was $0.03 and was estimated on the date of the grant using
a probability weighted fair value model similar to a lattice valuation model
with the following assumptions: dividend yield at 0%, risk free interest rate of
3.50%, an expected life of 6 years, and volatility of 106.52%. The
aggregate computed value of these options was $172,485 and this amount will be
charged as expense over the 1.4 year vesting period. Expense of
$119,898 and $52,587 was recorded in 2009 and 2008 respectively.
On April
29, 2009, the Company entered into an employment agreement with the Company’s
President and General Counsel. Pursuant to the terms of the
employment agreement, an option to purchase an aggregate of 4,500,000 shares of
the Company’s common stock at an exercise price of $0.08 was
granted. One million of the options vested immediately and the rest
vest over an eighteen (18) month period provided that the Company attains
certain performance metrics, as more fully described below.
Each
portion of the option grant vests as shown in the table below only if and when
(1) the executive has been continuously employed by the Company through the
applicable Vesting Date, and (2) with respect to the options that have Vesting
Dates of January 1 and September 15, 2010, the option shall not vest until
either the Company has (i) cash on hand in excess of $800,000, or (ii) a
positive, trailing 90-day EBITDA, or (iii) raised an additional $1,000,000 in
capital from new investments, excluding any proceeds from the exercise of any
warrants or options.
Vesting
Date
|
Number
of
Options
|
|
|
April
10, 2009
|
1,000,000
|
|
|
January
1, 2010
|
1,500,000
|
|
|
September
15, 2010
|
2,000,000
|
One
million options granted vested immediately. The January 1, 2010
conditions have been satisfied, as have the performance metrics related to the
September 15, 2010 vesting date stock options.
The fair
value of each option was $0.03 and was estimated on the date of the grant using
a probability weighted fair value model similar to a lattice valuation model
with the following assumptions: dividend yield at 0%, risk free interest rate of
3.50%, an expected life of 6 years, and volatility of 104.86%. The
aggregate computed value of these options was $175,331 and this amount will be
charged as expense over the 1.7 year vesting period. Expense of $120,774 was
recorded in 2009 in connection with this option grant.
Also
during the second quarter of 2009, in connection with an appointment to the
Company’s Board of Directors, the Company granted the new director an option to
purchase 500,000 shares of the Company’s common stock. The options vest 250,000
shares every six months, have an exercise price of $0.08, and expire on April
29, 2015. The fair value of each option granted was $0.06 and was
estimated on the date of grant using the Black-Scholes pricing model with the
following assumptions: dividend yield at 0%, risk-free interest rate of 3.50%,
an expected life of 6 years, and volatility
of 104.91%. The aggregate computed value of these options
was $28,292, and this amount will be charged as expense over the one year
vesting period.
Stock-based
expense included in the 2009 net loss consisted of $31,954 in compensatory
warrants, options and stock for professional consulting services and
compensation. Stock-based expense included in the net loss for 2008
consisted of $318,187 for the issuance of common stock, warrants and
options.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
I – STOCK COMPENSATION AND OTHER DERIVATIVE SECURITIES, continued
The
following table shows stock-based compensation and expense recorded in 2009 and
2008:
|
|
2009
|
|
|
2008
|
|
Options
and Warrants Issued for Services
|
|
$
|
86,967
|
|
|
$
|
227,002
|
|
|
|
|
|
|
|
|
|
|
Stock
Based Compensation Expense
|
|
|
240,663
|
|
|
|
91,185
|
|
|
|
|
|
|
|
|
|
|
Stock
Based Compensation Expense reversal
|
|
|
(295,676
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net
Increase
|
|
$
|
31,954
|
|
|
$
|
318,187
|
|
During
the fourth quarter of 2009, the Company reversed a previous accrual of expense
for warrants for consulting services in the amount of $361,000 as the warrants
were not issued and the Company has no obligation or intent to do
so. Of the $361,000 reversed, approximately $65,000 was accrued
ratably during the first three quarters of 2009 and $296,000 had been accrued
through December 31, 2008. This amount was not considered material
for restatement and was recorded in the fourth quarter of 2009 as a reduction in
stock compensation expense.
