Unassociated Document
As filed
with the Securities and Exchange Commission on April 28, 2005
Registration
No. 333-119425
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
Amendment
No. 2 to
FORM
SB-2
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
GRANT
LIFE SCIENCES, INC.
(Name of
Small Business Issuer in Its Charter)
Nevada
|
|
3841
|
|
82-0490737
|
(State
or Other Jurisdiction of Incorporation or Organization) |
|
(Primary
Standard Industrial Classification Code Number) |
|
(I.R.S.
Employer Identification Number) |
64
East Winchester, Suite 205
Murray,
Utah 84107
(801)
261-8736
(Address
and Telephone Number of Principal Executive Offices)
Stan
Yakatan, Chief Executive Officer
64
East Winchester, Suite 205
Murray,
Utah 84107
(801)
261-8736
(Name,
Address and Telephone Number of Agent for Service)
Copies
to:
Gregory
Sichenzia, Esq.
Sichenzia
Ross Friedman Ference LLP
1065
Avenue of the Americas, 21st Floor
New York,
NY 10018
(212)
930-9700
(212)
930-9725
Approximate Date of Commencement of Proposed Sale to the Public:
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
If delivery of the prospectus is expected to be made pursuant to Rule 434, check
the following box. o
Title
of each class of Securities to be Registered |
|
Amount
to be registered |
|
Proposed
Maximum Offering Price Per Unit (1) |
|
Proposed
Maximum Aggregate Offering Price |
|
Amount
of Registration Fee |
|
Common
Stock |
|
|
24,268,495
|
|
|
|
|
|
$16,987,946.50 |
|
|
$2,152.37 |
|
Common
Stock |
|
|
1,895,268 |
|
|
$0.55 |
|
|
$1,042,397 |
|
|
$122.69 |
|
Total |
|
|
26,163,763 |
|
|
|
|
|
$18,323,973.50 |
|
|
$2,275.06(2) |
|
(1) Estimated solely for
the purpose of calculating the amount of the registration fee pursuant to Rule
457(c) under the Securities Act of 1933, as amended, based upon the average of
the bid and asked prices of the Registrant’s common stock on January 21,
2004.
(2) We
previously paid $2309.62 for the registration of 26,177,105 shares. We have
reduced the number of shares being registered to
26,163,763
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 thereafter 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 prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted.
Preliminary
Prospectus, subject to Completion, dated April 28, 2005
GRANT
LIFE SCIENCES, INC.
26,163,763
Shares
Common
Stock
This prospectus relates to the sale of up to 26,163,763 shares of our common
stock by selling stockholders. The prices at which the selling stockholders
may sell shares will be determined by the prevailing market price for the shares
or in negotiated transactions. We will not receive any proceeds from the
sale of our shares by the selling stockholders.
Our common stock is listed on the Over-the-Counter Bulletin Board under the
symbol “GLIF.OB.” On April 26, 2005, the last reported bid price of our
common stock was $0.35 per share.
INVESTING
IN OUR SECURITIES INVOLVES RISKS. SEE “RISK FACTORS” BEGINNING ON PAGE 2.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS
IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date
of this Prospectus is __________, 2005.
64
East Winchester, Suite 205
Murray,
Utah 84107
(801)
261-8736
TABLE
OF CONTENTS
|
Page
|
PROSPECTUS
SUMMARY |
1
|
RISK
FACTORS |
2
|
USE
OF PROCEEDS |
8
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
8
|
MARKET
FOR COMMON STOCK |
11
|
DESCRIPTION
OF BUSINESS |
11 |
DESCRIPTION
OF PROPERTY |
20
|
LEGAL
PROCEEDINGS |
20
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS |
20
|
INDEMNIFICATION
OF OFFICERS AND DIRECTORS |
23
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT |
24
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS |
26
|
SELLING
STOCKHOLDERS |
27
|
PLAN
OF DISTRIBUTION |
33
|
DESCRIPTION
OF SECURITIES |
34
|
LEGAL
MATTERS |
34
|
EXPERTS
|
34
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOURE |
34 |
FURTHER
INFORMATION |
35
|
CONSOLIDATED
FINANCIAL STATEMENTS |
F-1
|
PROSPECTUS
SUMMARY
This
summary does not contain all of the information that you should consider before
investing in our common stock. You should carefully read the entire
prospectus prior to making an investment decision.
About
Grant Life Science
We are
developing protein-based screening tests to screen women for cervical cancer and
pre-cancerous conditions that typically result in cervical cancer. Our
tests detect the presence of certain antibodies that appear only when cervical
cancer or certain pre-cancerous conditions are present in the body. Our
tests are performed by analyzing a small amount of blood taken from the
patient. In one of our tests, the blood sample is analyzed in a clinical
testing laboratory using standard laboratory equipment and analytic software,
which generally can produce test results in about 2 hours. Our second
generation rapid test is designed to be administered by a health professional in
a doctor’s office, hospital, clinic or even at home, and can provide
easy-to-read results in approximately 15 minutes.
We have
not generated any revenues since inception in July 1998. We have a history of
losses and we expect to continue to incur losses for the foreseeable future. For
the year ended December 31, 2004, we generated no revenues and incurred a net
loss of $1,910,350. Cumulative losses since inception total $3,381,339. As a
result of recurring losses from operations, a working capital deficit and
accumulated deficit, our auditors, in their report dated March 18, 2005, have
expressed substantial doubt about our ability to continue as a going concern.
History
of Grant Life Sciences
Grant
Life Sciences was incorporated in Idaho in 1983 as Grant Silver Inc. In
2000, we reincorporated in Nevada. On July 30, 2004, we acquired Impact
Diagnostics, Inc, a Utah corporation, through the merger of our wholly owned
subsidiary into Impact Diagnostics. We sometimes refer to that transaction
as the “Merger”. As a result of the Merger, Impact Diagnostics is a wholly
owned subsidiary of Grant Life Sciences. Impact Diagnostics was formed in
1998 and has been developing a cervical cancer test. For several years
prior to our acquisition of Impact Diagnostics, we engaged in no business.
Impact
Diagnostics was formed in 1999 to license and develop certain technologies as
owned by Dr. Yao Xiong Hu. Initial funding provided by the founders, and
supplemented by two additional rounds of private funding, was used to fund the
collection of patient samples and validation study costs of the technology. Once
the technology was verified, Dr. Mark Rosenfeld drafted and applied for patents.
In early 2004, Impact Diagnostics received its first patent.
Pursuant
to the merger, each issued and outstanding share of common stock of Impact
Diagnostics was converted into the right to receive one share of our common
stock. In addition, each option to purchase one (1) share of common stock
of Impact Diagnostics was converted into the right to receive an option to
purchase one (1) share of our common stock. Upon completion of the merger,
nominees of Impact Diagnostics were appointed to our board of directors and, our
standing board of directors resigned.
For
accounting purposes, the acquisition of Impact Diagnostics through the Merger is
treated and presented as a recapitalization of Impact Diagnostics. The reverse
merger is treated and presented as a recapitalization because we did not have
any operating activity prior to the acquisition of Impact Diagnostics, ownership
of Grant Life Sciences upon the reverse merger was controlled by the
stockholders of Impact Diagnostics and the management of Impact Diagnostics
controlled our operating activity post-merger. Therefore,
in this prospectus, unless otherwise indicated, all historical financial
information presented about us is historical financial information of Impact
Diagnostics only, the historical audited and unaudited interim financial
statements are the financial statements of Impact Diagnostics.
By this
prospectus, the selling stockholders are offering up to 26,163,763 shares of our
common stock, of which 22,766,393 are shares of common stock currently held by
the selling stockholders, 2,979,704 are shares of common stock issuable upon
exercise of warrants, and 417,666 are shares issuable upon the conversion of
notes held by the selling stockholders. The selling stockholders are not
required to sell their shares, and any sales of common stock by the selling
stockholders are entirely at the discretion of the selling stockholders.
We will
receive no proceeds from the sale of the shares of common stock in this
offering. However, if all of the warrants are exercised in full, we would
receive $484,048 in proceeds. Any proceeds received upon exercise of the
warrants will be used for working capital, administrative expenses and product
development.
RISK
FACTORS
Investing in our securities involves a material degree of risk. Before
making an investment decision, you should carefully consider the risk factors
set forth in this prospectus and any accompanying prospectus supplement
delivered with this prospectus, as well as other information we include in this
prospectus and any accompanying prospectus supplement.
Risks
Related to our Business
We
are a development stage company and we have no meaningful operating history on
which to evaluate our business or prospects.
We
acquired Impact Diagnostics on July 30, 2004. For several years prior to
that acquisition, we did not engage in any business. Impact Diagnostics
was formed in 1998 and has been developing a cervical cancer screening
test. This is now our only business. Impact Diagnostics has only a
limited operating history and has generated no revenue. The limited
operating history of Impact Diagnostics makes it difficult to evaluate our
business prospects and future performance. Our business prospects must be
considered in light of the risks, uncertainties, expenses and difficulties
frequently encountered by companies in their early stages of development,
particularly companies in new and rapidly evolving markets, such as the
biotechnology market.
We
have not completed the development of our planned cervical cancer tests and we
are not currently developing any other products. We may not successfully
develop our cervical cancer tests or any other products.
The
cervical cancer tests are the only products we are developing. We have no
other products. We may never successfully complete the development of our
cervical cancer tests. If we do not complete the development of our
cervical cancer tests or develop other products, we will not be able to generate
any revenues or become profitable and you may lose your entire investment in us.
We
have incurred net losses to date and expect to continue to incur net losses for
the foreseeable future. We may never become profitable.
We have
had substantial operating losses since our inception and have never earned a
profit. We incurred net losses of $646,201 in fiscal 2002, $253,881 in fiscal
2003, $1,910,350 for the year ended December 31, 2004 and $3,381,339 from
inception in 1998 through December 31, 2004. Our accumulated deficit at December
31, 2004 was $3,381.339.
Our
losses have resulted principally from:
•
expenses
associated with our research and development programs and development or our
cervical cancer tests;
•
expenses
associated with the Merger; and
•
administrative
and facilities costs.
We expect
to incur significant and increasing operating losses for the next few years as
we complete development of our cervical cancer tests, initiate clinical trials,
seek regulatory approval, expand our research and development, advance other
product candidates into development and, if we receive regulatory approval,
market and sell our products. We may never become profitable.
We
will need to raise substantial additional capital to fund our operations, and if
we are unable to obtain funding when needed, we may need to delay completing the
development of our planned cervical cancer tests, scale back our operations or
close our business.
We
believe we have sufficient cash to sustain us through June 2005. Based on
our current plan, we will need to raise at least $3,000,000 to fund our
operations through April 2006. We plan to raise additional capital through
the sale of equity and/or debt securities. We do not currently have any
committed sources of financing and we may be unable to obtain financing on
acceptable terms or at all. If we are unable to raise sufficient funds, we
may have to delay, scale-back or eliminate aspects of our operations or close
our business. If we sell additional equity securities, we will dilute our
current stockholders’ equity interest in us.
Our
auditors have qualified their opinion to our financial statements because of
concerns about our ability to continue as a going concern. These concerns
arise from the fact that we have not yet established an ongoing source of
revenues sufficient to cover our operating costs and that we must raise
additional capital in order to continue to operate our business. If we are
unable to continue as a going concern, you could lose your entire investment in
us.
We
will not be able to sell our planned cervical cancer tests and generate revenues
if laboratories and physicians do not accept them.
If we
successfully complete development of our cervical cancer tests and obtain
required regulatory approval, we plan to market and sell our tests initially to
clinical testing laboratories in the United States, Western Europe and other
countries in which there is widespread cervical cancer screening and a
sophisticated testing infrastructure. We plan to market and sell the rapid
test to physicians, hospitals, clinics and other healthcare providers in some
developing countries where cervical cancer screening is not widespread and where
there is limited or non-standardized testing infrastructure. In order to
successfully commercialize our tests, we will have to convince both laboratories
and healthcare providers that our proposed tests are an effective method of
screening for cervical cancer, whether as an independent test, used in
conjunction with Pap Tests and/or HPV Tests or as a follow-up screening method
for women with equivocal Pap Tests. Pap Tests have been the principal
means of cervical cancer screening for over 50 years and, in recent years, HPV
Tests have been introduced primarily as an adjunct to Pap Tests. Failure to
achieve any of these goals, could have an adverse material effect on our
business, financial condition or results of operation.
Our
planned cervical cancer tests rely on an approach that is different from the
underlying technology of the Pap Tests and the HPV Tests and of healthcare
professionals, women’s advocacy groups and other key constituencies may not view
our planned tests as an accurate means of detecting cervical cancer or
pre-cancerous conditions. In addition, some parties may view using our
proposed test along with the Pap Tests and/or HPV Tests for primary screening as
adding unnecessary expense to the already accepted cervical cancer screening
protocol, which could cause our product revenue to be negatively
affected.
If
third-party health insurance payors do not adequately reimburse healthcare
providers or patients for our proposed cervical cancer tests, we believe it will
be more difficult for us to sell our tests.
We
anticipate that if government insurance plans (including Medicare and Medicaid
in the United States), managed care organizations and private insurers do not
adequately reimburse users for use of our tests, it will be more difficult for
us to sell our tests to laboratories and healthcare providers. Third-party
payors and managed care entities that provide health insurance coverage to
approximately 225 million people in the United States currently authorize almost
universal reimbursement for the Pap Tests, and Pap Tests are nearly fully
reimbursed in other markets where we plan to market and sell our proposed
tests. HPV Tests also are almost fully reimbursed for certain uses.
We will attempt to obtain reimbursement coverage in all markets in which we plan
to sell our proposed cervical cancer tests to the same degree as the Pap Test.
Our
management will be required to expend significant time, effort and expense to
provide information about the effectiveness of our planned cervical cancer tests
to health insurance payors who are willing to consider reimbursement for our
tests. However, reimbursement has become increasingly limited for medical
diagnostic products. Health insurance payors may not reimburse laboratories,
healthcare providers or patients in the United States or elsewhere for the use
of our planned tests, either as a stand-alone test or as an adjunct to Pap Tests
or HPV Tests, which would make it difficult for us to sell our tests, which
could make our business less profitable and cause our business to fail.
We
currently have no sales force or distribution arrangement in any market where we
intend to market and sell our tests.
We
currently have no sales or marketing organization. When we complete the
development of our cervical cancer tests and receive the required regulatory
approvals, we will attempt to market and sell our tests to laboratories and
directly to physicians, hospitals, clinics and other healthcare providers.
We plan to market and sell our tests to laboratories in the United States and
globally through third party distributors. We do not currently have any
arrangements with any distributors and we may not be able to enter into
arrangements with qualified distributors on acceptable terms or at all. If
we are unable to enter into distribution agreements with qualified distributors
on acceptable terms, we may be unable to successfully commercialize our tests.
Our
competitors are much larger and more experienced than we are and, even if we
complete the development of our tests, we may not be able to successfully
compete with them.
The
diagnostic testing industry is highly competitive. When completed, we
expect that our cervical cancer tests will compete with the Pap Tests, which
have been widely accepted by the medical community for many years.
Approximately 60 million Pap Tests are performed annually in the United States,
and an additional 60 million Pap Tests are performed annually in the rest of the
world. Manufacturers of Pap Tests include Cyctc Corporation and several
other companies. Future improvements to the Pap Test could hinder our
efforts to introduce our tests into the market.
Our
cervical cancer tests also will compete with HPV Tests, which are becoming
increasingly accepted in the medical community. Manufacturers of HPV Tests
include Digene Corporation, Ventana Medical Systems, Roche Diagnostics, Abbott
Laboratories, and Bayer Corporation. If market acceptance of HPV Tests
becomes greater, it may be more difficult for us to introduce our tests into the
market.
All of
the companies who manufacture Pap Tests and HPV Tests are more established than
we are and have far greater financial, technical, research and development,
sales and marketing, administrative and other resources than we do. Even
if we successfully complete the development of our tests, we may not be able to
compete effectively with these much larger companies and their more established
products.
We
will need to obtain regulatory approval before we can market and sell our
planned tests in the United States and in many other countries.
In the
United States, our planned cervical cancer tests will be subject to regulation
by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and
Cosmetic Act. Governmental agencies in other countries also regulate
medical devices. These domestic and foreign regulations govern the
majority of the commercial activities we plan to perform, including the purposes
for which our proposed tests can be used, the development, testing, labeling,
storage and use of our proposed tests with other products and the manufacturing,
advertising, promotion, sales and distribution of our proposed test for the
approved purposes. Compliance with these regulations could prove expensive
and time-consuming.
Products
that are used to diagnose diseases in people are considered medical devices,
which are regulated in the United States by the FDA. To obtain FDA
authorization for a new medical device, a company may have to submit data
relating to safety and efficiency based upon extensive testing. This
testing, and the preparation and processing of necessary applications, are
expensive and may take up to a few years to complete. Whether a medical
device requires FDA authorization and the data that must be submitted to the FDA
varies depending on the nature of the medical device.
Medical
devices fall into one of three classes (Class I, II, or III), in accordance with
the FDA’s determination of controls necessary to ensure the safety and
effectiveness of the device or diagnostic. As with most diagnostic products, we
anticipate that our planned cervical cancer tests will be classified by the FDA
as a Class II device. By definition, this means that there could be a potential
for harm to the consumer if the device is not designed properly and/or otherwise
does not meet strict standards. To market and sell a Class II
medical device, a company must first submit a 510(k) premarket notification,
also known as a 510(k). The 510(k) application is intended to demonstrate
substantial equivalency to a Class II device already on the market. The FDA will
still require that clinical studies of device safety and effectiveness be
completed.
In the
United States, prior to approval by the FDA, under certain conditions, companies
can sell investigational or research kits to laboratories under the Clinical
Laboratory Improvement Amendment (CLIA) of 1988. Under CLIA, companies can sell
diagnostic assays or tests to "high complexity" laboratories for validation as
an "analyte specific reagent". An analyte specific reagent is the active
ingredient of an "in-house" diagnostic test.
In
addition to any government requirements as to authorizing the marketing and
sales of medical devices, there are other FDA requirements. The manufacturer
must be registered with the FDA. The FDA will inspect what is being done on a
routine basis to ascertain compliance with those regulations prescribing
standards for medical device quality and consistency. Such standards refer to
but are not limited to manufacturing, testing, distribution, storage, design
control and service activities. The FDA also prohibits promoting a device for
unauthorized uses and routinely reviews labeling accuracy. If the FDA finds
failures in compliance, it can institute a range of enforcement actions, from a
public warning letter to more severe sanctions like withdrawal of approval;
denial of requests for future approval; fines, injunctions and civil penalties;
recall or seizure of the product; operating restrictions, partial suspension or
total shutdown of production; and criminal prosecution.
The FDA's
medical device reporting regulation also will require the reporting of
information on deaths or serious injuries associated with the use of our tests,
as well as product malfunctions that are likely to cause or contribute to death
or serious injury if the malfunction were to recur.
Regardless
of FDA approval status in the U.S., we will need to obtain certification of our
tests from regulatory authorities in other countries prior to marketing and
selling in such countries. The amount of time needed to achieve foreign approval
varies from country to country, and regulatory approval by regulatory
authorities of one country cannot by itself guarantee acceptance by another
country’s regulatory body.. Additionally, implementation of more stringent
requirements or the adoption of new requirements or policies could adversely
affect our ability to sell our proposed tests in other countries. We may be
required to incur significant costs to comply with these laws and regulations.
If the US and/or other countries do not issue patents to us, our operating
results will suffer and our business may fail.
In
addition to the rules and regulations of the FDA and similar foreign agencies,
we may also have to comply with other federal, state, provincial and local laws,
rules and regulations. Out tests could be subject to rules pertaining to the
disposal of hazardous or toxic chemicals or potentially hazardous substances,
infectious disease agents and other materials, and laboratory and manufacturing
practices used in connection with our research and development activities. If we
fail to comply with these regulations, we could be fined, may not be allowed to
operate certain portions of our business, or otherwise suffer consequences that
could materially harm our business.
If
we are unable to successfully protect our intellectual property or our licensor
is unsuccessful in defending the patents on our licensed technology against
infringement, our ability to develop, market and sell our tests and any other
product we may develop in the future will be harmed.
Our
success will partly depend on our ability to obtain patents and licenses from
third parties and protect our trade secrets.
We have
an exclusive license from Dr. Yao Xiong Hu for certain processes that we
currently include in our cervical cancer tests. Some of Dr. Hu’s
technology is covered by a United States patent that has been issued, and some
of the technology is covered by a United States patent application that has been
filed and is pending. The agreement with Dr. Hu also covers technology
included in foreign applications presently pending as PCT applications in China
and India. In the event a competitor uses our licensed technology, our licensor
may be unable to successfully assert patent infringement claims. In that event,
we may encounter direct competition using the same technology on which our
products are based and we may be unable to compete. If we cannot compete with
competitive products, our business will fail. In
addition, if any third party claims that our licensed products are infringing
their intellectual property rights, any resulting litigation could be costly and
time consuming and would divert the attention of management and key personnel
from other business issues. We also may be subject to significant damages or
injunctions preventing us from selling or using some aspect of our products in
the event of a successful patent or other intellectual property infringement
claim. In addition, from time
to time, we may be required to obtain licenses from third parties for some of
the technology or components used or included in our tests. If we are
unable to obtain a required license on acceptable terms or at all, our ability
to develop or sell our tests may be impaired and our revenue will be negatively
affected.
We plan
to file patent applications for any additional technology that we create in the
future. We cannot guarantee that our patent applications will result in
patents being issued in the United States or foreign countries. In
addition, the U.S. Patent and Trademark Office may reverse its decision or delay
the issuance of any patents that may be allowed. We also cannot guarantee
that any technologies or tests that we may develop in the future will be
patentable. In addition, competitors may develop products similar to ours
that do not conflict with patents we may receive.
If our patents are issued, others may challenge these patents and, as a result,
our patents could be narrowed or invalidated, which could have a direct adverse
effect on our earnings and profitability.
Our
confidentiality agreements may not adequately protect our proprietary
information, the disclosure of which could decrease our competitive
edge.
Our
technology and tests may be dependent on unpatented trade secrets.
However, trade secrets are difficult to protect. In an effort to protect
our trade secrets, we generally require our employees, consultants and advisors
to sign confidentiality agreements. In addition, our employees are parties
to agreements that require them to assign to us all inventions and other
technology that they create while employed by us. However, we cannot
guarantee that these agreements will provide us with adequate protection if
confidential information is used or disclosed improperly. In addition, in
some situations, these agreements may conflict with, or be limited by, the
rights of third parties with whom our employees, consultants or advisors have
prior employment or consulting relationships. Further, others may
independently develop similar proprietary information and techniques, or
otherwise gain access to our trade secrets. Any of these adverse consequences
could negatively impact our results of operations.
Our
products may infringe on the intellectual property rights of others and may
result in costly and time-consuming litigation.
Our
success will depend partly on our ability to operate without infringing upon the
proprietary rights of others, as well as our ability to prevent others from
infringing on our proprietary rights. We may be required at times to take
legal action in order to protect our proprietary rights. Although we
attempt to avoid infringing upon known proprietary rights of third parties, and
are not aware of any current or threatened claims of infringement, we may be
subject to legal proceedings and claims for alleged infringement by us or our
licensees of third-party proprietary rights, such as patents, trade secrets,
trademarks or copyrights, from time to time in the ordinary course of business.
Any claims relating to the infringement of third-party proprietary rights, even
if not successful or meritorious, could result in costly litigation, divert
resources and management's attention or require us to enter into royalty or
license agreements which are not advantageous to us. In addition, parties making
these claims may be able to obtain injunctions, which could prevent us from
selling our products. Any of these results could lead to liability, substantial
costs and reduced growth prospects, any or all of which could negatively affect
our business.
We
do not have any manufacturing facilities and although we have made arrangements
with a third party to use its manufacturing facility, the arrangement is subject
to a license agreement.
We have no capacity to manufacture our proposed
tests. Although we have not established any arrangements with third party
manufacturers, we plan to make arrangements pursuant to a licensing agreement to
use a manufacturing facility that our licensor has used in the past. If
the licensing agreement expires or is terminated, we cannot guarantee that we
will be able to enter into any such other arrangements on favorable terms, or at
all.
If
we are able to market and sell our cervical cancer tests, we may be subject to
product liability claims or face product recalls for which our insurance may be
inadequate.
If we
complete development of our cervical cancer tests and begin to sell them we will
be exposed to the risk of product liability claims and product recalls. We
currently do not market any products and therefore have obtained only general
liability insurance coverage. Any failure to obtain product liability
insurance in the future that is not continually available to us on acceptable
terms, or at all, or that is sufficient to protect us against product liability
claims or recalls, may not have enough funds to pay legal fees and/or any
judgments in connection with any such claims which would have an adverse affect
on our operating results and could cause our business to fail.
If
we are unable to manage our anticipated future growth, we may not be able to
implement our business plan.
We
currently have seven employees and retain consultants on a part-time
basis. In order to complete development of our tests, obtain FDA and other
regulatory approval, seek insurance reimbursement, begin to market and sell our
tests, begin the production of our tests and continue and expand our research
and development programs, we will need to hire significant additional qualified
personnel and expand or implement our operating, administrative, information and
other systems. We cannot guarantee that we will be able to do so or that,
if we do so, we will be able to effectively integrate them into our existing
staff and systems. We will also have to compete with other biotechnology
companies to recruit, hire and train qualified personnel. If we are unable
to manage our growth, we may not be able to implement our business plan and our
business could fail.
Risks
Related to our Common Stock
There
is only a limited market for our common stock and the price of our common stock
may be affected by factors that are unrelated to the performance of our
business.
Our
common stock has not actively traded during the past few years. If any of
the risks described in these Risk Factors or other unseen risks are realized,
the market price of our common stock could be materially adversely
affected. Additionally, market prices for securities of biotechnology and
diagnostic companies have historically been very volatile. The market for
these securities has from time to time experienced significant price and volume
fluctuations for reasons that are unrelated to the operating performance of any
one company. In particular, and in addition to the other risks described
elsewhere in these Risk Factors, the following factors can adversely affect the
market price of our common stock:
•
announcements
of technological innovation or improved or new diagnostic products by others;
•
general
market conditions;
•
changes
in government regulation or patent decisions;
•
changes
in insurance reimbursement practices or policies for diagnostic products.
