Research
and development costs
Research
and development expenses are the costs incurred in the process of our pre-clinical
research and/or our clinical trials. Clinical trial and pre-clinical expenses
include regulatory consultant compensation and fees, research expenses, purchase
of plasma, the cost of manufacturing IgG and payments to clinical research
organizations and to medical centers for patient recruitment and treatment.
During
the nine months ended June 30, 2008 and 2007, research and development expenses
included, among others, the cost of IgG used in the clinical trials and research
work, payments to medical centers and research labs for clinical trial and
pre-clinical trial work, regulatory and scientific consultants compensation,
costs related to the maintenance of our registered patents, costs related
to the filings of patent applications as well as salaries and related expenses
of research and development staff.
During
the nine months ended June 30, 2008, research and development expenses totaled
$1,350,956, compared to $762,778 for the nine months ended June 30, 2007.
The increase is attributable to assay development as well as pre-clinical
work related to the filing of the IND for VitiGam and collection of
plasma from donors.
General
and administrative expenses
General
and administrative expense includes the salaries and related expenses of
our management, consulting costs, legal and professional fees, traveling,
business development costs, insurance expenses and other general costs.
For
the nine months ended June 30, 2008, general and administrative expenses
totaled $1,979,379 compared to $2,902,678 for the nine months ended June
30, 2007. Costs incurred related to general and administrative activities
in the nine months ended June 30, 2008 reflect a decrease of $683,000 in
salary and related expenses due to lower stock based compensation expense
and a reduction of headcount, a decrease of $237,000 in stock based compensation
expenses for consultants, a decrease of $43,000 in public and investor relations
and a decrease of $35,000 in business development, offset by an increase
in professional and legal fees and an increase in general expenses such as
office rent and maintenance expenses and communication and IT expenses.
Financial
income/expense, net
During
the nine months ended June 30, 2008 and 2007, we generated interest income
on available cash and cash equivalents balance as well as bank charges.
Comparison
of the year ended September 30, 2007 and 2006
The
following table summarizes certain statement of operations data for the Company
for the year ended September 30, 2007 and 2006 (in US$):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
Operating Data:
|
|
September 30,
2007
|
|
September 30,
2006
|
|
|
|
|
|
|
|
Research and development costs
|
|
|
$
|
1,198,004
|
|
|
|
$
|
802,254
|
|
|
General and administrative expenses
|
|
|
|
4,090,163
|
|
|
|
|
1,263,070
|
|
|
Financial income, net
|
|
|
|
(110,771
|
)
|
|
|
|
(29,151
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before tax on income
|
|
|
|
5,177,396
|
|
|
|
|
2,036,173
|
|
|
Taxes on income
|
|
|
|
1,378
|
|
|
|
|
28,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period
|
|
|
$
|
(5,178,774
|
)
|
|
|
$
|
(2,064,795
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share basic and
diluted
|
|
|
$
|
(0.14
|
)
|
|
|
$
|
(0.07)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
|
38,043,043
|
|
|
|
|
28,052,065
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development costs
Research
and development expenses are the costs incurred in the process of our pre-clinical
and our clinical trials. Clinical trial and pre-clinical expenses include
regulatory consultant compensation and fees, research expenses, purchase
of plasma, the cost of manufacturing IgG and payments to medical centers
for patient recruitment and treatment.
During
the year ended September 30, 2007 and September 30, 2006, the research and
development expenses included, among others, the cost of IgG used in the
clinical trials and research work, payments to medical centers and research
labs for clinical trial and pre-clinical trial work, regulatory and scientific
consultant compensation, costs related to the maintenance of our registered
patents, costs related to the filings of patent applications as well as salaries
and related expenses of research and development staff.
During
the year ended September 30, 2007, the research and development expenses
totaled $1,198,004 compared to $802,254 during the year ended September 30,
2006. The increase is related to the pre-clinical, assay development and
regulatory work in preparation for the VitiGam FDA clinical trial as
well as stock-based compensation expenses. The research and development costs
include stock based compensation costs, which during the year ended September
30, 2007 totaled $166,147 as compared to $33,440 during the year ended September
30, 2006. This increase is attributable to the implementation of FAS123R
since October 1, 2006.
General
and administrative expenses
The
general and administrative expense includes the salaries and related expenses
of our management, consulting costs, legal and professional fees, travel
costs, business development costs, insurance expenses and other general costs.
For
the year ended September 30, 2007, general and administrative expenses totaled
$4,090,163 compared to $1,263,070 for the year ended September 30, 2006.
Costs incurred for general and administrative activities in the year ended
September 30, 2007 reflect an increase in the number of employees as compared
to the year ended September 30, 2006, from five to eight as well as additional
professional, legal and consulting expenses and an increase in general expenses
such as office and maintenance expenses. During the year ended September
30, 2007, as part of the general and administrative expenses, we incurred
$1,580,963 of compensation expenses due to the implementation of FAS 123R
related to stock options granted to employees. During the year ended September
30, 2006, we accounted for employee stock based compensation in accordance
with APB 25 and incurred $163,517 of costs. Additional costs in the year
ended September 30, 2007 included $474,087 related to the fair value of options,
warrants and shares issued to consultants during the period, with no similar
costs being incurred in the year ended September 30, 2006.
Financial
income/expense, net
During
the year ended September 30, 2007 and 2006, we generated interest income
on available cash and cash equivalents balance as well as bank charges. During
the year ended September 30, 2007, we incurred financial expenses related
to a convertible promissory note, issued on November 20, 2006, in the total
amount of $13,501.
26
Liquidity
and Capital Resources
Through
June 30, 2008, we incurred losses in an aggregate amount of $12,265,847.
We have financed our operations from the private placements of equity and
debt financings. Through June 30, 2008, we raised a total of $9,538,553,
net of transaction costs, through private placements of equity. We anticipate
that additional financing will be through similar sources. As of June 30,
2008, we had $861,531 available in cash, most of which is deposited in short
term, interest bearing, bank deposits. To implement our business plan, as
currently contemplated,
we anticipate we will need approximately $2 million for the remainder of
our fiscal year, and approximately $9 million for the twelve months following
July 1, 2008.
Although
we do not have material financing commitments, management is engaged in ongoing
financing discussions with third party investors and existing shareholders
to raise the necessary funds for future research and development activities
and general and administrative expenses in the public and private equity
markets. Although there is no assurance that we will be successful with these
initiatives, management expects to secure the necessary financing as a result
of the above ongoing discussions.
Off-Balance
Sheet Arrangements
We
have no off-balance sheet arrangements.
Planned
Expenditures
The
estimated expenses referenced herein are in accordance with our business
plan. As our technology is still in the development stage, it can be expected
that there will be changes in some budgetary items. Our planned expenditures
for the twelve months following July 1, 2008 are as follows:
Category
|
|
Amount
|
|
|
|
|
|
Research & Development
|
|
$
|
6,318,000
|
|
General & Administrative
Expenses
|
|
|
2,865,000
|
|
Finance
Income, net
|
|
|
(75,000
|
)
|
|
|
|
|
|
Total
|
|
$
|
9,108,000
|
|
|
|
|
|
|
As
previously indicated, we are planning to file an IND with the FDA for VitiGam
TM
.
Our ability to proceed with this IND application as well as the commencement
of the related clinical trial is dependent on several major factors including
the ability to attract sufficient financing on terms acceptable to us.
27
BUSINESS
General
We are a life science company focused on the development of immunotherapy and related approaches to treat cancer. To date, we have focused on the use of intravenous immunoglobulins, or
IgGs
, derived from human plasma to treat melanoma, and other cancers. We believe that IgGs may be the basis for safer, more effective and efficient cancer treatment as a mono-therapy, a combination therapy
and as an adjuvant therapy. Our business objective is to become a recognized leader in the development of immunotherapy and related approaches to treat cancer.
IgG-based Technology
: Based on our research, IgG-derived from human plasma has anti-cancer properties. These properties appear to be the result of the
immunomodulatory effects of IgGs, as well as the direct effects of certain antibody populations present in IgG fractions. We have demonstrated a reduction in metastatic lesions and an improved survival rate in mice injected with human sarcoma or
human melanoma cells when the animals were treated with IgGs. There is also clinical evidence suggesting that IgG-based therapy is efficacious in human cancers, including melanoma. Also, IgGs have been found to dramatically reduce the white blood
cell count in chronic lymphocytic leukemia.
In addition, we recognize that IgG-based therapies possess the following unique advantages as a result of more than thirty years of clinical experience and manufacturing know-how pertaining to the
treatment of immune deficiencies and autoimmune diseases:
Superior product safety
-
IgGs are
safe
and
non-toxic
;
and
Minimal manufacturing risk
the manufacturing process for IgGs is well established and optimized due to the numerous products
that have been developed from human plasma to date.
As a result, we are pursuing the development of IgG-based technology to develop therapies for the treatment of melanoma, as well as therapies directed toward disrupting the blood supply to cancers,
referred to as anti-angiogenesis.
Melanoma
:
The
incidence of melanoma, despite new developments in other cancers, continues
to increase with little or no therapeutic progress in the last ten years. Our
lead product candidate, VitiGam, is a first-in-class anti-cancer immunotherapy derived entirely from the plasma of donors with vitiligo, a benign autoimmune skin condition affecting up to two
percent of the general population. We have demonstrated that plasma from individuals with vitiligo contains anti-melanoma activities. Based on this, we are developing VitiGam to
initially address Stage III and Stage IV melanoma and possibly earlier stages
of melanoma at a future time.
28
In June 2007,
we completed a non-FDA Phase II clinical trial designed to test the safety
and efficacy of standard IgG (collected and manufactured from general
population donors, which may have included donors with vitiligo) in patients
with prostate cancer, colon cancer and melanoma. In this trial, no serious
untoward effects of IgGs were noted. In one patient with melanoma, the cancer
remained stable or improved over eight cycles of therapy (approximately ten
months).
In addition
to the pre-clinical evidence we have accumulated using vitiligo-derived plasma,
the above observations provide further validation for our plan to develop VitiGam.
We plan to file an Investigational New Drug Application, or
IND
,
for VitiGam in the near future. We believe that the FDA is well
acquainted with IgG-based therapies and their safety profiles resulting from
a long history of regulatory approvals of IgG-based products.
In addition to VitiGam, we are also developing
the following:
Next
generation (recombinant) VitiGam
- VitiGam is currently manufactured as a mixture that largely consists of IgG molecules (antibodies of the IgG
type). We anticipate that within this mixture, only a subset of IgG molecules will be responsible for the biological activity of VitiGam. Next generation VitiGam will
be composed of
only the IgGs
required to exert the anti-melanoma effect
, thereby creating a more effective compound. Identifying the relevant IgGs may also permit cost reductions; and
Cancer
vaccines based on VitiGam
- An off-the-shelf cancer vaccine is considered a silver bullet in cancer therapy. We anticipate
that based on our evolving understanding of the specific IgG molecules responsible for the biological activity of VitiGam,
we may be in a position to identify the corresponding antigens that may be used
to develop melanoma cancer vaccines.
Anti-angiogenesis
:
We are developing additional novel IgG-based therapies for cancer and other diseases. These therapies are
based on the disruption of the blood supply to cells. Our scientists have shown that several mechanisms may be involved in mediating the anti-cancer effects of IgG-based immunotherapies. Angiogenesis is one of a number of well known pathways to
deprive cells from their blood supply.
In June 2007, we announced the discovery of proprietary IgG sub-fractions, in human plasma, which contain potent anti-angiogenic properties. These sub-fractions may be used for treatment of disorders
resulting from neovascularization (the formation of new blood vessels or angiogenesis).
We have established a pre-clinical development program to define and characterize these anti-angiogenic anti-cancer fractions and to test their biological activity in animal models. We believe that
successfully developed therapies derived from our
29
novel IgG sub-fractions have the potential to address multi-billion dollar markets. For example, Avastin
®
, also known as
Bevacizumab
, counteracts VEGF, a growth factor which stimulates neovascularization, and is used to treat colon and other cancers. Sales for Avastin
®
in
2007 were in excess of $2 billion.
Intellectual Property
:
We own a significant portfolio of patents and patent applications covering
our technologies and are aggressively protecting these technology developments
on a worldwide basis. In addition, in August 2007, VitiGam received Orphan
Drug Status in the U.S. for Stage IIB to Stage IV metastatic melanoma. We are
currently applying for Orphan Drug Designation in the European Union (
E.U.
)
and its member states. Orphan Drug Status is granted by the U.S. and European
regulatory authorities to promote the development of drugs for diseases affecting
less than 200,000 people and in the E.U. for diseases affecting less than 5
cases per 10,000 people. In the U.S., Orphan Drug Status provides market exclusivity
for a seven year period as well as other regulatory and income tax advantages.
In the E.U. Orphan Drug Designation, if granted, will provide us with market
exclusivity for ten years, certain fee reductions, protocol assistance (scientific
advice), and various other E.U. and member state-specific incentives.
In-licensing and Acquisitions
:
We are continuously evaluating in-licensing and/or acquisition opportunities to broaden our
product portfolio and technology base.
Management
:
We
are led by a highly-experienced management team knowledgeable in immunotherapy
for the treatment of cancer. Our management team has access to our internationally
recognized Scientific Advisory Board whose members are thought-leaders in their
respective areas. Our subsidiarys Chief Scientist, Professor Yehuda Shoenfeld,
M.D., FRCP, is a world-recognized immunologist and the innovator primarily
responsible for much of our IgG-based technology development and knowhow.
Corporate History
We were incorporated
under the laws of the state of Delaware on October 6, 1998 under the name of
San Jose International, Inc. We engaged in several business models and acquisition
plans, until in June 2004, approximately 27% of our then outstanding shares
of common stock was acquired by Zeev Bronfeld and Vered Caplan in a private
transaction. Shortly thereafter, on August 14, 2004 we raised approximately $900,000
in a private placement, and, pursuant to an agreement for the purchase and
sale of intellectual property between our newly formed Israeli subsidiary,
GammaCan, Ltd., and ARP Biomed, Ltd. (
ARP
), our
subsidiary completed the purchase and sale of ARPs intellectual property on August 17, 2004 in consideration for the issuance to ARP of 12.5% of the outstanding shares of our subsidiary. As a result, we became the owner of 87.5% of our
subsidiary which in turn owns all of the aforementioned intellectual property consisting of IgG research and development, patents and other intellectual property. At the same time, we also made a loan of $800,000
from the proceeds of the
30
private placement to the subsidiary to finance its new business. On August 19, 2004, we changed our name to GammaCan International, Inc.
On
August 13, 2008, ARP sold to us 12.5% of the issued and outstanding shares
of our subsidiary such that we now own 100% of the outstanding shares of our
subsidiary. In consideration for such sale, we issued to ARP 3,389,902 shares
of our common stock. In connection with the sale, our subsidiary entered into
an amendment of the agreement for the purchase and sale of intellectual property
from ARP, which amendment specifically delineates clarity of title and related
issues to certain intellectual property sold under the original agreement.
The securities issued to ARP are also subject to a separate lock up agreement
and registration rights agreement.
Background
Current Approaches to Cancer Therapy
Cancer is a malignant condition which starts in a cell of a specific organ in the body. If left untreated, the cancer will grow in size, affect the organ, and ultimately spread (metastasize) to other
organs throughout the body where it will also grow and affect the vital function of the organs to which it has spread. Malignant cancers are ultimately terminal because they affect vital organ function. The rate at which these events occur depends
on the natural course of the specific cancer, host factors such as the general health of the patient, his or her age, the ability of his or her immune system to deal with the cancer, and other factors.
In general and whenever possible, primary cancers are surgically removed, particularly if the tumor has not spread beyond the site where it originated. In most cases excision will be curative if the
cancer has not spread (e.g. such is the case with early stage melanomas). For some cases, adjuvant chemo and/or radiation therapy may be indicated, even when the primary tumor does not appear to have spread elsewhere. Once the cancer has spread
beyond its primary site, a variety of therapeutic options are available depending on the location and extent of metastases and the natural history of the
31
cancer. Patient factors also play a role. Therapeutic options can be one or more of the following:
Further surgical removal;
Chemotherapy the
use of drugs designed to destroy cancer cells;
Radiotherapy the
use of radiation to kill the cancer. Radiation may be administered externally
(e. g. x-ray) or via a drug that targets the cancer (brachytherapy);
Hormonal
therapy Some cancers are hormone-sensitive (e. g. prostate and breast);
Immunotherapy the
use of drugs such as antibodies or cancer vaccines that attack the cancer immunologically;
and
Combinations of any of the above.
More recently, the use of antibodies plus chemotherapy has emerged as a promising approach to treat cancers.
Use of Immunotherapy in Cancer Treatment
Cancer develops
from a single abnormal cell. Most individuals immune systems recognize the cancer cell as a foreign invader and destroy it. Under certain conditions, however, when
the individuals immune system is inadequate or when the cancerous cell fools the
immune system into treating the cell as normal tissue, the cancerous cell will
multiply unchecked and over time cancer will develop. Because of the importance
of the immune system in protecting against cancer in the natural state, there
has been extensive research dedicated to enlisting immunological approaches to
treat cancer. These may be summarized as follows:
Immunoglobulin or Antibody-Based Treatments
Antibodies are plasma-derived proteins (also called immunoglobulins) that bind or interact with one specific (unique) target. The body synthesizes antibodies to destroy and eliminate any cell or
organism that bears (expresses) the target to which the immunoglobulin is specific. After the antibodies have bound to their targets, immune cells (B and T cells and macrophages) effect the destruction of the target cell and remove the debris.