Note J -
STOCKHOLDERS’ EQUITY
In
August 2008, the Company issued 515,384 shares of common stock to certain
investors, pursuant to the terms of the Securities Purchase Agreement dated
August 15, 2007, for no additional consideration. The Company
recorded expense of $36,076 or $0.07 per share. The Company did not
issue any other shares during the twelve months ended December 31,
2008.
In
connection with the 2007 private placement, the Company issued warrants to
purchase 51,538,822 shares of restricted common stock at an exercise price of
$0.14 (the “Tranche 1 Warrants”). Pursuant to the terms of the Tranche 1
Warrants, certain of the holders were obligated to exercise fifty percent of the
Tranche 1 Warrants if the market price for the Company’s common stock is $0.17
for a period of thirty consecutive calendar days, which occurred on November 6,
2009, or forfeit the right to acquire those shares. On November 7,
2009, the Company exercised its call rights related to certain of the Tranche 1
Warrants. As a result, the holders of the Tranche 1 Warrants who
received the Company’s call notice were obligated to purchase 17,637,467 shares
of common stock or forfeit an equal number of Tranche 1 Warrants. The
number of Tranche 1 warrant shares not called by the Company was 8,131,944. As
of December 31, 2009, 15,878,073 shares of common stock have been purchased
relating to the call notice and Tranche 1 Warrants to purchase 1,759,394 shares
were forfeited. Additional warrants not subject to the call notice totaling
1,625,000 shares were also exercised. As of December 31, 2009, the
total remaining unexercised Tranche 1 Warrants is 31,276,358.
Series
A Preferred Stock
The
shares of Series A Preferred Stock were entitled to be converted by the holders
into common stock by of the Company at any time without the payment of
additional consideration. The Series A Preferred Stock had to be
converted into common stock of the Company when the trading value of the common
stock of the Company exceeded $0.12 per share for a period of 30 consecutive
calendar days. The holder of the Series A Preferred Stock had the
right to receive dividends, the right to vote on matters presented to the common
stockholders, and a preference right in the event of liquidation in an amount
equal to $594,975. The Company had a right to redeem the shares of
Series A Preferred Stock upon the fifth anniversary of the issue date at a
redemption price of $0.08 per share if not previously converted. On
November 4, 2009, as a result of the trading value of the Company’s common stock
exceeding $0.12 per share for a period of 30 consecutive calendar days, all
outstanding shares of Series A Preferred Stock converted by its terms into
7,437,184 shares of common stock.
H
EALTH DISCOVERY
CORPORATION
Notes
to Financial Statements, continued
Note
J – STOCKHOLDERS’ EQUITY – continued
Series
B Preferred Stock
During
the first quarter of 2009 the Board of Directors authorized the designation of
Series B Preferred Stock. The number of shares originally constituting the
Series B Preferred Stock was 13,750,000, however, during the fourth quarter of
2009 the Board of Directors authorized the increase in the number of shares
constituting the Series B Preferred Stock to 20,625,000. The Company sold to
individual investors a total of 19,402,675 shares of Series B Preferred
Stock for $1,490,015, net of associated expenses, in 2009. The
Series B Preferred Stock has not been registered under either federal or state
securities laws and must be held until a registration statement covering such
securities is declared effective by the Securities and Exchange Commission or an
applicable exemption applies.
The
Series B Preferred Stock may be converted into Common Stock of the Company at
the option of the holder, without the payment of additional consideration by the
holder, so long as the Company has a sufficient number of authorized shares to
allow for the exercise of all of its outstanding warrants and options. The
Shares of Series B Preferred Stock must be converted into Common Stock of the
Company upon the demand by the Company after the fifth anniversary of the date
of issuance.
The
Series B Preferred Stock accrues dividends at the rate of 10% of the
Series B Original Issue Price per year, which shall be satisfied by the fifth
anniversary of the issuance of such shares of the Series B Preferred Stock
(the “Original Issue Date”) by the Company’s issuance of the number of shares of
Common Stock equal to such accrued dividends divided by the average closing
price of the Company’s Common Stock as reported on the Over-the-Counter-Bulletin
Board or other exchange on which the Company’s Common Stock trades during the
prior ten business days or by the payment of cash, as the Company may determine
in its sole discretion. Dividends in the amount of $14,993 have been accrued for
Series B Preferred stock as of December 31, 2009.
