UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-8
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
Grant
Life Sciences, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Nevada |
|
82-0490737
|
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
64
East Winchester, Suite 205
Murray,
Utah 84107
(801)
261-8736
(Address
of Principal Executive Offices)
2004
Amended Stock Incentive Plan
(Full
Titles of the Plans)
Stan
Yakatan, Chief Executive Officer
64
East Winchester, Suite 205
Murray,
Utah 84107
(801)
261-8736
(Name,
address, including zip code, and telephone number, including area
code,
of agent for service)
CALCULATION
OF REGISTRATION FEE
|
|
|
|
|
|
|
|
|
|
Title
of
securities
to be registered |
|
Amount to
be
registered(1) |
|
Proposed
maximum
offering
price
per
share(2) |
|
Proposed
maximum
aggregate
offering price |
|
Amount
of
registration
fee |
|
Common
Stock, $.001 par value |
|
|
8,645,867
(1) |
|
$ |
0.27 |
|
$ |
2,334,384 |
|
$ |
274.76 |
|
(1) |
Pursuant
to Rule 416 under the Securities Act of 1933, as amended (the “Securities
Act”), this Registration Statement covers, in addition to the number of
shares stated above, an indeterminate number of additional shares that may
be offered or issued under the 2004 Amended Stock Incentive Plan (the
“Plan”) in connection with stock splits, stock dividends and similar
transactions pursuant to any anti-dilution provisions of the Plan.
|
(2) |
This
calculation is made solely for the purpose of determining the registration
fee pursuant to the provisions of Rule 457(c) and (h) under the Securities
Act as follows (a) 5,993,254 outstanding options with exercise prices
ranging from $0.18 to $0.40 and a weighted average exercise price of $0.21
and (b) 2,652,613 shares, issuable under the 2004 Amended Stock Incentive
Plan which are not subject to outstanding options, at $0.40, the average
of the high and low sale prices per share of the Common Stock on the OTC
Bulletin Board on May 26, 2005. |
EXPLANATORY
NOTE
Pursuant
to General Instruction E of Form S-8, this Registration Statement is being filed
in order to register 8,645,867 shares of common stock, $0.001 par value per
share, of Grant Life Sciences, Inc. with respect to its 2004 Amended Stock
Incentive Plan.
The
Prospectus filed as part of this Registration Statement has been prepared in
accordance with the requirements of Form S-3 and may be used for reofferings and
resales of registered shares of common stock which have been issued upon the
grants of common stock to executive officers, directors, key employees and
consultants of Grant Life Sciences, Inc.
Prospectus
Grant
Life Sciences, Inc.
8,645,867 SHARES OF
COMMON STOCK
issued
pursuant to the
2004
Amended Stock Incentive Plan
This
prospectus relates to the sale of up to 8,645,867 shares of
common stock of Grant Life Sciences, Inc. offered by certain holders of our
common stock acquired upon the exercise of options issued to such persons
pursuant to our 2004Amended Stock Incentive Plan. The shares may be offered by
the selling stockholders from time to time in regular brokerage transactions, in
transactions directly with market makers or in certain privately negotiated
transactions. For additional information on the methods of sale, you should
refer to the section entitled "Plan of Distribution." We will not receive any of
the proceeds from the sale of the shares by the selling stockholders.
Our
common stock trades on The Over-The-Counter Bulletin Board under the symbol
"GLIF" On May
26, 2005, the closing sale price of the common stock was $0.40 per share. The
securities offered hereby are speculative and involve a high degree of risk and
substantial dilution. Only investors who can bear the risk of loss of their
entire investment should invest. See "Risk Factors" beginning on page
6.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus is May 27, 2005.
TABLE
OF CONTENTS
|
Page |
Prospectus
Summary |
2 |
Risk
Factors |
3 |
Selling
Stockholders |
9 |
Plan
of Distribution |
11 |
Incorporation
of Certain Documents by Reference |
13 |
Interests
of Named Experts and Counsel |
13 |
Disclosure
of Commission Position on Indemnification For Securities Act
Liabilities |
13 |
Exhibits |
14 |
Undertakings |
15 |
Signatures
|
16 |
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. For the three months ended March 31, 2005, we incurred a net
loss of $890,573. Cumulative losses since inception through March 31, 2005
totaled $4,271,912. 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.