Scientists
have harnessed the bodys tools and are now able to make antibodies against
virtually any target. Antibodies are manufactured outside the body, usually
in cell lines, in large manufacturing plants. These antibodies are generally
monoclonal - and may affect the cancer in a variety of ways:
32
|
|
|
A monoclonal antibody may attack the tumor
cell itself. An example of such a drug is Herceptin trastuzumab (it binds to
the HER-2 receptor which is over-expressed in cancerous breast tissue), used
in the treatment of certain patients with breast cancer;
|
|
|
|
|
|
|
|
The antibody may react against a substance
that is secreted by the tumor to enhance its own cancerous capabilities (for
example to stimulate the formation of new blood vessels). Avastin bevacizumab
(it targets VEGF, a growth factor that stimulates blood vessel formation or
angiogenesis), used to treat colon and other cancers, is an example of such
a drug;
|
|
|
|
|
|
|
|
The antibody may attack a target central
to the modulation of the immune system. Although there are no approved therapies
available for cancer, there are several products in late stage development
including anti-CTLA4 antibodies (Antegren natalizumab targets a receptor in
the Integrin family and is approved for the treatment of multiple sclerosis).
|
We are developing
immunoglobulin or antibody-based therapies. We use more than one antibody,
which we understand enhances our product vis-à-vis the others discussed
above. Moreover, we harvest IgG from human donors, which we think makes our
IgG-based therapy safer than others. Our donors are considered healthy and
are extensively screened for possible diseases or contaminants.
Immunoglobulins are also used in combination with chemotherapeutic drugs as an adjuvant therapy. We are active in developing this approach as well.
Cell-Based Therapies
There are two
basic approaches to this therapy. The first involves harvesting the patients own immune or other cells, manipulating them outside the body and then returning them to
the patient as an anti-cancer therapy. A second approach involves taking established immune
or other cells and giving them to a cancer patient. Clinical and commercial development
of cell-based therapies has been challenging and there are no commercial products
in the market at present.
Tumor Vaccinations
This is the
use of tumor extracts or other substances related to the tumor to induce the
patients immune system to act against the tumor. Such vaccines would work in a manner similar to any
other vaccine (e.g. rubella, varicella) except that the target is an internal invader, the cancer, rather than an external pathogen such as a virus. To date, only two cancer vaccines are commercially available (Melacine, sold by
GlaxoSmithKline in Canada to treat melanoma and Mercks Gardasil® human
papilloma virus vaccine to prevent cervical cancer)
.
We are also pursuing novel ways to leverage our
knowledge of the immune system, IgG biology, and the cellular immune response in order to develop cancer vaccines.
33
Immune Modulators
Small stretches of nucleic acids have been shown to be
immunostimulatory
.
These molecules affect the innate immune response by means of so called pattern recognition receptors.
Several therapies based on this concept are in clinical development.
Stage III and Stage IV Melanoma
Melanoma is
a serious skin cancer that originates from the transformation (e.g., conversion
from normal cells to cancerous cells) of melanocytes, the skins pigment
(melanin) producing cells. In 2002, the American Joint Committee on Cancer
(AJCC) published a revised staging system for melanoma comprising five different
stages of the degree of the disease (Stages 0 through IV).
Current therapies for melanoma, especially those available for the treatment of Stage III and Stage IV metastatic melanoma, are unsatisfactory. Chemotherapy, with or without the addition of biologics,
have improved survival only slightly, if at all, and the overall prognosis in these patients is poor. Interferon (IFN), interleukin-2 (IL-2) and dacarbazine are the most commonly prescribed therapeutics for the treatment of Stage III and Stage IV
melanoma. Their efficacy is moderate and these drugs are plagued by significant side effects. Newer therapies, including monoclonal antibodies and vaccines, are still in development stage. Accordingly, new approaches for the treatment of melanoma
are being actively pursued and metastatic melanoma remains a major unmet medical need.
According to the American Cancer Society (ACS):
-
there were 62,160 new cases of melanoma diagnosed in the U.S. during 2006; and
-
the incidence of melanoma in the U.S. has doubled since 1973 and has doubled around the world as well.
If recognized early, melanoma is curable by surgery alone. Most new cases are, in fact, cured surgically. For Stage 0, simple excision is 100% effective. For Stage I melanoma, surgery is also almost
100% effective.
Melanoma can be a particularly aggressive cancer. Although melanoma accounts for only 4% of all skin cancers, it accounts for 80% of all skin cancer deaths. Once the disease has spread, the prognosis
worsens dramatically. There have been no significant advances in improving the survival of patients with advanced melanoma (Stages II to IV) in the ten last years and limited success in improving their quality of life. We are committed to developing
better and safer immune-mediated approaches to treat melanoma and other cancers.
We believe that the U.S. melanoma market will continue to grow significantly in the next few years as a result of:
34
Market researchers estimate the number of melanoma cases will grow from 731,000 cases in 2004 to over 1,000,000 cases in 2010.
According to
Navigant Consulting, the worldwide melanoma market is expected to double from $265 million in 2004 to over $600 million in 2009. Experts estimate that it will exceed $1
billon in 2010. The U.S. accounts for close to 50% of the worldwide melanoma
market.
Intravenous Immunoglobulin (IgG)
Intravenous immunoglobulins are manufactured from human plasma. More than 12 million liters of source plasma are collected annually in the U.S. Virtually all this plasma is collected from paid donors.
The plasma industry has existed for more than 50 years and has developed substantial experience and know-how in methods to attract, recruit and retain donors. The industry recruits individuals to
donate plasma for the manufacture of standard plasma products as well as other individuals who agree to be immunized prior to the donation of plasma for the production of specific immunoglobulin preparations (e.g., rabies immune globulin, Rh immune
globulin, hepatitis B immune globulin, etc.). This also includes recruiting specific patients whose plasma contains commercially valuable constituents, particularly for use as control reagents in the diagnostic field and for research (e.g., patients
with anti-mitochondrial antibodies, patients with various hyperglobulinemic syndromes, etc.).
Plasma for manufacture into
plasma derivatives
is collected by
plasmapheresis
.
This is a process where the donor is connected to a machine for about 40 minutes.
The machine extracts plasma, and returns the bloods cellular components
to the donor automatically. Plasma collected by this approach is termed
source plasma
.
On average, about 800 to 850 mls of plasma are harvested per donation.
Donors may donate twice per week and are monitored with an FDA-mandated series
of tests with every donation which includes a plasma protein determination
and testing for transmissible diseases. There is substantial literature going
back more than 30 years indicating that regular plasmapheresis donors suffer
no ill effects from this activity.
35
Strategy
Our business objective is to become a recognized leader in the development of immunotherapy and related approaches to treat cancer. We intend to pursue our objective by implementing the following key
strategies:
Market Introduction of VitiGam Through Its Designation as an Orphan
Drug
In August of
2007, we received Orphan Drug Status by the FDA VitiGam for the treatment
of Stage IIB to Stage IV metastatic melanoma. Orphan Drug Status is granted
by the FDA to promote the development of drugs for diseases affecting fewer
than 200,000 people in the U.S. Orphan Drug Status provides us with the following:
-
seven year period of market exclusivity;
-
waiver of fees required for FDA filings and registrations; and
-
tax incentives for up to 50% of clinical development costs.
We are currently
also applying for Orphan Drug Designation for VitiGam for Stage IIB to
Stage IV metastatic melanoma in the E.U. and its member states. Similar to
the FDA, the European Medicines Agency (
EMEA
) grants Orphan
Drug Designation to promote the development of drugs for diseases with a prevalence
of fewer than 5 cases per 10,000 inhabitants. If granted, Orphan Drug Designation
would provide us with the following:
-
ten year period of market exclusivity;
-
fee reductions;
-
protocol assistance (scientific advice); and
-
European Community and member state specific incentives.
Leverage Our Capabilities in Order to Bring to Market Novel and Improved Cancer Therapy Products
We
intend to leverage our IgG-based technology, the expertise of our development
team and Professor Yehuda Shoenfeld, M.D., F.R.C.P., a world renowned immunologist.
36
Leverage Our Research and Development Efforts to Attract Collaborative Partners to Assist Us
We intend to utilize our research and development efforts to attract collaborative partners with expertise in, and resources necessary for, clinical trials and manufacturing. By entering into
collaborative arrangements, we anticipate that we will gain access to sales, marketing, and other resources to expedite commercialization of our product candidates.
Continue to Leverage Our Technology to Develop Additional Products
We intend to build upon our technology to develop the following:
Next
generation (recombinant) VitiGam
- VitiGam is currently manufactured as a mixture that largely consists of IgG molecules (antibodies of the IgG
type). We anticipate that within this mixture, only a subset of IgG molecules will be responsible for the biological activity of VitiGam. Next generation VitiGam will
be composed of
only the IgGs
required to exert the anti-melanoma effect
, thereby creating a more effective compound. Identifying the relevant IgGs may also permit cost reductions;
Cancer
vaccines based on VitiGam
- An off-the-shelf cancer vaccine is considered a silver bullet in cancer therapy. We anticipate
that based on our evolving understanding of the specific IgG molecules responsible for the biological activity of VitiGam,
we may be in a position to identify the corresponding antigens that may be used
to develop melanoma cancer vaccines; and
Anti-angiogenesis -
We are developing additional novel IgG-based therapies for cancer and other diseases. These therapies are based on the disruption of the
blood supply to cells. Our scientists have shown that several mechanisms may be involved in mediating the anti-cancer effects of IgG-based immunotherapies. Angiogenesis is one of a number of well known pathways to deprive cells of their blood
supply.
Research and Development Program
Foundational Research
Prior to our acquisition of ARP intellectual property by us, ARP scientists conducted extensive pre-clinical research to test the effectiveness of IgG immunotherapy in treating cancer. They have
employed mouse models of various types of cancers as well as various types of human cancers introduced into these mice. They have investigated the effectiveness of IgG treatment at various stages of disease progression, using alternative dosages and
routes of administration. These pre-clinical and preliminary experiments have shown that IgG treatment prevents metastases and tumor recurrence for a broad spectrum of cancers with few or no side effects.
37
Most pre-clinical experiments were conducted using a standard dosage of 2.0 grams per kilogram body weight. Additional experiments have shown that our proposed therapy is effective with low doses of
IgG representing 1% (20 milligrams per kilogram body weight) of the standard IgG dosage. These experiments suggest that IgG treatment could be affordably administered as a preventive measure. IgG has been shown in mice experiments to be effective
when administered subcutaneously, intravenously, or through intra-cavitary injection. The option of alternative routes of administration dramatically improves ease-of-use and enables the treatment of previously untreatable conditions such as
intra-peritoneal spread (i.e. ovarian carcinoma). IgG has also been shown to be effective when administered as a whole molecule or as a fraction.
Product Development
Our near term focus is to demonstrate efficacy of IgG-based cancer immunotherapy in human clinical trials. Efficacy is the ability of a drug or other treatments to produce the desired result when
taken by its intended users. If ultimately proven to be successful, and we can provide no assurance that it will be, we could be well-positioned to enter into a licensing agreement with one or more major pharmaceutical partners for late stage
clinical development and/or commercial market development and sales.
IgG immunotherapy
will require regulatory approval before being commercially marketed for human
therapeutic use. Clinical trials generally include three phases that together
may take several years to complete. Phase I clinical studies (toxicity trials)
are primarily conducted to establish the safety and determine the maximum tolerated
dose, or MTD. Phase II studies are designed to determine preliminary efficacy
and establish dosing. Phase III studies are conducted to demonstrate therapeutic
efficacy in a statistically significant manner at the levels of optimal dose,
method or route of delivery into the body, and the schedule of administration.
Once clinical trials are completed successfully, products may receive regulatory
approval. See
BusinessGovernment Regulation
.
We are pursuing the development of IgG-based technology to develop therapies for the treatment of melanoma, as well as therapies directed toward disrupting the blood supply to cancers, referred to as
anti-angiogenesis therapies.
Our lead product
candidate, VitiGam, is a first-in-class anti-cancer immunotherapy derived entirely from the plasma of donors with vitiligo, a benign autoimmune skin condition affecting up to
two percent of the general population. We have demonstrated that plasma from individuals with vitiligo contains anti-melanoma activities. Based on this, we are developing VitiGam to
initially address Stage III and Stage IV melanoma and possibly earlier stages
of melanoma at a future time.
In June 2007,
we completed a non-FDA Phase II clinical trial designed to test the safety
and efficacy of standard IgG (collected and manufactured from general
population donors, which may have included donors with vitiligo) in patients
with
38
prostate cancer, colon cancer and melanoma. In this trial, no serious untoward effects of IgGs were noted. In one patient with melanoma, the cancer remained stable or improved over eight cycles of therapy (approximately ten
months).
In addition
to the pre-clinical evidence we have accumulated using vitiligo-derived plasma,
the above observations provide further validation for our plan to develop VitiGam.
We plan to file an Investigational New Drug Application, or
IND
,
for VitiGam in the near future with the intent to conduct a Phase I/II
trial to evaluate VitiGam in patients with Stage III and IV melanoma. We
estimate that the costs of this Phase I/II will be substantial and the timing
of initiation of the Phase I/II trials will be based on several major factors,
including our ability to attract sufficient financing on acceptable terms.
We are developing additional novel IgG-based therapies for cancer and other diseases. These therapies are based on the disruption of the blood supply to cells. Our scientists have shown that several
mechanisms may be involved in mediating the anti-cancer effects of IgG-based immunotherapies. Angiogenesis is one of a number of well known pathways to deprive cells of their blood supply.
In June 2007, we announced the discovery of proprietary IgG sub-fractions which contain potent anti-angiogenic properties. These sub-fractions may be used for treatment of disorders resulting from
neovascularization (the formation of new blood vessels or angiogenesis).
We
have established a pre-clinical development program to define and characterize
these anti-angiogenic anti-cancer fractions and to test their biological activity
in animal models. We believe that successfully developed therapies derived
from our novel IgG sub-fractions have the potential to address multi-billion
dollar markets. For example, Avastin®, also known as
Bevacizumab
,
counteracts VEGF, a growth factor which stimulates neovascularization, and
is used to treat colon and other cancers. Sales for Avastin® in 2007 were
in excess of $2
billion.
We are also contemplating conducting additional clinical trials to test new formulations and/or combinations of IgG-based immunotherapies and to test these formulations and/or methods for different
cancers at different stages of disease progression with varying dosages and routes of administration. To achieve this, we may elect to partner with a pharmaceutical company to conduct these further clinical trials, in order to attain broad-based
regulatory approval.
We expect that it will take a number of years to receive final approval and registration of our IgG preparation for commercial use as an anti-cancer agent. Our strategy is to collaborate with a
suitable partner to support late stage (Phase III) clinical development, registration and/or sales for our IgG-based cancer products.
39
We have spent
approximately $2.7 million through September 30, 2007 on our research and
development.
Raw Materials
IgGs are manufactured
from human plasma. More than 12 million liters of source plasma are collected
annually in the U.S. Virtually all this plasma is collected from paid donors.
The U.S. supplies the majority of the plasma needed for the in excess of $6 billion plasma-derivatives market worldwide. The largest producers of IgG are CSL-Behring, a subsidiary of CSL LTD., Baxter Bioscience, a business of Baxter International Inc., and Talecris
Biotherapeutics, Inc. (formerly the plasma business of Bayer A.G.s Biological
Products business unit). In addition, there are numerous smaller suppliers serving
the market. We generally depend upon a limited number of suppliers for our IgGs.
Although alternative sources of supply for these materials are generally available,
we could incur significant costs and disruptions in changing suppliers. The termination
of our relationship with our suppliers or the failure of these suppliers to meet
our requirements for raw materials on a timely and cost-effective basis could
materially adversely affect our business, prospects, financial condition and
results of operations.
Patents and Licenses
To the best of our knowledge, we are the only entity to own issued patents covering the use of IgG-based therapies for the treatment of cancer. We have been issued two U.S. patents that cover the use
of basic IgG to treat cancers.
U.S.
Patent 5,562,902, Immunotherapeutic Method of Treating Cancerous Disease
by Administration of Intravenous Immunoglobulin
claims the use of
intravenous IgG or fragments to inhibit melanoma metastasis. The claims further recite the intracavitary and subcutaneous administration of intravenous IgG or fragments to inhibit tumor metastasis. The patent was issued on October 8, 1996.
U.S.
Patent 5,965,130, Immunotherapeutic Method of Treating Cancerous Disease
by Administration of Gamma Globulins
claims the use of 2g/kg
bodyweight/month to inhibit the growth of a primary tumor or metastases. The claims further recite the intracavitary and subcutaneous administration of intravenous IgG or fragments to inhibit tumor metastasis. The patent was issued on October 12,
1999.
In December
2006, we filed two Continuations in Part (
CIPs
) to these
patents. The first CIP is titled
Administration of Gamma Globulins
to Treat Metastatic Melanoma
and builds on the pre-clinical work conducted at GammaCan and substantiates these findings with data from our non-FDA clinical
trials. The second CIP is titled
Administration of Gamma Globulins to
Treat Cancer
and provides experimental data supporting the use of IgG-based therapy for colorectal cancers.
40
Consistent
with a strategy to seek protection in key markets worldwide, we have been issued
or are prosecuting international counterparts to our issued U.S. patents.
We have filed
two additional U.S. patent applications that cover both composition of matter and methods for using IgG manufactured from donors with Vitiligo (VitiGam)
and its use in melanoma. The prosecution of these and related patents is taking
place in the U.S. and worldwide.
We have also filed one additional U.S. patent application covering novel IgG sub-fractions with potent anti-angiogenic properties. In June 2007, we discovered that IgGs contain sub-fractions with
potent anti-angiogenic properties which may have application in disorders of neovascularization (the formation of new blood vessels), including cancer and other diseases. We anticipate that this discovery may be developed into broad-based cancer
therapies and other therapies that address non-cancer disorders.
We have also filed a patent application for the utilization of IgG therapy as a potential treatment of Avian Influenza.
Our patent strategy is as follows:
Aggressively protect all current and future
technological developments to assure strong and broad protection by filing
patents and/or continuations in part as appropriate;
Protect technological developments at various
levels, in a complementary manner, including the base technology, as well as
specific applications of the technology; and
Establish comprehensive coverage in the
U.S. and in all relevant foreign markets in anticipation of future commercialization
opportunities.
We believe that our success will depend in part on our ability to obtain patent protection for our intellectual property. Our patent coverage includes a wide range of matters including but not limited
to: a novel method of administering to a mammal a preparation of IgG for inhibiting tumor metastasis, for treating primary tumors, and for a broad spectrum of cancerous diseases. Our patents will both expire in November 2014.