Subject
to the limitations set forth in the Amended and Restated Articles of Amendment
to Articles of Incorporation and applicable law, as long as the Series B
Preferred Stock remain outstanding, the Company pay the holders of the Series B
Preferred Stock a special dividend equal to 15% of Company Net Revenue collected
beginning with the Original Issue Date and ending on the date the Series B
Preferred Stock cease to be outstanding (the “Cash Bonus”). Company
Net Revenue will include, but not be limited to, revenue derived from
development fees, license fees and royalties paid to the Company and revenue
collected as a result of the sale of any asset of the Company or distributions
from SVM Capital, LLC (each a “Revenue Contract”), reduced by the amount of any
out-of-pocket costs or expenses that are directly related to obtaining,
negotiating or documenting the Revenue Contracts and the performance of such
Revenue Contracts, but shall not include the proceeds of any capital infusions
from the exercise of outstanding options or warrants or as a result of any
capital raise undertaken by the Company. At any time following the
Original Issue Date, the Company may satisfy the special dividend right in its
entirety if the aggregate payments made to the Series B Holders is equal to that
value which provides an internal annual rate of return of twenty percent (20%)
on the Series B Preferred Stock. The maximum Cash Bonus to be paid
each year shall be the aggregate Series B Original Issue Price, and no amounts
in excess of such amount shall accrue or carry-over to subsequent
years.
No
dividend payment will be made if, after the payment of such dividend, the
Company would not be able to pay its debts as they become due in the usual
course of business, or the Company’s total assets would be less than the sum of
its total liabilities plus the amount that would be needed, if the Company were
to be dissolved, to satisfy the preferential rights upon the dissolution to
shareholders whose preferential rights are superior to those receiving the
dividend.
Note K -
RELATED PARTY TRANSACTIONS
The
Company acquired a specialized cryogenic freezer system used to keep tissue
samples from the Chief Executive Officer on July 11, 2008 for
$9,752.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
L – SUBSEQUENT EVENTS
The
Company received the final payment of $112,500, net of certain legal fees, that
was due under an agreement that settled the Company’s patent infringement
lawsuit against Vermillion, formerly known as Ciphergen Biosystems.
One of
our directors resigned during the first quarter of 2010. As a result
of his resignation, he forfeited options to acquire 750,000 shares of common
stock at $0.08 because the vesting provisions will not be
satisfied. A new outside director has been appointed to replace a
director who resigned for personal reasons and in connection with such
appointment, the new director was granted options to acquire 1,500,000 shares of
common stock at $0.26 per share.
In
connection with the 2007 private placement, the Company issued warrants to
purchase 51,538,822 shares of restricted common stock at an exercise price of
$0.19 (the “Tranche 2 Warrants”). Pursuant to the terms of the Tranche 2
Warrants, certain of the holders were obligated to exercise fifty percent of the
Tranche 2 Warrants if the average of the last reported closing bid and asked
prices on such day on the Over-the-Counter Bulleting Board for the Company’s
common stock was $0.24 for a period of thirty consecutive calendar days, which
occurred on February 28, 2010, or forfeit the right to acquire those
shares. The Company exercised its call rights relating to certain of
the Tranche 2 Warrants. As a result, the holders of the Tranche 2
Warrants who received the Company’s call notice were obligated to purchase
14,731,217 shares of restricted common stock or forfeit an equal number of
Tranche 2 Warrant shares. The number of Tranche 2 warrant shares not
called was 8,131,944 and 2,906,250 of the subject Tranche 2 Warrant shares had
already been exercised. The number of shares of common stock purchased relating
to the call notice was 11,729,390 and 3,001,827 Warrants were
forfeited. The Company has received $2,228,584 in gross proceeds from
the purchase of the common stock related to the call
provision.
Exercised
warrants from January 1, 2010 through March 23, 2010 that were not subject to
the Tranche 2 Warrant call totaled 4,531,250 warrant shares with proceeds
to the Company of $810,939. There are Tranche 2 Warrants to acquire
33,276,355 common shares outstanding.