Our
common shares have traded on the Over the Counter Bulletin Board at prices below
$5.00 for several years. As a result, our shares are characterized as
“penny stocks” which could adversely affect the market liquidity of our common
stock.
The
Securities Enforcement and Penny Stock Reform Act of 1990 requires additional
disclosure relating to the market for penny stocks in connection with trades in
any stock defined as a penny stock. Securities and Exchange Commission
regulations generally define a penny stock to be an equity security that has a
market price of less than $5.00 per share, subject to certain exceptions.
Such exceptions include any equity security listed on Nasdaq or a national
securities exchange and any equity security issued by an issuer that has:
•
net
tangible assets in excess of $2,000,000, if such issuer has been in continuous
operation for three years;
•
net
tangible assets in excess of $5,000,000, if such issuer has been in continuous
operation for less than three years; or
•
average
revenue of at least $6,000,000, for the last three years.
Unless an
exception is available, the regulations require, prior to any transaction
involving a penny stock, that a disclosure schedule explaining the penny stock
market and the risks associated therewith is delivered to a prospective
purchaser of the penny stock. We currently do not qualify for an
exception, and, therefore, our common stock is considered to be penny stock and
is subject to these requirements. The penny stock regulations adversely
affect the market liquidity of our common shares by limiting the ability of
broker/dealers to trade the shares and the ability of purchasers of our common
shares to sell in the secondary market. In addition, certain institutions
and investors will not invest in penny stocks.
Nevada
law provides certain anti-takeover provisions for Nevada companies that may
prevent or frustrate any attempt to replace or remove our current management by
the stockholders or discourage bids for our common stock. These provisions may
also affect the market price of our common stock. We have chosen not to
opt out of these provisions.
We are
subject to provisions of Nevada corporate law that limit the voting rights of a
person who, individually or in association with others, acquires or offers to
acquire at least 20% of our outstanding voting power unless a majority of our
disinterested stockholders elects to grant voting rights to such person.
We are also subject to provisions of Nevada corporate law that prohibit us from
engaging in any business combination with an interested stockholder, which is a
person who, directly or indirectly, is the beneficial owner of 10% or more of
our common stock, for a period of three years following the date that such
person becomes an interested stockholder, unless the business combination is
approved by our board of directors in a prescribed manner. These
provisions of Nevada law may make business combinations more time consuming or
expensive and have the impact of requiring our board of directors to agree with
a proposal before it is accepted and presented to stockholders for
consideration. Although we have the ability to opt out of these provisions, we
have not chosen not to do so. These anti-takeover provisions might
discourage bids for our common stock.
Our board
of directors has the authority, without further action by the stockholders, to
issue, from time to time, up to 20,000,000 shares of preferred stock in one or
more classes or series and to fix the rights and preferences of such preferred
stock. The board of directors could use this authority to issue preferred stock
to discourage an unwanted bidder from making a proposal to acquire us.
Future
sales of a significant number of shares of our common stock by existing
stockholders may lower the price of our common stock, which could result in
losses to our stockholders.
As of
April 26, 2005, we had outstanding 57,639,113 voting shares. Some of our
outstanding voting shares are eligible for sale under Rule 144, are otherwise
freely tradable or will become freely tradable under Rule 144. Sales of
substantial amounts of shares of our common stock into the public market could
lower the market price of our common shares.
In
general, under Rule 144 as currently in effect, a person (or persons whose
shares are required to be aggregated) who has owned shares for at least one year
would be entitled to sell within any three-month period a number of shares that
does not exceed the greater of (i) 1% of the number of our common shares
then outstanding (which equals approximately 576,391 shares of common
stock) or (ii) the average weekly trading volume of our common shares
during the four calendar weeks preceding the filing of a Form 144 with
respect to such sale. Sales under Rule 144 are public information
about us. Under Rule 144(k), a person who is not deemed to have been
our affiliate at any time during the three months preceding a sale, and who has
owned the shares proposed to be sold for at least two years, is entitled to sell
his shares without complying with the manner of sale, public information, volume
limitation or notice provisions of Rule 144.
FORWARD
LOOKING STATEMENTS
This
prospectus includes forward-looking statements. You can identify these
forward-looking statements when you see us using words such as “expect,”
“anticipate,” “estimate,” “believe,” “intend,” “may,” “predict,” and other
similar expressions. These forward looking statements cover, among other
items:
•
our
future capital needs;
•
our
expectations about our ability to complete development of our cervical cancer
tests;
•
our
expectations about the FDA and other regulatory approval process that will be
required for our cervical cancer tests;
•
our
expectations about reimbursement of our products by health insurance payors;
•
our
expectations about the future performance of the cervical cancer tests that we
are developing;
•
our
expectations about acceptance in the market of the cervical cancer tests we are
developing;
•
our
expectations about the ability of our planned cervical cancer tests to compete
in the market;
•
our
marketing and sales plans;
•
our
expectations about our financial performance;
•
our
intention to develop additional screening tests using our technology;
We have
based these forward-looking statements largely on our current
expectations. However, forward-looking statements are subject to a number
of risks and uncertainties, certain of which are beyond our control.
Actual results could differ materially from those anticipated as a result of the
factors described under “Risk Factors” including, among others:
•
problems
that we may face in successfully completing our planned cervical cancer tests;
•
our
inability to raise additional capital when needed;
•
uncertainty
of acceptance of our cervical cancer tests in the market;
•
reluctance
or unwillingness of laboratories and physicians to accept our tests;
•
refusal
of insurance companies and other third-party payors to reimburse patients,
clinicians and laboratories for our tests;
•
problems
that we may face in marketing and selling our tests;
•
the
possibility that we may not be able to compete with established companies;
•
delays in
obtaining, or our inability to obtain, approval by the FDA for our proposed
tests;
•
delays in
obtaining, or our inability to obtain, approval by certain foreign regulatory
authorities for our proposed tests;
•
problems
in acquiring and protecting intellectual property important to our business
through patents, licenses and other agreements;
•
our
ability to successfully defend claims that our tests may infringe the
intellectual property rights of others;
•
problems
that we may face in obtaining product liability insurance or defending product
liability claims;
•
problems
that we may face in manufacturing and distributing our proposed tests;
•
the risks
we face in potential international markets; and
•
the
limited market for our common stock and the adverse affect on liquidity that we
may face because our common stock is considered a “penny stock”.
We do not
undertake any obligation to publicly update or revise any forward-looking
statements contained in this prospectus or incorporated by reference, whether as
a result of new information, future events or otherwise. Because of these
risks and uncertainties, the forward-looking statements and circumstances
discussed in this prospectus might not transpire.
USE
OF PROCEEDS
This
prospectus relates to shares of our common stock that may be offered and sold
from time to time by selling stockholders. Certain of the selling
stockholders will receive 2,979,704 shares of our common stock upon conversion
of our outstanding warrants that they own. We will receive no proceeds
from the sale of shares of common stock in this offering. However, if all of the
warrants owned by the selling stockholders are exercised in full, we would
receive $484,048 in proceeds. Any proceeds received upon exercise of the
warrants will be used for working capital purposes, administrative expenses and
product development.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Some of
the information in this Form SB-2 contains forward-looking statements that
involve substantial risks and uncertainties. You can identify these statements
by forward-looking words such as "may," "will," "expect," "anticipate,"
"believe," "estimate" and "continue," or similar words. You should read
statements that contain these words carefully because they:
· |
discuss
our future expectations; |
· |
contain
projections of our future results of operations or of our financial
condition; and |
· |
state
other "forward-looking" information. |
We
believe it is important to communicate our expectations. However, there may be
events in the future that we are not able to accurately predict or over which we
have no control. Our actual results and the timing of certain events could
differ materially from those anticipated in these forward-looking statements as
a result of certain factors, including those set forth under "Risk Factors,"
"Business" and elsewhere in this prospectus. See "Risk Factors."
Overview
On July
30, 2004, we acquired Impact Diagnostics through the merger of our wholly owned
subsidiary, Impact Acquisition Corporation, into Impact Diagnostics. At the time
of the merger, we were an inactive publicly traded shell corporation with no
significant assets or operations. In accordance with SFAS No. 141, Impact
Diagnostics was the acquiring entity. While the transaction is accounted for
using the purchase method of accounting, in substance the merger is a
recapitalization of Impact Diagnostic’s capital structure. As a result of the
Merger, each issued and outstanding share of common stock of Impact Diagnostics
was converted into one share of our common stock, and Impact Diagnostics became
a wholly owned subsidiary of our company. We now own, indirectly though Impact
Diagnostics, all of the assets of Impact Diagnostics.
For
accounting purposes, Impact Diagnostics has accounted for the transaction
as a reverse acquisition and shall be the surviving entity. Impact Diagnostics
did not recognize goodwill or any intangible assets in connection with the
transaction and there have been no adjustments to the historical carrying values
of the assets and liabilities.
The
accompanying financial statements present the historical financial condition,
results of operations and cash flows of the Impact Diagnostics prior to the
merger with us.
We are
considered a development stage company. In 2003 and 2004, we had no revenues and
incurred net losses of $253,881 and $1,910,350, respectively. Since
inception in July 1998, we have incurred cumulative losses of $3,381,339.
Application
of Critical Accounting Policies
Our
consolidated financial statements and accompanying notes are prepared in
accordance with generally accepted accounting principles in the United States.
Preparing financial statements requires management to make estimates and
assumptions that affect the reported amounts of assets, liabilities, revenue,
and expenses. These estimates and assumptions are affected by management's
application of accounting policies. We believe that understanding the basis and
nature of the estimates and assumptions involved with the following aspects of
our consolidated financial statements is critical to an understanding of our
financials.
Stock-Based
Compensation
On
December 16, 2004, the Financial Accounting Standards Board published Statement
of Financial Accounting Standards No. 123 (Revised 2004), Share-Based Payment
(“SFAS 123R”). SFAS 123R requires that compensation cost related to share-based
payment transactions be recognized in the financial statements. Share-based
payment transactions within the scope of SFAS 123R include stock options,
restricted stock plans, performance-based equity awards, stock appreciation
rights, and employee share purchase plans. The provisions of SFAS 123R are
effective as of the first interim period that begins after December 15, 2005.
The Company is adopting this Statement early, for the year 2004. The company
incurred expense of $426,081 in 2004 for the stock options granted under its
2004 Stock Incentive Plan. The Company anticipates continuing to incur such
costs in order to conserve its limited financial resources. The determination of
the volatility, expected term and other assumptions used to determine the fair
value of equity based compensation issued to non-employees under SFAS 123
involves subjective judgment and the consideration of a variety of factors,
including our historical stock price, option exercise activity to date and the
review of assumptions used by comparable enterprises.
Plan
of Operations
In
connection with the acquisition of Impact Diagnostics, Stan Yakatan was
appointed as our Chief Executive Officer and President, John Wilson was
appointed as our Chief Financial Officer and Michael Ahlin and Dr. Mark
Rosenfeld were appointed as our Vice Presidents. All of these individuals
held these positions with Impact Diagnostics prior to the Merger. Dr. Mark
Rosenfeld resigned on Oct 11, 2004. Mr. Wilson resigned on March 31, 2005 and
was replaced by Don Rutherford. In addition to these officers, we currently have
four employees and have engaged a number of part-time scientific
consultants.
During
the next year, we expect to acquire laboratory assets to augment our clinical
research and development efforts. As part of this effort, we plan to develop a
laboratory facility through relocating its offices to California where our Chief
Executive Officer and Chief Financial Officer reside. We currently anticipate
leasing an office in the Los Angeles area and will seek to secure the necessary
mixed-use permits to operate a laboratory facility as part of such office. In
conjunction with this relocation, we are subleasing our office space in Raleigh,
North Carolina until the lease runs out in September 2005. This address is the
address where Mr. John Wilson, our former Chief Financial Officer maintained an
office. Effective March 31, 2005, Mr. Wilson resigned as Chief Financial
Officer, and Donald Rutherford, a Los Angeles based, experienced financial
executive, becoming our Chief Financial Officer. In addition to the termination
of our North Carolina office, we also plan to relocate our clinical laboratory
presently located in Sandy, Utah to the Los Angeles area.
During
the next 12 months, we plan to complete the development of our cervical
cancer screening tests. We intend to continue to validate the
effectiveness of the processes that we currently use in the tests we are
developing through trials which will be conducted for us by Allogen
Laboratories, a subsidiary of the Cleveland Clinic. In the near term, we plan to
meet with regulatory agencies in the United States and in other countries to
determine the clinical trials and studies we will have to undertake and the data
and other information we will be required to submit to them to support our
future applications for authority to market and sell our planned cervical cancer
tests in those countries. We also plan to begin studies and clinical
trials in the United States and other countries that will be required in
connection with our regulatory applications. During the next 12 months, we also
anticipate that we will add employees, including scientists and other
professionals in the research and development, product development, business
development, regulatory, manufacturing, marketing and clinical studies areas.
We plan
to invest any excess cash we have in investment grade interest bearing
securities. We do not anticipate investing in real estate or interests in real
estate, real estate mortgages, or securities of or interests in persons
primarily engaged in real estate activities. We do not intend to undertake
investments in real estate as a part of our normal operations.
Liquidity
and Capital Resources
We do not
have sufficient capital to satisfy our cash requirements through the next twelve
months. As of December 31, 2004, we had total current assets of $377,768 and
total current liabilities of $275,505. These current liabilities include notes
payable of $122,500 which converted to shares of common stock in March 2005. Our
cash flow deficit from operations was $1,484,935 during the year ended December
31, 2004. Additionally we used $16,873 to acquire new property and equipment
during the period. We met our cash requirements in 2004 through a private
placement in connection with the Merger. As of March 31, 2005, we have current
assets of approximately $248,000 and total current liabilities of approximately
$583,000.
In
connection with the Merger, between July 30, 2004 and August 19, 2004, we sold
1,912,125 units in a private placement, at a purchase price of $0.9175 per unit
($0.1835 per share), resulting in gross proceeds to our company of $1,754,375,
or $1,494,937 net after deduction of offering costs. Net proceeds after
legal, accounting, printing and other fees was approximately $1,437,000. Each
unit was comprised of five (5) shares (or 9,560,625 shares) of our common stock
and a warrant to purchase one (1) share of our common stock at an exercise price
of $0.1835 per share.
Our
continuation as a going concern is dependent on our ability to generate
sufficient cash flows to meet our obligations on a timely basis and to obtain
additional financing as may be required. We plan to raise additional capital in
the next three months through the sale of equity and/or debt securities to
support our development plan in the medical diagnostics industry. However,
we currently do not have any committed sources of financing. We may not be
able to raise additional financing on acceptable terms when we need to, or we
may be unable to raise additional financing as all. We plan to invest any excess
cash we have in investment grade interest bearing securities.
Duncan
Bridge Financing
On March
15, 2005, we completed the sale of $200,000 aggregate principal amount of an 8%
Senior Secured Note due June 15, 2005 and a warrant to purchase up to an
aggregate of 250,000 shares of our common stock to DCOFI Master LDC. The note
and warrant were issued in a private placement pursuant to Section 4(2) of the
Exchange Act of 1933 and Rule 506. The note bears interest at a rate of 8% per
annum, is due and payable on June 15, 2005 and is secured by our assets. Upon
the occurrence of an event of default, the full principal amount of the note
will become due and payable and we will be required to issue to DCOFI warrants
to purchase an aggregate of 250,000 shares of common stock. The note may be
prepaid by us at a price equal to 100% of the outstanding principal balance, if
within 60 days of the issue date and at a price equal to 106% of the outstanding
principal balance if prepaid after 60 days after the issue date. The warrant is
exercisable until five years from the date of issuance at a purchase price of
$0.40 per share, subject to adjustment. DCOFI may exercise the warrant on a
cashless basis if, one year after the issue date, the shares of common stock
underlying the warrant are not then registered pursuant to an effective
registration statement. In the event the investors exercise the warrant on a
cashless basis, then we will not receive any proceeds. In addition, the exercise
price of the warrant will be adjusted in the event we issue common stock at a
price below the exercise price of the warrant. Upon an issuance of shares of
common stock at a price below the exercise price, the exercise price of the
warrant will be reduced to the price such shares of common stock were issued.
The exercise price of the warrant will also be adjusted in certain circumstances
such as if we pay a stock dividend, subdivide or combine outstanding shares of
common stock into a greater or lesser number of shares, or take such other
actions as would otherwise result in dilution of DCOFI’s ownership. We received
net proceeds of $165,000, which was used for working capital.
Off-Balance
Sheet Arrangements
We do not
have any off-balance sheet arrangements as of the December 31, 2004 or as of the
date of this prospectus.
MARKET
FOR COMMON STOCK
Our common stock is quoted on the OTC Bulletin Board under the symbol
“GLIF.OB.” The following table sets forth, for the calendar periods
indicated, the range of the high and low last reported bid prices of our common
stock from January 1, 2002 through March 31, 2005, as reported by the OTC
Bulletin Board. The quotations represent inter-dealer prices without
retail mark-ups, mark-downs or commissions, and may not necessarily represent
actual transactions. The quotations may be rounded for presentation.
Period |
|
High |
|
Low |
|
|
|
|
|
First
Quarter 2003 |
|
$0.04
|
|
$0.04
|
Second
Quarter 2003 |
|
$0.04
|
|
$0.04
|
Third
Quarter 2003 |
|
$0.04
|
|
$0.04
|
Fourth
Quarter 2003 |
|
$0.04
|
|
$0.04
|
First
Quarter 2004 |
|
$0.04
|
|
$0.04
|
Second
Quarter 2004 |
|
$0.04
|
|
$0.04
|
Third
Quarter 2004 |
|
$0.80 |
|
$0.04 |
Fourth
Quarter 2004 |
|
$1.40 |
|
$0.64 |
First
Quarter 2005 |
|
$0.82 |
|
$0.40 |
On April 26, 2005, the last reported bid price of our common stock as reported
on the OTC Bulletin Board was $0.35 per share. As of April 26, 2005,
we had approximately 140 shareholders of record. Certain of the
shares of common stock are held in “street” name and may be held by numerous
beneficial owners.
DESCRIPTION
OF BUSINESS
Overview
of Our Business
We are
developing protein-based screening tests to screen woman for cervical cancer and
pre-cancerous conditions that become cervical cancer. Our tests detect the
presence of certain antibodies that appear only when cervical cancer or certain
pre-cancerous conditions are present in the body. Our tests are performed
by analyzing a small amount of the patient’s blood. In one version of our
test, the blood sample is analyzed in a clinical setting using standard
laboratory equipment and analytic software, which generally can produce
completed results in about 2 hours. Our rapid test provides easy-to-read
results in approximately 15 minutes and is designed to be administered by a
health professional in a doctor’s office, hospital, and clinic or even at home.
Our
planned cervical cancer test uses proprietary technology to detect the presence
of specific antibodies associated with cervical pre-cancers and cancer. We
believe that in the future we may be able to use that technology to develop
rapid tests for other diseases and cancers.
As part
of our expansion of our diagnostic mission, we have also acquired exclusive
rights to a rapid testing product for HIV-1, HIV-2 and dengue fever as well as a
proprietary colloidal gold reagent from AccuDx Corp., a California biotechnology
corporation.
Cervical
Cancer
Invasive
cervical cancer affects over 500,000 women worldwide annually, and approximately
300,000 women die each year from this disease (National Institutes of Health
Notices, Federal Press Release Library Assession Number A00295; Cleveland Clinic
Journal of Medicine, 70:641). Cervical cancer is second only to breast
cancer as the leading `cause of cancer death among women (Cancer Journal,
9:348). In the United States, Western Europe and other countries where
there is widespread screening and a well developed testing or diagnostic
infrastructure, invasive cervical cancer is less prevalent. In Latin
America, China, India and many other countries, there is a much higher incidence
of invasive cervical cancer because of the lack of testing and limited or
diagnostic testing infrastructure.
Pap Tests, a microscopic examination of cells scraped from the cervix, have been
the most prevalent cervical cancer screening method for more than 50
years. In recent years, gene- or DNA-based HPV tests have been introduced
as an adjunct to the Pap Test. In the United States, more than 82% of
women 25 years or older have gotten Pap Tests over the last three years (Cancer,
97:1528), equated to a total of more than 50 million Pap Tests performed each
year (CDC Morbidity and Mortality Weekly Report, 49:1001). An equivalent number
of Pap Tests are performed annually across the rest of the world, mainly in
Canada, Western Europe and Japan. Outside the United States, approximately
1.7 billion women do not undergo regular cervical cancer testing (United States
Census Bureau International Data Base statistics). In many cases, this
scarcity of testing is the result of a lack of economic resources, as well as
social, cultural and/or religious factors which may contribute to women not
undergoing cervical cancer screening. Under these circumstances, in some
nations, the mortality rate of cervical cancer is not unlike that for incidence
of cervical cancer (Journal of American Medical Association, 285:3107; Annals of
Oncology, 16:489). In other words, the mortality rate for those with cervical
cancer may approach 100% in some places.
Virtually
all-cervical cancer is caused by humanpapilloma virus or HPV. However, of the
more than 100 specific types of HPV, the scientific community believes only 7 to
15 are positively correlated with most cervical cancers. There are two types of
cervical cancer. Squamous cell carcinoma, a cancer of the flat, scale-like
cells that coat the cervix, is the most prevalent type. Adenocarcinoma is a more
virulent cancer that stems from cervical cells with glandular or secretory
properties that are increasing in incidence (Canadian Medical Association
Journal, 164:1151) but often goes undetected by Pap Tests. The missing of
adenocarcinomas is largely due to problems in collecting and interpreting the
correct cervical cells (Cancer [Cancer Cytopathology], 99:324 and
102:280).
Traditional
Testing for Cervical Cancer
Pap
Tests
The most
common means of screening for cervical cancer is the Pap Test, or papanicolaou
smear cytology, which has been used as the primary screen for over 50 years. The
Pap Test is performed by swabbing the cervical surface to collect cells that are
then placed on a microscopic slide for examination. A specially-trained licensed
cytotechnologist, a technician trained in the microscopic examination and
identification of cellular abnormalities of the cervix, usually in a hospital or
pathology laboratory, observes the cells using a microscope and other
specialized equipment to determine whether abnormal cells are present. When a
cytotechnologist identifies a potential abnormality, a cytopathologist, a
physician specialized in assessing cervical cells, verifies the interpretation.
A second generation Pap Test, known as a “Liquid Pap Test”, involves as special
procedures for placing cells onto a microscopic slide in a manner that is
intended to allow for more clear-cut scrutiny by cytotechnologists and
cytopathologists.
Women
whose Pap test results are normal do not undergo further inspection, but instead
characteristically return for routine Pap screening on an annual basis.
However, women with abnormal Pap test results may be subjected to follow-up Pap
tests, colposcopy (a visual examination of the cervix with the aid of a
distinctive microscope) and biopsy to clearly identify cancerous conditions.
Cancerous and precancerous lesions may then be removed with a cauterizing device
or scalpel, and in some cases women may have to undergo a hysterectomy, or
removal of the entire cervix. If a
patient’s Pap Test cannot specifically be classified as normal or abnormal, the
result is classified as “equivocal”, or Atypical Squamous Cells of Undetermined
Significance (ASC-US). This occurs in approximately 2-7% of cases, or maybe even
more cases (Cancer [Cervical Cytopathology], 72:3002). Patients with
equivocal Pap Test results typically will undergo multiple repeat Pap
Tests. Many of these patients will also undergo a colposcopy and a biopsy.
However, the overwhelming majority of women with ASC-US who then experience
these costly follow-up procedures to ascertain their heath conditions, do not
have either precancerous, high-grade cervical dysplasias or cervical cancer
(Cancer [Cervical Cytopathology], 72:3002; Medscape
Medical News, November 8, 2004 - http://www.medscape.com/viewarticle/493298).
While Pap
Tests have been an important screening tool for many years and have helped
reduce deaths caused by cervical cancer, they still have some significant
shortcomings, including:
•
limited
predictive value — in the United States, each year several million colposcopies
are performed on patients with abnormal Pap Test results, but only 20% of the
colposcopies reveal cervical cancer or pre-cancerous lesions (Journal of the
American Medical Association, 287:2382).
•
false
negative results — in the United States,
Pap Tests
fail to diagnose cervical cancer or pre-cancerous conditions that often lead to
cervical cancer in approximately 30% to 60% (depending on whether a Liquid Pap
Test or a regular Pap Test is used) of the cases where cervical cancer or
pre-cancerous conditions are present (American Journal of Obstetrics and
Gynecology, 175-1110).
•
false
positive results — Distinguishing between cervical cancer or pre-cancerous
states and benign conditions mimicking them can be difficult via Pap Tests.
(Singapore Medical Journal, 42:351).
•
inability
to detect adenocarcinomas — Pap Tests appear deficient for detecting the
presence of the more virulent adenocarcinoma (Cancer [Cervical Cytopathology],
102:282).
•
invasive
procedure — Pap Tests require healthcare professionals to extract cells from the
cervix by inserting a collecting device into the cervix. In some
non-Western countries, women may be inhibited from undergoing this procedure for
social, cultural or religious reasons.
•
high
costs — highly trained physicians and other specialists are required to collect,
examine and interpret the Pap Test specimen, which contributes to a higher cost
structure for the Pap Test. Following a positive test result, colposcopies and
biopsies are required, raising the overall potential cost of screening.
Some of
these deficiencies may be due primarily to visual limitations associated with
the microscopic examination of chemically stained cells, the inadequate or
inappropriate sampling of cells or other technical problems and to the
subjective nature of cytology interpretation.
HPV
Tests
In the
past few years, HPV testing has been introduced as another element of the
cervical cancer screening process. The HPV Test is a gene-based test that
detects the presence or absence of DNA from the cancer-causing ones.
The only
HPV Test approved by the United States Food and Drug Administration (FDA) is the
HC2 High-Risk HPV DNA Test, manufactured by Digene Corporation of Gaithersburg,
Maryland. Like the
Pap Test, it is performed by swabbing the cervix to extract cells. The
specimen is then analyzed using expensive specialized equipment and software
programs in a laboratory.
In the
United States, women with ASC-US results from an initial Pap Test often undergo
an HPV Test to determine if HPV is present. That test can be performed
using the same sample taken for a Liquid Pap Test or a stand-alone one.