This
Offering
Shares
of common stock outstanding prior to this offering
|
58,139,113
as of May 26, 2005
|
Shares
offered in this prospectus
|
8,645,867
|
Total
shares outstanding after this offering
|
66,784,980
|
Use
of proceeds
|
We
will not receive any proceeds from the sale of the shares of common stock
offered in this prospectus.
|
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, $890,573 for the three
months ended March 31, 2005, and $4,271,912 from inception in 1998 through March
31, 2005. Our accumulated deficit at March 31, 2005 was $4,271,912.
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 May
27, 2005, we had outstanding 58,139,113 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 581,391 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.
Selling
Stockholders
The table
below sets forth information concerning the resale of the shares of common stock
by the selling stockholders. We will not receive any proceeds from the resale of
the common stock by the selling stockholders. We will receive proceeds from the
exercise of the warrants
The
following table also sets forth the name of each person who is offering the
resale of shares of common stock by this prospectus, the number of shares of
common stock beneficially owned by each person, the number of shares of common
stock that may be sold in this offering and the number of shares of common stock
each person will own after the offering, assuming they sell all of the shares
offered.
|
Shares
Beneficially Owned
Prior
to the Offering |
|
|
Shares
Beneficially Owned
After
the Offering |
Name |
Number |
Percent |
Number
Assuming Full Vesting |
Total
Shares
Offered |
Number |
Percent |
Stan
Yakatan
|
573,650
|
1.0%
|
2,868,254
(1)
|
2,868,254
|
0
|
0
|
John
Wilson
|
1,000,000
|
1.7%
|
1,000,000
(2)
|
750,000
|
250,000
|
*
|
Jack
Levine
|
588,555
|
1.0%
|
763,555
(3)
|
175,000
|
588,555
|
*
|
Eric
Wilkinson
|
0
|
0
|
150,000
(4)
|
150,000
|
0
|
0
|
Kevin
Crow
|
985,080
|
1.7%
|
1,160,080
(5)
|
175,000
|
985,080
|
1.5%
|
David
Bolick
|
1,193,185
|
2.0%
|
1,693,185
(6)
|
750,000
|
943,185
|
1.4%
|
Linda
Koch
|
40,000
|
*
|
200,000
(7)
|
200,000
|
0
|
0
|
Don
Rutherford
|
312,499
|
*
|
750,000
(8)
|
750,000
|
0
|
0
|
Dan
Cook
|
0
|
0
|
25,000
(9)
|
25,000
|
0
|
0
|
Seth
Yakatan
|
0
|
0
|
50,000
(10)
|
50,000
|
0
|
0
|
Carmen
Medina
|
0
|
0
|
100,000
(11)
|
100,000
|
0
|
0
|
* Less
than one percent.
The
number and percentage of shares beneficially owned is determined in accordance
with Rule 13d-3 of the Securities Exchange Act of 1934, and the information
is not necessarily indicative of beneficial ownership for any other purpose.
Under such rule, beneficial ownership includes any shares as to which the
selling stockholder has sole or shared voting power or investment power and also
any shares, which the selling stockholder has the right to acquire within 60
days. The actual number of shares of common stock issuable upon the conversion
of the debentures and exercise of the debenture warrants is subject to
adjustment depending on, among other factors, the future market price of the
common stock, and could be materially less or more than the number estimated in
the table.
(1)
Includes options to purchase 2,868,254 shares of our common stock, of
which 573,650 options are currently exercisable.
(2)
Includes (i) 250,000 shares of common stock and (ii) options to purchase 750,000
shares of our common stock , all of which are currently
exercisable.
(3)
Includes (i) 490,463 shares of common stock, (i) warrants to purchase 98,092
shares of our common stock and (iii) options to purchase 175,000 shares of our
common stock. None of the options are exercisable within the next 60
days.
(4)
Includes options to purchase 150,000 shares of our common stock. None of the
options are exercisable within the next 60 days.