On March
11, 2010, the Company, Smart Personalized Medicine, LLC and Quest
Diagnostics Incorporated entered into a Development
Agreement. The Company, SPM and Quest also entered a related
Licensing Agreement (the “Quest License”). In consideration for the
license, Quest will separately make payments to the Company and SPM.
Payments to the Company will include a $500,000 up front “Development License
Fee,” monthly “License Maintenance Fees” equal to $8,750 per month for the first
year and $17,500 per month for each year thereafter. Quest will also pay, upon
the publication of a study performed for the Validation Work, an Initial Product
License Fee of $125,000 for each of the first two Products, and Royalty Payments
equal to 2.45% of the net sales of each Licensed Product.
Effective
March 11, 2010, the Company and SPM amended the original License Agreement,
dated August 22, 2008 pursuant to which HDC had licensed its
intellectual property to SPM for use in the development of breast cancer
products. As amended, the Company will receive all payments under the
Quest Development Agreement and License Agreement directly from Quest, and SPM
will not be required to make any additional payments to the Company related to
either such agreement. In addition, the Company’s equity percentage
interest in SPM was increased from 15% to 20%, and such equity percentage
interest may be diluted only to the same extent and in the same manner as each
other initial equity percentage interest holder; provided, however, that when
raising additional equity, SPM must obtain the Company’s prior written approval
of the terms and conditions of such equity offering.
HEALTH
DISCOVERY CORPORATION
Notes
to Financial Statements, continued
Note
M – COMMITMENTS AND CONTINGENCIES
The
Company is subject to various claims primarily arising in the normal course of
business. Although the outcome of these matters cannot be determined,
the Company does not believe it is probable that any such claims will result in
material costs and expenses.
The
Company has received letters from an investor in the Company’s 2007 private
placement (“2007 Private Placement”), claiming (a) that certain
rights to receive additional common stock of the Company for no additional
consideration have been triggered by certain actions of the Company,
(b) breaches of its contractual rights to approve certain issuances of
derivative securities, (c) breaches of other covenants made by the Company
in the 2007 Private Placement, (d) the Company had violated its SEC
disclosure obligations, and (e) various breaches by the members of the
Board of Directors of their fiduciary duties. The Company denies the
allegations and intends to vigorously defend these claims. However,
due to the uncertainties inherent in litigation, we cannot predict the outcome
of this matter if the investor brings suit against the Company. Such
a lawsuit would be time consuming, distract our management from the business of
the Company and result in substantial expenditures to defend the claim, each of
which could have a material adverse impact on our business, financial condition
and results of operations. Moreover, if we are unsuccessful in
defending against the claims, the Company may be required, among other things,
to issue approximately 146,664,375 shares to such investor, and, if all of the
other investors in the 2007 Private Placement sought the same remedy, the
Company may be required to issue approximately 1,099,494,872 shares in the
aggregate. Issuing any significant portion of such shares of Common
Stock would cause substantial dilution to existing shareholders.
70,549,868
Shares of
Common
Stock To Be Issued Upon Exercise Of Warrants
352,746
Shares of Common Stock
HEALTH
DISCOVERY CORPORATION
PROSPECTUS
April
____, 2009
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13.
|
Other
Expenses of Issuance and
Distribution
|
The
following table sets forth the costs and expenses, other than underwriting
discounts and commissions, to be paid in connection with the sale of shares of
our common stock being registered, all of which will be paid by
us. All amounts are estimates except the registration
fee.
Securities
and Exchange Commission registration fee
|
|
$
|
668.41
|
|
Legal
fees and expenses
|
|
—
|
|
Accounting
fees and expenses
|
|
|
3000.00
|
|
Transfer
Agent and Registrar fees
|
|
|
0.00
|
|
Blue
Sky fees and expenses
|
|
|
550.00
|
|
Printing
and engraving expenses
|
|
|
0.00
|
|
Miscellaneous
|
|
|
0.00
|
|
Total
|
|
$
|
5218.41
|
|
Item
14.