We believe anyone selling IgG for treatment of cancer is subject to these patents. However, the validity and breadth of claims in medical technology patents involve complex legal and factual questions
and, therefore, may be highly uncertain. No assurance can be given that any patents based on pending patent applications or any future patent applications by us will be issued, that the scope of any patent protection will exclude competitors or
provide competitive advantages to us, that any of the patents that have been or may be issued to us will be held valid if subsequently challenged or that others will not claim rights in or ownership of the patents and other proprietary rights held
or licensed by us. Furthermore, there can be no assurance that others have not
41
developed or will not develop similar products, duplicate any of our technology or design around any patents that have been or may be issued to us. Since patent applications in the United States are maintained in secrecy for the
initial period of time following filing, we also cannot be certain that others did not first file applications for inventions covered by our pending patent applications, nor can we be certain that we will not infringe any patents that may be issued
to others on such applications.
We also rely
on trade secrets and unpatentable know-how that we seek to protect, in part,
by confidentiality agreements. Our policy is to require our employees, consultants,
contractors, manufacturers, outside scientific collaborators and sponsored
researchers, board of directors, technical review board and other advisors
to execute confidentiality agreements upon the commencement of employment or
consulting relationships with us. These agreements provide that all confidential
information developed or made known to the individual during the course of
the individuals relationship with us is to be kept confidential and not
disclosed to third parties except in specific limited circumstances. We also
require signed confidentiality or material transfer agreements from any company
that is to receive our confidential information. In the case of employees,
consultants and contractors, the agreements provide that all inventions conceived
by the individual while rendering services to us shall be assigned to us as
the exclusive property of our company. There can be no assurance, however,
that all persons who we desire to sign such agreements will sign, or if they
do, that these agreements will not be breached, that we would have adequate
remedies for any breach, or that our trade secrets or unpatentable know-how
will not otherwise become known or be independently developed by competitors.
Our success will also depend in part on our ability to commercialize our technology without infringing the proprietary rights of others. Although we have conducted freedom of use patent searches, no
assurance can be given that patents do not exist or could not be filed which would have an adverse affect on our ability to market our technology or maintain our competitive position with respect to our technology. If our technology components,
products, processes or other subject matter are claimed under other existing United States or foreign patents or are otherwise protected by third party proprietary rights, we may be subject to infringement actions. In such event, we may challenge
the validity of such patents or other proprietary rights or we may be required to obtain licenses from such companies in order to develop, manufacture or market our technology. There can be no assurances that we would be able to obtain such licenses
or that such licenses, if available, could be obtained on commercially reasonable terms. Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing our proposed technology
or the inability to proceed with the development, manufacture or sale of products requiring such licenses, which could have a material adverse effect on our business, financial condition and results of operations. If we are required to defend
ourselves against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether we are successful. Such proceedings are typically protracted with no certainty of
success. An adverse outcome could subject us to
42
significant liabilities to third parties and force us to curtail or cease our development and commercialization of our technology.
Partnerships and Collaborative Arrangements
We anticipate
that we will enter into strategic relationships for plasma collection and for
the manufacture of VitiGam. There is considerable specialized expertise
associated with the collection and manufacture (fractionation) of plasma products.
There are also significant expenses, capital expenditures and infrastructure
involved in the manufacture of plasma. We believe that working together with
strategic partners will expedite product formulation, production and approval.
In October
2006, we entered into a strategic agreement with Life Therapeutics, Inc. (
Life
) for the purpose of collecting source
plasma from individuals with Vitiligo. Under the agreement, Life will be responsible for the collection, storage, quality control, import/export, delivery, and supply of plasma to us in such amounts as required to complete Phase I and Phase II
clinical trials for VitiGam. Life is a U.S./Australian
43
company that specializes in niche therapeutic hyperimmune
products. Life currently operates 13 plasma collection centers in eight American
states and has considerable experience recruiting and collecting hard to find plasma
donors. Life is headquartered in Atlanta, Georgia and operates facilities in the U.S. and in Australia. In the event that Life, for any reason, fails to provide us with its total required plasma for the timely initiation and completion of
Phase I and Phase II clinical testing for VitiGam, we will have the unrestricted right to acquire plasma from other sources. We recognize the importance of having access to sufficient plasma for the clinical development of VitiGam as
well as for commercial sale. Life and GammaCan have been approved for a $1 million dollar grant for VitiGams Phase
I and Phase II clinical program by the BIRD Foundation, an Israeli Government
non-profit organization that promotes U.S./Israeli joint programs.
On September
6, 2007, we entered into an agreement for the purchase and sale of blood plasma
with DCI Management Group, LLC (
DCI
). Under the terms of the agreement, DCI will collect plasma from vitiligo donors at DCI operated FDA-approved, IQPP certified donor centers for the manufacture of VitiGam. The entry into this agreement is part of our
revised strategy to assure a continued and uninterrupted supply of Vitiligo plasma for the clinical development and long-term commercial sale of VitiGam as we gear up to submit an Investigational New Drug Application (IND) for VitiGam.
We have engaged INC Research to assist us in conducting our clinical trials. INC Research is a therapeutically focused contract research organization engaged in conducting global Phase I - Phase IV
clinical development programs in therapeutic areas including oncology. INC Research is headquartered in Raleigh, North Carolina and has 24 offices with a presence in 36 locations worldwide.
We have also
engaged BioSolutions Services, LLC (
BioSolutions
) for various projects to assist us with the commercialization of
our anti-cancer immunotherapy to treat metastatic cancer. The first project relates to regulatory consulting services to be provided by BioSolutions in connection with the application for an IND with the FDA for VitiGam.
On
March 27, 2008, our Subsidiary sent a notice of termination, effective March
31, 2008, to Tel HaShomer-Medical
Research Infrastructure and Services LTD. (
THM
) terminating the
Research and Licensing Agreement originally entered into on December 13,
2005, as amended during the term (the
THM
Agreement
). Under the THM Agreement,
the Subsidiary commissioned THM to conduct certain IgG related research activities
in return for which THM was entitled to research fees, royalties and warrants.
With the termination of the THM Agreement, the warrants previously granted
were cancelled.
Termination
by the Subsidiary of the THM Agreement was based, in addition to other considerations,
on our decision to increase the speed and efficiency at which third party
research is conducted by shifting research activities from a university-driven
model to a primarily contract research organization and otherwise commercially-driven
model. We have already transitioned the majority of our research activities
to contract research organizations. In addition, we are also evaluating whether
to establish our own research facility to expedite research activities.
Most recently, on May 30, 2008, we entered into a Contract Manufacture Agreement with Bio Products Laboratory (
BPL
) engaging BPL as our manufacturer of VitiGam from plasma derived from Vitiligo donors. BPL is a division of National Health Service Blood and Transplant, a unit of the United Kingdom National Health Service and is a leading
manufacturer of plasma-based products distributed worldwide. The agreement further provides that BPL will manufacture VitiGam utilizing its proprietary GAMMAPLEX process and will supply us with VitiGam for
our immediate clinical testing needs and for future commercial sale. In addition,
the agreement provides that BPL will make available to us technical, scientific
and other data, including specific support for our U.S. regulatory filings and
future regulatory approvals in other markets. Under the terms of the agreement,
we agreed to pay to BPL certain manufacturing and service fees as well as royalties
for the manufacture of VitiGam.
Government Regulation
The Drug and Therapeutic Product Development Process
The FDA requires that pharmaceutical and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or introduction to the general
public. Clinical testing, known as
clinical trials
or
clinical studies
, is either conducted internally by life science,
pharmaceutical, or biotechnology companies or is conducted on behalf of these companies by contract research organizations.
44
The process of conducting clinical studies is highly regulated by the FDA, as well as by other governmental and professional bodies. Below we describe the principal framework in which clinical studies
are conducted, as well as describe a number of the parties involved in these studies.
Protocols.
Before commencing human clinical studies, the sponsor of a new drug or therapeutic product must submit an investigational new drug application, or IND, to
the FDA. The application contains what is known in the industry as a
protocol
. A protocol is the blueprint for each drug study. The protocol sets forth, among other things, the following:
-
who must be recruited as qualified participants;
-
how often to administer the drug or product;
-
what tests to perform on the participants; and
-
what dosage of the drug or amount of the product to give to the participants.
Institutional Review Board
.
An institutional review board is an independent committee of professionals
and lay persons which reviews clinical research studies involving human beings
and is required to adhere to guidelines issued by the FDA. The institutional
review board does not report to the FDA, but its records are audited by the
FDA. Its members are not appointed by the FDA. All clinical studies must be
approved by an institutional review board. The institutional review boards
role is to protect the rights of the participants in the clinical studies.
It approves the protocols to be used, the advertisements which the company
or contract research organization conducting the study proposes to use to recruit
participants, and the form of consent which the participants will be required
to sign prior to their participation in the clinical studies.
Clinical Trials
. Human clinical studies or testing of a potential product are generally done in three stages known as Phase I through Phase III testing. The names of
the phases are derived from the regulations of the FDA. Generally, there are multiple studies conducted in each phase.
Phase I
.
Phase I studies involve testing a drug or product on a limited number of healthy
participants, typically 24 to 100 people at a time. Phase I studies determine
a products basic safety and how the product is absorbed by, and eliminated
from, the body. This phase lasts an average of six months to a year;
Phase II
. Phase II trials involve testing up to 200 participants at a time who may suffer from the targeted disease or condition. Phase II testing typically lasts
an average of one to two years. In Phase II, the drug is tested to determine its safety and effectiveness for treating a specific illness or condition. Phase II testing also involves determining acceptable dosage levels of the drug. If Phase II
studies show that a new drug has an acceptable range of safety risks and probable effectiveness, a company
45
will continue to review the substance in Phase III studies.
Phase III
. Phase III studies involve testing large numbers of participants, typically several hundred to several thousand persons. The purpose is to verify
effectiveness and long-term safety on a large scale. These studies generally last two to three years. Phase III studies are conducted at multiple locations or sites. Like the other phases, Phase III requires the site to keep detailed records of
data collected and procedures performed.
New Drug Approval.
The
results of the clinical trials are submitted to the FDA as part of a new drug
application (
NDA
). Following the completion of Phase III studies, assuming the sponsor of a potential product in the United States believes it has sufficient information to support the safety and effectiveness of
its product, it submits an NDA to the FDA requesting that the product be approved for marketing. The application is a comprehensive, multi-volume filing that includes the results of all clinical studies, information about the drugs
composition, and the sponsors plans for producing, packaging and labeling the product. The FDAs
review of an application can take a few months to many years, with the average
review lasting 18 months. Once approved, drugs and other products may be marketed
in the United States, subject to any conditions imposed by the FDA.
Phase IV
. The FDA may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as Phase IV studies,
is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness. In recent years, the FDA has increased its reliance on these trials. Phase IV studies usually involve thousands of participants. Phase IV
studies also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug. For example, large-scale trials may also be used to prove effectiveness and safety of new forms of drug delivery for approved
drugs. Examples may be using an inhalation spray versus taking tablets or a sustained-release form of medication versus capsules taken multiple times per day.
Biologics License Application.
Once
clinical trials are completed and the results tabulated and analyzed, a Biologics
License Application (
BLA
) is submitted to the FDA. The application presents to FDA reviewers the entire history or the whole story of the drug product including animal studies/human studies, manufacturing, and
labeling/medical claims. Before the FDA applies its scientific technical expertise to the review of the application, it will decide if the application gets a priority review or a standard review.
This classification determines the review timeframe. A priority review is for
a drug that appears to represent an advance over available therapy, whereas,
a standard review is for a drug that appears to have therapeutic qualities similar
to those of an already marketed product. Generally, an advisory committee (the
Oncology Drug Advisory Committee, ODAC) will review the BLA and make a recommendation
to the FDA. This outside advice is sought so that the FDA will have the benefit
of wider expert input. The FDA usually agrees with advisory committee decisions
but they are not binding.
46
The FDA takes action on the BLA after their review is complete. There are three possible actions to be taken by the review team:
Approved This indicates to a company
that it may now market in the U. S. ;
Not Approved This tells a company
that the product may not be marketed in the U. S. and is accompanied by a detailed
explanation as to why; or
Approvable This indicates that the
FDA is prepared to approve the application upon the satisfaction of certain
conditions. These drug products may not be legally marketed until the deficiencies
have been satisfied, as well as any other requirements that may be imposed
by the FDA.
The drug approval process is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the illness in question, the availability
of alternative treatments, and the risks and benefits demonstrated in the clinical trials.
Orphan Drug Act.
The
Orphan Drug Act provides incentives to develop and market drugs (
Orphan Drugs
) for rare disease conditions in the United States. A drug that receives Orphan Drug designation and is the first product to receive FDA marketing approval for its product claim is entitled to a seven-year exclusive marketing
period in the United States for that product claim. A drug which is considered by the FDA to be different than such FDA-approved Orphan Drug is not barred from sale in the United States during such exclusive marketing period even if it receives
approval for the same claim. We can provide no assurance that the Orphan Drug Acts
provisions will be the same at the time of the approval, if any, of our products.
Orphan Drug Designation.
The E.U. offers a range of incentives to encourage the development of orphan drugs for rare disease conditions in the E.U and its member
states. A drug that receives orphan drug designation and is the first product to receive EMEA marketing approval for its product claim is entitled to a ten-year exclusive marketing period in the E.U and its member states for that product claim. A
drug which is considered by the EMEA to be different than such EMEA-approved orphan drug is not barred from sale in the E.U and its member states during such exclusive marketing period even if it receives approval for the same claim. We can provide
no assurance that the above provisions will be the same at the time of the approval, if any, of our products.
Other Regulations
Various federal and state laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement,
import, export, use, and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities. They
47
include, among others, the United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, and Resources
Conservation and Recovery Act, national restrictions on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation. The extent of governmental regulation which might result
from future legislation or administrative action cannot be accurately predicted.
Competition
Competition in General
Competition in the area of biomedical and pharmaceutical research and development is intense and significantly depends on scientific and technological factors. These factors include the availability
of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain governmental approval for testing, manufacturing and marketing. Our competitors include major
pharmaceutical, medical products, chemical and specialized biotechnology companies, many of which have financial, technical and marketing resources significantly greater than ours. In addition, many biotechnology companies have formed collaborations
with large, established companies to support research, development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other public and private research organizations are also
conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures. We are aware of certain other products manufactured or under development by competitors that are used for the
treatment of the diseases and health conditions that we have targeted for product development. We can provide no assurance that developments by others will not render our technology obsolete or noncompetitive, that we will be able to keep pace with
new technological developments or that our technology will be able to supplant established products and methodologies in the therapeutic areas that are targeted by us. The foregoing factors could have a material adverse effect on our business,
prospects, financial condition and results of operations. These companies, as well as academic institutions, governmental agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific
personnel and consultants.
Competition within our sector itself is increasing, so we will encounter competition from existing firms that offer competitive solutions in cancer treatment. These competitive companies could develop
products that are superior to, or have greater market acceptance, than the products being developed by us. We will have to compete against other biotechnology and pharmaceutical companies with greater market recognition and greater financial,
marketing and other resources.
Our competition will be determined in part by the potential indications for which our technology is developed and ultimately approved by regulatory authorities. In addition, the first product to reach
the market in a therapeutic or preventive area is often
48
at a significant competitive advantage relative to later entrants to the market. Accordingly, the relative speed with which we, or our potential corporate partners, can develop products, complete the clinical trials and approval
processes and supply commercial quantities of the products to the market are expected to be important competitive factors. Our competitive position will also depend on our ability to attract and retain qualified scientific and other personnel,
develop effective proprietary products, develop and implement production and marketing plans, obtain and maintain patent protection and secure adequate capital resources. We expect our technology, if approved for sale, to compete primarily on the
basis of product efficacy, safety, patient convenience, reliability, value and patent position.
Competition for VitiGam
We anticipate
VitiGam to be a competitive anti-melanoma drug because of its anticipated
efficacy and safety profile. Treatment options for Stage III and Stage IV melanoma
comprise three drugs from major drug classes as follows:
Antineoplastics Antineoplastics include
chemotherapeutics (alkylating agents, antimetabolites and antimitotic agents)
that are administered intravenously or orally. Generally speaking, they have
significant toxicity associated with severe side effects to the patient. Antineoplastics
are typically used to treat Stage IV melanoma.
Immunomodulators Substances that
suppress, stimulate or boost the immune system. These have some efficacy (10%
to 20%), with side effects that are moderate compared to antineoplastics.
Vaccines Preparations that aim at coaxing the patients
immune system to mount an immune response against the tumor.
Because of
the paucity of safe and effective therapies to treat late stage melanomas,
so called off-label use of drugs is common and physicians typically
use antineoplastics approved for other cancers in treating melanoma.
Antineoplastics and immunomodulators account for 80% of the treatment for Stage III and Stage IV melanoma. Interferon (IFN), interleukin-2 (IL-2) and dacarbazine are the most commonly prescribed
therapeutics in these categories.
Schering Corporations INTRON® A
(Interferon alfa-2b, recombinant) dominates the melanoma market with a 46%
market share;
Chirons PROLEUKIN® (aldesleukin,
recombinant human interleukin-2, rhIL-2) commands approximately 28% of the
total melanoma market; and
Bayers DITCDOME (dacarbazine,
alkylating agent) accounts for 9%.
49
The majority of the remaining 17% of the market is comprised of a group of antineoplastics that are sold by Bristol Myers Squibb, Daiichi, Eli Lilly, and Roche. GlaxoSmithKline is currently the only
company selling a melanoma vaccine.
Scientific Advisory Board
We maintain a scientific advisory board consisting of internationally recognized scientists who advise us on scientific and technical aspects of our business. The scientific advisory board meets
periodically to review specific projects and to assess the value of new technologies and developments to us. In addition, individual members of the scientific advisory board meet with us periodically to provide advice in particular areas of
expertise. The scientific advisory board consists of the following members, information with respect to whom is set forth below: David Sidransky; Richard Spritz, M.D.; Yoseff Yarden M.D., Ph D.; Lynn M. Schuchter M.D.; and Pearl E. Grimes M.D.
David Sidransky, M.D.
Dr.