HPV testing has also been introduced in conjunction with Pap Tests as an
optional screening protocol for women 30 years of age and older, even in the
absence of ASC-US or worse results.
While HPV
Tests are helpful in detecting the presence of HPV, which is a precursor for
virtually all cervical cancer, they too suffer from some significant
shortcomings:
•
limited
predictive value — HPV tests
actually detect virus
presence in all forms as opposed to just the HPV DNA associated with cervical
cancer and/or associated pre-cancerous lesions. In fact, the FDA-approved
HC2
High-Risk HPV DNA Test yields a
positive predictive value as low as 19% for ascertaining precancerous lesions or
cervical cancer (Acta Cytologica, 49:120).
•
invasive
procedure — Like Pap
smear cytology, the HPV test requires that the attending healthcare professional
get cells by inserting a collection device into the cervix. As earlier stated,
women in certain non-Western cultures may be prohibited from undergoing such a
procedure for social, cultural or religious reasons
•
high cost
and complex — The HPV
test specimen must be processed by special and dedicated, expensive laboratory
equipment and interpretational computer software by highly trained technicians,
thus the higher costs associated with HPV tests (American Journal of Obstetrics
and Gynecology, 177:930). Following a positive test result, colposcopy and
biopsies are required, thus further elevating diagnostic costs (Journal of the
American Medical Association, 287:2382).
Our
Planned Cervical Cancer Test
We are developing cervical cancer tests that will detect the presence or absence
of specific antibodies that are produced only if cancer-causing HPV is present
in the body, and consequent oncogenic, or cancer-promoting, changes have
occurred. Cancer-causing HPV have unique proteins that trigger the
disease. Upon disease onset, the body makes large numbers of antibodies to
these unique proteins. By detecting specific antibodies to cancer-causing
HPVs, we believe that our tests will be able to more reliably determine whether
a patient has cervical cancer or pre-cancerous lesions than can Pap smear
cytology or HPV testing.
We
believe that our tests will efficiently and accurately screen for cervical
cancer. When completed, we believe that our tests will differ in several
important respects from the Pap Tests and HPV tests that are currently in use:
· |
Our
tests are done with patient’s blood from either a finger prick or veinous
puncture, a procedure universally considered as safe and minimally
invasive).
In contrast, the Pap and HPV tests require cervical cells harvested by
inserting a collecting device into a woman’s
cervix. |
· |
Our
tests will be done in a laboratory by a technician using standard, readily
available laboratory equipment, or by a doctor or other healthcare
provider at the point-of-care as a self-contained, easy-to-use test.
Virtually any trained laboratory technician can do our tests. By contrast,
Pap Test specimens must be examined under a microscope by a
specially-trained cytotechnologist to assess the presence of cancerous or
pre-cancerous cells. The HPV tests now available require dedicated,
expensive laboratory equipment and sophisticated analytical computer
software for interpreting results. |
· |
Our
tests will detect antibodies only if a woman has cervical cancer or those
pre-cancerous conditions that typically lead to cervical cancer. In
preliminary trials that used one version of our test to analyze blood from
patients already diagnosed with cervical cancer or pre-cancerous lesions,
our test was able to detect cervical cancer or pre-cancerous conditions
when such conditions existed, but otherwise ruled out cervical disease
when it did not exist. |
· |
Pap
tests results may be limited by inefficiencies in sampling cervical cells
and the subjective nature of cytology. Pap tests frequently fail to
detect cervical cancer or pre-cancerous conditions when actually present
(Cancer
[Cervical Cytopathology], 72:3002)
and otherwise do not permit the differentiation of cancerous or
pre-cancerous states from benign conditions mimicking them (American
Journal of Clinical Pathology, 94:754). Woman with abnormal Pap tests must
often experience a colposcopy (a visual examination of the cervix by means
of a special microscope) and a biopsy. This triage is quite
inefficient, as evidenced by colposcopy with biopsy not revealing cervical
cancer or precursor lesions most of the time (Cancer
[Cervical Cytopathology], 72:3002; Medscape
Medical News, November 8, 2004 -
http://www.medscape.com/viewarticle/493298). |
· |
The
human papillomavirus, or HPV, causes virtually all cervical cancers. There
are more than 100 types of HPV, but the scientific community considers
only 7 to 15 of these responsible for this disease. Gene- or
DNA-based HPV tests actually detect HPV infection, but infection and
cervical cancer are not the same
In
fact, cervical HPV infections clear or become undetectable for 90% of
afflicted women within two years and only a small proportion individuals
experience a persistent HPV infection and subsequently cervical cancer
(CDC, National
Center for HIV, STD and TB Prevention,
Division
of Sexually Transmitted Diseases, STD
Prevention, Genital HPV Infection,
http://www.cdc.gov/std/HPV/STDFact-HPV.htm). |
Our tests
involve the analysis of a small amount of blood taken from the patient. The
collection of small volumes of blood is accepted virtually everywhere as being
of “minimal risk”. Importantly, it is not necessary to probe the cervix to
get results. Given the previously discussed socio-religious hesitance or
prohibitions as to getting cells from the cervix, our tests logically have
inherently broad acceptability and/or desirability. Our tests involve a few
readily done steps:
•
The
sample is placed into a receptacle coated with proprietary detection proteins of
a specific nature. Only certain antibodies to cancer-causing HPVs can
adhere to these proteins.
•
The
container is then rinsed, thus removing everything but antibodies that have
adhered to the proteins.
•
A special
solution is added to the container. This solution includes “detector”
antibodies that attach to those specific antibodies to cancer-causing HPVs
adhered to the special detector proteins. The solution changes color with
attachment of the “detector” antibodies, an indicator of a positive result
(i.e., cervical cancer or a pre-cancerous condition present).
We are
developing two tests. One, known as the Enzyme Linked Immunosorbent Assay
Test (ELISA), is designed to be run in a laboratory. The blood specimen is
sent to the laboratory, where a laboratory technician runs the test using
standard, readily available laboratory equipment. No unique analytic or
diagnostic software is required, while such software is essential for HPV
testing. While test results typically are available in about two hours, we
anticipate that the typical turnaround time from the laboratory to the doctor
will be approximately one day. We believe that a doctor will be able to
order this test as one of a battery of tests that is run on a patient’s blood
sample after a typical office visit.
Our
second generation rapid test is designed to be a point-of-care test that will be
able to be administered in the hospital, physician’s office, clinic or even at
home or in outdoor settings. The test kit will contain the required
container and reagents, with a color change will indicate the presence of
cancer-causing proteins. We anticipate results will be available in 10 to
15 minutes.
We have
not yet completed the development of our cervical cancer tests. We are
continuing to refine the existing proteins and processes currently used in our
tests and are testing other proteins and processes, which may be included in our
tests in the future.
We
believe that, when completed, our tests will be a more accurate and efficient
way to diagnose cervical cancer for the following reasons:
•
greater
accuracy — Our
cervical cancer tests will detect specific antibodies present only if
cancer-causing HPV is present and cancer-related cellular changes have
occurred. As a result, we believe our tests will be able to more
accurately diagnose cancer or pre-cancerous conditions than do Pap and HPV
tests, thus making for fewer false positive or false negative
results.
•
ability
to detect adenocarcinomas - Our antibody detection approach is well suited for
finding adenocarcinomas as well as squamous cell carcinomas since cell samples
are not required.
•
non-invasive
— Our tests
require a small amount of blood, which may be quickly and safely taken via a
finger prick or from a vein in the arm. We believe that in countries where
women are reluctant to allow a healthcare professional to sample their cervix
there will be greater willingness to allow blood sampling to ascertain cervical
disease.
•
reduced
costs — We
believe that because our tests will be run by laboratory technicians using
standard, readily available equipment or by a healthcare professional using a
point-of-care test, overall costs for our screening tests will be less than
experienced with Pap or HPV tests. In addition, by providing more accurate
results, we believe that our tests may reduce the number of repeated cervical
cancer tests of any sort along with expensive colposcopies, biopsies and related
medical procedures.
Initial
Validation Studies
We have
conducted initial studies to validate our planned cervical cancer tests.
In the
United States, the Institutional Review Board (IRB) governs collection and use
of patient specimens for research and testing purposes. The IRB Committee at
Intermountain Health Care, the largest hospital facility in the intermountain
western United States, and at St. Mark’s Hospital in Salt Lake City, Utah,
approved the evaluation of our technology for screening blood serum from
patients, some of whom had negative Pap Tests and some of whom had previously
been diagnosed with cervical cancer or intraepithelial lesions, the immediate
precursor to cervical cancer. These initial non-blind studies were performed in
May 2003 by Ameripath, Inc. on a total of 65 American patient samples from
these IRB approved sources. Our tests detected cervical cancer or pre-cancerous
conditions 94% of the time such conditions existed, and were able to rule out
cervical cancer or pre-cancerous conditions 82% of the time the patient did not
have these conditions.
Similar
testing was done in April 2003, under a Chinese IRB equivalent, at the
China Cancer Institute, China Academy of Medical Sciences on 70 samples, of
which over half were from cervical cancer patients. Our tests detected cervical
cancer or pre-cancerous conditions 97% of the time such conditions existed and
were able to rule out cervical cancer or pre-cancerous conditions 85% of the
time the patient did not have these conditions.
The
initial studies conduced by Ameripath and in China used a “cut off” value or
measurement standard to differentiate benign from cancerous or pre-cancerous
conditions that is higher than would typically be used in a commercially
available test. We currently are refining our technology in order to enable our
tests to achieve similar results using a measurement standard appropriate for a
commercial cervical cancer diagnostic test.
We plan
to conduct validation studies on a refined version of our cervical cancer test
in the next few months. Allogen Laboratories, a wholly owned subsidiary of the
Cleveland Clinic Foundation, has agreed to conduct these studies for us.
Although it is possible that these later studies may not support the results of
the initial validation studies, preliminary indications have been positive.
Allogen Laboratories will also assist us in developing a proposed protocol of
clinical trials and other studies that will be used to support the submissions
we intend to make to the FDA and other foreign regulatory authorities.
Regulatory
Approval
In the
United States, our planned cervical cancer tests will be subject to regulation
by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and
Cosmetic Act. Governmental agencies in other countries also regulate
medical devices. These domestic and foreign regulations govern the
majority of the commercial activities we plan to perform, including the purposes
for which our proposed tests can be used, the development, testing, labeling,
storage and use of our proposed tests with other products and the manufacturing,
advertising, promotion, sales and distribution of our proposed test for the
approved purposes. Compliance with these regulations could prove expensive
and time-consuming.
Products
that are used to diagnose diseases in people are considered to be medical
devices, which are regulated in the United States by the FDA. To obtain
FDA authorization for a new medical device, a company may have to submit data
relating to safety and efficiency based upon extensive testing. This
testing, and the preparation and processing of necessary applications, are
expensive and may take up to a few years to complete. Whether a medical
device requires FDA authorization and the data that must be submitted to the FDA
varies depending on the nature of the medical device.
Medical
devices fall into one of three classes (Class I, II, or III), in accordance with
determination by the FDA of controls needed to ensure the safety and
effectiveness of the device or diagnostic test. Class I devices are devices
which are deemed to be of minimal potential for harm to the user and include
items, such as elastic bandages and cholesterol and pregnancy tests. As with the
majority of diagnostic products, we anticipate that our planned cervical cancer
tests will be classified as Class II or Class III devices. A medical device is
classified as Class II if general controls alone are insufficient to assure
safety and effectiveness, but methods are available to provide assurance. Class
III devices are those for which insufficient information exists in to order to
assure safety and effectiveness from other controls. Categorization is
predicated by an FDA assessment of the complexity and safety of doing the test
as well as on intended use. With regard to intended use, a test used in
conjunction with other laboratory or clinical methods to monitor for cancer may
be given Class II status. The same test used alone or solely to diagnose or
screen for cancer might be classified as Class III. For FDA purposes, our
planned cervical cancer tests will be used in consort with other clinical
methods like Pap smear cytology. Furthermore, our planned cervical cancer tests
are of lesser complexity, either to be performed as an Enzyme-Linked
Immunosorbent Assay (ELISA) in the laboratory, a common or routine procedure, or
as a rapid immunotest, with a processing complexity requiring almost no training
and/or expertise to successfully perform. Hence, anticipation of Class II status
is not inappropriate.
For our
planned cervical cancer tests, we are required to submit to the FDA either a
premarket approval (PMA) or a premarket notification (510(k)) application for
marketing and sales. Our planned cervical cancer tests may be preferentially
reviewed through the 510(k) submission process, as opposed to the more expensive
and lengthy PMA one, which is required for Class III devices. Class III devices
cannot be distributed until they have had PMA, unless they are subject to an
exemption. A 510(k) is a submission made to the FDA for showing the safety and
effectiveness of a device, and that it is substantially equivalent to a legally
marketed device not subject to PMA. To market Class I, II and III devices, a
510(k) application to the FDA is done at least 90 days before marketing, unless
the device is exempt from 510(k) requirements. Most Class I devices are exempt
from the 501(k) requirement. Our planned cervical cancer tests will not be
exempt.
Applicants
are required to compare their 510(k) device to devices for the same purpose
already in the marketplace and then to support equivalency claims. For our
planned tests, this means other diagnostic or clinical methods for looking at
cervical dysplasia and cancer. Applicants must submit descriptive and
performance data to establish that their device is substantially equivalent to a
predicate device. In this regard, the FDA will require that clinical studies of
device safety and effectiveness be satisfactorily completed for our planned
cervical cancer tests. In addition, Class II devices have special labeling
requirements and performance standards and are subject to postmarket
surveillance.
For all
medical device classes, marketing and sales are predicated on the FDA approval
and registration status described above. Almost all Class I medical devices are
exempt from FDA submission review. However, a Class I product must still be FDA
registered, which requires demonstration that the Class I medical device being
commercialized is being made according to Quality Systems Regulations (formerly
called Good Manufacturing Practices), after which marketing and sales can
proceed in virtually unencumbered fashion.
As stated
previously, Class II and III designations are highly likely for our proposed
cervical cancer tests. For devices that are categorized as Class II, after
pre-market notification under the 510(k) process which will include at its core
data on analytical performance relative to predicate devices, tests may then be
sold. It is anticipated that considerable clinical data will be required to
support intended uses and that the FDA could restrict sales to certain
laboratories, hospitals and medical practices. A Class III designation requires
submission to the FDA of a PMA application for designated uses of the device,
which includes documentation of clinical studies demonstrating safety and
effectiveness prior to marketing and sales to prescribed users. Post marketing
and sales controls by the FDA for Class III devices includes Device Listing
(mechanism for keeping the FDA advised of the devices being marketed and sold by
a particular entity), Medical Device Reporting (mechanism for receiving
significant adverse event information for a medical device from manufacturers
and end users), Establishment Registration (registration with the FDA of
establishments involved in the production and distribution of medical devices)
and Quality System Compliance Inspection (inspectional process for assessing
compliance by the manufacturer of a medical device regarding the Quality System
Regulation and related regulations).
Prior to
our submissions, we are requesting meetings with the FDA. Such meetings will
provide we with FDA mandates as to not only the Class II or III status for our
proposed cervical cancer tests but also regarding scientific or clinical
evidence necessary to determine effectiveness for the intended uses, and will
allow FDA personnel to familiarize themselves with our technologies. Such
interactions between the FDA and us should help to speed the regulatory process
and minimize delays regarding permission to market and sell our
products.
In the
United States, prior to approval by the FDA, under certain conditions, companies
can sell investigational or research kits to laboratories under the Clinical
Laboratory Improvement Amendment (CLIA) of 1988. Under CLIA, companies can sell
diagnostic assays or tests to "high complexity" laboratories for validation as
an "analyte specific reagent". An analyte specific reagent is the active
ingredient of an "in-house" diagnostic test.
We intend
to sell the ELISA version of our cervical cancer test to high complexity
laboratories for validation as an analyte specific reagent or for use by such
laboratories in their own homebrew (or in-house) diagnostic assays. Such sales
would not require FDA approval, but we are aware that the FDA might deny
approval under CLIA for sales of our product as an analyte specific
reagent.
We have
not yet submitted an application for approval to the FDA or regulatory agencies
in any other countries of the cervical cancer tests we are developing. It
is highly likely that we will have to conduct clinical trials and other studies
to generate data that the FDA and other regulatory authorities will require in
support of our application. We have not yet designed or initiated any of
these trials. We anticipate it will take a minimum oft one to two years to
complete the review and approval process.
In
addition to any government requirements as to authorizing the marketing and
sales of medical devices, there are other FDA requirements. The manufacturer
must be registered with the FDA. The FDA will inspect what is being done on a
routine basis to ascertain compliance with those regulations prescribing
standards for medical device quality and consistency. Such standards refer to
but are not limited to manufacturing, testing, distribution, storage, design
control and service activities. The FDA also prohibits promoting a device for
unauthorized uses and routinely reviews labeling accuracy. If the FDA finds
failures in compliance, it can institute a range of enforcement actions, from a
public warning letter to more severe sanctions like withdrawal of approval;
denial of requests for future approval; fines, injunctions and civil penalties;
recall or seizure of the product; operating restrictions, partial suspension or
total shutdown of production; and criminal prosecution.
The FDA's
medical device reporting regulation also will require the reporting of
information on deaths or serious injuries associated with the use of our tests,
as well as product malfunctions that are likely to cause or contribute to death
or serious injury if the malfunction were to recur.
Regardless
of FDA approval status in the U.S., we will need to obtain certification of our
tests from regulatory authorities in other countries prior to marketing and
selling in such countries. The amount of time needed to achieve foreign approval
varies from country to country. Approval by the regulatory authority in one
country cannot by itself guarantee acceptance by another country's regulatory
body. Additionally, implementation of more stringent requirements or the
adoption of new requirements or policies could adversely affect our ability to
sell our proposed tests in other countries in the world. We may be required to
incur significant costs to comply with these laws and regulations. If we fail to
obtain regulatory approval out business could fail.
In
addition to the rules and regulations of the FDA and similar foreign agencies,
we may also have to comply with other federal, state, provincial and local laws,
rules and regulations. Out tests could be subject to rules pertaining to the
disposal of hazardous or toxic chemicals or potentially hazardous substances,
infectious disease agents and other materials, and laboratory and manufacturing
practices used in connection with our research and development activities. If we
fail to comply with these regulations, we could be fined, may not be allowed to
operate certain portions of our business, or otherwise suffer consequences that
could materially harm our business.
Competition
We are
not aware of other companies that are developing a protein-based screening test
that detects antibodies to cervical cancer. However, when completed, we
expect that our cervical cancer tests will compete with the Pap Tests, which
have been widely accepted by the medical community for over 50 years.
Approximately 60 million Pap Tests are performed annually in the United States,
and an additional 60 million Pap Tests are performed annually in the rest of the
world. Manufacturers of Pap Tests include Cyctc Corporation, TriPath
Imaging, Inc. and several other companies.
Our
cervical cancer test also will compete with HPV Tests, which are becoming
increasingly accepted in the medical community. Manufacturers of HPV Tests
include Digene Corporation, Ventana Medical Systems, Roche Diagnostics, Abbott
Laboratories, and Bayer Corporation.
All of
the companies who make Pap Tests and HPV Tests have far greater financial,
technical, research and development, sales and marketing, administrative and
other resources than we do.
For our
proposed tests to become accepted in the medical community, we will need to
convince those who use established tests that our proposed tests are more
reliable for the screening of cervical cancer, either as stand-alone tests or in
conjunction with the Pap Test and/or HPV Tests.
In
addition, we will need to obtain reimbursement coverage for our proposed
cervical cancer tests. In the United States, the American Medical
Association assigns specific Current Procedural Terminology, or CPT, codes
necessary for reimbursement. Third-party payors and managed care entities
that provide health insurance coverage to approximately 225 million people in
the United States currently authorize almost universal reimbursement for the Pap
Test, and the Pap Test is nearly fully reimbursed in other markets where we will
sell our proposed tests. The HPV Test now has full reimbursement as well for
certain uses. We will attempt to obtain reimbursement for our planned cervical
cancer tests to the same degree as the Pap Test, but it is possible that we will
be unable to obtain third-party reimbursement for these tests.
Sales
and Marketing
When we have completed the development of our cervical cancer tests and received
any required regulatory approval, we plan to market and sell our ELISA test to
laboratories in the United States, Canada, Western Europe, Japan and other
countries with established cervical cancer screening programs for use as a
screening test. Initially, we do not plan to sell our test in these
countries directly to primary healthcare providers.
In developing nations and other markets where cervical cancer screening is not
widespread and where there are few laboratories or other testing facilities, we
plan to market and sell our rapid test to primary healthcare providers as a
stand alone point-of-care test. In some of these countries, we plan to
sell our proposed test directly to the governments or to other national
healthcare distributors who distribute tests to national healthcare providers.
We do not currently have a marketing or sales force or a distribution
arrangement in place. We will need to expend resources to develop our own
marketing and sales force or enter into third party distribution arrangements.
HIV
and Dengue Fever Tests
In
conjunction with the primary diagnostic cervical cancer blood test that we are
developing, we have also recently acquired the exclusive worldwide rights to
diagnostic devices for HIV-1, HIV-2 and dengue fever and proprietary diagnostic
reagent a key ingredient commonly used by leading manufacturers of rapid tests
as a detectable label. We acquired these rights from AccuDx.
As access
to antiretroviral treatment is scaled up in low income countries, there is a
critical opportunity to expand access to HIV prevention. Among the interventions
which play a critical role both in treatment and prevention, HIV testing and
counseling stands out as paramount. An estimated 40 million people are now
living with HIV/AIDS of which nearly 18 million are women (UNAIDS Report: The
Global Coalition on Women and AIDS, November 2004) and 2 million children (WHO,
Regional Offices for South-East Asia: HIV/AIDS Facts and Figures). In 2004
alone, over 5 million new infections were reported. (UNAIDS Report, Regional
HIV/AIDS Statistics and Features, end of 2004). Determination of the specific
anti-HIV antibodies still forms the primary screening/diagnostic procedure for
HIV infection.
The
AccuDx AIDS test device consists of a blood sample pad containing HIV-antigen
gold conjugate, a capillary membrane with three capture lines for HIV-1, HIV-2
and a control line, and a fluid absorption pad. When test strips are placed in
the tube containing the test serum or plasma, the liquid migrates upwardly by
capillary action. Colloidal gold conjugates of the HIV antigen react with
anti-HIV-1 and anti-HIV-2 antibodies in the samples which then are captured on
specific antigen lines as they migrate up the membrane and into the fluid
absorption pad. The results are visual and easy to interpret. For example, a
single pink line corresponding to the control is a negative, two lines
corresponding to the control and HIV-1 is an HIV-1 positive sample. In the cases
where all two lines corresponding to HIV-2 and control would be an HIV-2
infection. The test is simple to use and performance characteristics are
comparable to laboratory-based assays. We believe that extensive utilization of
HIV antibody point-of-care tests should help to combat the current HIV/AIDS
pandemic worldwide.
Another
global illness, dengue fever, which is transmitted by mosquitoes, has had a
dramatic increase in incidence in recent decades. Dengue fever, dengue
haemorrhagic fever (DHF) and dengue shock syndrome (DDS) occur in over 100
countries and territories and threaten the health of more than 2.5 billion
people in urban, peri-urban and rural areas of the tropics and subtropics
(Dengue fever WHO Fact Sheet No. 117, April 2002). The disease is endemic in
Africa, the Americas, the Eastern Mediterranean, Southeast Asia and the Western
Pacific. Although the major disease burden is in Southeast Asia and the Western
Pacific, rising trends are also reflected in increased reporting of dengue fever
and DHF cases in the Americas. In 1998, a total of 1.2 million cases of dengue
and DHF were reported to WHO including 15,000 deaths (USDA,
Agricultural Research Services, Center for Medical, Agricultural and Veterinary
Entomology, March 2003).
Globally,
the annual number of infections is much higher than is indicated by the number
of reported cases. Based on statistical modeling methods there are an estimated
51 million infections each year (USDA,
Agricultural Research Serivces, Center for Medical, Agricultural and Veterinary
Entomology, March 2003).
Rapid and reliable tests for primary
and secondary infections of dengue fever are essential for patient management.
Primary dengue infection is associated with mild to high fever, headache, muscle
pain and skin rash. Secondary infections often result in high fever and in many
cases, with haemorrhagic events and circulatory failure. Secondary infections
induce Immunoglobuins of type M (IgM) response after 20 days of infection and
Immunoglobulins of G type (IgGs) rise within 1-2 days after the onset of
symptoms. A reliable and sensitive rapid test that can simultaneously detect the
presence of anti-dengue IgG and IgM is of great clinical utility.
Pursuant
to the agreement with AccuDx, AccuDx will assist us in arranging to use a
‘maquiladora’-modeled contract manufacturing facility in Tijuana, Mexico to
manufacture the AccuDx tests, a facility that is registered with the FDA and is
ISO 9002-certified and has been used by AccuDx in the past. We will seek
recertification approval in countries where the AccuDx tests had previously
received certificates of resale and we will seek governmental approval in other
countries including China, Brazil and India. We plan on generating revenues from
the sale of AccuDx tests in the last quarter of 2005, provided that we receive
such recertifications in a timely manner.
Intellectual
Property
We rely on patents, licenses from third parties, trade secrets, trademarks,
copyright registrations and non-disclosure agreements to establish and protect
our proprietary rights in our technologies and products.
We entered into an exclusive license with Dr. Yao Xiong Hu on July 20, 2004 for
certain processes that we currently include in our cervical cancer tests.
Some of the technology owned by Dr. Hu is covered by a United States patent that
has been issued, and some of the technology is covered by a United States patent
application that has been filed and is pending. The agreement with Dr. Hu also
covers technology included in foreign applications presently pending as PCT
applications in China and India. We entered into the license agreement with Dr.
Hu on July 20, 2004. The initial term of this license is 17 years, and it
automatically renews for successive one-year periods unless voluntarily
terminated by us or by Dr. Hu in the event of our insolvency. Under the
license agreement, we are required to pay Dr. Hu a minimum licensing fee of
$48,000 per year, which is paid on a monthly basis of $4,000 per month. If the
annual royalty exceeds, $48,000, we will also be required to pay to Dr. Hu
royalties on a quarterly basis ranging from 1% to 3% depending on the net sales
of our product. We have the option to purchase the licensed technology for
$250,000 within two years from the date of the agreement. As of the date of this
prospectus we have made $32,000 in license fee payments to Dr. Hu.