|
Indemnification
of Directors and Officers
|
Our articles of incorporation provide
that we will indemnify, to the fullest extent permitted by the Georgia Business
Corporation Code, our directors and officers against expenses and liabilities
arising from such director or officer being named as an individual party to a
proceeding by reason of having served in the role of director or
officer. Our bylaws provide that advances against expenses shall be
made so long as the person seeking indemnification gives the Company a written
affirmation that he or she in good faith believes that he or she has met the
standard of conduct for indemnification and agrees to refund the advances if it
is ultimately determined that he or she is not entitled to indemnification. A
determination of whether indemnification of a director or officer is proper
because he or she met the applicable standard of conduct shall be made (1) by
our board of directors or a committee duly designated thereby, (2) in particular
circumstances, by independent legal counsel in a written opinion or (3) by the
affirmative vote of a majority of the shares entitled to vote.
In addition, Article 7 of our
articles of incorporation, subject to limited exceptions, eliminates the
potential personal liability of a director for monetary damages to Health
Discovery Corporation and to our shareholders for breach of duty as a director,
except for liability for (1) breach of duty involving appropriation of business
opportunity of Health Discovery Corporation, (2) an act of omission not in good
faith or involving intentional misconduct or a knowing violation of law, (3) a
transaction from which the director derives an improper material tangible
personal benefit or (4) the types of liability set forth in Section 14-2-832 of
the Georgia Business Corporation Code dealing with unlawful distributions of
corporate assets to shareholders.
Insofar as indemnification for
liabilities arising under the Securities Act of 1933 may be permitted to our
directors, officers and controlling persons pursuant to the foregoing
provisions, we have been informed that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is therefore unenforceable. In the event that a claim
for indemnification against such liabilities (other than the payment by us of
expenses incurred or paid by a director, officer or controlling person of our
company in the successful defense of any action, suit or proceeding) is asserted
by that director, officer or controlling person in connection with the
securities being registered, we will, unless in the opinion of our counsel the
matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether this indemnification by us is
against public policy as expressed in such Act and will be governed by the final
adjudication of such issue.
Item
15.
|
Recent
Sales of Unregistered Securities
|
In 2007,
the Company issued 51,538,822 shares of restricted Common Stock in return for
$2.55 million in cash and the conversion of approximately $1.6 million in
debt. Proceeds from the private placement were used for general
working capital purposes. Each purchaser of Common Stock also
received one warrant to acquire an equal number of shares at $0.14 (the “Tranche
1 Warrants”) and one warrant to acquire an equal number of shares at $0.19 (the
“Tranche 2 Warrants”). As a result of the Company’s Common Stock
achieving minimum trading price thresholds, the Company elected to require the
exercise or forfeiture of certain of the Tranche 1 Warrants in November, 2009,
and of the Tranche 2 Warrants in March 2010. As a result of the
Company’s election of its rights and other voluntary exercises by the holders of
the warrants, the Company issued 33,763,712 shares of Common Stock for gross
proceeds of $5,489,952 and warrants to acquire 4,761,222 shares were
forfeited. Warrants to purchase 31,276,358 shares at $0.14 and
33,276,355 shares at $0.19 remain outstanding.
In 2007,
the Company issued 7,437,184 shares of Series A Preferred Stock in a conversion
of $594,975 of secured debt to equity. On November 4, 2009, as a
result of the trading value of the Common Stock exceeding $0.12 per
share for a period of 30 consecutive calendar days, all outstanding shares of
Series A Preferred Stock converted by its terms into 7,437,184 shares of Common
Stock.
The
shares and the warrants were offered and sold in each of the Company’s private
placements were offered and sold in reliance upon exemptions from registration
pursuant to Section 4(2) under the Securities Act of 1933, as amended, and
Regulation D promulgated thereunder. Based on the information
provided by each of the investors, all investors qualify as accredited investors
(as defined by Rule 501 under the Securities Act of 1933, as
amended). There were no underwriters in connection with either of
these transactions, and there were no underwriting discounts or
commissions.