Sidransky is the Director of the Head and Neck Cancer Research Division at
Johns Hopkins University School of Medicine. In addition, he is Professor of
Oncology, Otolaryngology-Head and Neck Surgery, Cellular & Molecular Medicine,
Urology, Genetics, and Pathology at Johns Hopkins University and Hospital.
Dr. Sidransky is certified in Internal Medicine and Medical Oncology by the
American Board of Medicine. He has served as a Director of Imclone since January
2004. He is a founder of several private biotechnology companies and has served
on the scientific advisory boards of many private and public companies including
MedImmune, Telik, Roche and Amgen. He was formerly on the Board of Scientific
Counselors at the NIDCR and is currently a member of the Recombinant DNA Advisory
Committee at the National Institute of Health (NIH). Dr. Sidransky is a member
of numerous editorial boards. He has over 250 peer-reviewed publications, has
contributed more than 40 cancer reviews, and also has numerous issued biotechnology
patents. He has been the recipient of many awards and honors, including the
1997 Sarstedt International Prize from the German Society of Clinical Chemistry,
the 1998 Alton Ochsner Award Relating To Smoking and Health by the American
College of Chest Physicians, and the 2004 Hinda and Richard Rosenthal Award
from the American Association of Cancer Research.
Richard Spritz, M.D.
Dr. Spritz is the Director Human Medical Genetics Program and Professor of Pediatrics, Biochemistry and Molecular Genetics at the University of
Colorado Health Science Center. Prior to his tenure at the University of Colorado, Dr. Spritz served as Professor of Medical Genetics and Pediatrics at the University of Wisconsin. Among his numerous accomplishments, Dr. Spritz sits on the Medical
Advisory Board of Vitiligo Support International, is a member of the Council of the PanAmerican Pigment Cell Society, and has chaired a number of NIH Committees. He has for many years served on various national research advisory committees and for
the March of Dimes Birth Defects Foundation. He has published over 170 peer-reviewed papers and receives ongoing research support from the NIH, specifically for studies of the genetics of human pigmentation and autoimmune disorders. Dr. Spritz holds
an M.D.
50
from Pennsylvania State University, was a Resident
in Pediatrics at the Childrens Hospital of Philadelphia, and was a Fellow
in Human Genetics at the Yale University School of Medicine. Dr. Spritz has
received many honors and awards, including the first Annual Research Award
from the Society for Pediatric Dermatology, the Vitiligo and Melanocyte Biology
Research Achievement Award from the American Skin Association, the Tanioku
Memorial Lectureship from the Japanese Society for Investigative Dermatology,
and the Alumni Fellow Medal from Pennsylvania State University.
Yoseff Yarden M.D., Ph D.
Dr.
Yarden is professor in the Department of Biological Regulation at the Weizmann
Institute of Science in Rehovot. He received his B.Sc. in Biology and Geology
(cum laude) at the Hebrew University in Jerusalem in 1979, and his Ph.D. at
the Weizmann Institute in 1985. Dr. Yardens research career has been
devoted to understanding the role of the EGFR family of growth-factor receptors
and EGF-like growth factors in human cancers. He has been involved in many
crucial developments in this field, including isolating the EGFR, isolating
several neuregulins, establishing the pivotal role of receptor dimerization
in transmembrane signaling, understanding the role of HER2 in signal transduction
and tumor development, and resolving the process of ligand-induced degradation
of oncogenic receptors.
Lynn M. Schuchter M.D.
Dr.
Schuchter is Director of the Abramson Cancer Center at the University of Pennsylvania
and is a world renowned hematologist and oncologist. Her published research
and focus of investigative clinical trial activity is melanoma and breast cancer.
Dr. Shuchters research has led to the development of leading-edge approaches
to melanoma therapy.
Pearl E. Grimes M.D.
Dr.
Grimes is nationally and internationally recognized for her work on pigmentary
disorders. She lectures worldwide on pigmentary disorders including Vitiligo,
Melasma, and post-inflammatory hyperpigmentation. Dr. Grimes is the past Assistant
Editor of the Journal of the American Academy of Dermatology, and has served
on the Editorial Board of the Journal of Clinical Dermatology, Practical Dermatology,
and Skin & Allergy News. Dr. Grimes is presently a contributing editor to Cosmetic Dermatology. As founder of The Vitiligo and Pigmentation Institute of Southern California and its ongoing research program, Dr.
Grimes mission is to provide cutting edge therapies to patients suffering
from Vitiligo and other pigmentary disorders. She has authored over 100 publications
and abstracts and is a member of: The American Academy of Dermatology; the American
Society of Dermatological Surgery; the American Dermatological Association; Society
of Investigative Dermatology; Dermatology Foundation; and the International Pigment
Cell Society. Dr. Grimes is a graduate of Washington University in St. Louis,
Missouri and completed her Dermatology Residency at Howard University Hospital
in Washington, D.C.
Employees
We have been successful in retaining the experienced personnel involved in our research and development program. In addition, we believe we have successfully recruited clinical/regulatory, quality
assurance and other personnel needed to advance
51
through clinical studies or have engaged the services
of experts in the field for these requirements. As of March 31, 2008, we employed
seven individuals and engaged the services of several consultants. Of our employees,
two were senior management, three were engaged in research and development
work, and the remaining in administration work.
Facilities
Our
principal executive offices are located in approximately 1337 square feet of
office space in Kiryat Ono, Israel. The lease commenced on August 10, 2006
and lasts for a period of 36 months. The aggregate annual base rental for this
space is $26,827. Since June 8, 2006, we leased a suite in New
York for the use of our CEO which expired on June 30, 2008. We are currently
in the process of seeking an alternative space. We believe that our existing
facilities are suitable and adequate to meet our current business requirements.
In the event that we should require additional or alternative facilities, we
believe that such facilities can be obtained on short notice at competitive
rates.
52
MARKET PRICE
FOR THE COMMON STOCK
Our
common stock is quoted on the OTC Bulletin Board (the
OTCBB
) under the symbol GCAN.OB. The
quarterly high and low reported sales prices for our common stock as quoted on
the OTCBB for the periods indicated are as follows:
|
|
|
|
|
|
|
|
|
|
High
|
|
Low
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, 2006
|
|
|
|
|
|
|
Three Months
Ended December 31, 2005
|
|
$1.75
|
|
$1.01
|
|
|
Three Months
Ended March 31, 2006
|
|
$1.72
|
|
$1.05
|
|
|
Three Months
Ended June 30, 2006
|
|
$1.69
|
|
$0.71
|
|
|
Three Months
Ended September 30, 2006
|
|
$1.20
|
|
$0.53
|
|
|
|
|
|
|
|
|
Year Ended September 30, 2007
|
|
|
|
|
|
|
Three Months
Ended December 31, 2006
|
|
$0.70
|
|
$0.35
|
|
|
Three Months
Ended March 31, 2007
|
|
$0.68
|
|
$0.37
|
|
|
Three Months Ended June 30, 2007
|
|
$0.70
|
|
$0.45
|
|
|
Three Months Ended September 30, 2007
|
|
$0.79
|
|
$0.40
|
|
|
|
|
|
|
|
|
Year Ending September 30, 2008
|
|
|
|
|
|
|
Three Months
Ended December 31, 2007
|
|
$0.56
|
|
$0.40
|
|
|
Three Months
Ended March 31, 2008
|
|
$0.45
|
|
$0.38
|
|
|
Three Months Ended June 30, 2008
|
|
$0.40
|
|
$0.18
|
|
|
Three Months Ending September 30, 2008
(through August 18, 2008)
|
|
$0.39
|
|
$0.22
|
|
The
foregoing quotations were provided by Yahoo finance and the quotations reflect
inter-dealer prices, without retail mark-up, mark-down or commission and may
not represent actual transactions.
The
last reported sale price per share of common stock as quoted on the OTCBB was
$0.27 on August 18, 2008. As of such date, we had 48,348,819 shares of
common stock outstanding. Based on information available from our registrar and
transfer agent, we estimate that we had approximately 31 stockholders of record
on August 18, 2008.
Securities Authorized for Issuance under
Equity Compensation Plans
The
following table summarizes securities authorized under equity compensation
plans:
Equity Compensation Plan Information
|
|
|
|
Plan Category
|
Number of securities to be
issued upon exercise of
outstanding options,
warrants and rights
|
Weight-average
exercise price of
outstanding options,
warrants and rights
|
Number of securities remaining
available for future issuance under
equity compensation plans
(excluding securities reflected in
column (a))
|
|
|
(a)
|
(b)
|
(c)
|
Equity
compensation plans approved by security holders
|
|
|
|
|
|
|
|
Equity
compensation plans not approved by security holders
|
6,585,000
|
0.55
|
3,415,000
|
|
|
|
|
Total
|
|
|
|
53
MANAGEMENT
Executive Officers, Directors, and Key
Employees
Set
forth below is certain information with respect to the individuals who are our
directors, executive officers and key employees.
|
|
|
|
|
|
|
|
Name
|
|
|
Age
|
|
|
Position
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven Katz
|
|
60
|
|
Chairman of the Board of Directors and President
|
|
Patrick Schnegelsberg
|
|
44
|
|
Chief Executive Officer
|
|
Albert Passner
(2)
|
|
69
|
|
Director of GammaCan International,
Inc.
|
|
David DeMedio
(1) (2)
|
|
36
|
|
Director of GammaCan International,
Inc.
|
|
Josef Neuhaus
(1)(2)
|
|
44
|
|
Director of GammaCan International,
Inc.
|
|
Limor Zur-Stoller
|
|
39
|
|
Chief Financial Officer, Treasurer
|
|
Prof. Yehuda Shoenfeld, M.D.
|
|
60
|
|
Chief Scientist of GammaCan, Ltd.
|
|
|
|
(1)
|
Member of the Audit Committee.
|
|
|
(2)
|
Member of the Compensation Committee.
|
Set
forth below is biographical information with respect to each of the
aforementioned individuals.
Mr. Steven Katz
has
served as our Chairman of the Board since November 2006 and since May 2007
has served as President. Mr. Katz has been, since 1982, President of Steven
Katz & Associates, Inc., a health care and technology-based management consulting firm specializing in strategic planning, corporate development, new product planning, technology licensing, and structuring and securing various forms of
financing. From January 2000 to October 2001, he was President and Chief Operating Officer of Senesco Technologies, Inc., an American Stock Exchange company engaged in the identification and development of proprietary gene technology with
application to human, animal and plant systems. He was a co-founder and Executive Vice President, from 1983 to 1984, of S.K.Y. Polymers, Inc., a biomaterials company. Prior thereto, Mr. Katz was Vice President and General Manager of a non-banking
division of Citicorp and from 1976 to 1981 held various senior management positions at National Patent Development Corporation, including President of three subsidiaries. He had been employed by Revlon, Inc. in 1975 and Price Waterhouse & Co.
from 1969 to 1974. Mr. Katz received a Bachelors of Business Administration degree
in Accounting from the City College of New York (CCNY) in 1969. He is presently
a member of the Board of Directors of several private companies and the following
publicly-held corporations: USA Technologies, Inc. (NASDAQ: USAT); NaturalNano,
Inc. (OTCBB: NNAN); and Health Systems Solutions, Inc. (OTCBB: HSSO).
Mr. Patrick Schnegelsberg
has
served as our Chief Executive Officer since April 2006. Prior to joining us
from April 2005 to April 2006, he served as Director of Investment Banking
for Global Capital Markets Group (GCMG), an independent investment bank known
internationally for advising on mergers and acquisitions and crafting innovative
financial and strategic solutions for clients globally, with offices in New
York and Sydney, Australia. Prior to GCMG Mr. Schnegelsberg served as Director
of Investment Banking at Rodman & Renshaw from March 2004 to April 2005. In this position, he led M&A and private transactions for a host of significant
companies in Life Sciences. Prior to entering investment banking, from March 2002 to March 2004, Mr. Schnegelsberg acted as a buy-side analyst and portfolio manager for Mehta Partners, a leading healthcare-focused hedge fund. He joined Mehta
Partners after having worked for several years in the consulting industry with tenures at Booz Allen Hamiltons New York healthcare practice and at Boston-based Global Prior Art, where he founded and fostered the growth of the Companys
Life Sciences practice and intellectual property practice. The client roster
included top tier pharmaceutical and biotechnology companies as well as some
of the top U.S. and EU IP law firms. Mr. Schnegelsberg graduated from Harvard
Medical School and performed his Ph.D. thesis research in the laboratory of Dr.
Rudolf Jaenisch at the Whitehead Institute/M.I.T. He published his first peer-reviewed
paper as an undergraduate and since then his work has been published in peer
reviewed journals including
Cell
and
Nature
.
54
Mr. David DeMedio
has
served as our director since October 2007. He currently serves as Chief Financial
Officer of USA Technologies, Inc. (NASDAQ: USAT), a provider of wireless networking,
cashless transactions, asset monitoring and energy management products, and
has held this position since April 2005. Since joining USA Technologies in
March 1999, Mr. DeMedio has held various positions including Vice President-Financial & Data
Services, interim Chief Financial Officer, Director of Network and Financial
Services, and Controller. Prior to joining USA Technologies, Mr. DeMedio was
employed by Elko, Fischer, Cunnane and Associates, LLC as a supervisor of its
accounting and auditing and consulting practice. Prior thereto, Mr. DeMedio
held various accounting positions with Intelligent Electronics, Inc. Mr. DeMedio
graduated with a Bachelor of Science in Business Administration from Shippensburg
University and is a Certified Public Accountant.
Mr. Josef Neuhaus
has served as our director since March 2006. Mr. Neuhaus has been an independent consultant since 2004 and brings extensive experience as a senior
executive in a number of companies. From August 2006 to February 2007, Mr. Neuhaus served as Chief Financial Officer, Treasurer and Secretary of Advanced Technology Acquisition Corp. (AMEX: AXC). Prior to that, between August 2005 and February 2006,
Mr. Neuhaus served as Chief Financial Officer of Axis Mobile Ltd. (LSE: AXIS.L). From March 2003 to November, 2003, he served as CEO of RoadEye FLR G.P. and Managing Director of Gintec Active Safety Ltd., both private companies dealing with
collision avoidance systems. During 2002, Mr. Neuhaus took a sabbatical year to complete an Executive M.B.A. From 2000 to 2001, Mr. Neuhaus was the CFO of PassCall Advanced Technologies LTD., a start-up dealing with wireless Internet. From 1998 to
2000 he was Acting Managing Director and CFO of ITA (International Tourist Attractions) Ltd. a private company initiating and building tourist attractions. From 1995 to 1998 he served as the CFO of ICTS International NV (NASDAQ: ICTS). Prior to
1995, Mr. Neuhaus was a senior auditor at Somekh Chaikin (KPMG in Israel). Mr. Neuhaus received both his M.B.A and B.A. in Accounting and Economics at the Tel Aviv University. He is an Israeli CPA. Mr. Neuhaus currently serves on the board of the
following publicly-held corporation: Global Energy, Inc. (OTCBB: GEYI).
Mr. Albert Passner
has
served as our director since November 2006. He has been for more than five
years a consultant in the fields of physics and engineering following an illustrious
career at Lucent/AT&T Bell Labs of more than thirty years. Among his many achievements with Lucent were: the development of ultra-low noise amplifiers used to measure transistor noise; the design of the worlds
most powerful pulsed electromagnet; the production of a positron plasma in
the laboratory; the
55
production of the first transverse laser in semi-conductor
thin film, and the demonstration that stellar images could be corrected in
real time using an electronically deformed mirror. Mr. Passner has authored
and co-authored more than fifty publications. Between August 2004 and December
2006, Mr. Passner served as director of Nanoscience Technologies, Inc. (OTCBB:
NANS) and between June 2006 and March 2007, Mr. Passner served as director
of USA Technologies, Inc. (NASDAQ: USAT). Prior to Lucent /AT&T Bell Labs,
Mr. Passner served as an engineer at RCA from 1961 to 1963 and a member of
the staff at the Princeton-Penn Accelerator in Princeton, N.J. from 1963 to
1969. He received a B.S. in Physics from the City College of New York in 1960
and an M.S. in Physics from New York University in 1966.
Ms. Limor Zur-Stoller
has served as our Chief Financial Officer since March 2008. Prior to joining us she served as RadView Software Ltd.s (OTCBB:
RDVWF) Vice President of Finance from August 2006 until March 2008, its Director of Finance from July 2004 until August 2006, and its Controller from November 2001 until July 2004. RadView develops and markets software for testing the performance,
scalability and reliability of internet applications. Ms. Zur-Stoller, also served as the International Controller at Check Point Software Technologies Ltd. from December 1997 until June 2001. Prior to this, Ms. Zur-Stoller was an auditor with the
accounting firm of Deloitte Brightman Almagor, a member of Deloitte Touche Tohmatsu, from June 1994 until December 1997. Ms. Zur-Stoller received a B.A. in Accounting and Economics from Tel Aviv University, and an M.B.A. in Finance and Accounting
from The College of Management in Israel. Ms. Zur-Stoller is an Israeli Certified Public Accountant.
Prof. Yehuda Shoenfeld, M.D.
FRCP.
has served as Chief Scientist of our subsidiary since August 2004. He is one
of Israels most prominent physicians and
scientists in the field of immunology. He heads the Department of Internal Medicine at Israels largest hospital, Sheba Medical Center at Tel HaShomer.
Professor Shoenfeld also heads the Research Center for Autoimmune Diseases at
Sheba Medical Center and is a Professor of Medicine in Tel Aviv University and
the incumbent of the Laura Schwartz-Kipp Chair for Autoimmunity. He is the author
of more than 1,000 scientific papers and more than 40 scientific books. Fifty
eight of his publications relate to intravenous IgG, of which seven focus on
intravenous IgG as a treatment for cancer. Prof. Shoenfeld also serves as editor
of several medical journals and as scientific consultant to a number of biotechnology
companies. He received the prestigious Carol Nachman Award for Rheumatology in
2004 for outstanding innovative research work and the EULAR (European Union Congress
of Rheumatology) Prize in 2005.
56
Board of Directors and Officers
Each
director is elected for a period of one year at our annual meeting of
stockholders and serves until the next such meeting and until his or her
successor is duly elected and qualified. Officers are elected by, and serve at
the discretion of, our board of directors. The board of directors may also
appoint additional directors up to the maximum number permitted under our
by-laws. A director so chosen or appointed will hold office until the next
annual meeting of stockholders.