We plan to file patent applications for any additional technology that we create
in the future.
We anticipate that we may need to license additional technology for use in our
planned cervical cancer tests from other third parties. We may be unable to
obtain these licenses on acceptable terms or at all.
Our technology is also dependent upon unpatented trade secrets. However,
trade secrets are difficult to protect. In an effort to protect our trade
secrets, we have a policy of requiring our employees, consultants and advisors
to execute non-disclosure agreements. These agreements provide that
confidential information developed or made known to an individual during the
course of their relationship with us must be kept confidential, and may not be
used, except in specified circumstances. In addition, our employees are
parties to agreements that require them to assign to us all inventions and other
technology that they create while employed by us.
On March
7, 2005, we entered into an Exclusive License Agreement with AccuDx Corporation
for a period of ten years, pursuant to which AccuDx granted us the exclusive
right to its rapid tests for HIV-1, HIV-2 and dengue fever and its colloidal
gold reagent. Pursuant
to the license agreement AccuDx
will assist us in arranging to use an FDA/GMP-compliant contract
manufacturing maquiladora facility in Tijuana, Mexico to
manufacture AccuDx’s tests that AccuDx has used in the past. In
consideration for the license, we agreed to pay AccuDx $15,000 in cash and
deliver a promissory note in the principal amount of $35,000 payable in equal
quarterly installments for a two-year period and bearing 6% interest on the
unpaid principal. We also agreed to pay AccuDx a 3% royalty on net sales of the
products under the license.
Research
and Development
Our research and development program is focused on completing development of our
cervical cancer tests. We continue to refine existing technology and
develop further improvements to our tests.
We believe that in the future we may be able to apply our technology to develop
rapid tests for other diseases and certain other cancers. We plan to
pursue development of these other tests.
For
the fiscal years ended December 31, 2003 and 2004 and for the period from July
9, 1998 (the date of inception) through December 31, 2004, we spent
approximately $430,540 $51,108 and $841,930, respectively, on research and
development.
Manufacturing
We plan to outsource the manufacturing and assembly of our planned cervical
cancer tests to third parties. We do not currently have arrangements in
place with any such third parties.
Suppliers
We develop the processes including proteins and other technology that we use in
our proposed tests, and license certain other technology from third
parties. We believe that the reagents and other supplies we will use to
manufacture our test may be readily obtained from multiple suppliers.
Employees
As of April 26, 2005, we had seven employees and retained four consultants on a
part-time basis. Our employees consist of our three executive officers, a
Medical Director, one laboratory development manager, one controller and one
administrative assistant.
Principal
Executive Offices
Our principal executive offices are located at 64 East Winchester, Suite 205,
Murray, Utah 84107.
History
of Grant Life Sciences
We were incorporated in Idaho in 1983 as Grant Silver, Inc., for the purposes of
acquiring and developing mineral resources. We engaged in preliminary
mining work on certain mining claims that were eventually abandoned in
1984. Thereafter, we conducted no business until 1995. In October, 1997,
we acquired BrewServ Corporation, an Ohio Corporation (“BrewServ Ohio”).
In anticipation of the acquisition of BrewServ Ohio, in 1997, we changed our
name to BrewServ Corporation. BrewServ Ohio and its subsidiaries produced
and distributed alcohol-based cider products, operated coffee retail stores, and
developed theme restaurants. In 1999, the Brewserv Ohio acquisition was
rescinded, and in January 2000, we changed our name to Grant Ventures, Inc.
From 1999
to July 2004, we conducted no business. In 2000, we reincorporated in
Nevada through a merger with North Ridge Corporation. On July 30, 2004, we
acquired Impact Diagnostics, through a merger of our wholly owned subsidiary
into Impact Diagnostics. Impact Diagnostics was incorporated in Utah in
1998. Impact Diagnostics develops products to improve the efficiency of
diagnosing cervical cancer, including a sensitive, reliable, non-invasive,
point-of-care test which is expected to cost less than other tests currently
used.
Impact
Diagnostics was formed in 1999 to license and develop certain technologies as
owned by Dr. Yao Xiong Hu. Initial funding provided by the founders, and
supplemented by two additional rounds of private funding, was used to fund the
collection of patient samples and validation study costs of the technology. Once
the technology was verified, Dr. Mark Rosenfeld drafted and applied for patents.
In early 2004, Impact Diagnostics received its first patent.
Pursuant
to the merger, each issued and outstanding share of common stock of Impact
Diagnostics was converted into the right to receive one share of our common
stock. In addition, each option to purchase one (1) share of common stock
of Impact Diagnostics was converted into the right to receive an option to
purchase one (1) share of our common stock. Upon completion of the merger,
nominees of Impact Diagnostic were appointed to our board of directors and, our
then current directors resigned.
Available
Information
Our electronic filings with the United States Securities and Exchange Commission
(including our annual report on Form 10-K, quarterly reports on Form 10-Q and
current reports on Form 8-K, and any amendments to these reports) are available
free of charge on the Securities and Exchange Commission’s website at
http://www.sec.gov.
DESCRIPTION
OF PROPERTY
We lease
our principal executive offices in Murray, Utah, office space in Raleigh,
N.C. and our clinical laboratory in Sandy, Utah. The material terms of
our property leases are set forth in the table below. Part of our Raleigh office
is subleased for $800 per month for the period beginning March 1, 2005 through
the term of our lease.
Location
|
|
Use
|
|
Square
Feet |
|
Rent
Payments |
|
Term
|
|
Leased
From |
|
5511
Capital Center Drive Suite 224 Raleigh, NC 27606 |
|
Principal
Executive Offices |
|
Approximately
1,438 square feet |
|
$1,600
per month |
|
October
1, 2004 — September 30, 2004 |
|
HD
Capital Center, LLC |
|
64
East Winchester Suite 205 Murray, Utah 84107 |
|
Executive
Offices |
|
Approximately
1330 square feet |
|
$1,663
per month |
|
September
1, 2004 — August 31, 2005 |
|
Plaza
6400, LLC |
|
10011
Centennial Parkway Suite 300 Sandy, Utah 84070 |
|
Clinical
Laboratory |
|
Approximately
800 square feet |
|
$600
per month |
|
April
1, 2004 — March 31, 2005 |
|
Rocky
Mountain Pathology, LLC |
|
LEGAL
PROCEEDINGS
We are not currently a party to any litigation.
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
Set forth below is certain information regarding our directors and executive
officers. Our Board of Directors is comprised of six directors.
There are no family relationships between any of our directors or executive
officers. Each of our directors is elected to serve until our next annual
meeting of our stockholders and until his successor is elected and qualified or
until such director’s earlier death, removal or termination.
Name
|
|
Age
|
|
Position
|
|
Stan
Yakatan |
|
62
|
|
President,
Chief Executive Officer and Chairman of the Board of Directors
|
|
Michael
Ahlin |
|
56
|
|
Vice
President and Director |
|
Don
Rutherford |
|
65 |
|
Chief
Financial Officer |
|
Jack
Levine |
|
54
|
|
Director
|
|
Eric
Wilkinson |
|
46
|
|
Director
|
|
Kevin
Crow |
|
43
|
|
Director
|
|
Carmen
Medina |
|
48 |
|
Director |
|
Stan
Yakatan.
Mr. Yakatan has been the Chief Executive Officer and the Chairman of the Board
of Directors since July 2004. From May 2004 to the present, Mr. Yakatan has been
the Chief Executive Officer and the Chairman of the Board of Directors of Impact
Diagnostics and a consultant to Impact Diagnostics. From September 1984 to
the present, Mr. Yakatan has been the Chairman, President and Chief Executive
Officer of Katan Associates, a life sciences advisory business. Mr.
Yakatan is also a director of Lifepoint, Inc., a manufacturer of drug and
alcohol testing systems, and is a strategic advisor to the state government of
Victoria, Australia. Between 1968 and 1989, Mr. Yakatan held various
senior executive positions with New England Nuclear Corporation (a division of
E.I. DuPont), ICN Pharmaceuticals, Inc., New Brunswick Scientific Co., Inc. and
Biosearch.
Michael
Ahlin.
Mr. Ahlin has been a Vice President and a director since July 2004. From
May 2004 to the present, Mr. Ahlin has been the Vice President and a member of
the Board of Directors of Impact Diagnostics. From July 1998 to May 2004,
Mr. Ahlin was the Chairman of the Board, President and Chief Executive Officer
of Impact Diagnostics. Mr. Ahlin has been President of WetCor, Inc., a
land development company, since 1983.
Don
Rutherford. Mr.
Rutherford, becomes the Chief Financial Officer on April 1, 2005. He is a
limited partner with Tatum CFO Partners, LLP in Orange County, California, which
he joined in January 2000. Tatum CFO Partners provides supplemental, interim,
project, or employed executives for clients that range from emerging growth to
large multinational public companies. Pursuant to such employment, Mr.
Rutherford has been contracted out as an executive officer for various
corporations. Since January 2004, he has been a board member and chairman of the
audit committee of Performance Capital Management LLC, a public financial
services company. Mr. Rutherford started his career with Coopers and Lybrand in
its Toronto audit practice and is a Chartered Accountant. He holds a BASc in
Industrial Engineering from the University of Toronto.
Jack
Levine.
Mr. Levine has been a director since July 2004. Since 1984, Mr. Levine has
been the President of Jack Levine, PA, a certified public accounting firm.
Since 1999, Mr. Levine has served as a director and the chairman of the audit
committee of SFBC International Inc., a clinical research organization.
Mr. Levine is also a director, Chairman of the Audit and Asset Liability
Committees and a member of the Executive Committee of Beach Bank, a director and
Chairman of the Audit Committee of The Prairie Fund, a mutual fund, and a
director of RealCast Corporation, an internet streaming company. Mr.
Levine is a certified public accountant licensed by the State of Florida.
Eric
Wilkinson.
Mr. Wilkinson has been a director since July 2004. Since June 2003, Mr.
Wilkinson has been the Vice President of Life Sciences for XL TechGroup, a
biotechnology company. From September 2001 to May 2003, Mr. Wilkinson
worked as a consultant for Tyrgen Technologies, a biotechnology-consulting
firm. From December 1999 to August 2001, Mr. Wilkinson was the President
of Genetic Vectors, Inc., a biotechnology company. Mr. Wilkinson served as
a consultant for the Cleveland Clinic Medical Foundation from November 1998 to
November 1999.
Kevin
Crow.
Mr. Crow has been a director since July 2004. Since April 2004, Mr. Crow
has been the Chief Executive Officer of Diversified Corporation Solutions, LLC,
a business advisory company. From September 2000 to December 2003, Mr.
Crow was the Chief Operating Officer of the Women’s United Soccer Association, a
professional athletic league. Mr. Crow was President of ZipDirect, LLC, a
full service printing, mailing and shipping company, from February 1994 to
September 2000. Mr. Crow is also a director of Knobias, Inc. Mr. Crow is
the brother of Michael Crow, who serves as the Chairman and Chief Executive
Officer of Duncan Capital Group LLC, which is our financial advisor.
Carmen
Medina. Ms.
Medina was appointed to the board of directors on February 21, 2005. Ms. Medina,
is Founder and President of Precision Consultants, Inc., headquartered in
Coronado, CA. Prior to founding Precision Consultants in January 1992, Ms.
Medina served as Director of Regulatory Affairs & Product Development for
Ivax Corporation. From 1986 to 1992, she served as an FDA Field Investigator and
Commissioned Officer in the United States Public Health Service. Ms. Medina
earned a master’s degree in public health at Columbia University’s School of
Public Health in 1987, and a BS at City College of NY in 1978. She has published
numerous journal articles and is a frequent presenter at national and
international conferences.
Executive
Compensation
The
following table sets forth information concerning the total compensation that we
have paid or that has accrued on behalf of our Chief Executive Officer and other
executive officers with annual compensation exceeding $100,000 during fiscal
2004, 2003 and 2002
|
|
|
|
Annual
Compensation |
|
Long-Term
Compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Awards |
|
Payouts |
|
|
|
Name
and Principal
Position |
|
Year |
|
Salary |
|
Bonus |
|
Other
Annual
Compensation |
|
Restricted
Stock
Awards |
|
Securities
Underlying
Options/SARs |
|
LTIP
Payouts |
|
All
Other Compensation |
|
|
|
|
|
($) |
|
($) |
|
($) |
|
($) |
|
(#) |
|
($) |
|
($) |
|
Stan
Yakatan
Chief
Executive Officer (1) |
|
2004
2003
2002 |
|
60,000
0
0 |
|
—
|
|
—
|
|
—
|
|
2,868,254
—
|
|
—
|
|
—
|
|
John
C. Wilson
Former
Chief Financial Officer (2) |
|
2004
2003
2002 |
|
36,000
0
0 |
|
— |
|
— |
|
— |
|
750,000
— |
|
— |
|
— |
|
Dr.
Mark Rosenfeld
Former
Vice President (3) |
|
2004
2003
2002 |
|
111,429
58,050
92,000 |
|
18,106
0
0 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Michael
Ahlin
Vice
President and Director
(4) |
|
2004
2003
2002 |
|
144,000
58,050
0 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
—
|
|
Pete
Wells
former
President and Director (5)
|
|
2004
2003
2002 |
|
— |
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
______________
(1) |
Between
May and June 2004, Impact Diagnostics paid Mr. Yakatan $5,500 per month
for consulting services to Impact Diagnostics in connection with the
Merger. Beginning in July 2004, Mr. Yakatan receives $10,000 per
month for acting as our Chief Executive Officer . As of the end of 2004,
$15,000 of his gross salary had not been paid to Mr. Yakatan. Mr. Yakatan
does not have an employment contract with the company. As an incentive to
join the company, Mr. Yakatan was granted 2,868,254 stock options, with an
exercise price of $0.18, under the Company’s Stock Incentive Plan. These
options vest as follows: 573,650 on July 6, 2004; 1,147,302 on July 6,
2005 and 1,147,302 on July 6, 2006. |
(2) |
Mr.
Wilson became the Chief Financial Officer on July 1, 2004 and is retiring
from his position on March 31, 2005. Mr. Wilson receives $6,000 per month
for acting as our Chief Financial Officer. Prior to July 1, 2004, his
company, Wentworth Advisors LLC had received consulting fees in the form
of stock for services provided to Impact Diagnostic, Inc. As an incentive
to join the company, Mr. Wilson was granted 750,000 stock options with an
exercise price of $0.18, half of which vested July 6, 2005 and half on
July 6, 2006, under the Company’s stock incentive plan. Mr. Wilson does
not have an employment agreement with the company. Mr. Wilson is retiring
as CFO effective March 31, 2005. The Board has fully vested his 750,000
options effective on his retirement date. |
(3) |
Dr.
Mark Rosenfeld resigned on Oct 11, 2004. He had an employment contract
with the company which set his monthly salary for 2004 at $12,000 per
month. After his resignation, he continued to work as a consultant to the
company through December 31, 2004. He was paid $5,000 per month for his
consulting work. |
(4) |
Mr.
Ahlin had an employment contract with the company which sets his monthly
salary at $12,000. The employment contract can be terminated by the
Company at any time. |
(5) |
Mr.
Wells was President of the inactive public company prior to the
merger. |
Michael Ahlin and Mark Rosenfeld each have an employment agreement with Impact
Diagnostics. Pursuant to those employment agreements, Impact Diagnostics
pays to each of Mr. Ahlin and Dr. Rosenfeld an annual salary of $144,000 and the
Board of Directors of Impact Diagnostics has the discretion to grant an annual
bonus to each of them. Mr. Ahlin and Dr. Rosenfeld are each entitled to
participate in all employee benefit plans or programs that are available to
management employees of Impact Diagnostics and all other benefit plans or
programs as may be specified by the Board of Directors of Impact Diagnostics.
Each of the employment agreements provide that either we or Mr. Ahlin or
Dr. Rosenfeld may terminate the respective agreement at any
time.
Compensation
of Non-Employee Directors
We pay our directors who are not employees of Grant Life Sciences a director’s
fee of $4,000 per year. Each non-employee director also is paid $300 per
hour for attending any meeting of the Board of Director and each Board committee
meeting, up to a maximum of $1,200 per meeting. We have granted each
non-employee director options to purchase 100,000 shares of our common stock at
marke price on the date they join the board. Half of these options will be
exercisable one year from the date of grant and half will be exercisable two
years from the date of the grant.
Non-employee directors will receive additional options to purchase 50,000 shares
of our common stock at the start of each year that they serve as
directors. These options will have an exercise price equal to the market
value at the time they are granted. One third of the options will first
become exercisable on the first, second and third anniversary of the date of
their grant. Jack Levine, Kevin Crow, Eric Wilkinson and Carmen
Medina are non-employee directors.
In addition to the fees and options which they receive for serving as
non-employee directors, the chairman of our Audit Committee and Compensation
Committee each receives an annual fee of $2,500 and $1,500, respectively for
each year that he or she serves as chair of their respective committees.
The chairman of each of these committees will also receive options to purchase
an additional 25,000 shares of our common stock for each year that he or she
serves as chairman of the committee. The options will be exercisable at
the market price at the time they are granted. One third of these options
will first become exercisable on the first, second, and third anniversary of the
date of the grant. Jack Levine is the chairman of the Audit Committee and
Kevin Crow is the chairman of the Compensation Committee.
INDEMNIFICATION
OF OFFICERS AND DIRECTORS
Section
78.7502 of the Nevada Revised Statutes allows a corporation to indemnify any
officer, director, employee or agent who is a party or is threatened to be made
a party to a litigation by reason of the fact that he or she is or was an
officer, director, employee or agent of the corporation, or is or was serving at
the request of the corporation as an officer, director, employee or agent of
another corporation, partnership, joint venture, trust or other enterprise,
against expenses, including attorneys’ fees, judgments, fines and amounts paid
in settlement actually and reasonably incurred by such director or officer if:
•
there was
no breach by the officer, director, employee or agent of his or her fiduciary
duties to the corporation involving intentional misconduct, fraud or knowing
violation of law; or
•
the
officer, director, employee or agent acted in good faith and in a manner which
he or she reasonably believed to be in or not opposed to the best interests of
the corporation, and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his or her conduct was unlawful.
Our
Amended and Restated Articles of Incorporation provide for the indemnification
of our officers and directors to the maximum extent permitted by Nevada law, and
also provide that:
•
the
indemnification right is a contract right that may be enforced in any manner by
our officers and directors,
•
the
expenses of our officers and directors incurred in any proceeding for which they
are to be indemnified are to be paid to them as they are incurred, with such
payments to be returned to us if it is determined that an officer or director is
not entitled to be indemnified,
•
the
indemnification right is not be exclusive of any other rights that our officers
and directors have or may acquire and includes any other rights of
indemnification under any bylaw, agreement, vote of stockholders or provision of
law,
•
our Board
of Directors may adopt bylaws to provide for the fullest indemnification
permitted by Nevada law,
•
our Board
of Directors may cause us to purchase and maintain insurance for our officers
and directors against any liability asserted against them while acting in their
capacity as our officers or directors, and
•
these
indemnification rights shall continue to apply after any officer or director has
ceased being an officer or director and shall apply to their respective heirs,
executors and administrators.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons of Grant Life Sciences
pursuant to the foregoing provisions, or otherwise, we have been advised that in
the opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act and is, therefore,
unenforceable.
These
provisions of our Amended and Restated Articles of Incorporation become
effective Nov 12, 2004.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table lists stock ownership of our common stock as of April 26,
2005. The information includes beneficial ownership by (i) holders of more
than 5% of our common stock, (ii) each of our current directors and executive
officers and (iii) all of our directors and executive officers as a group.
The information is determined in accordance with Rule 13d-3 promulgated under
the Exchange Act based upon information furnished by the persons listed or
contained in filings made by them with the Commission. Except as noted
below, to our knowledge, each person named in the table has sole voting and
investment power with respect to all shares of our common stock beneficially
owned by them.
Name
and Address of Beneficial
Owner |
|
Director/Officer
|
|
Amount
and Nature of
Beneficial
Ownership (1) |
|
Percentage
of
Class (1) |
|
|
|
|
|
|
|
|
|
Dr.
Mark Rosenfeld
1075
Skyler Drive
Draper,
UT 84020 |
|
— |
|
6,077,050 |
|
10.5% |
|
Blaine
Taylor
634
Hidden Circle
North
Salt Lake City, UT 84054 |
|
—
|
|
3,600,718
(2) |
|
6.2% |
|
Mitchell
T. Godfrey
P.O.
Box 10206
Bozeman,
MT 59719 |
|
—
|
|
3,730,607
|
|
6.5%
|
|
Begona
LLC
2325-A
Renaissance Drive
Las
Vegas, NV 89119 |
|
—
|
|
3,256,905
|
|
5.7%
|
|
Bridges
& Pipes LLC
830
Third Avenue
New
York, NY 10022 |
|
—
|
|
3,103,625
(3) |
|
5.4%
|
|
Stan
Yakatan
155
Lyndon — First Court
Hermosa
Beach, CA 90254 |
|
President,
Chief Executive Officer and Chairman of the Board of Directors
|
|
573,650
(4) |
|
1.0% |
|
Michael
Ahlin
3125
Creek Road
Park
City, UT 84098 |
|
Vice
President and Director |
|
6,640,900
(5) |
|
11.5% |
|
|
|
|
|
|
|
|
|
Don
Rutherford
C/o
Grant Life Sciences, Inc.
64
East Winchester
Murray,
UT 84107 |
|
Chief
Financial Officer |
|
291,666
(6) |
|
* |
|
Jack
Levine
16855
N.E. 2nd
Avenue,
Suite 303
N.
Miami Beach, FL 33162 |
|
Director |
|
585,555(7) |
|
1.0% |
|
Eric
Wilkinson
1845
Charlesmonte Drive
Indialantic,
FL 32903 |
|
Director |
|
0(8) |
|
* |
|
Kevin
Crow
5120
Park Brooke Walk Way
Alpharetta,
GA 30022 |
|
Director |
|
985,080(9) |
|
1.7% |
|
Carmen
Medina
46
The Point
Coronado,
CA 92118 |
|
Director |
|
0
(10) |
|
* |
|
Richard
Smithline
830
Third Avenue
New
York, NY 10022 |
|
— |
|
3,727,152(11) |
|
6.4% |
|
David
Fuchs
830
Third Avenue
New
York, NY 10022 |
|
— |
|
3,248,305(12) |
|
5.6% |
|
DCOFI
Master LDC
803
Third Avenue
New
York, NY 10022 |
|
|
|
3,258,400
(13) |
|
5.6% |
|
All
directors and officers as a group (6) |
|
|
|
9,079,851
(14) |
|
15.5% |
|
______________________
* Less
than one percent
(1) Applicable
percentage ownership is based on 57,639,113 shares of common stock outstanding
as of April 26, 2005, together with securities exercisable or convertible into
shares of common stock within 60 days of April 26, 2005 for each stockholder.
Beneficial ownership is determined in accordance with the rules of the
Securities and Exchange Commission and generally includes voting or investment
power with respect to securities. Shares of common stock that are currently
exercisable or exercisable within 60 days of April 26, 2005 are deemed to be
beneficially owned by the person holding such securities for the purpose of
computing the percentage of ownership of such person, but are not treated as
outstanding for the purpose of computing the percentage ownership of any other
person.
(2)
Includes 1,253,000 shares of our common stock held by Six Way, Inc. Mr.
Taylor is the President, a director and principal shareholder of Six Way, Inc.
(3)
Includes 2,999,131 shares of our common stock and warrants to purchase 104,495
shares of our common stock exercisable within 60 days.
(4)
Represents options to purchase 573,651 shares of our common stock exercisable
within 60 days. Does not include options to purchase 2,294,603 shares of
our common stock held by Mr. Yakatan that are not exercisable within 60 days.
(5)
Includes
1,253,000 shares of our common stock held by Princess Investments. Mr.
Ahlin has voting power over securities held by Princess Investments.
(6)
Does not include options to purchase 458,334 shares of our common stock that are
not exercisable within 60 days.
(7)
Includes warrants to purchase 98,092 shares of our common stock beneficially
owned by Mr. Levine that are exercisable within 60 days. Does not include
options to purchase 175,000 shares of our common stock that are not exercisable
within 60 days.
(8)
Does not include options to purchase 150,000 shares of our common stock that are
not exercisable within 60 days.
(9)
Includes shares of 4 trusts, each with 246,270 shares, of which Mr. Crow is the
trustee. Does not include options to purchase 175,000 shares of our common stock
that are not exercisable within 60 days.
(10) Does
not include options to purchase 100,000 shares of our common stock that are not
exercisable within 60 days.
(11)
Includes 3,008,400 shares and warrants to purchase 250,000 shares of common
stock held by DCOFI Master LDC, 420,525 shares held by Mr. Smithline and 48,227
warrants held by Mr. Smithline. Mr. Smithline is a director of DCOFI.
(12)
Includes the 2,999,131 shares and warrants to purchase 104,495 shares of our
common stock held by Bridges and Pipes LLC, warrants to purchase 130,900 shares
held by Duncan Capital LLC and warrants to purchase 13,779 shares held by Mr.
Fuchs. Mr. Fuchs is a manager of Bridges and Pipes, LLC and president of Duncan
Capital LLC.
(13)
Includes 3,008,400 shares and warrants to purchase 250,000 shares of common
stock held by DCOFI Master LDC. Richard Smithline has voting power over the
securities held by DCOFI.
(14)
Includes options to purchase 865,316 shares of our common stock and warrants to
purchase a total of 98,092 shares of our common stock exercisable within 60
days. Does not include options to purchase a total of 3,352,937
shares of our common stock not exercisable within 60 days.
Securities
Authorized for Issuance Under Equity Compensation Plans
As of the end of fiscal year 2003, we had no compensation plans under which our
equity securities were authorized for issuance. On August 2, 2004, our
Board of Directors adopted our 2004 Stock Incentive Plan, subject to stockholder
approval. The Plan provides for the issuance of qualified and
non-qualified incentive stock options and direct restricted stock grants to
officers, employees, consultants and others providing services to us. Our
directors will be eligible to be issued options to purchase shares of our common
stock, or to receive awards of restricted stock, under the Plan. Up to
25,000,000 shares of our common stock may be issued in connection with awards
granted under the Plan.