(5)
Includes shares of 4 trusts, each with 246,270 shares, of which Mr. Crow is the
trustee, and options to purchase 175,000 shares of our common stock. None of the
options are exercisable within the next 60 days.
(6)
Includes (i) 800,408 shares of common stock, (ii) warrants to purchase 110,081
shares of our common stock beneficially owned by Dr. Bolick and (iii) options to
purchase 750,000 shares of our common stock. 250,000 of the options are
exercisable in the next 60 days. Also includes 27,247 shares and warrants to
purchase 5,449 shares of our common stock held by Julia Bolick, Dr. Bolick’s
wife.
(7)
Includes options to purchase 200,000 shares of our common stock, 40,000 of which
are currently exercisable.
(8)
Includes options to purchase 750,000 shares of our common stock. 312,499 of
these options are exercisable within the next 60 days.
(9)
Includes options to purchase 25,000 shares of our common stock. The options are
not exercisable within the next 60 days.
(10)
Includes options to purchase 50,000 shares of our common. The options are not
exercisable within the next 60 days.
(11)
Includes options to purchase 100,000 shares of our common stock. The options are
not exercisable within the next 60 days.
Plan
of Distribution
Sales of
the shares may be effected by or for the account of the selling stockholders
from time to time in transactions (which may include block transactions) on The
Over-The-Counter Bulletin Board, in negotiated transactions, through a
combination of such methods of sale, or otherwise, at fixed prices that may be
changed, at market prices prevailing at the time of sale or at negotiated
prices. The selling stockholders may effect such transactions by selling the
shares directly to purchasers, through broker-dealers acting as agents of the
selling stockholders, or to broker-dealers acting as agents for the selling
stockholders, or to broker-dealers who may purchase shares as principals and
thereafter sell the shares from time to time in transactions (which may include
block transactions) on The Over-The-Counter Bulletin Board, in negotiated
transactions, through a combination of such methods of sale, or otherwise. In
effecting sales, broker-dealers engaged by a selling stockholder may arrange for
other broker-dealers to participate. Such broker-dealers, if any, may receive
compensation in the form of discounts, concessions or commissions from the
selling stockholders and/or the purchasers of the shares for whom such
broker-dealers may act as agents or to whom they may sell as principals, or both
(which compensation as to a particular broker-dealer might be in excess of
customary commissions).
The
selling stockholders and any broker-dealers or agents that participate with the
selling stockholders in the distribution of the shares may be deemed to be
"underwriters" within the meaning of the Securities Act of 1933. Any commissions
paid or any discounts or concessions allowed to any such persons, and any
profits received on the resale of the shares purchased by them may be deemed to
be underwriting commissions or discounts under the Securities Act of
1933.
We have
agreed to bear all expenses of registration of the shares other than legal fees
and expenses, if any, of counsel or other advisors of the selling stockholders.
The selling stockholders will bear any commissions, discounts, concessions or
other fees, if any, payable to broker-dealers in connection with any sale of
their shares.
We have
agreed to indemnify the selling stockholders, or their transferees or assignees,
against certain liabilities, including liabilities under the Securities Act of
1933 or to contribute to payments the selling stockholders or their respective
pledgees, donees, transferees or other successors in interest, may be required
to make in respect thereof.
8,645,867 SHARES OF
COMMON STOCK
PROSPECTUS
_______________
May 27,
2005
PART
I
INFORMATION
REQUIRED IN THE SECTION 10(a) PROSPECTUS
Information
required by Part I of Form S-8 to be contained in a prospectus meeting the
requirements of Section 10(a) of the Securities Act of 1933, as amended (the
“Securities Act”), is not required to be filed with the Securities and Exchange
Commission and is omitted from this registration statement in accordance with
the explanatory note to Part I of Form S-8 and Rule 428 of the Securities
Act.