Each
of our executive officers serves at the discretion of our board of directors
and holds office until his or her successor is elected or until his or her
earlier resignation or removal in accordance with our certificate of
incorporation and by-laws.
Meetings and Committees of the Board of
Directors
During
the year ended September 30, 2007, our board of directors held 10 meetings and
took actions by written consent on 26 occasions.
Committees of the Board of Directors
On
January 11, 2005, we established an Audit Committee and a Compensation
Committee, which is responsible, respectively, for the matters described
below.
Audit
Committee
The
Audit Committee is responsible for the following:
|
|
|
|
|
reviewing
the results of the audit engagement with the independent auditors;
|
|
|
|
|
|
identifying
irregularities in the management of our business, and suggesting an
appropriate course of action;
|
|
|
|
|
|
reviewing
the adequacy, scope, and results of the internal accounting controls and
procedures;
|
|
|
|
|
|
reviewing
the degree of independence of the auditors, as well as the nature and scope
of our relationship with our independent auditors;
|
|
|
|
|
|
reviewing
the auditors fees; and
|
|
|
|
|
|
recommending
the engagement of auditors to the full board of directors.
|
A
charter has been adopted to govern the Audit Committee. The Board has
determined that each of the members of the Audit Committee is an unrelated,
outside member with no other affiliation with us and is independent as defined
by the rules of the SEC. The Board has determined that Messrs. Josef Neuhaus and David DeMedio are audit committee financial experts as
defined by the SEC. The Audit Committee was formed on January 11, 2005.
Compensation
Committee
The
Compensation Committee determines the salaries and incentive compensation of
our officers and provide recommendations for the salaries and incentive
compensation of its other employees and consultants. The members of the
compensation committee are Albert Passner, Josef Neuhaus, and David DeMedio. The compensation of our
executive officers is generally determined by the compensation committee of the
board of directors, subject to applicable employment agreements. Our
compensation programs are intended to enable the attraction, motivation,
reward, and retention of the management talent required to achieve corporate
objectives and thereby increase stockholder value. Our policy has been to
provide incentives to our senior management to achieve both short-term and
long-term objectives and to reward exceptional performance and contributions to
the development of our business. To attain these objectives, the executive
compensation program may include a competitive base salary, cash incentive
bonuses, and stock-based compensation.
57
Relationship
of Compensation to Performance and Compensation of Executive Officers
The
compensation committee annually establishes, subject to the approval of our
board of directors and any applicable employment agreements, the salaries that
will be paid to our executive officers during the coming year. In setting
salaries, the compensation committee intends to take into account several
factors, including the following:
|
|
|
|
|
competitive
compensation data;
|
|
|
|
|
|
the extent
to which an individual may participate in the stock plans which may be
maintained by us; and
|
|
|
|
|
|
qualitative
factors bearing on an individuals experience, responsibilities, management
and leadership abilities, and job performance.
|
Code of Ethics
We
have adopted a Code of Ethics for our officers, directors and employees. A
copy of the Code of Ethics is located at our website at www.gammacan.com.
Part III
ITEM 10 - EXECUTIVE COMPENSATION
Summary Compensation Table
The
following table sets forth the compensation earned during the years ended
September 30, 2007 and 2006 by our President and Chairman of the Board, Chief
Executive Officer, our former Chief Financial Officer and former Vice President of
Corporate Development (the
Named Executive Officers
)
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name and
Principal
Position
|
|
Year
(1)
|
|
Salary
($)
|
|
Bonus
($)
(2)
|
|
Stock
Awards
($)
(3)
|
|
Option
Awards
($)
(4)
|
|
Non-Equity
Incentive
Plan
Compensation
($)
(5)
|
|
Nonqualified
Deferred
Compensation
($)
(6)
|
|
All Other
Compensation
($)
(7)
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven
Katz,
|
|
2007
|
|
466,070
(9)
|
|
Nil
|
|
Nil
|
|
119,450
|
|
Nil
|
|
Nil
|
|
Nil
|
|
585,520
|
|
President
and Chairman of Board
(8)
|
|
2006
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Patrick
Schnegelsberg,
|
|
2007
|
|
212,170
|
|
Nil
|
|
Nil
|
|
992,858
|
|
Nil
|
|
Nil
|
|
Nil
|
|
1,205,028
|
|
Chief
Executive Officer
(10)
|
|
2006
|
|
99,084
|
|
Nil
|
|
Nil
|
|
494,557
|
|
Nil
|
|
Nil
|
|
Nil
|
|
593,641
|
|
Vered
Caplan,
|
|
2007
|
|
82,113
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
29,727
|
|
111,841
|
|
Former
Vice President of Corporate Development
(11)
|
|
2006
|
|
82,113
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
29,496
|
|
111,609
|
|
Chaime
Orlev,
|
|
2007
|
|
94,055
|
|
Nil
|
|
Nil
|
|
121,662
|
|
Nil
|
|
Nil
|
|
25,568
|
|
241,285
|
|
Former
Chief Financial Officer
(12)
|
|
2006
|
|
74,868
|
|
Nil
|
|
Nil
|
|
174,887
|
|
Nil
|
|
Nil
|
|
21,175
|
|
270,930
|
|
|
|
|
|
|
(1)
|
The information is
provided for each fiscal year which begins on October 1 and ends on September
30.
|
|
|
(2)
|
No bonus awards were made
to the Named Executive Officers in the fiscal years ended September 30, 2007
and
|
|
2006.
|
|
|
(3)
|
No stock awards were
granted to the Named Executive Officers in the fiscal years ended September
30, 2007 and 2006.
|
|
|
(4)
|
The amounts reflect the
compensation expense in accordance with FAS 123(R) of these option awards.
The assumptions used to determine the fair value of the option awards for
fiscal years ended September 30, 2007 and 2006 are set forth in Note 8 of our
audited consolidated financial statements included in our Form 10-KSB for
fiscal year ended September, 2007. Our Named Executive Officers will not
realize the value of these awards in cash unless and until these awards are
exercised and the underlying shares subsequently sold.
|
|
|
(5)
|
We do not have a
non-equity incentive compensation plan.
|
|
|
(6)
|
We do not have a deferred
non-qualified compensation plan.
|
|
|
(7)
|
See
All Other Compensation Table below.
|
|
|
(8)
|
Mr.
Katz was appointed Chairman of the Board on November 6, 2006 and President
on May 22, 2007
|
|
|
(9)
|
Pursuant
to an agreement between the Company and Steven Katz & Associates, Inc. (
SKA
),
a company wholly-owned by Steven Katz, we pay SKA consulting fees for
consulting services provided. The amount includes $216,635 paid to SKA and
$249,435 accrued but not yet paid as of September 30, 2007.
|
|
|
(10)
|
Mr.
Schnegelsberg was appointed Chief Executive Officer on April 16, 2006 and
served as Chief Executive Officer of our subsidiary, GammaCan Ltd, from May
22, 2007.
|
|
|
(11)
|
Ms.
Caplan served as acting Chief Executive Officer from July 2, 2005 until April
15, 2006 and served as Chief Executive Officer of our subsidiary, GammaCan
Ltd, from July 2, 2005 until May 22, 2007. From May 22, 2007 until November
30, 2007, Ms. Caplan served as our Vice President of Corporate Development.
As of November 30, 2007 Ms. Caplan is no longer employed by the Company.
|
|
|
(12)
|
Mr.
Orlev was appointed Chief Financial Officer on October 6, 2005 and served in
such capacity until his resignation which took effect on February 29,
2008.
|
|
|
58
|
|
|
All Other Compensation Table
|
|
|
|
All
Other Compensation amounts in the Summary Compensation Table consist
of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
|
Year
|
|
|
Automobile
Related Expenses
($)
|
|
|
Managers
Insurance *
($)
|
|
|
Education
Fund*
($)
|
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vered
Caplan
|
|
|
2007
|
|
|
15,063
|
|
|
11,129
|
|
|
3,535
|
|
|
29,727
|
|
|
|
2006
|
|
|
15,225
|
|
|
11,129
|
|
|
3,142
|
|
|
29,496
|
|
Chaime
Orlev
|
|
|
2007
|
|
|
9,285
|
|
|
12,748
|
|
|
3,535
|
|
|
25,568
|
|
|
|
2006
|
|
|
7,886
|
|
|
10,147
|
|
|
3,142
|
|
|
21,175
|
|
|
|
|
|
|
*
|
Managers insurance and
education funds are customary benefits provided to employees based in Israel.
Managers insurance is a combination of severance savings (in accordance with
Israeli law), defined contribution tax-qualified pension savings and
disability insurance premiums. An Education fund is a savings fund of pre-tax
contributions to be used after a specified period of time for educational or
other permitted purposes.
|
|
|
59
|
|
Outstanding Equity Awards at Fiscal Year-End
|
|
The
following table sets forth information concerning stock options and stock
awards held by the Named Executive Officers as of September 30, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option
Awards
|
|
Stock
Awards
|
|
|
|
|
|
|
|
Name
|
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
|
Equity
Incentive
Plan
Awards
Number of
Securities
Underlying
Unexercised
Unearned
Options
(#)
|
|
Option
Exercise
Price
($)
|
|
Option
Expiration
Date
|
|
Number of
Shares or
Units of
Stock Held
That Have
Not Vested
(#)
|
|
Market
Value
of Shares or
Units of
Stock Held
That Have
Not Vested
($)
|
|
Equity
Incentive
Plan
Awards:
Number of
Unearned
Shares,
Units
or Other
Rights That
Have Not
Vested
(#)
|
|
Equity
Incentive
Plan
Awards:
Market or
Payout
Value of
Unearned
Shares,
Units or
Other Rights
That Have
Not
Vested
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven Katz,
President and
Chairman
|
|
Nil
|
|
|
150,000
|
(1)
|
|
Nil
|
|
$
|
0.45
|
|
11/06/16
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
|
Nil
|
|
|
1,150,000
|
(2)
|
|
Nil
|
|
$
|
0.53
|
|
02/25/17
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Patrick
Schnegelsberg
CEO
|
|
Nil
|
|
|
250,000
|
(3)
|
|
Nil
|
|
$
|
0.53
|
|
02/25/17
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
|
400,000
|
(4)
|
|
1,100,000
|
(4)
|
|
Nil
|
|
$
|
0.61
|
|
05/16/17
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Chaime Orlev,
Former CFO
|
|
Nil
|
|
|
300,000
|
(5)
|
|
Nil
|
|
$
|
0.53
|
|
02/25/17
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
|
150,000
|
(6)
|
|
150,000
|
(6)
|
|
Nil
|
|
$
|
0.61
|
|
05/16/17
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Vered Caplan
Former Vice
President of
Corporate
Development
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
Nil
|
|
|
Nil
|
|
Nil
|
|
Nil
|
|
Nil
|
|
|
|
|
|
|
(1)
|
On November 7, 2006, Mr.
Katz was granted options under the 2004 Stock Option Plan to purchase 150,000
shares of our common stock at an exercise price of $0.45 per share. These
options are exercisable with respect to 37,500 shares on November 7, 2007 and
the remaining in equal installments on the last day of each month for 36
months thereafter.
|
|
|
(2)
|
On February 26, 2007, Mr.
Katz was granted options under the 2007 Stock Option Plan to purchase
1,150,000 shares of our common stock at an exercise price of $0.53 per share,
one third of which vest on each of the first, second and third anniversaries
of the grant date.
|
|
|
(3)
|
On February 26, 2007, Mr.
Schnegelsberg was granted options under the 2007 Stock Option Plan to
purchase 250,000 shares of our common stock at an exercise price of $0.53,
one third of which vest on each of the first, second and third anniversaries
of the grant date.
|
|
|
(4)
|
On May 17, 2007, the grant
of options to Mr. Schnegelsberg under the 2004 Stock Option Plan to purchase
1,400,000 shares of our common stock at an exercise price of $1.29 per share
was cancelled. On the same day, Mr. Schnegelsberg was granted options under
the 2007 Stock Option Plan to purchase 1,500,000 shares of our common stock
at an exercise price of $0.61 per share. These options are exercisable with
respect to 400,000 on the grant date and the remaining 1,100,000 in two equal
installments on the first and second anniversary of the grant date.
|
|
|
(5)
|
On February 26, 2007, Mr.
Orlev was granted options to purchase 300,000 shares of our common stock at
an exercise price of $0.53, one third of which vest on each of the first,
second and third anniversaries of the grant date.
|
|
|
(6)
|
On May 17, 2007, the grant
of options to Mr. Orlev under the 2004 Stock Option Plan to purchase 350,000
shares of our common stock at an exercise price of $0.93 per share was
cancelled. On the same day, Mr. Orlev was granted options under the 2007
Stock Option Plan to purchase 300,000 shares of our common stock at an
exercise price of $0.61. These options are exercisable with respect to 150,000
on the grant date and the remaining 150,000 in two equal installments on the
first and second anniversaries of the grant date.
|
|
|
60
|
|
Stock
Option Plans
|
|
2004
Employees and Consultants Stock Option Plan
|
On
August 17, 2004, our board adopted the 2004 Employees and Consultants Stock
Option Plan in order to attract and retain quality personnel. Under the 2004
Plan, 5,000,000 shares have been reserved for the grant of options by the
board. As of September 30, 2007, options with respect to 1,425,000 shares
have been granted under the 2004 Stock Option Plan.
|
2007
Global Share Option Plan
|
On
February 26, 2007, our board adopted the 2007 Global Share Option Plan in
order to attract and retain quality personnel. Under the 2007 Stock Option
Plan, 5,000,000 shares have been reserved for the grant of options, which may
be issued at the discretion of our board of directors from time to time. As
of September 30, 2007, options exercisable for an aggregate of 4,510,000
shares have been granted.
|
|
Employment
and Consulting Agreements
|
On
August 17, 2004, our subsidiary, GammaCan, Ltd. entered into a consultancy
agreement with Professor Yehuda Shoenfeld, M.D., providing for a monthly
compensation of 22,685 NIS (approximately $5,300 as of the date hereof) for
his services as the Chief Scientist of GammaCan, Ltd. Either
Prof. Shoenfeld or GammaCan, Ltd. may terminate the agreement without cause,
for any reason, with 30 days notice.
|
|
On
March 1, 2005, GammaCan, Ltd. entered into an employment agreement with Vered
Caplan for her to be Vice President of Business Development and provide at
least 20 hours of service per week for a salary of $4,000 per month. She was
appointed as acting Chief Executive Officer of both the Company and its
subsidiary, effective July 2, 2005 at a salary of $6,475 per month. Ms.
Caplan has devoted approximately 70% of her business time during the period
to the affairs of both companies. She resigned from her position as our acting
Chief Executive Officer, effective April 15, 2006. As of May 22, 2007, Ms.
Caplan became our Vice President of Corporate Development and commencing with
this appointment, Ms. Caplan ceased her service as Chief Executive Officer
of our subsidiary. As of November 30, 2007, Ms. Caplan is no longer employed
by the Company.
|
|
On
September 6, 2005, GammaCan, Ltd. entered into an employment agreement with
Chaime Orlev pursuant to which he has served as Chief Financial Officer of
the Company and its subsidiary since October 6, 2005. Mr. Orlev resigned
from this position effective February 29, 2008. He received a salary pursuant
to the agreement of 25,000 NIS per month (approximately US$7,500, as of the
date hereof), which was increased on April 16, 2006 to $6,500 per month.
His salary was subsequently increased on October 24, 2007 to $8,333 effective
from April 1, 2007. The agreement provided for the grant of 350,000 of our
stock options at an exercise price of $0.93 per share. On May 17, 2007, these
options were cancelled and surrendered for options
to purchase 300,000 shares of our common stock at an exercise price of $0.61.
These options were exercisable with
respect to 150,000 on the grant date and the remaining 150,000 in two equal
installments on the first and second anniversary of the grant date. Previously,
on February 26, 2007, Mr. Orlev was granted options to purchase 300,000 shares
of our common stock at an exercise price of $0.53, one third of which vest
on each of the first, second and third anniversaries of the grant date. Upon
Mr. Orlevs resignation a total of 250,000 options vested and the exercise
period for these options has been extended to February 29, 2009. The agreement
further provided for the provision of a company car and managers
insurance as well as the maintenance of an education fund.
|
|
61
|
|
On
April 16, 2006, we entered into an agreement with Patrick Schnegelsberg
employing him as our Chief Executive Officer. The agreement provides for an
annual salary of $200,000 and an annual bonus of up to $200,000 upon
achieving certain objectives. The agreement provided for the grant of
1,400,000 stock options at an exercise price of $1.29 per share. On May 17,
2007, these options were cancelled and surrendered for options to
purchase 1,500,000 shares of our common stock at an exercise price of $0.61.These
options are exercisable with respect to 400,000 on the grant date
and the remaining 1,100,000 in two equal installments on the first and second
anniversary of the grant date. Previously on February 26, 2007, Mr.