On September 30, 2004, a total of 17 stockholders owning 25,696,014 shares of
our common stock, acting by written consent, approved the Plan. On September 30,
2004, we filed a preliminary information statement with the Securities and
Exchange Commission that includes a description of the Plan and its approval by
the stockholders. The Plan became effective on November 12, 2004.
Currently,
Stan Yakatan holds options to purchase 2,868,254 shares of our common stock,
former CFO John C. Wilson held options to purchase 750,000 shares of our common
stock, Don Rutherford held options to purchase 750,000 shares of our common
stock, Jack Levine held options to purchase 175,000 shares of our common stock,
Eric Wilkinson held options to purchase 150,000 shares of our common stock,
Kevin Crow held options to purchase 175,000 shares of our common stock and
Carmen Medina held options to purchase 100,000 shares of our common stock.
An additional 175,000 options to purchase shares of our common stock are
held by our consultants and 950,000 options are held by non-executive employees.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Except as
set forth below, there have been no material transactions during the past two
years between us and any officer, director or any stockholder owning greater
than 5% of our outstanding shares, or any of their immediate family members.
In August
2004, we paid $100,000 and issued warrants to purchase 2,670,000 shares, at an
exercise price of $0.01 per share, of our common stock to Duncan Capital Group
LLC as compensation for acting as our financial advisor in connection with the
Merger. In August 2004, we paid $77,000 and issued warrants to purchase
411,104 shares of our common stock to Duncan Capital LLC as compensation for
acting as our placement agent in connection with the sale of our units in a
private financing. The warrants have an exercise price of $0.1835 per
share. Both Duncan Capital LLC and Duncan Capital Group LLC are affiliates of
Bridges & Pipes LLC, which is one of our stockholders. Michael Crow,
the brother of Kevin Crow, one of our directors, is Chairman and Chief Executive
Officer of Duncan Capital Group LLC, which is our financial advisor, and a
manager of Bridges &Pipes LLC. In November 2004, 2,403,000 warrants were
exercised by Duncan Capital Group. In March 2005, we issued warrants to purchase
250,000 shares at an exercise price of $0.40 to DCOFI in connection with bridge
financing.
In 2002
and 2003, Impact Diagnostics made interest free advances in the amount of $6,000
and $3,000, respectively, to Michael Ahlin, a director and Vice President of
Grant Life Sciences, and $14,533 and $6,500, respectively, to Dr. Mark
Rosenfeld, a former director and Vice President. At the time of the
advances, Mr. Ahlin was Chairman of the Board, President and Chief
Executive Officer of Impact Diagnostics, and Dr. Rosenfeld was Secretary
and Chief Technical Officer of Impact Diagnostics. These advances were repaid in
full on June 30, 2004 by Mr. Ahlin and Dr. Rosenfeld.
In 2002
and 2003, Impact Diagnostics made interest free advances in the amount of
$22,631 and $6,229, respectively, to Seroctin Research & Technology.
Michael Ahlin, a director and Vice President, owns 20%, and Dr. Mark
Rosenfeld, a former director and former Vice President, owns 18.4% of Seroctin
Research & Technology. Seroctin advanced funds interest free to Impact
Diagnostics during 2004, such that the receivable became a small payable. In
December 2004, Impact made a payment of $1,220 to Seroctin, so that at year-end
2004 neither company owed the other. From time to time since 1999, Seroctin
Research & Technology has leased office facilities from Impact Diagnostics,
pursuant to a verbal agreement. Seroctin Research & Technology has
made payments to Impact Diagnostics of between $1,500 and $2,764 each month
(approximately $55,000 in the aggregate since 1999) it has leased such
facilities. In September 2004, Impact Diagnostics moved into its own office
space.
In 2002,
Impact Diagnostics paid management and consulting fees of $114,560 to WetCor,
Inc. In 2002 and 2003, Impact Diagnostics advanced $11,922 and $7,820,
respectively, to WetCor, Inc. Michael Ahlin, a director and Vice President, is
the President of WetCor, Inc The $7,820 of advances receivable on the
balance sheet as of December 31, 2003 was written off by Impact Diagnostics in
January 2004. After June 2004, there were no further transactions between the
two companies and neither company owed the other.
In 2002
and 2003, Impact Diagnostics received advances of $10,000 and $20,000 from
Blaine Taylor, pursuant to a non-interest bearing demand note. Mr. Taylor
beneficially currently owns 6.4% of our outstanding capital stock. As of
December 31, 2003, the amount outstanding under the note was approximately
$16,500. Effective July 30, 2004, this note was converted to 89,918
shares of our common stock.
In 2001,
Mitchell Godfrey loaned Impact Diagnostics $50,000, pursuant to a 5% unsecured
promissory note. Mr. Godfrey beneficially owns 6.9% of our
outstanding capital stock. As of December 31, 2003 and 2002, the
amount outstanding under the note was $29,279. Effective July 30,
2004, this note, excluding accrued interest which was forgiven by Mr. Godfrey,
was converted into 159,557 shares of our common stock.
Messrs.
Seth Yakatan and Clifford Mintz have been contracted as consultants to us in the
business development area since November 1, 2004 and August 1, 2004,
respectively. They are paid each $5,000 each month for their services. Mr.
Yakatan is the son of Stan Yakatan, our President, CEO and Board Chairman. Mr.
Mintz is an affiliate of Katan Associates, of which Stan Yakatan is the
Chairman.
With the
exception of the advances to officers, on which no interest was due, we believe
that these transactions were on terms as favorable as could have been obtained
from unaffiliated third parties. All future transactions we enter into with our
directors, executive officers and other affiliated persons will be on terms no
less favorable to us than can be obtained from an unaffiliated party and will be
approved by a majority of the independent, disinterested members of our board of
directors, and who had access, at our expense, to our or independent legal
counsel.
SELLING
STOCKHOLDERS
The
following table details the name of each selling stockholder, the number of
shares owned by that selling stockholder, and the number of shares that may be
offered by each selling stockholder for resale under this prospectus. The
selling stockholders may sell up to 26,163,763 shares of our common stock from
time to time in one or more offerings under this prospectus, of which 22,766,393
are shares of common stock currently held by the selling stockholders and
3,397,370 are shares of common stock issuable upon exercise of warrants or the
conversion of notes held by the selling stockholders. Because each selling
stockholder may offer all, some or none of the shares it holds, and because,
based upon information provided to us, there are currently no agreements,
arrangements, or understandings with respect to the sale of any of the shares,
no definitive estimate as to the number of shares that will be held by each
selling stockholder after the offering can be provided. The following table has
been prepared on the assumption that all shares offered under this prospectus
will be sold to parties unaffiliated with the selling stockholders. Except as
indicated below, no selling stockholder nor any of their affiliates have held a
position or office, or had any other material relationship, with us.
Name
of Selling Stockholder |
|
Number
of Shares Owned Before Offering |
|
Number
of Shares Offered for Sale |
|
Number
of Shares Owned After Completion of Offering |
|
Percentage
of Common Stock Owned After Completion of Offering
|
|
Michael
Ahlin (1) |
|
6,640,900
|
|
1,000,000
|
|
5,640,900
|
|
9.1% |
|
AJW
Offshore, Ltd. (2) |
|
241,960
|
|
241,960
|
|
0
|
|
0 |
|
AJW
Partners (3) |
|
104,631
|
|
104,631
|
|
0
|
|
0 |
|
AJW
Qualified Partners, LLC (4) |
|
287,738
|
|
287,738
|
|
0
|
|
0 |
|
Alan
Gelband Co. Defined Contribution Pension Plan & Trust
(5) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Armadillo
Partners (6) |
|
653,950
|
|
653,950
|
|
0
|
|
0 |
|
Thomas
J. Axon (7) |
|
788,200
|
|
788,200
|
|
0
|
|
0 |
|
Bridges
& Pipes LLC (8) |
|
3,096,974
|
|
3,096,974
|
|
0
|
|
0 |
|
Shekhar
K. Basu and Sita Basu (9) |
|
653,950
|
|
653,950
|
|
0
|
|
0 |
|
BIP
Partners (10) |
|
117,710
|
|
117,710
|
|
0
|
|
0 |
|
Daniel
C. Bolick (11) |
|
653,950
|
|
653,950
|
|
0
|
|
0 |
|
Dr.
David R. Bolick (12) |
|
1,160,489 |
|
1,160,489
|
|
0
|
|
0 |
|
Julia
Bolick (13) |
|
32,696
|
|
32,696
|
|
0
|
|
0 |
|
Larry
and Glenda Bolick Family Trust (14) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Marie
Bono (15) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
Mike
Cassidy (16) |
|
130,789
|
|
130,789 |
|
0
|
|
0 |
|
Peter
L. Coker and Susan H. Coker (17) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
DCOFI
Master LDC (18) |
|
3,007,200
|
|
3,007,200
|
|
0
|
|
0 |
|
James
H. Donell, as receiver of Citadel Capital Management, Inc.
(19) |
|
507,166
|
|
507,166
|
|
0
|
|
0 |
|
Thomas
Doyle (20) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
Richard
Smithline (21) |
|
468,752 |
|
468,752 |
|
0 |
|
0 |
|
Robert
MacGregor (22) |
|
13,779 |
|
13,779 |
|
0 |
|
0 |
|
David
Skriloff (23) |
|
297,619 |
|
297,619 |
|
0 |
|
0 |
|
Rockwood
Group LLC (24) |
|
68,895 |
|
68,895 |
|
0 |
|
0 |
|
David
Fuchs (25) |
|
13,779 |
|
13,779 |
|
0 |
|
0 |
|
M.
W. Crow Family Trust (26) |
|
531,125 |
|
531,125 |
|
0 |
|
0 |
|
Trevor
Crow (27) |
|
216,270 |
|
216,270 |
|
0 |
|
0 |
|
Michelle
Crow Trust (28) |
|
246,270 |
|
246,270 |
|
0 |
|
0 |
|
Spencer
Crow Trust (28) |
|
246,270 |
|
246,270 |
|
0 |
|
0 |
|
Olivia
Crow Trust (28) |
|
246,270 |
|
246,270 |
|
0 |
|
0 |
|
Duncan
Crow Trust (28) |
|
246,270 |
|
246,270 |
|
0 |
|
0 |
|
Blair
Eddins (29) |
|
29,427
|
|
29,427 |
|
0
|
|
0 |
|
John
A. Fahlberg (30) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Bruce
A. Falbaum (31) |
|
65,394
|
|
65,394
|
|
0 |
|
0 |
|
Anthony
Falcone (32) |
|
130,789 |
|
130,789 |
|
0 |
|
0 |
|
Richard
Gillings (33) |
|
326,974 |
|
326,974 |
|
0 |
|
0 |
|
Mitchell
Godfrey (34) |
|
3,370,607 |
|
159,557 |
|
3,211,050 |
|
5.2% |
|
Francesco
Gozzo (35) |
|
326,974 |
|
326,974 |
|
0 |
|
0 |
|
Harold
Gubnitsky (36) |
|
163,486
|
|
163,486
|
|
0
|
|
0 |
|
Steven
T. Hague (37) |
|
78,819
|
|
78,819
|
|
0
|
|
0 |
|
Roberta
B. Hardy (38) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
Frank
L. Hoffecker (39) |
|
270,000
|
|
270,000
|
|
0
|
|
0 |
|
HT
Ardinger & Sons, Inc. (40) |
|
326,974
|
|
326,974
|
|
0
|
|
0 |
|
Ira
A. Hunt Jr. (41) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Horace
Mann Johnson III (42) |
|
98,091
|
|
98,091
|
|
0
|
|
0 |
|
David
P. Kalm (43) |
|
78,819
|
|
78,819
|
|
0
|
|
0 |
|
Don
Larsen (44) |
|
98,091
|
|
98,091
|
|
0
|
|
0 |
|
Steven
W. Lefkowitz (45) |
|
1,576,401
|
|
1,576,401
|
|
0
|
|
0 |
|
Jack
Levine and Susan Levine (46) |
|
588,555
|
|
588,555
|
|
0
|
|
0 |
|
Timothy
McNamee (47) |
|
326,974
|
|
326,974
|
|
0
|
|
0 |
|
Andreas
Michailidis (48) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Network
1 Financial Securities Inc. (49) |
|
104,905
|
|
104,905
|
|
0
|
|
0 |
|
New
Millenium Capital Partners II, LLC (50) |
|
19,617
|
|
19,617
|
|
0
|
|
0 |
|
Pershing
LLC, as custodian of Robert L. Bolick, Roth IRA (51) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Christina
Recchia (52) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
Peter
Reichard (53) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
RH
Damon & Co. Inc. (54) |
|
501,200
|
|
501,200
|
|
0
|
|
0 |
|
Michael
Rosenbaum (55) |
|
326,974
|
|
326,974
|
|
0
|
|
0 |
|
Dr.
Mark Rosenfeld (56) |
|
6,077,050 |
|
1,000,000 |
|
5,077,050 |
|
8.2% |
|
David
Ruggieri (57) |
|
490,462
|
|
490,462
|
|
0
|
|
0 |
|
Peter
Siraslian (58) |
|
326,974
|
|
326,974
|
|
0
|
|
0 |
|
SilverDeer
LLC (59) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
Blaine
Taylor (60) |
|
3,600,718 |
|
89,918 |
|
3,510,800 |
|
5.7% |
|
Carl
B. Turner and Alison M. Turner (61) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
John
F. Turner and Emily F. Turner (62) |
|
130,789
|
|
130,789
|
|
0
|
|
0 |
|
Donna
Viemeister (63) |
|
65,394
|
|
65,394
|
|
0
|
|
0 |
|
Wentworth
Advisors, LLC (64) |
|
250,000
|
|
250,000
|
|
0
|
|
0 |
|
Michael
Bascetta (65) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
Calvin
Vaughn (66) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
Gregory
Ruff (67) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
Doris
Ruff (68) |
|
57,496 |
|
57,496 |
|
0 |
|
0 |
|
Harold
Kaufman (69) |
|
91,995 |
|
91,995 |
|
0 |
|
0 |
|
Mendel
Klein (70) |
|
54,242 |
|
54,242 |
|
0 |
|
0 |
|
Craig
Littler (71) |
|
160,991 |
|
160,991 |
|
0 |
|
0 |
|
Maana
Enterprises (72) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
Robert
O’Brian (73) |
|
57,496 |
|
57,496 |
|
0 |
|
0 |
|
Congregation
Zichron Malka (74) |
|
54,242 |
|
54,242 |
|
0 |
|
0 |
|
Murray
Sternfeld (75) |
|
113,909 |
|
113,909 |
|
0 |
|
0 |
|
James
Hori (76) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
J
Michael Kellum (77) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
Tom
Linton (78) |
|
114,993 |
|
114,993 |
|
0 |
|
0 |
|
Joe
Willis and Jann H. Willis (79) |
|
30,000 |
|
30,000 |
|
0 |
|
0 |
|
Anasazi
Partners III, LLC (80) |
|
250,000 |
|
250,000 |
|
0 |
|
0 |
|
Duncan
Capital LLC (81) |
|
130,900 |
|
130,900 |
|
0 |
|
0 |
|
(1) Michael
Ahlin has served as a director and Vice President since July 2004. He was an
existing Impact Diagnostics shareholder. The shares shown as owned by Mr. Ahlin
include 1,253,000 shares owned by Princess Investments. Mr. Ahlin has voting and
dispositive rights over these shares.
(2)
AJW
Offshore, Ltd., formerly known as AJW/New Millennium Offshore, Ltd., is a
private investment fund that is owned by its investors
and
managed by First Street Manager II, LLC. First Street Manager II, LLC, of which
Corey S. Ribotsky is the fund manager, has voting and investment control over
the shares listed below owned by AJW Offshore, Ltd. Represents
(i) 201,634 shares of common stock and (ii) 40326 warrants exercisable at
$0.1835 per share purchased for cash in a private placement in July
2004.
(3)
AJW
Partners, LLC is a private investment fund that is owned by its investors and
managed by SMS Group, LLC. SMS Group, LLC, of which Corey S. Ribotsky is the
fund manager, has voting and investment control over the shares listed below
owned by AJW Partners, LLC. Represents
(i) 87,193 shares of common stock and (ii) 17,438 warrants exercisable at
$0.1835 per share purchased for cash in a private placement in July
2004.
(4)
AJW
Qualified Partners, LLC, formerly known as Pegasus Capital Partners, LLC, is a
private investment fund that is owned by its investors and managed by AJW
Manager, LLC, of which Corey S. Ribotsky and Lloyd A. Groveman are the fund
managers, have voting and investment control over the shares listed below owned
by AJW Qualified Partners, LLC. Represents
(i) 239,782 shares of common stock and (ii) 47,956 warrants exercisable at
$0.1835 per share purchased for cash in a private placement in July
2004.
(5) Alan
Gelband has voting and dispositive rights over the shares held by Alan Gelband
Co. Defined Contribution and Pension Plan & Trust. Represents (i) 108,991
shares of common stock and (ii) 21,798 warrants exercisable at $0.1835 per share
purchased for cash in a private placement in July 2004.
(6)
Michael Weprin has the voting and dispositive rights over the shares held by
Armadillo Partners. Represents (i) 544,959 shares of common stock and (ii)
108,991 warrants exercisable at $0.1835 per share purchased for cash in a
private placement in July 2004.
(7)
Represents (i) 134,250 shares of Impact Diagnostic and (ii) (a) 544,959 shares
and (ii) 108,991warrants exercisable at $0.1835 per share purchased for cash in
a private placement in July 2004.
(8)
Bridges & Pipes LLC is an affiliate an affiliate of Duncan Capital LLC,
which served as placement agent in connection with the sale of our units in the
private financing that we completed in connection with the Merger.
Includes warrants to purchase 104,495 shares of our common stock held by Bridges
& Pipes LLC. David Fuchs has voting and dispositive rights over the shares
owned by Bridges & Pipes LLC. Bridges and Pipes made a $200,000 bridge
financing loan to us which converted into 2,720,000 shares at the time of the
merger. They also made a $50,000 loan to us which was converted into 272,479
shares and 104,495 warrants exercisable at $0.1835.
(9)
Represents (i) 544,959 shares of common stock and (ii) 108,991 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(10)
Bobby Stanley, Ike Lewis and Peter Coker hold the voting and dispositive rights
over the shares held by BIP Partners. Represents (i) 98,092 shares of common
stock and (ii) 19,618 warrants exercisable at $0.1835 per share purchased for
cash in a private placement in July 2004.
(11)
Represents (i) 544,959 shares of common stock and (ii) 108,991 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(12) David
R. Bolick provided consulting services to us on a part-time basis from July 2004
through October 2004. As of November 1, 2004, Dr. Bolick was hired as an
employee and appointed as our Medical Director, a part-time position. Dr. Bolick
is also an employee of Ameripath, Inc. We lease our clinical laboratory space
from Rocky Mountain Pathology, LLC, an affiliate of Ameripath, Inc. In addition,
Ameripath has conducted initial studies of our technology for us. Dr. Bolick
obtained 250,000 warrants and 250,000 shares through his work as a consultant
for us. Includes (i) 550,408 shares of common stock and (ii) 110,081 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(13)
Represents (i) 27,247 shares of common stock and (ii) 5,449 warrants exercisable
at $0.1835 per share purchased for cash in a private placement in July
2004.
(14)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(15)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(16)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(17)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(18)
Richard Smithline has voting and dispositive rights over the shares owned by
DCOFI Master LDC. DCOFI was an Impact Diagnostics shareholder.
(19)
Citadel, James Donell receiver, holds (i) an Impact Diagnostics note which was
renegotiated in connection with the merger and (ii) 89,500 warrants with an
exercise price of $0.01. The note is convertible into 417,666 shares of common
stock.
(20)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(21)
Includes 420,525 shares received through the exercise of warrants by Duncan
Capital Group LLC and 48,227 of warrants transferred to him by Duncan Capital
LLC.
(22)
Represents 13,779 warrants obtained from Duncan Capital LLC in connection with
its action as placement agent for the private placement.
(23)
Represents (i) 267,000 warrants originally granted Duncan Capital Group LLC
which served as financial advisor to us in
connection
with the merger and (ii) 30,619 of the warrants originally granted to Duncan
Capital LLC in connection with its acting as placement agent for the private
placement.
(24)
Represents 68,895 warrants originally given to Duncan Capital LLC in connection
with the private placement. Dan Purjes has voting and investment control over
the warrants held by the Rockwood Group.
(25)
Represents 13,779 of the warrants originally granted to Duncan Capital LLC in
connection with its acting as placement agent for the private
placement.
(26)
Shares were obtained from the exercise of warrants given to Duncan Capital Group
LLC which served as financial advisor to us in connection with the
merger.
(27)
Shares were obtained from the exercise of warrants given to Duncan Capital Group
LLC which served as financial advisor to us in connection with the
merger.
(28)
Kevin Crow, one of our directors, is the trustee. These shares were obtained
through the exercise of warrants by Duncan Capital Group LLC which served as
financial advisor to us in connection with the merger.
(29)
Represents (i) 24,523 shares of common stock and (ii) 4,904 warrants exercisable
at $0.1835 per share purchased for cash in a private placement in July
2004.
(30)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(31)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(32)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(33)
Represents (i) 272,479 shares of common stock and (ii) 54,495 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(34)
Represents 159,557 shares being sold are the result of the conversion of a
promissory note from Impact Diagnostics.
(35)
Represents (i) 272,479 shares of common stock and (ii) 54,495 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(36)
Represents (i) 136,239 shares of common stock and (ii) 27,247 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(37)Steven
Hague held 13,425 shares of common stock of Impact Diagnostics, Inc. and
obtained (i) 54,495 shares of common stock and (ii) 10,899 warrants exercisable
at $0.1835 per share purchased for cash in a private placement in July
2004.
(38)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(39)
Represents (i) 225,000 shares of common stock and (ii) 45,000 warrants
exercisable at $0.1835 per share were purchased for cash in a private placement
in July 2004.
(40)
Horace Ardinger holds the voting and dispositive rights over the shares held by
HT Ardinger & Sons, Inc. Represents (i) 272,479 shares of common stock and
(ii) 54,495 warrants exercisable at $0.1835 per share purchased for cash in a
private placement in July 2004.
(41)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(42)
Represents (i) 81,743 shares of common stock and (ii) 16,348 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(43)
David P. Kalm held 13,425 shares of common stock of Impact Diagnostics, Inc. and
obtained (i) 54,495 shares of common stock and (ii) 10,899 warrants exercisable
at $0.1835 per share purchased for cash in a private placement in July
2004.
(44)
Represents (i) 81,743 shares of common stock and (ii) 16,348 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(45)
Steven Lefkowitz held 268,000 shares of common stock of Impact Diagnostics
shareholder. The shares also include 1,089,918 shares of common stock and
217,983 warrants exercisable at $0.1835 purchased for cash in a private
placement in July 2004.
(46) Jack
Levine has served as a director of Grant Life Sciences and chairman of our Audit
Committee since August 2004. Represents (i) 490,463 shares of common stock
and (ii) 98,092 warrants exercisable at $0.1835 per share purchased for cash in
a private placement in July 2004.
(47)
Represents (i) 272,479 shares of common stock and (ii) 54,495 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(48)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(49)
Network 1 Financial Securities Inc. is a broker-dealer. Damon Testaverde has
voting and dispositive rights over the shares owned by Network 1 Financial
Securities Inc. Network 1 received 104,905 warrants which were originally given
to Duncan Capital LLC as part of the private placement. The shares were not
received as underwriting compensation.
(50) New
Millennium Capital Partners II, LLC is a private investment fund that is owned
by its investors and managed by First Street Manager II, LLC. First Street
Manager II, LLC, of which Corey S. Ribotsky is the fund manager, has voting and
investment control over the shares listed below owned by New Millennium Capital
Partners II, LLC.
Represents (i) 16,348 shares of common stock and (ii) 3,269 warrants exercisable
at $0.1835 per share purchased for cash in a private placement in July
2004.
(51)
Robert Bolick holds the voting and dispositive rights over the shares held by
Pershing LLC, as custodian of Robert L. Bolick, Roth IRA. Represents (i) 108,991
shares of common stock and (ii) 21,798 warrants exercisable at $0.1835 per share
purchased for cash in a private placement in July 2004.
(52)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(53)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(54)
Damon Testaverde holds the voting and dispositive rights over the shares held by
RH Damon & Co. Inc. RH Damon & Co. Inc. was an Impact Diagnostic
shareholder.
(55)
Represents (i) 272,479 shares of common stock and (ii) 54,495 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(56)
Represents shares received for services performed on our Company as a director
and Vice President from August through October 11, 2004.
(57)
Represents (i) 408,719 shares of common stock and (ii) 81,743 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(58)
Represents (i) 272,479 shares of common stock and (ii) 54,495 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(59)
Howard Jacobson holds the voting and dispositive rights over the shares held by
SilverDeer LLC. Represents (i) 54,495 shares of common stock and (ii) 10,899
warrants exercisable at $0.1835 per share purchased for cash in a private
placement in July 2004.
(60)
Blaine Taylor was an existing shareholder of Impact Diagnostics, Inc. Represents
shares received in connection with the conversion of a Impact Diagnostics
promissory note.
(61)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(62)
Represents (i) 108,991 shares of common stock and (ii) 21,798 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(63)
Represents (i) 54,495 shares of common stock and (ii) 10,899 warrants
exercisable at $0.1835 per share purchased for cash in a private placement in
July 2004.
(64) John
C. Wilson, our former Chief Financial Officer, is Managing Principal and 100%
owner of Wentworth Advisors.
(65)
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated January 2, 2004.
(66)
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated January 5, 2004.
(67)
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated January 5, 2004.
(68)
Represents 57,496 shares of common stock issuable upon conversion of the
convertible promissory note dated January 5, 2004.
(69)
Represents 91,995 shares of common stock issuable upon conversion of the
convertible promissory note dated January 5, 2004.
(70)
Represents 54,242 shares of common stock issuable upon conversion of the
convertible promissory note dated January 5, 2004.