The
Company has received letters from an investor in the Company’s 2007 private
placement, (“2007 Private Placement”), claiming, among other things further
described in Item 1A - Risk Factors to the 2009 Form 10-K, that the investor is
entitled to receive additional shares of Common Stock for no additional
consideration . Pursuant to the terms of the securities purchase
agreement in the 2007 Private Placement, the investors may be entitled to
receive shares of Common Stock in certain circumstances. The investor
claims that the provision providing for the issuance of additional Common Stock
was triggered as a result of certain actions taken by the
Company. The Company denies the investor’s allegations and intends to
vigorously defend these claims. If we are unsuccessful in our
defense, the Company may be required under the terms of the securities purchase
agreement to issue approximately 146,664,375 shares to the investor, and, if all
of the other investors sought the same remedy as a result of the amendment to
the warrant, the Company may be required to issue approximately 1,099,494,872
shares in the aggregate. Issuing any significant portion of such
shares of Common Stock would cause substantial dilution to existing
shareholders.
During 2009,
pursuant to a Securities Purchase Agreement, as amended and restated (the
"Purchase Agreement"), we completed the sale of Series B Preferred
Stock for $1,490,015 in cash net of associated expenses. The
Series B Preferred Stock may be converted into Common Stock of the Company at
the option of the holder, at a price of $0.08 per share (subject to adjustment)
so long as the Company has a sufficient number of authorized shares to allow for
the exercise of all of its outstanding derivative securities, and without the
payment of additional consideration by the holder. The Shares of
Series B Preferred Stock must be converted into Common Stock of the Company upon
the demand by the Company after the fifth anniversary of the date of
issuance. The Series B Preferred Stock will not be immediately
registered under either federal or state securities laws and any may not be sold
unless a registration statement covering such securities is declared effective
by the Securities and Exchange Commission or an applicable exemption from
registration applies. In connection with the sale of the Series B
Preferred Stock, we paid $51,748 in finder’s fees.
Additional
Issuance of Securities
In June
2008, our new director was awarded warrants to purchase 1,500,000 shares of
Company common stock, which vest over three years and expire in six
years. These warrants have an exercise price of $0.06, and will be
charged as directors’ fees over the vesting period.
In April
2009, in connection with the employment of the Company’s President and General
Counsel, the Company granted to its President and General Counsel an option to
purchase an aggregate of 4,500,000 shares of the Common Stock at an exercise
price of $0.08. One million of the options vested immediately, and
one million five hundred thousand vested on January 1, 2010. The
remaining two million options vest on September 15, 2010. The options
expire on April 29, 2019.
Also
during the second quarter of 2009, in connection with an appointment to the
Company’s Board of Directors, the Company granted the new director an option to
purchase 500,000 shares of the Common Stock. The options vest 250,000 shares
every six months, have an exercise price of $0.08, and expire on April 29,
2015.
In
February 2010, in connection with an appointment to the Company’s Board of
Directors, the Company granted the new director an option to purchase 1,500,000
shares of Common Stock. The option vests 250,000 shares every six months, have
an exercise price of $0.26, and expire on February 24, 2015.
All of
these issuances of equity securities were made in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended.
In August
2008, in connection with entering into his employment agreement, Dr. Barnhill
was also granted an option to purchase an aggregate of 6,000,000 shares of the
Company’s common stock at an exercise price of $0.08. The options
vest over a two year period, assuming a minimum share price, and with respect to
a portion of the options, the Company attaining certain performance metrics, as
more fully described in the Option Award.
All of
these issuances of equity securities were made in reliance upon exemptions from
registration pursuant to Section 4(2) under the Securities Act of 1933, as
amended.
Item
16.
|
Exhibits
and Financial Statement Schedules
|
The
following exhibits are filed as part of this registration
statement:
Exhibit
|
|
Number
|
Description
|
|
|
3.1
|
Articles
of Incorporation. Registrant incorporates by reference Exhibit 3.1 to Form
8-K filed July 18, 2007.
|
|
|
|
|
3.1(a)
|
Articles
of Amendment to Articles of Incorporation. Registrant
incorporates by reference Exhibit 99.1 to Form 8-K filed October 10,
2007.
|
|
|
3.1(b)
|
Articles
of Amendment to Articles of Incorporation. Registrant
incorporates by reference Exhibit 3.1(b) to Form 10-K filed March 31,
2009.
|
|
|
3.2
|
By-Laws.