Schnegelsberg was granted options to purchase 250,000 shares of our common
stock at an exercise price of $0.53, one third of which vest on each of the
first, second and third anniversaries of the grant date. If
we terminate Mr. Schegelsbergs employment without cause, he shall continue
to be entitled to his compensation under the employment agreement during the
advance notice of termination period which is 45 days during the first year
of employment, 90 days during the second year of employment and 180 days
thereafter.
|
|
We entered into an employment agreement with Limor Zur-Stoller dated March 11, 2008 employing her as our Chief Financial Officer and Treasurer, with a salary of 35,000 NIS per month
(approximately $10,500, as of the date hereof) commencing March 19, 2008. In addition, the agreement provided for the grant of options to acquire 600,000 shares of our common stock at an exercise price per share equal to the price per share at
which our common stock is traded on March 19, 2008. These options vest in equal installments over three years on the first, second, and third anniversary of her appointment. If we terminate Ms. Zur-Stollers employment without cause, she shall
continue to be entitled to her salary under the agreement during the advance notice of termination period which is 60 days and in the case of her termination of employment, Ms. Zur-Stollers pension scheme shall be transferred to her in lieu of
payment of any severance. The agreement also provides for other usual and customary employment benefits.
|
|
|
On
October 31, 2006, we entered into a consulting agreement with Steven Katz
& Associates, Inc., (
SKA
),
a company wholly-owned by Steven Katz, the Companys Chairman of the Board
and President, engaging it as a consultant at a fee of $345 per hour.
|
|
On
December 20, 2007, we entered into an indemnification agreement with our
directors and officers which supersedes any indemnification agreements
previously entered into with such individuals. Each new member of the board
and officer subsequent to December 20, 2007 has also entered into an indemnification
agreement with us.
|
|
Director
Compensation
|
|
Directors
are entitled to reimbursement for reasonable travel and other out-of-pocket
expenses incurred in connection with attendance at meetings of our board of
directors. Effective October 1, 2006, each
outside director is entitled to receive as remuneration for his or her
service as a member of the board a sum equal to US$8,000 per annum, to be
paid quarterly and shortly after the close of each quarter. Effective as of
October 1, 2007, this amount was increased to $12,000. The board of directors may
award special remuneration to any director undertaking any special services
on behalf of us other than services ordinarily required of a director.
|
|
Other
than indicated in this prospectus, no director received and/or accrued any
compensation for his or her services as a director, including committee
participation and/or special assignments.
|
|
62
|
|
The
following table sets forth director compensation for the year ended September
30, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name of
Director
|
|
|
Fees
Earned
or Paid in
Cash
($)
|
|
|
Stock
Awards
($)
|
|
Option
Awards
($)
|
|
|
Non-Equity
Incentive Plan
Compensation
($)
|
|
|
Nonqualified
Deferred
Compensation
|
|
|
All Other
Compensation
($)
|
|
Total
($)
|
|
Yair
Aloni
(
2)
|
|
$
|
8,000
|
|
|
Nil
|
|
$
|
78,564
|
(1)
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
$
|
86,564
|
|
Steven
Katz
(
3)
|
|
|
Nil
|
|
|
Nil
|
|
$
|
39,503
|
(1)
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
$
|
39,503
|
|
Shmuel
Levi
(4)
|
|
$
|
8,000
|
|
|
Nil
|
|
$
|
78,564
|
1)
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
$
|
86,564
|
|
Josef
Neuhaus
|
|
$
|
8,000
|
|
|
Nil
|
|
$
|
89,502
|
(1)
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
$
|
97,502
|
|
Albert
Passner
|
|
$
|
8,000
|
|
|
Nil
|
|
$
|
39,503
|
(1)
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
$
|
47,503
|
|
|
|
|
|
|
|
|
(1)
|
The amounts reflect the
compensation expense in accordance with FAS 123(R) of these option awards.
The assumptions used to determine the fair value of the option awards are set
forth in Note 8 of our audited consolidated financial statements included in
this Form 10-KSB. Our directors will not realize the value of these awards in
cash unless and until these awards are exercised and the underlying shares
subsequently sold.
|
|
|
|
(2)
|
On August 19, 2008, Mr. Aloni resigned from our board of directors and our
audit committee.
|
|
|
|
(3)
|
Please refer to the summary compensation
table for executive compensation with respect to the named individual.
|
|
|
(4)
|
On October 30, 2007, Mr. Levi resigned
from our board of directors and our audit and compensation committees.
His vacancy was filled by Mr. DeMedio.
|
|
63
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Our
policy is to enter into transactions with related parties on terms that, on the
whole, are more favorable, or no less favorable, than those available from
unaffiliated third parties. Based on our experience in the business sectors in
which we operate and the terms of our transactions with unaffiliated third
parties, we believe that all of the transactions described below met this
policy standard at the time they occurred.
Mr. Yair Aloni, a former director of our company, and Professor Yehuda Shoenfeld, M.D., the Chief Scientist of our subsidiary, GammaCan, Ltd., are authorized signatories of ARP Biomed Ltd. (
ARP
) for the Intellectual Property Purchase and Sale Agreement (
Purchase
Agreement
) we entered into with ARP on June 11, 2004. Mr. Aloni is the Chief Executive Officer of ARP and Professor Shoenfeld is an advisor to ARP. As a result of the Purchase Agreement, ARP owns 12.5% of our subsidiary, Gammacan Ltd.
On December 13, 2007, we entered into a Share Purchase Agreement made as of November 26, 2007 with ARP. The Share Purchase Agreement provided that, subject to fulfillment of certain closing conditions, including the receipt of an Israeli tax ruling, ARP will sell to us 12.5% of the issued and outstanding shares of our subsidiary such that at closing we will own 100% of the issued and outstanding shares of our subsidiary. In consideration for such sale, we agreed to issue to ARP, at closing, 2,697,535 shares of our common stock, a warrant to acquire 1,123,973 shares of our common stock and an additional warrant to acquire 449,589 shares of our common stock. Both warrants are exercisable for five years at an exercise price equal to the average last sales price of our common stock during the sixty trading days prior to November 26, 2007. The warrants are subject to adjustment for, among other things, stock splits, stock dividends, distr
ibutions and reclassifications. In the case of the warrant to acquire 1,123,973 shares, if there is a change of control (as defined therein), then subject to certain restrictions, the warrant shall be deemed exercised in full and no exercise price shall be payable by the holder. The securities (and underlying securities) to be issued under the Share Purchase Agreement will also be subject to a separate lock up agreement and registration rights agreement upon issuance. In connection with the Share Purchase Agreement, ARP and our subsidiary
agreed to enter into an amendment of the agreement for the purchase and sale of intellectual property from ARP, which amendment specifically delineates clarity of title and related issues to certain intellectual property sold under the original agreement.
On
August 11, 2008, we executed an Amendment Agreement with ARP made as of June,
2008 (the
Amendment
Agreement
) amending the Share Purchase Agreement and certain
other ancillary agreements entered into at the same time. In consideration
for the sale, according to the Amendment Agreement, the number of shares
of common stock issuable to ARP at closing and upon receipt of an Israeli
tax ruling has been increased to 3,389,902 shares of our common stock and
no warrants will be issued. Further, the Amendment Agreement amended the
Lock-Up Agreement dated as of November 26, 2007 between ARP and the Company
by increasing the number of locked-up shares that can be sold during the
period after May 26, 2009 from one-sixth per month to one-eight per month.
The Amendment Agreement also amended the effective date of the Agreement
to Sale of Intellectual Property Agreement dated as of November 26, 2007
between ARP and the Company to the earlier of the receipt of the Israeli
tax ruling and June 15, 2008. Subsequently on August 13, 2008, we conducted
a closing of the Share Purchase Agreement, as amended by the Amendment
Agreement.
On
March 1, 2005, we and our subsidiary entered into an agreement appointing Ms.
Caplan as Vice President of Business Development according to which Ms. Caplan,
received a salary of $4,000 per month for at least 20 hours of service per
week.
On
June 6, 2005, we and our subsidiary appointed Ms. Caplan as acting Chief
Executive Officer of both companies, effective July 2, 2005 at a salary of
$6,475 per month. On April 15, 2006,
Ms. Caplan resigned from her position as the acting Chief Executive Officer.
Ms. Caplan remained as the Chief Executive Officer of our subsidiary, GammaCan,
Ltd.
On
October 31, 2006, we entered into a consulting agreement with Steven Katz and
Associates, Inc., (
SKA
) a
company wholly-owned by Steven Katz, the Chairman of the Board of GammaCan
International, Inc.
For
a description of employment agreements, please see Management Employment
and Consultancy Agreements.
64
PRINCIPAL AND
MANAGEMENT STOCKHOLDERS
The
following table sets forth certain information regarding beneficial ownership
of our common stock as of August 19, 2008 by (i) by each person who is
known by us to own beneficially more than 5% of our common stock, (ii) by
each of the Named Executive Officers and (iv) by all our directors and
executive officers as a group. On such date, we had 48,348,819 shares of common
stock outstanding.
As
used in the table below and elsewhere in this prospectus, the
term
beneficial
ownership
with respect to a
security consists of sole or shared voting power, including the power to vote
or direct the vote and/or sole or shared investment power, including the power
to dispose or direct the disposition, with respect to the security through any
contract, arrangement, understanding, relationship, or otherwise, including a
right to acquire such power(s) during the next 60 days following May 31,
2008.
|
|
|
|
|
|
|
|
Name and
address of Beneficial Owner
|
|
|
Number of Shares
|
|
Percentage of Shares Beneficially Owned
|
|
|
|
|
|
|
|
Andrew
Lessman
430 Parkson Rd.
Henderson, NV
|
|
|
7,666,668
|
(1)(14)
|
|
14.7
|
|
|
|
|
|
|
|
|
|
MM&B
Holdings, a California general partnership
23622 Calabassas Road
Calabassas, California
|
|
|
5,000,000
|
(2)(14)
|
|
9.8
|
|
|
|
|
|
|
|
|
|
Zeev
Bronfeld
6 Uri St.
Tel Aviv, Israel
|
|
|
3,900,006
|
|
|
8.1
|
|
|
|
|
|
|
|
|
|
Vered Caplan
69 Deganya St.
Pardes Hanna Karkur, Israel
|
|
|
3,900,006
|
|
|
8.1
|
|
|
|
|
|
|
|
|
|
Yair Aloni
(7)
12A Shabazy St.
Tel Aviv, Israel
|
|
|
3,784,907
|
(3)
|
|
7.8
|
|
|
|
|
|
|
|
|
|
ARP Biomed Ltd
at Tamares Capital
America House
35 Shaul Hamelech Boulevard
PO Box 33381
Tel Aviv, Israel
|
|
|
3,389,902
|
|
|
7
|
|
|
|
|
|
|
|
|
|
JMG Triton
Offshore Fund Ltd
11601 Wilshire Blvd., Suite 2180
Los Angeles, CA 90025
|
|
|
3,000,000
|
(4)(14)
|
|
6
|
|
|
|
|
|
|
|
|
|
JMG Capital
Partners LP
11601 Wilshire Blvd., Suite 2180
Los Angeles, CA 90025
|
|
|
3,000,000
|
(4)(14)
|
|
6
|
|
|
|
|
|
|
|
|
|
Ram Capital
Group LLC
1974 Sproul Road, Suite 204
Broomall, PA 19008
|
|
|
2,500,000
|
(5)(14)
|
|
5
|
|
|
|
|
|
|
|
|
|
65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven Katz
(6)(8)
20 Rebel Run Drive
East Brunswick NJ 08816
|
|
|
455,208
|
(11)
|
|
*
|
|
|
|
|
|
|
|
|
|
Josef
Neuhaus
(6)
45 Eliezer Yafeh St.
Raanana, Israel
|
|
|
115,000
|
(11)
|
|
*
|
|
|
|
|
|
|
|
|
|
Albert
Passner
(6)
3 Disbrow Court
East Brunswick, NJ 08816
|
|
|
96,875
|
(11)
|
|
*
|
|
|
|
|
|
|
|
|
|
David De Medio
(6)
100 Deerfield Lane
Malvem, PA 19355
|
|
|
0
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Patrick
Schnegelsberg
(8)
100 John St. 2401
New York, NY
|
|
|
1,033,333
|
(11)
|
|
2.1
|
|
|
|
|
|
|
|
|
|
Limor Zur-Stoller
(8)
8 Alexander Pen
Tel Aviv, Israel
|
|
|
0
|
|
|
*
|
|
|
|
|
|
|
|
|
|
Chaime Orlev
(9)
10 Hameyasdim St.
Kiryat-Ono, Israel
|
|
|
250,000
|
(11)
|
|
*
|
|
|
|
|
|
|
|
|
|
Prof. Yehuda
Shoenfeld, M.D.
(10)
26 Sapir St.
Ramat Gan, Israel
|
|
|
719,788
|
(12)
|
|
1.5
|
|
|
|
|
|
|
|
|
|
All current
Executive Officers and Directors as a group (seven persons)
|
|
|
2,420,204
|
(13)
|
|
4.8
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Less than 1%
|
|
|
(1)
|
Includes 3,833,334 shares
of common stock issuable upon the exercise of warrants beneficially owned by
the referenced entity.
|
|
|
(2)
|
Includes 2,500,000 shares
of common stock issuable upon the exercise of warrants beneficially owned by
the referenced entity.
|
|
|
(3)
|
Includes 115,000 shares of common stock issuable
upon the exercise of outstanding stock options and includes 3,389,902
shares issued to ARP Biomed Ltd.
|
|
|
(4)
|
Includes 1,500,000 shares
of common stock issuable upon the exercise of warrants beneficially owned by
the referenced entity.
|
|
|
(5)
|
Includes 1,250,000 shares
of common stock issuable upon the exercise of warrants beneficially owned by
the referenced entity.
|
|
|
(6)
|
Indicates Director.
|
|
|
(7)
|
Indicates Former Director.
|
|
|
(8)
|
Indicates Officer.
|
|
|
(9)
|
Former Officer.
|
|
|
(10)
|
The referenced individual serves as our subsidiarys
Chief Scientist and for the purposes of this table only is considered
an executive officer.
|
|
|
(11)
|
Consists of shares
of common stock issuable upon the exercise of outstanding stock options.
|
|
|
(12)
|
Includes 19,972 shares
of common stock issuable upon the exercise of outstanding stock options.
|
|
|
(13)
|
Includes 1,720,208 shares of
common stock issuable upon the exercise of outstanding stock options.
|
|
|
(14)
|
Notwithstanding the
inclusion of warrants beneficially owned by the referenced entity in the
beneficial ownership calculation, the warrants provide that the holder of the
warrants shall not have the right to exercise any portion of the warrants,
and we shall not effect any exercise of such warrants, to the extent that
after giving effect to such issuance after exercise such holder of the
warrants, together with his, her or its affiliates, would beneficially own in
excess of 4.99% of the number of shares of common stock outstanding
immediately after giving effect to such issuance. Such 4.99% limitation may
be waived by each holder upon not less than 61 days prior notice to change
such limitation to 9.99% of the number of shares of common stock outstanding
immediately after giving effect to such issuance.
|
|
|
66
SELLING
STOCKHOLDERS
The selling stockholders are offering 16,583,753 Shares of our common stock. Of the Shares, 16,250,000 Shares are issuable upon the exercise of warrants (the
Private Placement Warrants
) issued by us in a private placement (the
2007 Private Placement
) of securities
exempt from the registration requirements of the Securities Act of 1933, as amended (the
Securities Act
), in February 2007, and 250,000 Shares are issuable upon the
exercise of warrants (the
Consulting Warrants
and, together with the Private Placement Warrants, the
Warrants
) issued by us to consultants in June 2007 in a transaction exempt from the registration requirements of the Securities Act.
We
have granted registration rights to the purchasers in the 2007 Private
Placement under the Securities Act at our expense with respect to the
securities acquired in such offering.
The
following table details the name of each selling stockholder, the number of
shares of our common stock beneficially owned by each selling stockholder and
the number of shares of our common stock that may be offered for resale under
this prospectus. To the extent permitted by law, the selling stockholders who
are not natural persons may distribute shares from time to time, to one or more
of their respective affiliates, which may sell shares pursuant to this
prospectus. We have registered the shares to permit the selling stockholders
and their respective permitted transferees or other successors in interest that
receive their shares from selling stockholders after the date of this
prospectus to resell the shares. Because each selling stockholder may offer all,
some or none of the shares it holds, and because 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 selling
stockholders may from time to time offer all or some of the shares pursuant to
this offering.
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 by footnote, none of the selling stockholders
has had a significant relationship with us within the past three years, other
than as a result of the ownership of our shares or other securities. Except as
indicated by footnote, the selling stockholders have sole voting and investment
power with their respective shares. Percentages in the table below are based
on 48,348,819 shares of our common stock outstanding as of August 19, 2008
and assume that, except for the shares issuable to a selling stockholder
in question, no Warrants are exercised.