(71)
Represents 160,991 shares of common stock issuable upon conversion of the
convertible promissory note dated January 9, 2004.
(72)
Robert Baron has the voting and dispositive rights of Maana Enterprises, Inc.
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated January 13, 2004.
(73)
Represents 57,496 shares of common stock issuable upon conversion of the
convertible promissory note dated January 13, 2004.
(74) Mr.
Eluzer Bald has the voting and dispositive rights for the shares held by
Congregation Zichron Malka. Represents 54,242 shares of common stock issuable
upon conversion of the convertible promissory note dated January 21,
2004.
(75)
Represents 113,909 shares of common stock issuable upon conversion of the
convertible promissory note dated January 21, 2004.
(76)
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated February 4, 2004.
(77)
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated February 5, 2004.
(78)
Represents 114,993 shares of common stock issuable upon conversion of the
convertible promissory note dated February 25, 2004.
(79)
Represents (i) 25,000 shares of common stock and (ii) 5,000 warrants exercisable
at $0.1835 per share purchased for cash in a private placement in July
2004.
(80)
Chris Baker is the fund manager and has voting and investment control over the
shares. The shares were obtained from MW Crow Family, L.P. which exercised
warrants originally given to Duncan Capital Group LLC. The shares were not
received as underwriting compensation.
(81)
David Fuchs has voting and investment power over the warrants held by Duncan
Capital LLC. These warrants, which are exercisable at $0,1835 per share, were
received for its acting as placement agent in connection with the private
placement.
PLAN
OF DISTRIBUTION
The common stock offered by this prospectus is being offered by the selling
stockholders. The common stock may be sold or distributed from time to
time by the selling stockholders directly to one or more purchasers or through
brokers, dealers or underwriters who may act solely as agents at market prices
prevailing at the time of sale, at prices related to the prevailing market
prices, at negotiated prices, or at fixed prices, which may be changed.
The sale of the common stock offered by this prospectus may be effected in one
or more of the following methods:
•
ordinary brokers’ transactions,
•
through brokers, dealers, or underwriters who may act solely as agents,
•
“at the market” into an existing market for the common stock,
•
in other ways not involving market makers or established trading markets,
including direct sales to purchasers or sales effected through agents,
•
in privately negotiated transactions, and
•
any combination of the foregoing.
In order to comply with the securities laws of certain states, if applicable,
the shares may be sold only through registered or licensed brokers or dealers.
In addition, in certain states, the shares may not be sold unless they have been
registered or qualified for sale in the state or an exemption from the
registration or qualification requirement is available and complied with.
The selling stockholders may pledge their shares to their brokers under the
margin provisions of customer agreements. If a selling stockholder defaults on a
margin loan, the broker may, from time to time, offer and sell the pledged
shares. Broker-dealers engaged by a selling stockholder may arrange for other
broker-dealers to participate in sales. Broker-dealers may receive commissions
or discounts from the selling stockholders (or, if any broker-dealer acts as
agent for the purchaser of shares, from the purchaser) in amounts to be
negotiated.
The selling stockholders and any broker-dealers or agents that are involved in
selling the shares may be deemed to be “underwriters” within the meaning of the
Securities Act of 1933, as amended, in connection with such sales. In such
event, any commissions received by such broker-dealers or agents and any profit
on the resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act of 1933, as amended.
We will pay all of the expenses incident to the registration, offering, and sale
of the shares to the public other than commissions or discounts of underwriters,
broker-dealers, or agents. We have also agreed to indemnify the selling
stockholders and related persons against specified liabilities, including
liabilities under the Securities Act.
While they are engaged in a distribution of the shares included in this
prospectus the selling stockholders are required to comply with Regulation M
promulgated under the Securities Exchange Act of 1934, as amended. With certain
exceptions, Regulation M precludes the selling stockholders, any affiliated
purchasers, and any broker-dealer or other person who participates in the
distribution, from bidding for or purchasing, or attempting to induce any person
to bid for or purchase any security which is the subject of the distribution
until the entire distribution is complete. Regulation M also prohibits any bids
or purchases made in order to stabilize the price of a security in connection
with the distribution of that security. All of the foregoing may affect the
marketability of the shares offered by this prospectus.
The
selling stockholders may also sell shares under Rule 144 promulgated under the
Securities Act of 1933, as amended, rather than selling under this prospectus.
This offering will terminate on the date that all shares offered by this
prospectus have been sold by the selling stockholders or are eligible for sale
under Rule 144(k). In general, under Rule 144 as currently in effect, a
person (or persons whose shares are required to be aggregated) who has owned
shares for at least one year would be entitled to sell within any three-month
period a number of shares that does not exceed the greater of (i) 1% of the
number of shares of our common stock then outstanding (which, after our increase
in authorized capital is effective, will equal approximately 535,908 shares of
common stock) or (ii) the average weekly trading volume of our shares of common
stock during the four calendar weeks preceding the filing of a Form 144 with
respect to such sale. Under Rule 144(k), a person who is not deemed to have been
our affiliate at any time during the three months preceding a sale, and who has
owned the shares proposed to be sold for at least two years, is entitled to sell
his shares without complying with the manner of sale, public information, volume
limitation or notice provisions of Rule 144.
DESCRIPTION
OF SECURITIES
Our authorized capital stock currently consists of 150,000,000 shares of common
stock and 20,000,000 shares of preferred stock. Each share of common stock is
entitled to one vote on all matters voted upon by our stockholders.
Holders of our common stock have no preemptive or other rights to subscribe for
additional shares or other securities. There are no cumulative voting
rights.
Holders of our common stock are entitled to dividends in such amounts as may be
declared by our board of directors from time to time from funds legally
available therefore. We have not declared or paid cash dividends or made
distributions in the past on our common stock, and we do not anticipate that we
will pay cash dividends or make distributions in the foreseeable future.
We currently intend to retain and invest future earnings to finance operations.
Our
Amended and Restated Articles of Incorporation allow our Board of Directors the
authorization, without further stockholder approval, to issue up to 20,000,000
shares of preferred stock from time to time in one or more series and to fix the
number of shares and the relative dividend rights, conversion rights, voting
rights and other rights and qualifications of any such series. The Board
has not fixed any series of preferred stock and no shares of preferred stock are
issued and outstanding.
LEGAL
MATTERS
Certain matters relating to the offering of securities covered by this
prospectus will be passed upon for us by Sichenzia Ross Friedman Ference LLP,
New York, New York.
EXPERTS
Our audited financial statements for the fiscal years ended December 31, 2004
and 2003 have been audited by Russell Bedford Stefanou Mirchandani LLP and
Tanner LC ("Tanner"), independent public accountants. The report of each
of these registered public accounting firms, which appears elsewhere herein,
includes an explanatory paragraph as to our ability to continue as a going
concern. Our financial statements are included in reliance upon such
report and upon the authority of such firm as an expert in auditing and
accounting.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
On
December 17, 2004, Tanner LC (formerly Tanner+Co.) advised us of its intention
to cease to act as our independent public accountant for the audit of the year
ending December 31, 2004. On January 24, 2005, we engaged Russell Bedford
Stefanou Mirchandani LLP, as our principal independent accountant. The decision
to engage Russell Bedford was taken by our Audit Committee.
From the
date of Tanner’s appointment through the date of their dismissal on December 17,
2004, there were no disagreements between us and Tanner on any matter listed
under Item 304 Section (a)(1)(iv) A to E of Regulation S-B, including accounting
principles or practices, financial statement disclosure or auditing scope or
procedure which, if not resolved to the satisfaction of Tanner would have caused
them to make reference to the matter in its reports on our financial
statements.
Tanner
reports on our financial statements for the past two fiscal years ended December
31, 2003 and 2002 contained an opinion expressing substantial doubt as to our
ability to continue as a going concern. The audit reports contained no other
adverse opinion, disclaimer of opinion, nor was it qualified or modified as to
uncertainty, audit scope or accounting principles.
We
requested that Tanner furnish us with a letter addressed to the SEC stating
whether they agree with the above statements. A copy of this letter, dated
December 22, 2004, was filed as Exhibit 16.1 to Form 8-K, dated December 22,
2004.
On August
2, 2004, we dismissed HJ & Associates, LLC as the independent accountant
engaged to audit our financial statements. HJ performed the audit of our
financial statements for the fiscal years ended December 31, 2003 and December
31, 2002. The audit reports of HJ on the financial statements for the
fiscal years ended December 31, 2003 and December 31, 2002 did not contain any
adverse opinion or disclaimer of opinion, nor were such reports modified as to
uncertainty, audit scope or accounting principles. During the fiscal years ended
December 31, 2003 and December 31, 2002, and the subsequent interim period prior
to the dismissal of HJ, there were no disagreements with HJ on any matter of
accounting principles or practices, financial statement disclosure, or auditing
scope or procedure, which disagreements, if not resolved to HJ’s satisfaction,
would have caused HJ to make reference to the subject matter of the disagreement
in connection with its report, nor were there any “reportable events” (as such
term is explained in Item 304(a)(1)(iv) of Regulation S-K promulgated by the
Securities and Exchange Commission) involving HJ.
We
requested that HJ furnish us with a letter addressed to the Securities and
Exchange Commission stating whether it agrees with the above statements. A
copy of such letter was filed as Exhibit 16.1 to Form 8-K, dated August 30,
2004.
FURTHER
INFORMATION
We are subject to the reporting requirements of the Securities Exchange Act of
1934, as amended, and file reports, proxy statements and other information with
the Securities and Exchange Commission. These reports, proxy statements
and other information may be inspected and copied at the public reference
facilities maintained by the Securities and Exchange Commission at 450 Fifth
Street, N.W., Washington, D.C. 20549 and at the Securities and Exchange
Commission’s regional offices. You can obtain copies of these materials
from the Public Reference Section of the Securities an Exchange Commission upon
payment of fees prescribed by the Securities and Exchange Commission. You
may obtain information on the operation of the Public Reference Room by calling
the Securities and Exchange Commission at 1-800-SEC-0330. The Securities
and Exchange Commission’s Web site contains reports, proxy and information
statements and other information regarding registrants that file electronically
with the Securities and Exchange Commission. The address of that site is
http://www.sec.gov.
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FINANCIAL
STATEMENTS AND SCHEDULES
DECEMBER
31, 2004 AND 2003
FORMING
A PART OF ANNUAL REPORT
PURSUANT
TO THE SECURITIES EXCHANGE ACT OF 1934
GRANT
LIFE SCIENCES, INC.
(A
development stage company)
GRANT
LIFE SCIENCES, INC.
(A
development stage company)
Index to
Financial Statements
|
|
|
Page |
|
Reports
of Independent Registered Certified Public Accounting Firm
|
|
|
F-3
|
|
Consolidated
Balance Sheets as of December 31, 2004 and 2003 |
|
|
F-5 |
|
Consolidated
Statements of Losses for the years ended December 31, 2004 and 2003 and
for the period July 9, 1998 (date of inception) through December 31,
2004 |
|
|
F-6 |
|
Consolidated
Statement of Deficiency in Stockholders’ Equity for the period July 9,
1998 (date of inception) through December 31, 2004 |
|
|
F-7 |
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2004 and 2003
and for the period July 9, 1998 (date of inception) through December 31,
2004 |
|
|
F-8 |
|
Notes
to Consolidated Financial Statements |
|
|
F-9
to F-20 |
|
|
|
|
|
|
RUSSELL
BEDFORD STEFANOU MIRCHANDANI LLP
CERTIFIED
PUBLIC ACCOUNTANTS
REPORT
OF INDEPENDENT REGISTERED CERTIFIED PUBLIC ACCOUNTING
FIRM
Board of
Directors
Grant
Life Sciences, Inc.
Murray,
UT
We have
audited the accompanying consolidated balance sheet of Grant Life Sciences,
Inc., (a development stage company) as of December 31, 2004 and the related
consolidated statements of losses, deficiency in stockholders equity, and cash
flows for the year ended December 31, 2004. These financial statements are the
responsibility of the company’s management. Our responsibility is to express an
opinion on the financial statements based upon our audit.
We have
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States of America). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that our
audit provide a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Grant Life Sciences,
Inc. (a development stage company) at December 31, 2004 and the results of its
operations and its cash flows for the year ended December 31, 2004, in
conformity with accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming the company will
continue as a going concern. As discussed in the Note L to the accompanying
financial statements, the company is in the development stage and has not
established a source of revenues. This raises substantial doubt about the
company’s ability to continue as a going concern. Management’s plan in regard to
these matters are also described in Note L. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
|
|
/s/ RUSSELL BEDFORD STEFANOU
MIRCHANDANI LLP |
|
|
Russell Bedford Stefanou
Mirchandani LLP |
|
|
|
|
|
|
Certified Public Accountants |
|
New York,
New York
March 18,
2005
REPORT
OF INDEPENDENT REGISTERED
PUBLIC
ACCOUNTING FIRM
To
the Stockholders’ and
Board
of Directors of Grant Life Sciences, Inc.
(Formerly
Impact Diagnostics, Inc.)
We have
audited the accompanying balance sheet of Grant Life Sciences, Inc. (A
Development Stage Company) as of December 31, 2003 and the related statements of
losses, deficiency in stockholders’ equity, and cash flows for the year then
ended and for the period from July 6, 1998 (date of inception) to December 31,
2003. These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial
statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Grant Life Sciences, Inc. (A
Development Stage Company) as of December 31, 2003 and the results of its
operations and its cash flows for the period then ended and for the period from
July 9, 1998 (date of inception) to December 31, 2003, in conformity with
accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note L to the financial
statements, the Company has a working capital deficit and a stockholders’
deficit. The Company has not generated revenue and has incurred losses since
inception. These conditions raise substantial doubt about its ability to
continue as a going concern. Management’s plans regarding those matters also are
described in Note L. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
/s/
TANNER LC
Salt Lake
City, Utah
April 15,
2004
GRANT
LIFE SCIENCES, INC.
(A
development stage company)
CONSOLIDATED
BALANCE SHEETS
|
|
December
31, |
|
|
|
2004 |
|
|
2003 |
|
ASSETS |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
365,958 |
|
$ |
11,299 |
|
Miscellaneous
receivables |
|
|
3,000
|
|
|
-
|
|
Prepaid
expenses |
|
|
5,213
|
|
|
-
|
|
Due
from employees (Note D) |
|
|
334
|
|
|
33,343
|
|
Note
receivable - related party (Note D) |
|
|
- |
|
|
14,049 |
|
Deposits |
|
|
3,263
|
|
|
700
|
|
Total
current assets |
|
|
377,768
|
|
|
59,391
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net of accumulated depreciation |
|
|
|
|
|
|
|
of
$5,857 and $8,186 at December 31, 2004 and 2003, respectively (Note
C) |
|
|
15,240
|
|
|
6,713
|
|
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
393,008 |
|
$ |
66,104 |
|
|
|
|
|
|
|
|
|
LIABILITIES
AND (DEFICIENCY IN) STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
95,841 |
|
$ |
33,531 |
|
Accrued
liabilities |
|
|
37,000
|
|
|
-
|
|
Accrued
interest payable |
|
|
7,005
|
|
|
142,086
|
|
Accrued
payroll liabilities |
|
|
13,159
|
|
|
51,194
|
|
Notes
payable - related party (Note D and Note E) |
|
|
- |
|
|
37,934 |
|
Notes
payable, current portion (Note E) |
|
|
122,500
|
|
|
587,753
|
|
Total
current liabilities |
|
|
275,505
|
|
|
852,498
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities: |
|
|
|
|
|
|
|
Note
payable - long term (Note E) |
|
|
350,000
|
|
|
-
|
|
Note
payable - related party-long term (Note E) |
|
|
-
|
|
|
12,845
|
|
Total
long term liabilities |
|
|
350,000
|
|
|
12,845
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies (Note K) |
|
|
-
|
|
|
- -
|
|
|
|
|
|
|
|
|
|
(Deficiency
in) stockholders' equity: |
|
|
|
|
|
|
|
Preferred
stock, par value: $.001, authorized 20,000,000 shares; no shares issued
and outstanding at December 31, 2004 and 2003 (Note F) |
|
|
-
|
|
|
-
|
|
Common
stock, par value; $.001, authorized 150,000,000 and 100,000,000 shares at
December 31, 2004 and 2003, respectively; 56,243,791 and 34,572,060 shares
issued and outstanding
at
December 31, 2004 and 2003, respectively (Note F) |
|
|
56,244
|
|
|
34,572
|
|
Additional
paid in capital |
|
|
4,190,485
|
|
|
637,178
|
|
Deferred
compensation |
|
|
(1,097,886 |
) |
|
- |
|
Deficit
accumulated during development stage |
|
|
(3,381,340 |
) |
|
(1,470,989 |
) |
Total
(deficiency in) stockholders' equity: |
|
|
(232,496 |
) |
|
(799,239 |
) |
Total
liabilities and (deficiency in) stockholders' equity: |
|
$ |
393,008 |
|
$ |
66,104 |
|
See
accompanying notes to consolidated financial statements
GRANT
LIFE SCIENCES, INC.
(A
development stage company)
CONSOLIDATED
STATEMENT OF LOSSES
|
|
For
the Year Ended December 31, |
|
For
the Period July 9, 1998 (date of inception) through
|
|
|
|
|
2004 |
|
|
2003 |
|
|
December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
|
|
General
and administrative |
|
$ |
1,562,388 |
|
$ |
135,155 |
|
$ |
2,463,238 |
|
Depreciation
(Note C) |
|
|
4,555 |
|
|
3,665 |
|
|
12,741 |
|
Acquisition
cost (Note B) |
|
|
65,812 |
|
|
- |
|
|
65,812 |
|
Research
and development |
|
|
430,540
|
|
|
51,108
|
|
|
841,930
|
|
Total
Operating Expenses |
|
|
2,063,295 |
|
|
189,928 |
|
|
3,383,721 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from Operations |
|
|
(2,063,295 |
) |
|
(189,928 |
) |
|
(3,383,721 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other
income (expenses): |
|
|
|
|
|
|
|
|
|
|
Gain
on extinguishment of debt (Note E) |
|
|
411,597
|
|
|
-
|
|
|
510,104
|
|
Interest
expense |
|
|
(258,652 |
) |
|
(63,953 |
) |
|
(507,722 |
) |
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes |
|
|
(1,910,350 |
) |
|
(253,881 |
) |
|
(3,381,339 |
) |
Income
tax benefit |
|
|
-
|
|
|
-
|
|
|
-
|
|
Net
loss |
|
$ |
(1,910,350 |
) |
$ |
(253,881 |
) |
$ |
(3,381,339 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share - |
|
|
|
|
|
|
|
|
|
|
basic
and diluted (Note I) |
|
$ |
(0.04 |
) |
$ |
(0.01 |
) |
|
n/a |
|
Weighted
average shares - |
|
|
|
|
|
|
|
|
|
|
basic
and diluted |
|
|
42,751,142
|
|
|
33,842,000
|
|
|
n/a |
|
See
accompanying notes to consolidated financial statements
GRANT
LIFE SCIENCES, INC.
(A
development stage company)
CONSOLIDATED
STATEMENT OF DEFICIENCY IN STOCKHOLDERS’ EQUITY
FOR
THE PERIOD JULY 9, 1998 (Date of Inception) THROUGH
DECEMBER
31, 2004
|
|
|
Common
Shares |
|
|
Common
Shares
Amount |
|
|
Subscription
Receivable |
|
|
Deferred
Compensation |
|
|
Additional
Paid
In
Capital |
|
|
Accumulated
Deficit |
|
|
Total
(Deficiency)
In
Stockholders
Equity |
|
Balance,
July 9, 1998 (date of inception) |
|
|
9,272,200
|
|
$ |
9,272 |
|
$ |
- |
|
$ |
- |
|
$ |
(9,272 |
) |
$ |
- |
|
$ |
- |
|
Issued
stock for subscription receivable at $0.005 per share |
|
|
18,795,000
|
|
|
18,795
|
|
|
(100,000 |
) |
|
-
|
|
|
81,205
|
|
|
-
|
|
|
-
|
|
Balance,
December 31, 1998 |
|
|
28,067,200
|
|
|
28,067
|
|
|
(100,000 |
) |
|
-
|
|
|
71,933
|
|
|
-
|
|
|
-
|
|
Issued
stock for cash at $0.004 per share |
|
|
1,253,000
|
|
|
1,253
|
|
|
-
|
|
|
-
|
|
|
3,747
|
|
|
-
|
|
|
5,000
|
|
Net
loss |
|
|
- |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(5,053 |
) |
|
(5,053 |
) |
Balance,
December 31, 1999 |
|
|
29,320,200
|
|
|
29,320
|
|
|
(100,000 |
) |
|
-
|
|
|
75,680
|
|
|
(5,053 |
) |
|
(53 |
) |
Payment
of subscriptions receivable |
|
|
- |
|
|
-
|
|
|
100,000
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
100,000
|
|
Net
loss |
|
|
- |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(43,641 |
) |
|
(43,641 |
) |
Balance,
December 31, 2000 |
|
|
29,320,200
|
|
|
29,320
|
|
|
-
|
|
|
-
|
|
|
75,680
|
|
|
(48,694 |
) |
|
56,306
|
|
Issued
stock for cash at $0.004 per share |
|
|
250,600
|
|
|
251
|
|
|
-
|
|
|
-
|
|
|
749
|
|
|
-
|
|
|
1,000
|
|
Net
loss |
|
|
- |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(522,213 |
) |
|
(522,213 |
) |
Balance,
December 31, 2001 |
|
|
29,570,800
|
|
|
29,571
|
|
|
-
|
|
|
-
|
|
|
76,429
|
|
|
(570,907 |
) |
|
(464,907 |
) |
Beneficial
conversion feature on issuance of debt |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
98,507
|
|
|
-
|
|
|
98,507
|
|
Gain
on extinguishment of debt |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(98,507 |
) |
|
-
|
|
|
(98,507 |
) |
Issued
stock for cash at $0.13 per share |
|
|
689,150
|
|
|
689
|
|
|
|
|
|
-
|
|
|
91,811
|
|
|
|
|
|
92,500
|
|
Issued
stock for services at $0.06 per share |
|
|
1,591,310
|
|
|
1,591
|
|
|
-
|
|
|
-
|
|
|
101,659
|
|
|
-
|
|
|
103,250
|
|
Issued
stock in satisfaction of debt at $0.14 per share |
|
|
1,790,000
|
|
|
1,790
|
|
|
-
|
|
|
-
|
|
|
248,210
|
|
|
-
|
|
|
250,000
|
|
Net
loss |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(646,201 |
) |
|
(646,201 |
) |
Balance,
December 31, 2002 |
|
|
33,641,260
|
|
|
33,641
|
|
|
-
|
|
|
-
|
|
|
518,109
|
|
|
(1,217,108 |
) |
|
(665,358 |
) |
Issued
stock for cash at $0.13 per share |
|
|
930,800
|
|
|
931
|
|
|
-
|
|
|
-
|
|
|
119,069
|
|
|
-
|
|
|
120,000
|
|
Net
loss |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(253,881 |
) |
|
(253,881 |
) |
Balance,
December 31, 2003 |
|
|
34,572,060
|
|
|
34,572
|
|
|
-
|
|
|
-
|
|
|
637,178
|
|
|
(1,470,989 |
) |
|
(799,239 |
) |
Issued
stock for cash at $0.0838 per share |
|
|
238,660
|
|
|
239
|
|
|
-
|
|
|
-
|
|
|
19,761
|
|
|
-
|
|
|
20,000
|
|
Issued
stock for services at $0.08 per share |
|
|
500,000
|
|
|
500
|
|
|
-
|
|
|
-
|
|
|
39,500
|
|
|
-
|
|
|
40,000
|
|
Issued
stock for cash at $0.1835 per share |
|
|
9,560,596
|
|
|
9,561
|
|
|
-
|
|
|
-
|
|
|
1,485,376
|
|
|
-
|
|
|
1,494,937
|
|
Reverse
merger with Grant Ventures, Inc. |
|
|
6,000,000
|
|
|
6,000
|
|
|
-
|
|
|
-
|
|
|
- |
|
|
- |
|
|
6,000 |
|
Warrants
issued as part of restructuring of debt (89,500 valued at $0.03779)
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
3,382
|
|
|
-
|
|
|
3,382
|
|
Recognition
of beneficial conversion feature on issuance of note payable
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
200,000
|
|
|
-
|
|
|
200,000
|
|
Conversion
of note payable and accrued interest at $0.07569 per share
|
|
|
2,720,000
|
|
|
2,720
|
|
|
-
|
|
|
-
|
|
|
203,165
|
|
|
-
|
|
|
205,885
|
|
Issued
stock in satisfaction of debt at $0.1835 per share |
|
|
249,475
|
|
|
249
|
|
|
-
|
|
|
-
|
|
|
45,530
|
|
|
-
|
|
|
45,779
|
|
Exercise
of $0.01 warrants |
|
|
2,403,000
|
|
|
2,403
|
|
|
- |
|
|
- |
|
|
21,627
|
|
|
- |
|
|
24,030
|
|
Issued
250,000 warrants for services |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
11,000
|
|
|
- |
|
|
11,000
|
|
Stock
options issued to employees, directors, consultants |
|
|
- |
|
|
- |
|
|
- |
|
|
(1,523,966 |
) |
|
1,523,966 |
|
|
- |
|
|
- |
|
Vesting
of deferred compensation |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
426,081
|
|
|
-
|
|
|
-
|
|
|
426,081
|
|
Net
loss |
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(1,910,350 |
) |
|
(1,910,350 |
) |
Balance,
December 31, 2004 |
|
|
56,243,791
|
|
$ |
56,244 |
|
$ |
- |
|
$ |
(1,097,886 |
) |
$ |
4,190,485 |
|
$ |
(3,381,340 |
) |
$ |
(232,496 |
) |
See
accompanying notes to consolidated financial statements
GRANT
LIFE SCIENCES, INC.