Registrant incorporates by reference Exhibit 3.2 to Form 8-K filed July
18, 2007.
|
|
|
4.1
|
Copy
of Specimen Certificate for shares of common stock. Registrant
incorporates by reference Exhibit 4.1 to Registration Statement on Form
SB-2, filed June 4, 2001.
|
|
|
4.1(a)
|
Copy
of Specimen Certificate for shares of common stock. Registrant
incorporates by reference Exhibit 4.1 (b) to Form 10-KSB, filed March 30,
2004.
|
|
|
4.1(b)
|
Copy
of Specimen Certificate for shares of Series A Preferred
Stock. Registrant incorporates by reference Exhibit 4.1(b) to
Form 10-K filed March 31, 2008.
|
|
|
4.1(c)
|
Copy
of Specimen Certificate for shares of Series B Preferred
Stock. Registrant incorporates by reference Exhibit 4.1(c) to
Form 10-K filed March 31, 2009.
|
|
|
5.1
|
Opinion
of Powell Goldstein LLP. Registrant incorporates by reference Exhibit 5.1
to Registration Statement on Form S-1 filed September 25,
2008.
|
|
|
10.1
|
Employment
Agreement between the Company and Stephen Barnhill dated August 15,
2008. Registrant incorporates by reference Exhibit 10.2 to Form
8-K filed August 18, 2008. *
|
|
|
10.2
|
License
Agreement between the Company and Clarient, Inc. dated July 31,
2007. Registrant incorporates by reference Exhibit 10.1 to Form
8-K filed August 3, 2007.
|
|
|
10.2(a)
|
Amendment
to License Agreement between Health Discovery Corporation and Clarient,
Inc., dated January 13, 2009. Registrant incorporates by
reference Exhibit 10.2 to Form 8-K filed February 5,
2009.
|
10.3
|
Securities
Purchase Agreement by and among the Company, the Cash Purchasers and the
Lender Purchasers. Registrant incorporates by reference Exhibit
10.11 to Form 10-QSB filed August 16, 2007.
|
|
|
10.4
|
Form
of Warrant to Cash and Lender Purchasers. Registrant
incorporates by reference Exhibit 10.14 to Form 10-K filed March 31,
2008.
|
|
|
10.5
|
Amendment
to Stock Purchase Warrant with Dr. Richard Caruso. Registrant
incorporates by reference Exhibit 10.1 to Form 8-K filed August 18,
2008.
|
|
|
10.6
|
Option
Award to Stephen D. Barnhill, M.D. dated August 15,
2008. Registrant incorporates by reference Exhibit 10.3 to Form
8-K filed August 18, 2008. *
|
|
|
10.7
|
License
and Development Agreement by and between the Company and DCL Medical
Laboratories, LLC dated July 14, 2008. Registrant incorporates
by reference Exhibit 10.17 to Registration Statement on Form S-1 filed
September 19, 2008.
|
|
|
10.7(a)
|
Mutual
Termination and Release Agreement between the Company and DCL Medical
Laboratories, LLC dated January 28, 2010. Filed
herewith.
|
|
|
10.8
|
License
Agreement between Health Discovery Corporation and Abbott Molecular Inc.,
dated January 30, 2009. Registrant incorporates by reference
Exhibit 10.13 to Form 10-K filed March 31, 2009.**
|
|
|
10.9
|
License
Agreement between Health Discovery Corporation and Quest Diagnostics
Incorporated, dated January 30, 2009. Registrant incorporates
by reference Exhibit 10.3 to Form 8-K filed February 5, 2009.
**
|
|
|
10.10
|
Form
of Securities Purchase Agreement. Registrant incorporates by
reference Exhibit 10.15 to Form 10-K filed March 31,
2009.
|
|
|
10.10(a)
|
Form
of Amendment to Securities Purchase Agreement. Filed
herewith.
|
|
|
10.10(b)
|
Form
of Amended and Restated Securities Purchase Agreement. Filed
herewith.
|
|
|
10.11
|
Employment
Agreement between the Company and R. Scott Tobin dated as of April 15,
2009. Registrant incorporates by reference Exhibit 10.1 to Form
8-K filed May 5, 2009. *
|
|
|
10.12
|
Option
Award to R. Scott Tobin dated April 29, 2009. Registrant
incorporates by reference Exhibit 10.2 to Form 8-K filed May 5, 2009.