67
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
of Common Stock
|
Percentage
of
Common
Stock Owned
After Offering
Complete
|
|
Name
|
|
Owned
Prior to
this Offering
|
|
Number
Offered
|
|
Owned
After
Offering Complete
|
|
|
|
|
|
|
|
|
|
|
|
|
JMG Capital Partners,
LP
|
|
|
3,000,000
|
(1)
|
|
1,500,000
|
|
|
1,500,000
|
|
3.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
JMG Triton Offshore Fund, Ltd.
|
|
|
3,000,000
|
(1)
|
|
1,500,000
|
|
|
1,500,000
|
|
3.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM & B Holdings,
a California general partnership
|
|
|
5,000,000
|
(2)
|
|
2,500,000
|
|
|
2,500,000
|
|
5.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John B. Davies
|
|
|
250,000
|
(3)
|
|
125,000
|
|
|
125,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven B. Dunn
|
|
|
1,250,000
|
(4)
|
|
625,000
|
|
|
625,000
|
|
1.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Muhl Family Trust, Phillip E. Muhl & Kristin
A. Muhl TTEE DTD 10-11-95
|
|
|
125,000
|
(5)
|
|
62,500
|
|
|
62,500
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Apex Investment Fund,
Ltd.
|
|
|
1,066,666
|
(6)
|
|
500,000
|
|
|
566,666
|
|
1.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
G. Tyler Runnels or Jasmine Niklas
Runnels TTEES The Runnels Family Trust DTD 1-11-2000
(14)
|
|
|
750,000
|
(7)
|
|
375,000
|
|
|
375,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
High Tide, LLC
(14)
|
|
|
750,000
|
(7)
|
|
375,000
|
|
|
375,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TRW Capital Growth Fund, LP
(14)
|
|
|
875,000
|
(8)
|
|
437,500
|
|
|
437,500
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joseph H. Merback & Tema
N. Merback Co-TTEE FBO Merback Family Trust UTD 8-30-89
|
|
|
500,000
|
(9)
|
|
250,000
|
|
|
250,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
B & R Richie’s
|
|
|
250,000
|
(3)
|
|
125,000
|
|
|
125,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charles B. Runnels
Family Trust DTD 10-14-93 Charles B. Runnels & Amy Jo Runnels TTEES
|
|
|
125,000
|
(5)
|
|
62,500
|
|
|
62,500
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christopher G. Niklas
|
|
|
75,000
|
(10)
|
|
37,500
|
|
|
37,500
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bristol Investment
Fund, Ltd.
|
|
|
2,304,800
|
(11)
|
|
1,250,000
|
|
|
1,054,800
|
|
2.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John W. Galuchie, Jr. & Marianne
C. Galuchie Trustees Galuchie Living Trust DTD 9/11/00
|
|
|
50,000
|
(12)
|
|
25,000
|
|
|
25,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew Lessman
|
|
|
7,666,668
|
(2)(15)
|
|
2,500,000
|
|
|
5,166,668
|
(15)
|
10.4
|
|
68
|
|
|
|
|
|
|
|
|
|
|
|
|
Newberg Family Trust UTD 12/18/90
|
|
|
1,250,000
|
(4)
|
|
625,000
|
|
|
625,000
|
|
1.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RAM Capital Group, LLC
|
|
|
2,500,000
|
(11)
|
|
1,250,000
|
|
|
1,250,000
|
|
2.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arden Merback
|
|
|
250,000
|
(3)
|
|
125,000
|
|
|
125,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Larry Cohen TTEE Paulette Cohen TTEE
dated 1-05-1999 Cohen Family Trust u/a dtd 01-05-1999
|
|
|
500,000
|
(9)
|
|
250,000
|
|
|
250,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Martin and Marsha Brander Living Trust
|
|
|
500,000
|
(9)
|
|
250,000
|
|
|
250,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew C. Sankin
|
|
|
500,000
|
(9)
|
|
250,000
|
|
|
250,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matthew Weiss and Michele Weiss JTWROS
|
|
|
500,000
|
(9)
|
|
250,000
|
|
|
250,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Wilstein and Susan Wilstein,
as Trustees of the Century Trust
|
|
|
350,000
|
(3)
|
|
125,000
|
|
|
225,000
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ATON Select Fund Limited
|
|
|
1,750,000
|
(13)
|
|
875,000
|
|
|
875,000
|
|
1.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ROI LLC
|
|
|
300,000
|
(16)
|
|
300,000
|
|
|
0
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional Trading Services SA
|
|
|
33,753
|
|
|
33,753
|
|
|
0
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Less than 1.0%.
|
|
|
(1)
|
Includes 1,500,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(2)
|
Includes 2,500,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(3)
|
Includes 125,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(4)
|
Includes 625,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(5)
|
Includes 62,500 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(6)
|
Includes 500,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(7)
|
Includes 375,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(8)
|
Includes 437,500 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(9)
|
Includes 250,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(10)
|
Includes 37,500 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(11)
|
Includes 1,250,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(12)
|
Includes 25,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(13)
|
Includes 875,000 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(14)
|
The referenced entity
is
affiliated with T.R. Winston & Company, LLC, a member firm of the
National Association of Securities Dealers.
|
|
|
(15)
|
Includes 1,333,334 shares of common stock
issuable upon the exercise of the Private Placement Warrants beneficially
owned by the referenced entity.
|
|
|
(16)
|
Includes 250,000 shares of common stock
issuable upon exercise of the Consulting Warrants owned by the referenced
entity.
|
Notwithstanding
the inclusion of the Private Placement Warrants beneficially owned by a number
of the referenced investors in the beneficial ownership calculation, the
Private Placement Warrants provide that the holder of the Private Placement
Warrants shall not have the right to exercise any portion of the Private
Placement Warrants, and we shall not effect any exercise of such Private
Placement Warrants, to the extent that after giving effect to such issuance
after exercise such holder of the Private Placement Warrants, together with
his, her or its affiliates, would beneficially own in excess of 4.99% of
the number of shares of common stock outstanding immediately after giving
effect to such issuance. Such 4.99% limitation may be waived by each holder
upon not less than 61 days prior notice to change such limitation to 9.99%
of the number of shares of common stock outstanding immediately after giving
effect to such issuance.
69
DESCRIPTION OF CAPITAL STOCK
General
We
are authorized by our certificate of incorporation to issue an aggregate
of 200,000,000 shares of common stock, par value $0.0001 per share, and 20,000,000
shares of preferred stock, par value $0.0001 per share. As of August 19,
2008, 48,348,819 shares of common stock were outstanding and held of record
by 32 stockholders and no shares of preferred stock were outstanding.
Common Stock
Holders
of common stock are entitled to one vote for each share held of record on
each matter submitted to a vote of stockholders. There is no cumulative voting
for the election of directors. Subject to the prior rights of any class or
series of preferred stock which may from time to time be outstanding, if
any, holders of common stock are entitled to receive ratably, dividends when,
as, and if declared by the board of directors out of funds legally available
for that purpose and, upon our liquidation, dissolution, or winding up, are
entitled to share ratably in all assets remaining after payment of liabilities
and payment of accrued dividends and liquidation preferences on the preferred
stock, if any. Holders of common stock have no preemptive rights and have
no rights to convert their common stock into any other securities. The outstanding
common stock is validly authorized and issued, fully-paid and nonassessable.
In the event we were to elect to sell additional shares of common stock following
this offering, investors in this offering would have no prior right to purchase
additional shares. As a result, their percentage equity interest in us would
be diluted.
The
shares of common stock offered in this offering will be, when issued and
paid for, fully paid and not liable for further call or assessment. Holders
of the common stock do not have cumulative voting rights, which means that
the holders of more than one half of the outstanding shares of common stock,
subject to the rights of the holders of the preferred stock, can elect all
of our directors, if they choose to do so. In this event, the holders of
the remaining shares of common stock would not be able to elect any directors.
Except as otherwise required by Delaware law, and subject to the rights of
the holders of preferred stock, all stockholder action is taken by the vote
of a majority of the outstanding shares of common stock voting as a single
class present at a meeting of stockholders at which a quorum consisting of
a majority of the outstanding shares of common stock is present in person
or proxy.
Preferred Stock
Preferred
stock may be issued in one or more series and having the rights, privileges
and limitations, including voting rights, conversion privileges and redemption
rights, as may, from time to time, be determined by the board of directors.
Preferred stock may be issued in the future in connection with acquisitions,
financings, or other matters as the board of directors deems appropriate.
In the event that any shares of preferred stock are to be issued, a certificate
of designation containing the rights, privileges and limitations of such
series of preferred stock shall be filed with the Secretary of State of the
State of Delaware. The effect of such preferred stock is that the board of
directors alone, and subject to, Federal securities laws and Delaware law,
may be able to authorize the issuance of preferred stock which could have
the effect of delaying, deferring, or preventing a change in control of us
without further action by the stockholders, and may adversely affect the
voting and other rights of the holders of the common stock. The issuance
of preferred stock with voting and conversion rights may also adversely affect
the voting power of the holders of common stock, including the loss of voting
control to others.
Warrants
At
the date hereof, there are Warrants outstanding exercisable for an aggregate
of 16,250,000 shares of common stock. The Warrants are exercisable through
February 27, 2012 at the exercise price of $0.48 per share, subject to adjustment
for, among other things, stock splits, stock dividends, reverse stock splits,
certain fundamental transactions, issuances of equity securities at effective
prices less than the then effective exercise price of the Warrants, and pro
rata distributions to stockholders. Further, commencing at any time after
the sixteenth month anniversary from the date of issuance of the Warrants,
if at the time of exercise, there is no effective Registration Statement
registering, or no current prospectus available for, the resale of the shares
of Common Stock issuable upon the exercise of the Warrants, then the Warrants
may also be exercised at such time on a cashless
or net issuance basis. The Warrants contain standard reorganization provisions.
Quotation on OTCBB
Our
common stock is quoted on the OTCBB under the symbol GCAN.
Transfer Agent and Registrar
The
transfer agent and registrar for the common stock is PACWest Transfer LLC
located at 2510 Pine Road North, Spokane Valley, WA 99206.
70
Directors Limitation Of Liability
Our
certificate of incorporation and by-laws include provisions to (1) indemnify
the directors and officers to the fullest extent permitted by the Delaware
General Corporation Law, including circumstances under which indemnification
is otherwise discretionary and (2) eliminate the personal liability of directors
and officers for monetary damages resulting from breaches of their fiduciary
duty, except for liability for breaches of the duty of loyalty, acts, or
omissions not in good faith or which involve intentional misconduct or a
knowing violation of law, violations under Section 174 of the Delaware General
Corporation Law, or for any transaction from which the director derived an
improper personal benefit. We believe that these provisions are necessary
to attract and retain qualified persons as directors and officers.
We
have entered into an indemnification agreement with each of our directors
which provides that we will indemnify our directors and advance expenses
to our directors, to the extent permitted by the laws of the State of Delaware.
We
have directors and officers liability insurance in an amount of $10 million.
Insofar
as indemnification for liability arising under the Securities Act may be
permitted to our directors, officers and controlling persons as stated in
the foregoing provisions or otherwise, we have been advised that, in the
opinion of the Commission, this indemnification is against public policy
as expressed in the Securities Act and is, therefore, unenforceable.
71
SHARES ELIGIBLE FOR FUTURE SALE
Sales
of substantial numbers of shares of our common stock in the public market
following this offering, or the perception that such sales may occur, could
adversely affect prevailing market prices of shares.
Assuming
the exercise in full of the Warrants, immediately following the effectiveness
under the Securities Act of the registration statement of which this prospectus
forms a part, and further assuming no exercise of options outstanding following
this offering, we will have an aggregate of 64,848,819 shares of common stock
outstanding upon completion of this offering. Except for 3,389,902 shares, all these shares (including
the 83,753 shares sold in this offering) will be freely tradable under a
currently effective registration statement or pursuant to Rule 144 (subject
to the lock-up agreements), unless purchased by affiliates as
that term is defined under Rule 144 of the Securities Act, who may sell only
the volume of share described below and whose sales would be subject to additional
restrictions described below.
Eligibility of Restricted Shares for Sale in the Public Market
Immediately
after the effectiveness under the Securities Act of the registration statement
of which this prospectus forms a part, we will have outstanding 48,348,819
shares of common stock. Except for 3,389,902 shares, all shares, including 83,753 of the shares being
offered in this offering, will be freely tradable under a currently effective
registration statement or pursuant to Rule 144 subject to the lock-up agreements
under purchased by affiliates as that term is defined under Rule
144 of the Securities Act, who may sell subject to the restrictions contained
in Rule 144. Giving effect to the exercise in full of the Warrants, immediately
after the commencement of this offering, we would have outstanding 64,848,819
shares of common stock.
Rule 144
The
SEC has recently adopted amendments to Rule 144 which became effective on
February 15, 2008 and apply to securities acquired both before and after
that date. Under these amendments, a person who has beneficially owned restricted
shares of our common stock for at least six months would be entitled to sell
their securities provided that (1) such person is not deemed to have been
one of our affiliates at the time of, or at any time during the three months
preceding, a sale, (2) we are subject to the Exchange Act reporting requirements
for at least 90 days before the sale and (3) if the sale occurs prior to
satisfaction of a one-year holding period, we provide current information
at the time of sale.
Persons
who have beneficially owned restricted shares of our common stock for at
least six months but who are our affiliates at the time of, or at any time
during the three months preceding, a sale, would be subject to additional
restrictions, by which such person would be entitled to sell within any three-month
period only a number of securities that does not exceed the greater of:
-
1% of the number of shares of common
stock then outstanding, which as of August 19, 2008 would
equal
483,488 shares; or
provided, in each case, that we are
subject to the Exchange Act periodic reporting requirements for at least
three months before the sale. However, since our shares are quoted on the
OTC Bulletin Board, which is not an
automated quotation system, our stockholders will not be able to
rely on the market-based volume limitation described in the second bullet above.
If, in the future, our securities are listed on an exchange or quoted on an
automatic quotation system, then our stockholders would be able to rely on
the market-based volume limitation. Unless and until our stock is so listed
or quoted, our stockholders can only rely on the percentage based volume limitation
described in the first bullet above.
Such
sales by affiliates must also comply with the manner of sale, current public
information and notice provisions of Rule 144.
Rule 701
In
general, under Rule 701, any of our employees, directors, officers, consultants,
or advisors who purchased shares of
72
common stock from us under a compensatory stock option plan or
other written agreement before the closing of this offering is entitled to
resell these shares. These shares can be resold 90 days after the effective
date of this offering in reliance on Rule 144, without having to comply with
restrictions, including the holding period, contained in Rule 144.
The
Securities and Exchange Commission has indicated that Rule 701 will apply
to typical share options granted by an issuer before it becomes subject to
the reporting requirements of the Securities Exchange Act of 1934, along
with the shares acquired upon exercise of these options, including exercises
after the date of this prospectus. Securities issued in reliance on Rule
701 are restricted securities and, subject to the contractual restrictions
described above, beginning 90 days after the date of this prospectus, may
be sold:
|
|
|
|
|
by persons other than affiliates subject only
to the manner of sale provisions of Rule 144; and
|
|
|
|
|
|
by affiliates under Rule 144 without compliance
with its one year minimum holding period requirement.
|
Registration Rights
The
holders of the Warrants are entitled to the registration of the resale of
the shares of common stock issuable upon the exercise of the Warrants following
the effectiveness of the registration statement of which this prospectus
forms a part, subject to limitations established by the Securities and Exchange
Commission.
Following
the completion of this offering, the holders of an aggregate of 4,723,234
shares of common stock are entitled to request that we register their shares
of common stock under the Securities Act, subject to cutback for marketing
reasons, and also are entitled to piggy back registration rights,
also subject to cutback for marketing reasons. Registration of such shares
under the Securities Act would result in such shares becoming freely tradable
without restriction under the Securities Act, except for shares purchased
by affiliates, immediately upon the effectiveness of such registration. Any
sales of securities by these stockholders could have a material adverse effect
on the trading price of our common stock.
73
PLAN OF DISTRIBUTION
Each
selling stockholder of the common stock and any of their pledgees (which
are accredited investors (as defined in Regulation D under the Securities
Act) or which are in connection with bona fide margin accounts with a registered
broker-dealer or financial institution which is an accredited investor),
assignees and successors-in-interest may, from time to time, sell any or
all of their shares of common stock on the OTC Bulletin Board or any other
stock exchange, market or trading facility on which the shares are traded
or in private transactions. These sales may be at fixed or negotiated prices.
A selling stockholder may use any one or more of the following methods when
selling shares:
|
|
|
|
|
ordinary brokerage transactions and transactions
in which the broker-dealer solicits purchasers;
|
|
|
|
|
|
block trades in which the broker-dealer will
attempt to sell the shares as agent but may position and resell a portion
of the block as principal to facilitate the transaction;
|
|
|
|
|
|
purchases by a broker-dealer as principal
and resale by the broker-dealer for its account;
|
|
|
|
|
|
an exchange distribution in accordance with
the rules of the applicable exchange;
|
|
|
|
|
|
privately negotiated transactions;
|
|
|
|
|
|
settlement of short sales entered into after
the effective date of the registration statement of which this prospectus
is a part;
|
|
|
|
|
|
broker-dealers may agree with the selling
stockholders to sell a specified number of such shares at a stipulated
price per share;
|
|
|
|
|
|
through the writing or settlement of options
or other hedging transactions, whether through an options exchange
or otherwise;
|
|
|
|
|
|
a combination of any such methods of sale;
or
|
|
|
|
|
|
any other method permitted pursuant to applicable
law.
|
The
selling stockholders may also sell shares under Rule 144 under the Securities
Act if available, rather than under this prospectus. Broker-dealers engaged
by the selling stockholders may arrange for other brokers-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, but, except as set
forth in a supplement to this prospectus, in the case of an agency transaction
not in excess of a customary brokerage commission in compliance with NASDR
Rule 2440; and in the case of a principal transaction a markup or markdown
in compliance with NASDR IM-2440.
In
connection with the sale of the common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling stockholders
may also sell shares of the common stock short and deliver these securities
to close out their short positions, or loan or pledge the common stock to
broker-dealers that in turn may sell these securities. The selling stockholders
may also enter into option or other transactions with broker-dealers or other
financial institutions or the creation of one or more derivative securities
which require the delivery to such broker-dealer or other financial institution
of shares offered by this prospectus, which shares such broker-dealer or
other financial institution may resell pursuant to this prospectus (as supplemented
or amended to reflect such transaction).
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 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. Each selling stockholder
has informed us that it does not have any written or oral agreement or understanding,
directly or indirectly, with any person to distribute the common stock. In
no event shall any broker-dealer receive fees, commissions and markups which,
in the aggregate, would exceed eight percent (8%).
We
are required to pay certain fees and expenses incurred by us incident to
the registration of the shares. We have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
74
Because selling stockholders may be deemed to be underwriters within
the meaning of the Securities Act, they will be subject to the prospectus
delivery requirements of the Securities Act including Rule 172 thereunder.
In addition, any securities covered by this prospectus which qualify for
sale pursuant to Rule 144 under the Securities Act may be sold under Rule
144 rather than under this prospectus. There is no underwriter or coordinating
broker acting in connection with the proposed sale of the resale shares by
the selling stockholders.
We
agreed to keep this prospectus effective until the earlier of (i) the date
on which the shares may be resold by the selling stockholders without registration
and without regard to any volume limitations by reason of Rule 144(k) under
the Securities Act or any other rule of similar effect or (ii) all of the
shares have been sold pursuant to this prospectus or Rule 144 under the Securities
Act or any other rule of similar effect. The resale shares will be sold only
through registered or licensed brokers or dealers if required under applicable
state securities laws. In addition, in certain states, the resale shares
may not be sold unless they have been registered or qualified for sale in
the applicable state or an exemption from the registration or qualification
requirement is available and is complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged
in the distribution of the resale shares may not simultaneously engage in
market making activities with respect to the common stock for the applicable
restricted period, as defined in Regulation M, prior to the commencement
of the distribution. In addition, the selling stockholders will be subject
to applicable provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of purchases
and sales of shares of the common stock by the selling stockholders or any
other person. We will make copies of this prospectus available to the selling
stockholders and have informed them of the need to deliver a copy of this
prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
75
LEGAL MATTERS
Certain
legal matters in connection with this offering will be passed upon for us
by Reitler Brown & Rosenblatt LLC, New York, New York.