(A
development stage company)
CONSOLIDATED
STATEMENT OF CASH FLOWS
|
|
For
the Year Ended December 31, |
|
For
the Period July 9, 1998 (date of inception) through
|
|
|
|
|
2004 |
|
|
2003 |
|
|
December
31, 2004 |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
Net
(loss) |
|
$ |
(1,910,350 |
) |
$ |
(253,881 |
) |
$ |
(3,381,340 |
) |
Adjustments
to reconcile net (loss) to cash |
|
|
|
|
|
|
|
|
|
|
(used
in) operations: |
|
|
|
|
|
|
|
|
|
|
Depreciation
(Note C) |
|
|
4,555
|
|
|
3,665
|
|
|
12,741
|
|
Loss
on abandonment of assets (Note C) |
|
|
3,790
|
|
|
- |
|
|
3,790
|
|
Deferred
compensation (Note J) |
|
|
426,081
|
|
|
- -
|
|
|
426,081
|
|
Common
stock issued in exchange for services
rendered
(Note F) |
|
|
40,000
|
|
|
-
|
|
|
144,250
|
|
Warrants
issued in exchange for services rendered (Note J) |
|
|
11,000
|
|
|
- |
|
|
11,000
|
|
Beneficial
conversion feature discount (Note E) |
|
|
200,000
|
|
|
-
-- |
|
|
298,507
|
|
Gain
on extinguishment of debt (Note E) |
|
|
(411,597 |
) |
|
- -
|
|
|
(510,104 |
) |
Write
off of accounts payable due to stockholders |
|
|
(878 |
) |
|
- -
|
|
|
(878 |
) |
Acquisition
cost (Note B) |
|
|
65,812 |
|
|
- |
|
|
65,812 |
|
Decrease
(increase) in: |
|
|
|
|
|
|
|
|
|
|
Related
party receivables |
|
|
14,050
|
|
|
-
- |
|
|
-
|
|
Employee
receivables |
|
|
33,009
|
|
|
9,894
|
|
|
(334 |
) |
Miscellaneous
current assets |
|
|
(10,776 |
) |
|
(700 |
) |
|
(11,476 |
) |
(Decrease)
increase in: |
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
|
59,882
|
|
|
(21,316 |
) |
|
93,313
|
|
Accounts
payable - assumed liabilities |
|
|
(17,506 |
) |
|
-
|
|
|
(17,506 |
) |
Accounts
payable - stockholders |
|
|
(38,900 |
) |
|
-
|
|
|
(38,900 |
) |
Accrued
expenses |
|
|
36,900
|
|
|
-
|
|
|
35,000
|
|
Accrued
payroll liabilities |
|
|
(38,035 |
) |
|
51,194
|
|
|
13,159
|
|
Accrued
interest payable |
|
|
48,030
|
|
|
59,062
|
|
|
190,117
|
|
Net
cash (used in) operating activities |
|
|
(1,484,935 |
) |
|
(152,082 |
) |
|
(2,666,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
Payments
for property and equipment |
|
|
(16,873 |
) |
|
-
|
|
|
(31,772 |
) |
Net
cash used in investing activities |
|
|
(16,873 |
) |
|
-
|
|
|
(31,772 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
Proceeds
from sale of common stock, net of costs and fees (Note F) |
|
|
1,538,967
|
|
|
120,000
|
|
|
1,756,467
|
|
Proceeds
from note payable (Note E) |
|
|
322,500
|
|
|
20,000
|
|
|
1,180,253
|
|
Proceeds
from related party notes payable |
|
|
-
|
|
|
-
|
|
|
60,000
|
|
Payments
for related party notes payable |
|
|
(5,000 |
) |
|
(11,304 |
) |
|
(34,221 |
) |
Proceeds
from stock subscriptions receivable |
|
|
-
|
|
|
-
|
|
|
100,000
|
|
Net
cash provided by financing activities |
|
|
1,856,467
|
|
|
128,696
|
|
|
3,062,499
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents |
|
|
354,659
|
|
|
(23,386 |
) |
|
363,958
|
|
Cash
and cash equivalents at beginning of the period |
|
|
11,299
|
|
|
34,685
|
|
|
-
|
|
Cash
and cash equivalents at end of the period |
|
$ |
365,958 |
|
$ |
11,299 |
|
$ |
365,958 |
|
See
accompanying notes to consolidated financial statements
GRANT
LIFE SCIENCES, INC.
(A DEVELOPMENT STAGE
COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
A - SUMMARY OF ACCOUNTING POLICIES
Business
and Basis or Presentation
Grant
Life Sciences, Inc. (formerly Impact Diagnostics, Inc.) (the “Company”) was
organized under the laws of the State of Utah on July 9, 1998. The
Company’s purpose is to research, develop, market and sell diagnostic kits for
detecting disease with emphasis on the detection of low-grade cervical disease.
On July
30, 2004, the Company became a wholly owned subsidiary of Grant Ventures, Inc.,
a Nevada Corporation, by merging with Impact Acquisition Corporation, a Utah
corporation and wholly owned subsidiary of Grant Ventures, Inc.. Grant Ventures,
Inc. was an inactive publicly registered shell corporation with no significant
assets or operations. For accounting purposes the merger was treated as a
recapitalization of the Company. Grant Ventures, Inc. changed its name to Grant
Life Sciences, Inc. in November 2004.
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiary, Impact Diagnostics. All intercompany transactions and
balances have been eliminated in consolidation.
Development
Stage Company
Effective
July 9, 1998 (date of inception), the Company is considered a development stage
Company as defined in SFAS No. 7. The Company’s development stage activities
consist of the development of medical diagnostic kits. Sources of financing for
these development stage activities have been primarily debt and equity
financing. The Company has, at the present time, not paid any dividends and any
dividends that may be paid in the future will depend upon the financial
requirements of the Company and other relevant factors.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with a maturity of three months
of less to be cash equivalents.
Concentration
of Credit Risk
Financial
instruments and related items, which potentially subject the Company to
concentrations of credit risk, consist primarily of cash and cash equivalents.
The Company places its cash and temporary cash investments with credit quality
institutions. At times, such investments may be in excess of the FDIC insurance
limit.
Property
and Equipment
Furniture
and Equipment is stated at cost less accumulated depreciation. Depreciation is
computed using a straight-line basis based on the estimated useful lives of the
assets. Equipment is depreciated over 3 to 5 years and furniture over 7 years.
When assets are retired or otherwise disposed of, the cost and related
accumulated depreciation are removed and any resulting gain or loss is
recognized.
Long-Lived
Assets
The
Company has adopted Statement of Financial Accounting Standards No. 144 (“SFAS
144”). The Statement requires that long-lived assets and certain identifiable
intangibles held and used by the Company be reviewed for impairment whenever
events or changes in circumstances indicate that the carrying amount of an asset
may not be recoverable. Events relating to recoverability may include
significant unfavorable changes in business conditions, recurring losses, or a
forecasted inability to achieve break-even operating results over an extended
period. The Company evaluates the recoverability of long-lived assets based upon
forecasted undiscounted cash flows. Should an impairment in value be indicated,
the carrying value of intangible assets will be adjusted, based on estimates of
future discounted cash flows resulting from the use and ultimate disposition of
the asset. SFAS No. 144 also requires assets to be disposed of, be reported at
the lower of the carrying amount or the fair value less costs to
sell.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
A - SUMMARY OF ACCOUNTING POLICIES (Continued)
Fair
Value of Financial Instruments
Statement
of Financial Accounting Standards No. 107, "Disclosures About Fair Value of
Financial Instruments," requires disclosure of the fair value of certain
financial instruments. The carrying value of cash and cash equivalents, accounts
receivable, accounts payable and short-term borrowings, as reflected in the
balance sheets, approximate fair value because of the short-term maturity of
these instruments.
Revenue
Recognition
Revenues
are recognized in the period that services are provided. For revenue from
product sales, the Company recognizes revenue in accordance with Staff
Accounting Bulletin No. 104, REVENUE RECOGNITION ("SAB104"), which superceded
Staff Accounting Bulletin No. 101, REVENUE RECOGNITION IN FINANCIAL STATEMENTS
("SAB101"). SAB 101 requires that four basic criteria must be met before revenue
can be recognized: (1) persuasive evidence of an arrangement exists; (2)
delivery has occurred; (3) the selling price is fixed and determinable; and (4)
collectibility is reasonably assured. Determination of criteria (3) and (4) are
based on management's judgments regarding the fixed nature of the selling prices
of the products delivered and the collectibility of those amounts. Provisions
for discounts and rebates to customers, estimated returns and allowances, and
other adjustments are provided for in the same period the related sales are
recorded. The Company defers any revenue for which the product has not been
delivered or is subject to refund until such time that the Company and the
customer jointly determine that the product has been delivered or no refund will
be required.
SAB 104
incorporates Emerging Issues Task Force 00-21 ("EITF 00-21"),
MULTIPLE-DELIVERABLE REVENUE ARRANGEMENTS. EITF 00-21 addresses accounting for
arrangements that may involve the delivery or performance of multiple products,
services and/or rights to use assets. The effect of implementing EITF 00-21 on
the Company's consolidated financial position and results of operations was not
significant.
Advertising
The
Company follows the policy of charging the costs of advertising to expenses
incurred. The Company incurred no advertising costs for the years ended December
31, 2004 and 2003.
Research
and Development Costs
Research
and development costs are expensed as incurred. These costs include direct
expenditures for goods and services, as well as indirect expenditures such as
salaries and various allocated costs.
Liquidity
As shown
in the accompanying consolidated financial statements, the Company has incurred
a net loss of $1,910,350 and $253,881 during the years ended December 31, 2004
and 2003, respectively. Consequently, its operations are subject to all risks
inherent in the establishment of a new business enterprise.
Comprehensive
Income
The
Company adopted Statement of Financial Accounting Standards No. 130, “Reporting
Comprehensive Income”. SFAS No. 130 establishes standards for the reporting and
displaying of comprehensive income and its components. Comprehensive income is
defined as the change in equity of a business during a period from transactions
and other events and circumstances from non-owner sources. It includes all
changes in equity during a period except those resulting from investments by
owners and distributions to owners. SFAS No. 130 requires other comprehensive
income (loss) to include foreign currency translation adjustments and unrealized
gains and losses on available-for-sale securities.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
A - SUMMARY OF ACCOUNTING POLICIES (Continued)
Income
Taxes
Income
taxes are provided based on the liability method for financial reporting
purposes in accordance with the provisions of Statement of Financial Accounting
Standards No. 109, “Accounting for Income Taxes.” Under this method deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and are measured using enacted tax rates
expected to apply to taxable income in the years in which those temporary
differences are expected to be removed or settled. The effect on deferred tax
assets and liabilities of a change in tax rates is recognized in the statements
of operations in the period that includes the enactment date.
Net
Loss per Common Share
The
computation of net loss per common share is based on the weighted average number
of shares outstanding during each period. The computation of diluted earnings
per common share is based on the weighted average number of shares outstanding
during the period plus the common stock equivalents which would arise from the
exercise of stock options and warrants outstanding using the treasury stock
method and the average market price per share during the period. At year end
December 31, 2004, there were 2,979,704 warrants, 1,812,988 potential shares
resulting from note conversions, 613,650 vested stock options and 4,629,604
unvested options outstanding. These options and warrants and shares from
convertible notes were not included in the diluted loss per share calculation
because the effect would have been anti dilutive. There were no options and
warrants outstanding as of December 31, 2003.
Stock-Based
Compensation
In
December 2004, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment
(SFAS123R). This Statement requires public entities to measure the cost of
equity awards to employees based on the grant-date value of the award. The
Company has elected early adoption of this Statement, effective for 2004, in
advance of the Company's required adoption date of December 15, 2005.
The
Company began granting options to its employees, directors, and consultants in
the 3rd quarter of 2004 under the Company's Stock Incentive Plan. In 2004 a
total of 5,243,254 options with were granted which vest over time periods
ranging from 0 to 3 years. Fair value at the date of grant was estimated using
the Black-Scholes pricing model with the following assumptions: dividend yield
of 0%, expected volatility of 114%, risk-free interest rate of 3.69% and an
expected life of 3 years. The exercise price for all 5,243,254 options was
$0.18. The weighted average grant date fair value for these options was $0.29.
Use of
Estimates in the Preparation of Financial Statements
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the end of the financial
statements and the reported amounts of revenue and expenses during the reporting
period. Actual results could differ from those estimates.
New
Accounting Pronouncements
In
November 2004, the Financial Accounting Standards Board (FASB) issued SFAS 151,
Inventory Costs-- an amendment of ARB No. 43, Chapter 4. This Statement amends
the guidance in ARB No. 43, Chapter 4, "Inventory Pricing," to clarify the
accounting for abnormal amounts of idle facility expense, freight, handling
costs, and wasted material (spoilage). Paragraph 5 of ARB 43, Chapter 4,
previously stated that ". . . under some circumstances, items such as idle
facility expense, excessive spoilage, double freight, and rehandling costs may
be so abnormal as to require treatment as current period charges. . . ." This
Statement requires that those items be recognized as current-period charges
regardless of whether they meet the criterion of "so abnormal." In addition,
this Statement requires that allocation of fixed production overheads to the
costs of conversion be based on the normal capacity of the production
facilities. This Statement is effective for inventory costs incurred during
fiscal years beginning after June 15, 2005. The Company does not yet have any
inventory.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
A - SUMMARY OF ACCOUNTING POLICIES (Continued)
In
December 2004, the FASB issued SFAS No.152, "Accounting for Real Estate
Time-Sharing Transactions--an amendment of FASB Statements No. 66 and 67" ("SFAS
152) The amendments made by Statement 152 This Statement amends FASB Statement
No. 66, Accounting for Sales of Real Estate, to reference the financial
accounting and reporting guidance for real estate time-sharing transactions that
is provided in AICPA Statement of Position (SOP) 04-2, Accounting for Real
Estate Time-Sharing Transactions. This Statement also amends FASB Statement
No.67, Accounting for Costs and Initial Rental Operations of Real Estate
Projects, to state that the guidance for (a) incidental operations and (b) costs
incurred to sell real estate projects does not apply to real estate
time-sharingtransactions. The accounting for those operations and costs is
subject to the guidance in SOP 04-2. This Statement is effective for financial
statements for fiscal years beginning after June 15, 2005. with earlier
application encouraged. The Company does not anticipate that the implementation
of this standard will have a material impact on its financial position, results
of operations or cash flows.
On
December 16, 2004, the Financial Accounting Standards Board ("FASB") published
Statement of Financial Accounting Standards No. 123 (Revised 2004), Share-Based
Payment ("SFAS 123R"). SFAS 123R requires that compensation cost related to
share-based payment transactions be recognized in the financial statements.
Share-based payment transactions within the scope of SFAS 123R include stock
options, restricted stock plans, performance-based equity awards, stock
appreciation rights, and employee share purchase plans. The provisions of SFAS
123R are effective as of the first interim period that begins after December 15,
2005. The Company is adopting this Statement early, for the year 2004. No stock
options, restricted stock plans, performance-based equity awards, stock
appreciation rights, or employee share purchase plans were in existence prior to
2004.
On
December 16, 2004, FASB issued Statement of Financial Accounting Standards No.
153, Exchanges of Nonmonetary Assets, an amendment of APB Opinion No. 29,
Accounting for Nonmonetary Transactions (" SFAS 153"). This statement amends APB
Opinion 29 to eliminate the exception for nonmonetary exchanges of similar
productive assets and replaces it with a general exception for exchanges of
nonmonetary assets that do not have commercial substance. Under SFAS 153, if a
nonmonetary exchange of similar productive assets meets a commercial-substance
criterion and fair value is determinable, the transaction must be accounted for
at fair value resulting in recognition of any gain or loss. SFAS 153 is
effective for nonmonetary transactions in fiscal periods that begin after June
15, 2005. The Company does not anticipate that the implementation of this
standard will have a material impact on its financial position, results of
operations or cash flows.
NOTE
B - BUSINESS COMBINATION AND CORPORATE RESTRUCTURE
On July
30, 2004, the Company completed a merger transaction with Impact Diagnostics,
Inc., a privately held Utah company ("Impact"), pursuant to an agreement dated
July 6, 2004. As a result of the merger, there was a change in control of the
public entity. Impact Diagnostics is a wholly owned subsidiary of the Company.
In
accordance with SFAS No. 141, Impact was the acquiring entity. While the
transaction is accounted for using the purchase method of accounting, in
substance the Agreement is a recapitalization of the Impact’s capital
structure.
For
accounting purposes, the Company accounted for the transaction as a reverse
acquisition and Impact is the surviving entity. The total purchase price and
carrying value of net assets acquired was $65,812. The Company did not recognize
goodwill or any intangible assets in connection with the transaction. From 1999
until the date of the Agreement, Grant was an inactive corporation with no
significant assets and liabilities.
Effective
with the Agreement, all 35,060,720 previously outstanding shares owned by the
Impact’s members were exchanged on a share for share basis with shares of the
Company’s common stock.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
B - BUSINESS COMBINATION AND CORPORATE RESTRUCTURE
(Continued)
On
September 20, 2004, the Company’s Board of Directors approved a change in the
Company’s name to Grant Life Sciences, Inc. The accompanying financial
statements have been changed to reflect the change as if it had happened at the
beginning of the periods presented. Stockholders approved this change effective
November 12, 2004.
The total
consideration was $65,812 and the significant components of the transaction are
as follows:
Common
stock retained |
|
$ |
6,000 |
|
Assets
acquired |
|
|
(
- |
) |
Liabilities
assumed - accounts payable |
|
|
20,034 |
|
Liabilities
assumed - accounts payable - stockholder |
|
|
39,778 |
|
Cash
paid |
|
|
- |
|
Total
consideration paid/organization cost |
|
$ |
65,812 |
|
In
accordance with SOP 98-5, the Company expensed $65,812 as organization
costs.
NOTE
C - PROPERTY AND EQUIPMENT
Major
classes of property and equipment at December 31, 2004 and 2003 consist of the
followings:
|
|
|
2004 |
|
|
2003 |
|
Furniture
and fixtures |
|
$ |
17,758 |
|
$ |
11,560 |
|
Equipment |
|
|
3,339 |
|
|
3,339 |
|
|
|
|
21,097 |
|
|
14,899 |
|
Less:
Accumulated Depreciation |
|
|
(5,857 |
) |
|
(8,186 |
) |
|
|
|
|
|
|
|
|
Net
Property and Equipment |
|
$ |
15,240 |
|
$ |
6,713 |
|
Depreciation
expense was $4,555 and $3,665 for the years ended December 31, 2004 and 2003,
respectively.
During
the year ended December 31, 2004, furniture and fixtures costing $ 10,674 and
accumulated depreciation of $ 6,884 were abandoned, resulting in loss of
$3,790.
NOTE
D - RELATED PARTY TRANSACTIONS
During
the years ended December 31, 2004 and December 31, 2003, the Company shared
office space with a related entity. Reimbursement of overhead from the related
party totaled $33,168 in 2003 and $12,000 in 2004. The Company moved into
separate space in September 2004. Prior to July 31, 2004, the Company and the
related entities would, on occasion, pay invoices on behalf of the other and
track the net receivable/payable in the related party receivable
account.
The
company has receivables from entities with common shareholders of $0 and $14,049
as of December 31, 2004 and 2003, respectively.
As of
December 31, 2004 and 2003, the Company had receivables from employees of $334
and $33,343, respectively.
As of
December 31, 2003, the Company had a note payable to a shareholder for $29,279.
The note earned interest at 5% and was converted to equity in August 2004.
Interest payable of $1,439 was forgiven.
As of
December 31, 2003, the Company had a non-interest bearing note payable to a
shareholder for $21,500. The note was converted to equity in August 2004.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
E - NOTES PAYABLE
Notes
payable at December 31, 2004 and 2003 are as follows:
|
|
|
2004 |
|
|
2003 |
|
6%
convertible note payable, unsecured, due on 1/2/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of $0.092178 |
|
$ |
10,000 |
|
$ |
- |
|
6%
convertible note payable, unsecured, due on 1/5/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/5/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/5/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
5,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/5/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
8,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/5/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
5,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/9/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
14,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/13/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/13/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
5,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/21/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
5,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 1/21/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,500 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 2/4/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 2/5/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,000 |
|
|
- |
|
6%
convertible note payable, unsecured, due on 2/25/2005, principal and
interest is convertible at any time before maturity into common shares of
the company at the price per share of 0.092178 |
|
|
10,000 |
|
|
- |
|
Subtotal |
|
$ |
122,500 |
|
$ |
- |
|
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
E - NOTES PAYABLE (continued)
subtotal
brought forward |
|
$ |
122,500 |
|
$ |
- |
|
10%
note payable , unsecured, due on 11/30/2002, in default as of 12/31/2002
due to non-payment, The note payable was in default as of December 31,
2002. The venture capital firm that issued the loan has since been placed
in receivership. As of December 31, 2003 the note balance was $587,753
with accrued interest payable of $141,501. In August 2004, this note for
$587,753 and accrued interest of $175,787 was restructured into a 3-year
convertible note of $350,000 plus 89,500 5-year warrants to purchase
additional shares at $0.01 per share. The note is convertible into shares
of common stock at a conversion price of $0.83798 per share. Interest is
payable quarterly at 6% per year. The warrants have an option value of
$0.0378 per share. The conversion resulted in a $411,597 gain on
extinguishment of debt. |
|
|
350,000 |
|
|
587,753 |
|
Non-interest
bearing note payable to related party, unsecured, no specific repayment
terms. Converted to common shares in August 2004. |
|
|
- |
|
|
21,500 |
|
5%
note payable to related party, unsecured, due 9/30/04. Converted to common
shares in August 2004. |
|
|
- |
|
|
29,279 |
|
Total
notes payable |
|
|
472,500 |
|
|
638,532 |
|
Less:
current portion |
|
|
(122,500 |
) |
|
(625,687 |
) |
Balance
notes payable (long term portion) |
|
$ |
350,000 |
|
$ |
12,845 |
|
On July
30, 2004, in connection with the reverse merger, a bridge note for $200,000
which originated on April 14, 2004, plus accrued interest was converted into
2,720,000 shares, per the terms of the note. Since the conversion rate was less
than the market price on the loan commitment date, a beneficial conversion
feature existed. Calculation of the beneficial conversion feature resulted in an
amount in excess of the debt, and as a result, the Company recognized interest
expense in the amount of $200,000, as the beneficial conversion feature can not
exceed the value of the debt.
In
accordance with Emerging Issues Task Force Issue 98-5, Accounting for
Convertible Securities with a beneficial Conversion Features or Contingently
Adjustable Conversion Ratios ("EITF 98-5"), the Company recognized an imbedded
beneficial conversion feature present in the bridge note. The Company recognized
and measured an aggregate of $200,000, which equals to the intrinsic value of
the imbedded beneficial conversion feature, to additional paid-in capital and a
return to the bridge noteholders. The beneficial conversion feature discount has
been recognized as finance expenses (interest expenses) in full.
NOTE
F - COMMON STOCK
The
Company is authorized to issue 150,000,000 shares of common stock with $0.001
par value per share. As of December 31, 2004, the Company has issued and
outstanding 56,243,791 shares of common stock. Also, the Company is authorized
to issue 20,000,000 shares of preferred stock with $0.001 par value per share.
No shares of preferred stock have been issued to date.
During
2003, the Company issued 930,800 shares of common stock for $120,000 in
cash.
In July
2004, per the Agreement and Plan of Merger with Impact Diagnostics, Inc. all
previously outstanding 35,060,720 shares of common stock owned by the Impact’s
stockholders were exchanged for the same number of shares of the Company’s
common stock. The value of the stock that was issued was the historical cost of
the Company’s net tangible assets, which did not differ materially from their
fair value.
In
connection with the Merger, on July 5, 2004, the board of directors of Impact
Diagnostics, Inc. approved a stock split of 3.58 shares to 1. As a result of the
split, the outstanding common stock of Impact Diagnostics, Inc. increased from
9,793,497 to 35,060,720 shares. Pursuant to the Merger Agreement, each share of
Impact Diagnostics common stock was exchanged for one share of Grant Life
Sciences common stock. All numbers, in the financial statements and notes to the
financial statements have been adjusted to reflect the stock split for all
periods presented.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
F - COMMON STOCK (continued)
On
September 20, 2004, the Company’s Board of Directors approved a change in the
Company’s name to Grant Life Sciences, Inc. The accompanying financial
statements have been changed to reflect the change as if it had happened at the
beginning of the periods presented. Stockholders approved this change effective
November 12, 2004.
In March
and April of 2004, the Company issued 238,660 shares of common stock for cash at
$0.0838 per share for $20,000.
In June
2004, the Company issued 500,000 shares of common stock in exchange for services
valued at $40,000 to consultants. The stock issued was valued at $.08 per
share, which represents the fair value of the stock issued, which did not differ
materially from the value of the services rendered. Expense of $20,000, related
to financial consulting, is included in general administrative expense and
expense of $20,000 related to R&D consulting is included in R&D expense.
On August
19, 2004, the Company completed a private placement of 9,560,596 shares to
accredited investors at a price of $0.1835 per share. As an additional
enticement to purchase the shares, one 5-year warrant to purchase stock at
$0.1835 was issued for each 5 shares of stock purchased. The private placement
resulted in net proceeds to the company of approximately $1,494,937. The Company
also issued warrants to purchase 2,670,000 shares at an exercise price of $0.01
per warrant and warrants to purchase 411,104 shares at an exercise price of
$0.185 per warrant to its placement agent in connection with the Merger and
private placement.
A bridge
loan of $50,000, made to the Company on July 6, 2004, was converted to equity on
July 31, 2004 as part of the private placement. In addition to the warrants
received as part of the offering, 50,000 warrants with an exercise price of
$0.1835 were issued to the lender.
In July,
2004, the Company issued 2,720,000 shares of common stock for a convertible note
payable and accrued interest of $205,885.
In August
2004, the Company issued 249,475 shares of common stock at $0.1835 per share in
satisfaction of two related party notes payable of $45,779. Accrued interest was
forgiven by the lenders.
In
November 2004, the Company issued 2,403,000 shares of common stock for exercise
of warrants at $0.01 strike price, for total cash proceeds of $24,030. These
warrants were originally issued in connection with the Merger and private
placement of common stock.
NOTE
G - INCOME TAXES
The
Company has adopted Financial Accounting Standard No. 109 which requires the
recognition of deferred tax liabilities and assets for the expected future tax
consequences of events that have been included in the financial statement or tax
returns. Under this method, deferred tax liabilities and assets are determined
based on the difference between financial statements and tax bases of assets and
liabilities using enacted tax rates in effect for the year in which the
differences are expected to reverse. Temporary differences between taxable
income reported for financial reporting purposes and income tax purposes are
insignificant.