*
|
|
|
10.13
|
Employment
Agreement between the Company and John Norris dated as of September 1,
2009. Registrant incorporates by reference Exhibit 10.1 to Form
8-K filed September 18, 2009. *
|
|
|
10.14
|
Secured
Promissory Note by the Company in favor of Joseph
McKenzie. Registrant incorporates by reference Exhibit 99.1 to
Form 8-K filed July 7, 2009. *
|
|
|
10.15
|
Form
of 2009 Option Award. Filed herewith. *
|
|
|
10.16
|
Form
of 2010 Option Award. Filed herewith. *
|
|
|
10.17
|
Development
Agreement by and among the Company, Smart Personalized Medicine, LLC and
Quest Diagnostics Incorporated dated March 11, 2010. Filed
herewith.
|
10.18
|
Licensing
Agreement by and among the Company, Smart Personalized Medicine, LLC and
Quest Diagnostics Incorporated dated March 11, 2010. Filed
herewith.
|
|
|
10.19
|
License
Agreement, dated August 22, 2008, by and between the Company and Smart
Personalized Medicine, LLC. Filed herewith.
|
|
|
10.20
|
Amendment
to License Agreement by and between the Company and Smart Personalized
Medicine, LLC dated as of March 11, 2010. Filed
herewith.
|
|
|
10.21
|
Employment
Agreement by and between the Company and Thomas Gallagher effective
December 1, 2009. Filed herewith. *
|
|
|
16.1
|
Letter
from Porter Keadle Moore LLP regarding change in certifying
accountant. Registrant incorporates by reference Exhibit 16.1
to Form 8-K, filed September 27, 2006.
|
|
|
21.1
|
Subsidiaries
of the Registrant. Registrant incorporates by reference Exhibit
21.1 to Form 10-K filed March 31, 2010.
|
|
|
23.1
|
Consent
of Hancock Askew & Co. LLP.
|
|
|
23.2
|
Consent
of Powell Goldstein LLP (contained in Exhibit 5.1) Registrant incorporates
by reference Exhibit 5.1 to Registration Statement on Form S-1 filed
September 25, 2008.
|
|
|
24.1
|
Power
of Attorney (included with signature pages to this Registration
Statement).
|
*
Management contract or compensatory plan or arrangement
**
Portions of exhibit have been omitted pursuant to a request for confidential
treatment
The
undersigned registrant hereby undertakes that:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
|
(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
|
|
|
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a
fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or
decrease in the volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission
pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in
the effective registration statement.
|
|
|
|
|
(iii)
|
To
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration
statement.
|
(2) That,
for purposes of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial
bona fide
offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(4) That
each prospectus filed pursuant to Rule 424(b) as part of a registration
statement relating to an offering, other than registration statements relying on
Rule 430B or other than prospectuses filed in reliance on Rule 430A (§230.430A
of this chapter), shall be deemed to be part of and included in the registration
statement as of the date it is first used after effectiveness.
Provided, however
, that no
statement made in a registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed incorporated
by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale
prior to such first use, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of first
use.
(5) Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question of whether such
indemnification by it is against public policy as expressed in the Act and will
be governed by the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the Registrant has duly
caused this registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Savannah, State of
Georgia, on April 30, 2010
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HEALTH
DISCOVERY CORPORATION
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By:
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/s/ Stephen
D. Barnhill
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Stephen
D. Barnhill, M.D.
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Chief
Executive Officer
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Pursuant
to the requirements of the Securities Act of 1933, this Registration Statement
has been signed by the following persons in the capacities stated and on the
30
th
day
of April, 2010.
Signature
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Capacity
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/s/
Joseph
McKenzie
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Director
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Principal Financial Officer,
Principal Accounting
Officer,
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/s/
R.
Scott Tobin
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Director
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/s/
D.
Paul Graham
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Director
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Health Discovery (CE) (USOTC:HDVY)
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