PART
II
INFORMATION
REQUIRED IN THE REGISTRATION STATEMENT
Item
3. Incorporation of Documents by Reference.
The
Registrant hereby incorporates by reference into this Registration Statement the
documents listed below. In addition, all documents subsequently filed pursuant
to Sections 13(a), 13(c), 14 and 15(d) of the Securities Exchange Act of 1934
(the "Exchange Act"), prior to the filing of a post-effective amendment which
indicates that all securities offered have been sold or which deregisters all
securities then remaining unsold, shall be deemed to be incorporated by
reference into this Registration Statement and to be a part hereof from the date
of filing of such documents:
· |
Reference
is made to the Registrant’s annual report on Form 10-KSB for the period
ending December 31, 2004, as filed with the SEC on March 31, 2005 (file
no. 000-50133), which is hereby incorporated by
reference. |
· |
Reference
is made to the Registrant’s quarterly report on Form 10-QSB for the period
ending March 31, 2005 as filed with the SEC on May 16, 2005 (file no.
000-50133), which is hereby incorporated by
reference. |
· |
All
other reports filed pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 since the end of the 2004 fiscal year;
and |
· |
The
description of the Registrant’s common stock is incorporated by reference
to the Registrant’s annual report on Form 10-KSB for the year ended
December 31, 2004, as amended, as filed with the SEC on March 31, 2005,
which is hereby incorporated by reference. |
Item
4. Description of Securities.
Not
applicable.
Item
5. Interests of Named Experts and Counsel.
The
validity of the shares of common stock underlying the options offered hereby
will be passed upon for the Registrant by Sichenzia Ross Friedman Ference LLP,
1065 Avenue of the Americas, 21st Floor,
New York, NY 10018.
Item
6. Indemnification of Directors and Officers.
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.
We
maintain a directors and officers insurance policy that covers certain
liabilities of directors and officers of our corporation arising acting in their
capacities as directors or officers.
Item
7. Exemption from Registration Claimed.
Not
applicable.
Item
8. Exhibits.
Exhibit
No. |
|
Description
|
4.1 |
|
2004
Amended Stock Incentive Plan of Grant Life Sciences,
Inc. |
5.1
|
|
Opinion
of Sichenzia Ross Friedman Ference LLP |
23.1
|
|
Consent
of Independent Registered Public Accounting Firm Tanner LC |
|
23.2 |
|
Consent
of Independent Registered Public Accounting Firm Russell Bedford Stefanou
Mirchandani LLP |
|
23.3 |
|
Consent
of Sichenzia Ross Friedman Ference LLP (included in Exhibit
5.1) |
|
Item
9. Undertakings.
(a) The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement:
To
include any material information with respect to the plan of distribution not
previously disclosed in the Registration Statement or any material change to
such information in the Registration Statement;
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new Registration
Statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(b) The
undersigned registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act of 1933, each filing of the registrant's
annual report pursuant to Section 13(a) or Section 15(d) of the Securities
Exchange Act of 1934 that is incorporated by reference in the Registration
Statement shall be deemed to be a new Registration Statement relating to the
securities offered herein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act of
1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer, or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-8 and has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of Los
Angeles, State of California on this 27th day of
May, 2005.
|
GRANT
LIFE SCIENCES, INC. |
|
|
|
|
By: |
/s/ Stan
Yakatan |
|
|
|
Stan
Yakatan
President
and Chief Executive Officer |
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
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/
Stan Yakatan |
|
President,
Chief Executive Officer and Chairman of the Board |
|
May
27, 2005 |
Stan
Yakatan |
|
|
|
|
|
|
|
|
|
/s/
Don Rutherford |
|
Chief
Financial Officer |
|
May
27, 2005 |
Don
Rutherford |
|
|
|
|
|
|
|
|
|
/s/
Michael Ahlin |
|
Vice
President and Director |
|
May
27, 2005 |
Michael
Ahlin |
|
|
|
|
|
|
|
|
|
/s/
Jack Levine |
|
Director
|
|
May
27, 2005 |
Jack
Levine |
|
|
|
|
|
|
|
|
|
/s/
Kevin Crow |
|
Director
|
|
May
27, 2005 |
Kevin
Crow |
|
|
|
|
|
|
|
|
|
/s/
Eric Wilkinson |
|
Director
|
|
May
27, 2005 |
Eric
Wilkinson |
|
|
|
|
|
|
|
|
|
/s/
Carmen Medina |
|
Director |
|
May
27, 2005 |
Carmen
Medina |
|
|
|
|