For
income tax reporting purposes, the Company’s aggregate unused net operating
losses approximate $3,300,000 which expire through 2024, subject to limitations
of Section 382 of the Internal Revenue Code, as amended. The deferred tax asset
related to the carryforward is approximately $1,122,000. The Company has
provided a valuation reserve against the full amount of the net operating loss
benefit, because in the opinion of management based upon the earning history of
the Company, it is more likely than not that the benefits will not be
realized.
Components
of deferred tax assets as of December 31, 2004 and 2003, are as
follows:
Non
current: |
|
|
2004 |
|
|
2003 |
|
Net
operating loss carry forward |
|
$ |
1,122,000 |
|
$ |
548,000 |
|
Valuation
allowance |
|
|
(1,122,000 |
) |
|
(548,000 |
) |
Net
deferred tax asset |
|
$ |
- |
|
$ |
- |
|
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
H - SUPPLEMENTAL CASH FLOW INFORMATION
Supplemental
cash flow information for the years ended December 31, 2004 and 2003 and July 9,
1998 (date of inception) through December 31, 2004 is as follows:
|
|
|
2004 |
|
|
2003 |
|
|
July
9, 1998 (date of inception) through December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for interest |
|
$ |
10,622 |
|
$ |
344 |
|
$ |
12,597 |
|
Cash
paid for income taxes |
|
$ |
- |
|
$ |
- |
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
Non
Cash Investing and Financing Transactions: |
|
|
|
|
|
|
|
|
|
|
Loss
on abandonment of assets |
|
|
3,790
|
|
|
- |
|
|
3,790
|
|
Deferred
compensation |
|
|
426,081
|
|
|
- -
|
|
|
426,081
|
|
Common
stock issued in exchange for services rendered(1) |
|
|
40,000
|
|
|
- -
|
|
|
144,250
|
|
Warrants
issued in exchange for services rendered(1) |
|
|
11,000
|
|
|
- |
|
|
11,000
|
|
Beneficial
conversion feature discount |
|
|
200,000
|
|
|
-
-- |
|
|
298,507
|
|
Gain
on extinguishment of debt |
|
|
(411,597 |
) |
|
- -
|
|
|
(510,104 |
) |
Write
off of accounts payable due to stockholders |
|
|
(878 |
) |
|
- -
|
|
|
(878 |
) |
|
|
|
|
|
|
|
|
|
|
|
Merger
with Impact: (Note B) |
|
|
|
|
|
|
|
|
|
|
Common
stock retained |
|
|
6,000 |
|
|
- |
|
|
6,000 |
|
Liabilities
assumed in excess of assets acquired |
|
|
59,812 |
|
|
- |
|
|
59,812 |
|
Acquisition
cost recognized |
|
|
65,812 |
|
|
- |
|
|
65,812 |
|
(1)During
the year ended December 31, 2004, the Company issued 500,000 shares of stock and
one 5-year warrant to purchase 250,000 shares of stock for services provided by
consultants prior to the merger.
NOTE
I - LOSSES PER SHARE
The
following table presents the computations of basic and dilutive loss per
share:
|
|
|
2004 |
|
|
2003 |
|
Loss
Available to Common Shareholders |
|
$ |
(1,910,350 |
) |
$ |
(253,881 |
) |
Basic
and Fully Diluted Loss Per Share |
|
$ |
(0.04 |
) |
$ |
(0.01 |
) |
Weighted
Average Common Shares Outstanding |
|
|
42,751,142 |
|
|
33,842,000 |
|
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
J - STOCK OPTIONS AND WARRANTS
The
Company's has a Stock Incentive Plan. The options granted under the Plan may be
either qualified or non-qualified options. Up to 25,000,000 options may be
granted to employees, directors and consultants under the plan. Options may be
granted with different vesting terms and expire no later than 10 years from the
date of grant. In the third and fourth quarter of 2004, 5,243,254 options were
granted under the plan. All of the options granted in 2004 have an exercise
price of $0.18, but differing vesting terms. None of these options have yet been
exercised. Stockholders approved the plan effective November 12,
2004.
Stock
Options
Transactions
involving stock options issued to employees, directors and consultants under the
company’s 2004 Stock Incentive Plan are summarized below. Options issued under
the plan have a maximum life of 10 years. The following table summarizes the
changes in options outstanding and the related exercise prices for the shares of
the Company’s common stock issued under the 2004 Stock Incenctive plan and as of
December 31, 2004 :
Options
Outstanding |
Options
Exercisable |
Exercise
Prices |
Number
Outstanding |
Weighted
Average Remaining Contractual Life
(Years) |
Weighed
Average Exercise
Price |
Number
Exercisable |
Weighted
Average Exercise
Price |
$
0.18 |
5,243,254
|
9.4 |
$
0.18 |
613,650 |
$0.18 |
|
5,243,254
|
|
|
613,650 |
|
|
|
|
Number
of Shares |
|
|
Weighted
Average Price Per Share |
|
Outstanding
at January 1, 2003 |
|
|
- |
|
$ |
- |
|
Granted
|
|
|
- |
|
|
- |
|
Exercised |
|
|
- |
|
|
- |
|
Canceled
or expired |
|
|
- |
|
|
- |
|
Outstanding
at December 31, 2003 |
|
|
- |
|
|
- |
|
Granted
|
|
|
5,243,254 |
|
|
0.18 |
|
Exercised |
|
|
- |
|
|
- |
|
Canceled
or expired |
|
|
- |
|
|
- |
|
Outstanding
at December 31, 2004 |
|
|
5,243,254 |
|
$ |
0.18 |
|
The
weighted-average fair value of stock options vested during the year ended
December 31, 2004 and the weighted-average significant assumptions used to
determine those fair values, using a Black-Scholes option pricing model are as
follows:
|
|
|
2004 |
|
Significant
assumptions (weighted-average): |
|
|
|
|
Risk-free
interest rate at grant date |
|
|
3.69 |
% |
Expected
stock price volatility |
|
|
114 |
% |
Expected
dividend payout |
|
|
0 |
% |
Expected
option life-years (a) |
|
|
3yrs |
|
(a)The
expected option life is based on management’s estimate.
In
December 2004, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment
(SFAS123R). This Statement requires public entities to measure the cost of
equity awards to employees based on the grant-date value of the award. The
Company has elected early adoption of this Statement, effective for 2004, in
advance of the Company's required
adoption date of December 15, 2005. During the year ended December 31, 2004, the
Company recognized $426,081 as expense relating to vested stock options. $92,402
of the $426,081 is included on the statement of losses as R&D expense, the
remainder of the expense is included in general and administrative
expense.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
J - STOCK OPTIONS AND WARRANTS (continued)
Warrants
The
following table summarizes the changes in warrants outstanding and the related
exercise prices for the shares of the Company’s common stock issued by the
Company as of December 31, 2004:
Warrants
Outstanding & Exercisable |
Exercise
Prices |
|
|
Number
Outstanding |
|
|
Weighted
Average Remaining ContractualLife
(Years) |
|
|
Weighed
Average Exercise
Price |
|
$
0.01 |
|
|
267,000
|
|
|
4.5 |
|
$ |
0.01 |
|
$
0.1835 |
|
|
411,104
|
|
|
4.5 |
|
$ |
0.1835 |
|
$
0.1835 |
|
|
1,912,100
|
|
|
4.5 |
|
$ |
0.1835 |
|
$
0.01 |
|
|
89,500
|
|
|
4.5 |
|
$ |
0.01 |
|
$
0.18 |
|
|
250,000
|
|
|
5 |
|
$ |
0.18 |
|
$
0.1835 |
|
|
50,000
|
|
|
4.5 |
|
$ |
0.1835 |
|
|
|
|
2,979,704
|
|
|
|
|
$ |
0.16 |
|
|
|
|
Number
of Shares |
|
|
Weighted
Average Exercise Price |
|
Outstanding
at January 1, 2003 |
|
|
- |
|
$ |
- |
|
Granted
|
|
|
- |
|
|
- |
|
Exercised |
|
|
- |
|
|
- |
|
Canceled
or expired |
|
|
- |
|
|
- |
|
Outstanding
at December 31, 2003 |
|
|
- |
|
|
- |
|
Granted
|
|
|
5,382,704 |
|
|
0.09 |
|
Exercised |
|
|
(2,403,000 |
) |
|
0.01 |
|
Canceled
or expired |
|
|
- |
|
|
- |
|
Outstanding
at December 31, 2004 |
|
|
2,979,704 |
|
$ |
0.16 |
|
All
warrants were exercisable at the date of grant. All of the warrants, except
250,00 warrants, were issued in connection with financing. The Company granted a
warrant to purchase 250,000 shares at $0.18 per share to a non-employee for
consulting services in June 2004 The warrant was valued at the fair market value
of services performed. The Company recognized $11,000 as R&D expense
relating to this warrant for the year ended December 31, 2004. The Black-Scholes
option pricing model was used to value the 89,500 warrants with an exercise
price of $0.01 which were issued in connection with a restructure of a note
payable immediately prior to the merger. The $3,382 value of these warrants was
recorded as additional paid-in capital. The following assumptions were
used.
|
|
|
2004 |
|
Significant
assumptions (weighted-average): |
|
|
|
|
Risk-free
interest rate at grant date |
|
|
3.93 |
% |
Expected
stock price volatility |
|
|
0 |
% |
Expected
dividend payout |
|
|
0 |
% |
Expected
option life-years (a) |
|
|
5yrs |
|
(a)The
expected option life is based on management’s estimate.
GRANT
LIFE SCIENCES, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2004 and 2003
NOTE
K - COMMITMENTS
On July
20, 2004, the Company entered into an exclusive license agreement to use certain
technologies in its cervical cancer tests. The term of the license agreement is
17 years, and requires the Company to make annual royalty payments ranging from
1% to 3% of net sales, with annual minimum royalty payments of $48,000 to be
paid monthly in $4,000 installments. The license agreement can be terminated
with 90 days notice.
Minimum
payments due under this license agreement are as follows:
Year |
|
Amount |
|
2005 |
$ |
48,000 |
|
2006 |
|
48,000 |
|
2007
|
|
48,000 |
|
2008 |
|
48,000 |
|
2009
and after |
|
600,000 |
|
|
$ |
792,000 |
|
The
Company leases office space in North Carolina under a 1-year lease which expires
September 30, 2005. The Company leases office space in Utah under a 1-year lease
which expires August 31, 2005. Lab space is leased in Utah under a 1-year lease
which expires March 31, 2005.
NOTE
L - GOING CONCERN
The
accompanying statements have been prepared on a going concern basis, which
contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. As shown in the consolidated financial statements
during the years ended December 31, 2004 and 2003, the Company incurred losses
from operations of $1,910,350 and $253,881, respectively, and has a deficit
accumulated during the development stage of $3,381,340 as of December 31, 2004.
In addition, the Company has had negative cash flow from operating activities
since inception. These factors among others may indicate that the Company will
be unable to continue as a going concern for a reasonable period of
time.
The
Company’s existence is dependent upon management’s ability to develop profitable
operations and resolve its liquidity problems. Management anticipates the
Company will attain profitable status and improve its liquidity through the
continued development and sale of its products and additional equity investment
in the Company. The accompanying financial statements do not include any
adjustments that might result should the Company be unable to continue as a
going concern.
In order
to improve the Company’s liquidity, the Company is actively pursing additional
debt and equity financing through discussions with investment bankers and
private investors. There can be no assurance the Company will be successful in
its effort to secure additional equity financing.
NOTE
M- SUBSEQUENT EVENTS
In March
2005, convertible notes totaling $122,500 plus accrued interest of $7,350
converted into 1,395,322 shares of stock, per the terms of the notes. $1,230 of
interest was forgiven.
On March
7, 2005, the Company signed a 10-year licensing agreement for rapid test
technologies. Under the terms of the agreement, the Company will make an initial
payment of $15,000, execute a note for $35,000 payable over two years, and pay
royalties on net sales of licensed products. The license can be terminated with
90 days notice by the Company.
On March
15, 2005, the Company obtained bridge financing of $200,000. The Company signed
a $200,000 note, secured by the Company's assets, with an interest rate of 8%
due June 15, 2005 or when the Company receives proceeds of $2,000,000 from the
sale of stock or debt securities, whichever is sooner. Interest is payable in
cash at the end of each month. The Company issued 250,000 5-year warrants,
with an exercise price of $0.40, to the lender. The exercise price of the
warrants is adjustable downward if equity is issued in the future for a price
less than the exercise price of these warrants.
PART
II — INFORMATION
NOT REQUIRED IN PROSPECTUS
ITEM
24.
INDEMNIFICATION OF OFFICERS AND DIRECTORS
Under the Nevada Revised Statutes and our Amended and Restated Articles of
Incorporation, our directors and officers will have no individual liability to
us or our stockholders or creditors for any damages resulting from the officer's
or director’s act or failure to act in his or her capacity as an officer or
director unless it is proven that (i) the officer's or director’s act or failure
to act constituted a breach of his or her fiduciary duties as an officer or
director; and (ii) the officer's or director’s breach of those duties involved
intentional misconduct, fraud or a knowing violation of law. The effect of
this statute and our Amended and Restated Articles of Incorporation is to
eliminate the individual liability of our officers and directors to the
corporation or its stockholders or creditors, unless any act or failure to act
of an officer or director meets both situations listed in (i) and (ii) above.
Our
Amended and Restated Articles of Incorporation provide for the indemnification
of our officers and directors to the maximum extent permitted by Nevada
law. The Nevada Revised Statutes also provide that a corporation may
indemnify any officer or director who is a party or is threatened to be made a
party to a litigation by reason of the fact that he or she is or was an officer
or director of the corporation, or is or was serving at the request of the
corporation as an officer or director of another corporation, partnership, joint
venture, trust or other enterprise, against expenses, including attorneys’ fees,
judgments, fines and amounts paid in settlement actually and reasonably incurred
by such officer or director if (i) there was no breach by the officer or
director of his or her fiduciary duties to the corporation involving intentional
misconduct, fraud or knowing violation of law; or (ii) the officer or director
acted in good faith and in a manner which he or she reasonably believed to be in
or not opposed to the best interests of the corporation, and, with respect to
any criminal action or proceeding, had no reasonable cause to believe his or her
conduct was unlawful.
These
provisions of our Amended and Restated Articles of Incorporation become
effective 20 days after the Information Statement is first mailed to our
stockholders.
ITEM
25.
OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the fees and expenses we expect to incur in
connection with the issuance and distribution of the securities being
registered. With the exception of the SEC registration fee, all amounts are
estimates. .
Securities
and Exchange Commission Registration Fee |
$
|
2,310
|
|
Printing
Fees and Expenses |
$
|
1,000 |
|
Legal
Fees and Expenses |
$
|
72,000
|
|
Accounting
Fees and Expenses |
$
|
23,000 |
|
Miscellaneous
|
$
|
18,000
|
|
ITEM
26.
RECENT SALES OF UNREGISTERED SECURITIES
On July 30, 2004, in connection with the Merger, we issued
30,565,246 shares of our common stock, and options and warrants to purchase
6,972,754 shares of our common stock to the holders of common stock,
convertible notes and options to purchase common stock of Impact Diagnostics
Upon effectiveness of the increase in our authorized common stock on November
12, 2004, we issued 7,464,950 shares of our common stock to certain
stockholders of Impact Diagnostics who were entitled to receive shares of our
common stock in the Merger.
On July
30, 2004, we issued 2,270,000 shares of our common stock to Bridges & Pipes
LLC pursuant to the conversion of a $200,000 convertible promissory note dated
April 14, 2004.
Between
July 30 and August 19, 2004, we sold a total of 1,912,125 units, at a purchase
price of $0.9175 per unit ($0.1835 per share), resulting in gross proceeds to us
of $1,754,375. Each unit is comprised of five (5) shares of our common
stock and a warrant to purchase one (1) share of our common stock at an exercise
price of $0.1835 per share. The units were sold to individuals and
institutional investors, all of whom were “accredited investors”, as defined by
Rule 501 of Regulation D promulgated under the Securities Act of 1933, as
amended (the “Securities Act”). Each of the investors represented to us
that the investor was an accredited investor and represented to us the
investor’s intention to acquire our securities for investment purposes only and
not with a view to or for sale in connection with any distribution thereof.
In August 2004, we issued 2,670,000 warrants to Duncan Capital Group LLC as
compensation for acting as our financial advisor in connection with the Merger.
These warrants have an exercise price of $0.01 per share. In August 2004,
we issued 411,104 warrants to Duncan Capital LLC as compensation for acting as
our placement agent in connection with the sale of our units in a private
financing. The warrants have an exercise price of $0.1835 per
share. In November 2004, 2,403,000 of the warrants with the $0.01 exercise
price were exercised, resulting in $24,030 of proceeds to us.
In August
2004, we issued 89,918 shares of our common stock to Blaine Taylor in
consideration for the conversion of $16,500 owned to him by us pursuant to a
convertible promissory note.
In August
2004, we issued 159,557 shares of our common stock to Mitchell Godfrey in
consideration for the conversion of $29,278 owned to him by us pursuant to a
convertible promissory note.
In
November 2004, we issued 250,000 shares of our common stock to David Bolick in
connection with consulting services performed on our behalf prior to the
merger.
In March
2005, we issued 1,395,322 shares of our common stock to convertible note holders
in exchange for the cancellation of $122,500 of notes, plus accrued interest of
$7,350, pursuant to the original terms of the notes.
In March
2005, we issued a an 8% Senior Secured Note due June 15, 2005 in the principal
amount of $200,000 and a warrant to purchase up to an aggregate of 250,000
shares of our common stock to DCOFI Master LDC in connection with bridge
financing of $200,000.
* All of
the above offerings and sales were deemed to be exempt under rule 506 of
Regulation D and Section 4(2) of the Securities Act of 1933, as amended. No
advertising or general solicitation was employed in offering the securities. The
offerings and sales were made to a limited number of persons, all of whom were
accredited investors, business associates of Grant Life Sciences or executive
officers of Grant Life Sciences, and transfer was restricted by Grant Life
Sciences in accordance with the requirements of the Securities Act of 1933. In
addition to representations by the above-referenced persons, we have made
independent determinations that all of the above-referenced persons were
accredited or sophisticated investors, and that they were capable of analyzing
the merits and risks of their investment, and that they understood the
speculative nature of their investment. Furthermore, all of the above-referenced
persons were provided with access to our Securities and Exchange Commission
filings.
ITEM
27.
EXHIBITS
Exhibit
No. |
|
Description
|
|
2.1
|
|
Agreement
and Plan of Merger, dated as of July 6, 2004, by and among Grant
Ventures, Inc., Impact Acquisition Corporation and Impact Diagnostics,
Inc. (1) |
|
3.1
|
|
Articles
of Incorporation of North Ridge Corporation, filed with the Secretary of
State of Nevada on January 31, 2000. (1) |
|
3.2
|
|
Certificate
of Amendment to Articles of Incorporation of North Ridge Corporation,
changing its name to Grant Ventures, Inc. and changing its authorized
capital to 50,000,000 shares, par value $0.001 per share, filed with the
Secretary of State of Nevada on May 30, 2001. (1) |
|
3.3
|
|
Form
of Amended and Restated Articles of Incorporation of Grant Ventures, Inc.
(1) |
|
3.4
|
|
Articles
of Merger for the merger of Impact Diagnostics, Inc. (Utah) and Impact
Acquisitions Corporation (Utah), filed with the Secretary of State of Utah
on July 30, 2004. (1) |
|
3.5
|
|
Bylaws
of Grant Life Sciences, Inc. (2) |
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4.1
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Securities
Purchase Agreement between Grant Ventures, Inc. and the purchasers party
thereto. (1) |
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4.2
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Registration
Rights Agreement between Grant Ventures, Inc. and the purchasers party
thereto. (1) |
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4.3
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Form
of Common Stock Purchase Warrant. (1) |
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5.1
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Opinion
of Sichenzia Ross Friedman Ference LLP |
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10.1
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6%
Convertible Promissory Note in the amount of $350,000, dated as of July
23, 2004, between Impact Diagnostics, Inc. and James H. Donell, as
receiver of Citadel Capital Management, Inc. (1) |
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10.2
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Warrant,
dated July 23, 2004, of James H. Donell, as receiver of Citadel Capital
Management, Inc., to purchase 89,500 shares of common stock of Impact
Diagnostics, Inc. (1) |
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10.3
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Letter
Agreement, dated July 1, 2004, between Impact Diagnostics, Inc. and Duncan
Capital LLC. (1) |
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10.4
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Letter
Agreement, dated July 1, 2004, between Impact Diagnostics, Inc. and
Michael Ahlin. (1) |
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10.5
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Letter
Agreement, dated July 1, 2004, between Impact Diagnostics, Inc. and Dr.
Mark Rosenfeld. (1) |
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10.6
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2004
Stock Incentive Plan of Grant Ventures, Inc. (1) |
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10.7
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Incentive
Stock Option Agreement, dated as of July 6, 2004, between Impact
Diagnostics, Inc. and Stan Yakatan. (1) |
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10.8
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Incentive
Stock Option Agreement, dated as of July 6, 2004, between Impact
Diagnostics, Inc. and John C. Wilson.(1) |
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10.9
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Employment
Agreement between Michael L. Ahlin and Impact Diagnostics, Inc., dated
January 1, 2004, as amended by the Amendment of Employment Agreement,
dated July 1, 2004. (1) |
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10.10
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Employment
Agreement between Mark J. Rosenfeld and Impact Diagnostics, Inc., dated
January 1, 2004, as amended by the Amendment of Employment Agreement,
dated July 1, 2004. (1) |
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10.11
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Exclusive
License Agreement between Impact Diagnostics Incorporation and Dr. Yao
Xiong Hu, M.D., dated July 20, 2004 (incorporated by reference to Form
10-QSB filed with SEC on November 19, 2004). (2) |
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10.12 |
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Exclusive
License Agreement dated March 7, 2005 by and between Grant Life Sciences,
Inc. and AccuDx Corporation (incorporated by reference to Form 8-K filed
with SEC on March 11, 2005). |
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10.13 |
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Consulting
Agreement dated March 7, 2005 by and between Grant Life Sciences, Inc. and
Ravi and Dr. Indira Pottahil (incorporated by
reference to Form 8-K filed with SEC on March 11, 2005). |
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10.14 |
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Promissory
Note in the name of AccuDx Corporation dated March 7, 2005 (incorporated
by reference to Form 8-K filed with SEC on
March 11, 2005). |
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10.15 |
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Securities
Purchase Agreement dated as of March 15, 2005 among Grant Life Sciences,
Inc. and the purchasers signatory thereto (incorporated by reference to
Form 8-K filed with SEC on March 21, 2005). |
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10.16 |
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Security
Agreement dated as of March 15, 2005 among Grant Life Sciences, Inc. and
the holders of the Notes (incorporated by reference to Form 8-K filed with
SEC on March 21, 2005). |
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10.17 |
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Registration
Rights Agreement dated as of March 15, 2005 among Grant Life Sciences,
Inc. and the purchasers signatory thereto (incorporated by reference to
Form 8-K filed with SEC on March 21, 2005). |
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10.18 |
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8%
Senior Secured Note dated March 15, 2005 in the name of DCOFI Master LDC
(incorporated by reference to Form 8-K filed with
SEC on March 21, 2005). |
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10.19 |
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Securities
Purchase Agreement dated as of March 15, 2005 among Grant Life Sciences,
Inc. and the purchasers signatory thereto (incorporated by reference to
Form 8-K filed with SEC on March 21, 2005). |
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10.20 |
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Employment
Agreement dated April 6, 2005 between Don Rutherford and Grant Life
Sciences, Inc. (incorporated by reference herein to Form 8-K filed
with The SEC on April 12, 2005. |
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21.1 |
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Subsidiaries
of Grant Life Sciences, Inc. (1) |
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23.1
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Consent
of Tanner LC. |
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23.2 |
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Consent
of Russell Bedford Stefanou Mirchandani LLP |
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23.3 |
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Consent
of Sichenzia Ross Friedman Ference LLP (see exhibit 5.1). |
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(1)
Previously filed as an exhibit to registration statement on Form SB-2 filed
September 30, 2004
(2)
Previously filed as an exhibit to registration statement on Form SB-2 filed
February 11, 2005
SIGNATURES
In accordance with the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements of filing on Form SB-2 and authorized this registration
statement to be signed on its behalf by the undersigned, in the city of Los
Angeles, state of California on April 28, 2005.
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GRANT
LIFE SCIENCES, INC. |
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By: |
/s/ Stan Yakatan |
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Stan
Yakatan
President
and Chief Executive Officer
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POWER
OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Stan Yakatan and Don Rutherford and each or
either of them, his true and lawful attorneys-in-fact, with full power of
substitution and resubstitution, for him and in his name, place and stead, in
any and all capacities to sign any and all amendments (including post-effective
amendments) to this registration statement and to sign a registration statement
pursuant to Section 462(b) of the Securities Act of 1933, and to file the same
with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact, full
power and authority to do and perform each and every act and thing requisite and
necessary to be done in and about the premises, as fully to all intents and
purposes as he might or could do in person, hereby ratifying and confirming all
that said attorneys-in-fact or his substitute or substitutes, may lawfully do or
cause to be done by virtue hereof.
In accordance with the requirements of the Securities Act of 1933, this
registration statement was signed by the following persons in the capacities and
on the dates stated:
Signature
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Title
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Date
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/s/
Stan Yakatan |
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President,
Chief Executive Officer and Chairman of the Board |
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April
28, 2005 |
Stan
Yakatan |
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/s/
Don Rutherford |
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Chief
Financial Officer |
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April
28, 2005 |
Don
Rutherford |
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/s/
Michael Ahlin |
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Vice
President and Director |
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April
28, 2005 |
Michael
Ahlin |
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/s/
Jack Levine |
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Director
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April
28, 2005 |
Jack
Levine |
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/s/
Kevin Crow |
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Director
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April
28, 2005 |
Kevin
Crow |
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/s/
Erik Wilkinson |
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Director
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April
28, 2005 |
Erik
Wilkinson |
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/s/
Carmen Medina |
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Director |
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April
28, 2005 |
Carmen
Medina |
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