EXPERTS
The
financial statements as of September 30, 2007 and 2006 and for each of the
two years in the period ended September 30, 2007 and for the cumulative period
from October 6, 1998 (date of inception) (except as it relates to the cumulative
period from October 6, 1998 (date of inception) through September 30, 2003)
included in this Prospectus, have been so included in reliance on the report
of Kesselman & Kesselman, certified public accountants (Isr.), a member
of the Pricewaterhouse Coopers International Limited, an independent registered
public accounting firm, given on the authority of said firm as experts in
auditing and accounting.
The
audited financial statements as it relates to the cumulative period from
October 6, 1998 (date of inception) through September 30, 2003, not separately
presented in this prospectus, have been audited by Armando C. Ibarra, certified
public accountant and independent accounting, whose report thereon appears
herein. Such financial statements, to the extent they have been included
in the financial statements of Gammacan International, Inc. have been so
included in reliance on the report of such independent accountant given the
authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We
have filed with the Securities and Exchange Commission a registration statement
on Form S-1 under the Securities Act relating to this offering of shares
of our common stock. This prospectus does not contain all of the information
contained in the registration statement. The rules and regulations of the
Securities and Exchange Commission allow us to omit various information from
this prospectus that is included in the registration statement. Statements
made in this prospectus concerning the contents of any contract, agreement,
or other document are summaries of all material information about the documents
summarized, but are not complete descriptions of all terms of these documents.
If we filed any of these documents as an exhibit to the registration statement,
you may read the document itself for a complete description of its terms.
You
may read and copy the registration statement, including the related exhibits
and schedules, and any document we file with the Securities and Exchange
Commission without charge at the Securities and Exchange Commissions
public reference room at 100 F Street, N.E., Washington, D.C. 20549-1004.
You may also obtain copies of the documents at prescribed rates by writing
to the Public Reference Section of the Securities and Exchange Commission
by calling 1-800-SEC-0330 for further information on the public reference
room. In addition, the registration statement is publicly available through
the web site maintained by the Securities and Exchange Commission at www.sec.gov.
We
are subject to the informational requirements of the Securities Exchange
Act of 1934, or Exchange Act, and fulfill the obligations of these requirements
by filing reports with the Securities and Exchange Commission. You may obtain
copies of any documents that we file electronically with the Securities and
Exchange Commission through its website at www.sec.gov.
76
INDEX TO FINANCIAL
STATEMENTS
|
|
GAMMACAN INTERNATIONAL,
INC.
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Page
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CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS FOR THE
|
|
|
NINE MONTHS ENDED JUNE 30, 2008 (UNAUDITED)
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets at June 30, 2008 and September 30, 2007
|
|
F-2
|
|
|
|
Condensed Consolidated Statements
of Operations
|
|
F-3
|
for the three and nine months
ended June 30, 2008 and 2007
|
|
|
and the period from October
6, 1998 through June 30, 2008
|
|
|
|
|
|
Condensed Consolidated Statements
of Changes in Stockholders' Equity
|
|
F-4
|
for the period from October
6, 1998 (inception) to June 30, 2008
|
|
|
|
|
|
Condensed Consolidated Statements
of Cash Flows
|
|
F-5
|
for the nine months ended
June 30, 2008 and 2007
|
|
|
and for the period from October
6, 1998 (inception) to June 30, 2008
|
|
|
|
|
|
Notes to Condensed Consolidated
Financial Statements
|
|
F-6
|
|
|
|
CONSOLIDATED FINANCIAL
STATEMENTS AT AND FOR THE
|
|
|
YEARS ENDED SEPTEMBER
30, 2007 AND 2006
|
|
|
|
|
|
Report of Registered Independent
Certified Public Accounting Firm
|
|
F-13
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|
|
|
Independent Auditor's Report
|
|
F-14
|
|
|
|
Consolidated Balance Sheets
at September 30, 2007 and 2006
|
|
F-15
|
|
|
|
Consolidated Statements of
Operations
|
|
|
for the Years Ended September
30, 2007 and 2006
|
|
F-16
|
|
|
|
Consolidated Statements of
Changes in Stockholders' Equity
|
|
|
for the Year Ended September
30, 2007
|
|
F-17
|
|
|
|
Consolidated Statement of
Cash Flows for the Years Ended September 30, 2007 and 2006
|
|
F-18
|
|
|
|
Notes to Consolidated Financial
Statements
|
|
F-19
|
|
|
|
See accompanying notes to condensed
consolidated financial statements
F-1
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(US
$, except share data)
|
|
June
30,
2008
|
|
September
30,
2007
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
(Audited)
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
861,531
|
|
$
|
4,048,583
|
|
Prepaid
expenses
|
|
|
16,601
|
|
|
9,851
|
|
Other
|
|
|
49,243
|
|
|
47,271
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
927,375
|
|
|
4,105,705
|
|
|
|
|
|
|
|
|
|
FUNDS
IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT
|
|
|
|
|
|
49,281
|
|
|
|
|
|
|
|
|
|
LONG
TERM DEPOSITS
|
|
|
1,873
|
|
|
18,590
|
|
|
|
|
|
|
|
|
|
PROPERTY
AND EQUIPMENT, NET
|
|
|
35,447
|
|
|
26,338
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
964,695
|
|
$
|
4,199,914
|
|
|
|
|
|
|
|
|
|
Liabilities
and stockholders equity
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
393,478
|
|
$
|
797,515
|
|
Payroll
and related accruals
|
|
|
121,657
|
|
|
130,223
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
515,135
|
|
|
927,738
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
(NOTE 2)
|
|
|
|
|
|
|
|
LIABILITY
FOR EMPLOYEE RIGHTS UPON RETIREMENT
|
|
|
21,296
|
|
|
71,338
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY:
|
|
|
|
|
|
|
|
Preferred
stock, $ 0.0001 par value (20,000,000 shares authorized; none issued
and outstanding)
|
|
|
|
|
|
|
|
Common
stock, $ 0.0001 par value (200,000,000 authorized shares; 44,958,917
and 44,958,917 shares issued and outstanding as of June 30, 2008
and September 30, 2007, respectively)
|
|
|
4,495
|
|
|
4,495
|
|
Additional
paid-in capital
|
|
|
9,486,016
|
|
|
8,968,930
|
|
Warrants
|
|
|
3,203,600
|
|
|
3,203,600
|
|
Deficit
accumulated during the development stage
|
|
|
(12,265,847
|
)
|
|
(8,956,187
|
)
|
Services
not yet rendered
|
|
|
|
|
|
(20,000
|
)
|
|
|
|
|
|
|
|
|
Total
stockholders equity
|
|
|
428,264
|
|
|
3,200,838
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders equity
|
|
$
|
964,695
|
|
$
|
4,199,914
|
|
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of the financial statements.
F-2
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(US
$, except share data)
|
|
Nine
months ended
June 30
|
|
Three
months ended
June 30
|
|
Period
from
October 6,
1998*
through
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RESEARCH
AND DEVELOPMENT COSTS
|
|
$
|
1,350,956
|
|
$
|
762,778
|
|
$
|
450,279
|
|
$
|
279,908
|
|
$
|
4,064,134
|
|
GENERAL
AND ADMINISTRATIVE EXPENSES
|
|
|
1,979,379
|
|
|
2,902,678
|
|
|
591,960
|
|
|
1,270,878
|
|
|
8,358,253
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
|
3,330,335
|
|
|
3,665,456
|
|
|
1,042,239
|
|
|
1,550,786
|
|
|
12,422,387
|
|
FINANCIAL
INCOME
|
|
|
(62,446
|
)
|
|
(97,462
|
)
|
|
(6,456
|
)
|
|
(65,323
|
)
|
|
(279,367
|
)
|
FINANCIAL
EXPENSES
|
|
|
41,771
|
|
|
33,135
|
|
|
4,597
|
|
|
11,667
|
|
|
105,202
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
BEFORE TAXES ON INCOME
|
|
|
3,309,660
|
|
|
3,601,129
|
|
|
1,040,380
|
|
|
1,497,130
|
|
|
12,248,222
|
|
TAXES
ON INCOME
|
|
|
|
|
|
37,013
|
|
|
|
|
|
20,157
|
|
|
30,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS OF THE COMPANY AND ITS CONSOLIDATED SUBSIDIARY
|
|
|
3,309,660
|
|
|
3,638,142
|
|
|
1,040,380
|
|
|
1,517,287
|
|
|
12,278,222
|
|
MINORITY
INTERESTS IN LOSSES OF SUBSIDIARY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,375
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS FOR THE PERIOD
|
|
$
|
(3,309,660
|
)
|
$
|
(3,638,142
|
)
|
$
|
(1,040,380
|
)
|
$
|
(1,517,287
|
)
|
$
|
(12,265,847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(0.07
|
)
|
$
|
(0.10
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES USED IN COMPUTING BASIC AND DILUTED
LOSS PER COMMON SHARE
|
|
|
44,958,917
|
|
|
35,744,894
|
|
|
44,958,917
|
|
|
44,846,265
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
Inception date, see note 1a.
The
accompanying notes are an integral part of the financial statements.
F-3
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY
(US
$, except share data)
|
|
Number
of
Shares
|
|
Common
Stock
Amount
|
|
Additional
paid-in
capital
|
|
Warrants
|
|
Deficit
accumulated
during
the
development
stage
|
|
Services
not yet
rendered
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes
during the period from October 6, 1998 (date of inception) to September
30, 2005 (audited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock and warrants issued for cash
|
|
57,506,498
|
|
$
|
5,750
|
|
$
|
782,141
|
|
$
|
139,494
|
|
|
|
|
|
|
$
|
927,385
|
|
Contributed
capital
|
|
|
|
|
|
|
|
7,025
|
|
|
|
|
|
|
|
|
|
|
7,025
|
|
Cancellation
of shares at June 8, 2004
|
|
(32,284,988
|
)
|
|
(3,228
|
)
|
|
3,228
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain
on issuance of subsidiary Stock to third party
|
|
|
|
|
|
|
|
86,625
|
|
|
|
|
|
|
|
|
|
|
86,625
|
|
Common
stock and warrants issued for cash on November 11, 2004, net of issuance
costs
|
|
978,000
|
|
|
97
|
|
|
766,630
|
|
|
367,892
|
|
|
|
|
|
|
|
1,134,619
|
|
Common
stock and warrants issued for cash on January 25, 2005, net of issuance
costs
|
|
32,000
|
|
|
3
|
|
|
24,760
|
|
|
12,037
|
|
|
|
|
|
|
|
36,800
|
|
Issuance
of warrants to Consultants
|
|
|
|
|
|
|
|
97,192
|
|
|
|
|
|
|
|
|
|
|
97,192
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,712,618
|
)
|
|
|
|
(1,712,618
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2005 (audited)
|
|
26,231,510
|
|
|
2,622
|
|
|
1,767,601
|
|
|
519,423
|
|
|
(1,712,618
|
)
|
|
|
|
577,028
|
|
Common
stock and warrants issued for cash on October 31, 2005, net of issuance
costs
|
|
666,666
|
|
|
67
|
|
|
365,670
|
|
|
72,410
|
|
|
|
|
|
|
|
438,147
|
|
Common
stock and warrants issued for cash on December 20, 2005, net of issuance
costs
|
|
1,555,556
|
|
|
156
|
|
|
804,998
|
|
|
269,641
|
|
|
|
|
|
|
|
1,074,795
|
|
Options
issued to employees and directors
|
|
|
|
|
|
|
|
163,517
|
|
|
|
|
|
|
|
|
|
|
163,517
|
|
Options
and warrants issued to non-employees
|
|
|
|
|
|
|
|
70,498
|
|
|
|
|
|
|
|
|
|
|
70,498
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,064,795
|
)
|
|
|
|
(2,064,795
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2006 (audited)
|
|
28,453,732
|
|
|
2,845
|
|
|
3,172,284
|
|
|
861,474
|
|
|
(3,777,413
|
)
|
|
|
|
259,190
|
|
Common
stock and warrants issued for cash on February 27, 2007, net of issuance
costs
|
|
16,250,000
|
|
|
1,625
|
|
|
3,652,640
|
|
|
2,231,459
|
|
|
|
|
|
|
|
5,885,724
|
|
Common
stock issued as part of the prepayment of the convertible promissory
note
|
|
33,753
|
|
|
3
|
|
|
13,498
|
|
|
|
|
|
|
|
|
|
|
13,501
|
|
Amendment
of warrants exercise price
|
|
|
|
|
|
|
|
(110,667
|
)
|
|
110,667
|
|
|
|
|
|
|
|
|
|
Stock
based compensation expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services
|
|
221,432
|
|
|
22
|
|
|
149,978
|
|
|
|
|
|
|
|
|
|
|
150,000
|
|
Services
not yet rendered
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,000
|
)
|
|
(20,000
|
)
|
Options
issued to employees and directors
|
|
|
|
|
|
|
|
1,713,169
|
|
|
|
|
|
|
|
|
|
|
1,713,169
|
|
Options
and warrants issued to non-employees
|
|
|
|
|
|
|
|
378,028
|
|
|
|
|
|
|
|
|
|
|
378,028
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,178,774
|
)
|
|
|
|
(5,178,774
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2007 (audited)
|
|
44,958,917
|
|
|
4,495
|
|
|
8,968,930
|
|
|
3,203,600
|
|
|
(8,956,187
|
)
|
(20,000
|
)
|
|
3,200,838
|
|
Full
accretion in respect of services not yet rendered
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000
|
|
|
20,000
|
|
Options
issued to employees and directors
|
|
|
|
|
|
|
|
458,099
|
|
|
|
|
|
|
|
|
|
|
458,099
|
|
Options
and warrants issued to non-employees
|
|
|
|
|
|
|
|
58,987
|
|
|
|
|
|
|
|
|
|
|
58,987
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,309,660
|
)
|
|
|
|
(3,309,660
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at June 30, 2008 (unaudited)
|
|
44,958,917
|
|
$
|
4,495
|
|
$
|
9,486,016
|
|
$
|
3,203,600
|
|
$
|
(12,265,847
|
)
|
|
|
$
|
428,264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of the financial statements.
F-4
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(US
dollars)
|
|
Nine
months ended
June 30,
|
|
Period
from
October 6,
1998* to
June 30,
|
|
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the period
|
|
$
|
(3,309,660
|
)
|
$
|
(3,638,142
|
)
|
$
|
(12,265,847
|
)
|
Adjustments
required to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Income
and expenses not involving cash flows:
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
10,496
|
|
|
6,225
|
|
|
25,699
|
|
Exchange
differences on long term deposits
|
|
|
588
|
|
|
|
|
|
850
|
|
Common
stock issued for services
|
|
|
20,000
|
|
|
106,001
|
|
|
166,501
|
|
Minority
interests in losses of a subsidiary
|
|
|
|
|
|
|
|
|
(12,375
|
)
|
Write
off of in process research and development
|
|
|
|
|
|
|
|
|
100,000
|
|
Employees
and consultants stock based compensation expenses
|
|
|
517,086
|
|
|
1,523,709
|
|
|
2,902,432
|
|
Increase
(Decrease) in liability for employee rights upon retirement
|
|
|
(761
|
)
|
|
24,066
|
|
|
70,577
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Increase
in prepaid expenses
|
|
|
(6,750
|
)
|
|
(32,825
|
)
|
|
(16,601
|
)
|
Decrease
(Increase) in other current assets
|
|
|
14,157
|
|
|
(8,749
|
)
|
|
(32,454
|
)
|
Increase
(Decrease) in current liabilities
|
|
|
(412,603
|
)
|
|
378,032
|
|
|
515,135
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(3,167,447
|
)
|
|
(1,641,683
|
)
|
|
(8,546,083
|
)
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Increase
in long term deposits
|
|
|
|
|
|
(1,504
|
)
|
|
(20,512
|
)
|
Funds
in respect of employee rights upon retirement
|
|
|
|
|
|
(19,111
|
)
|
|
(49,281
|
)
|
Purchase
of property and equipment
|
|
|
(19,605
|
)
|
|
(5,304
|
)
|
|
(61,146
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(19,605
|
)
|
|
(25,919
|
)
|
|
(130,939
|
)
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock and warrants net of issuance costs
|
|
|
|
|
|
5,885,724
|
|
|
9,538,553
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
|
|
|
5,885,724
|
|
|
9,538,553
|
|
|
|
|
|
|
|
|
|
|
|
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
(3,187,052
|
)
|
|
4,218,122
|
|
|
861,531
|
|
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
|
|
4,048,583
|
|
|
538,738
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
|
$
|
861,531
|
|
$
|
4,756,860
|
|
$
|
861,531
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplementary
information on investing activity not involving cash flow:
During
the second quarter approximately $50,000 funded in respect of employee rights
upon retirement, was released from the insurance company directly to
the employees.
*
Inception date, see note 1a.
The
accompanying notes are an integral part of the financial statements.
F-5
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 - GENERAL:
GammaCan
International, Inc. (a Development Stage Company) was incorporated on October
6, 1998, under the laws of the State of Delaware, under the name of San Jose
International, Inc. Unless the context indicates otherwise, references to
the
Company
refer
to GammaCan International, Inc. and its Israeli subsidiary, GammaCan Ltd
(the
Subsidiary
).
The
Company is engaged in research and development in the biotechnology field
and is considered a development stage company in accordance with Statement
of Financial Accounting Standard (
SFAS
)
No. 7
Accounting and Reporting
by Development Stage Enterprises
.
The
Companys lead product candidate, VitiGam, is an anti-cancer immunotherapy
derived entirely from the plasma of donors with vitiligo, a benign skin condition
affecting up to 2% of the general population. The Company is developing VitiGam to
treat melanoma. The Company has demonstrated that plasma from individuals
with vitiligo contains anti-melanoma activities, and the Company is seeking
to develop VitiGam for the treatment of Stage III and Stage IV melanoma.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. The Company has net losses for the period
from inception (October 6, 1998) through June 30, 2008 of $12,265,847,
as well as negative cash flow from operating activities. Based upon the Companys
existing spending commitments, the Company may not have sufficient cash resources
to meet its liquidity requirements through September 30, 2008. Accordingly,
these factors raise substantial doubt about the Companys ability to
continue as a going concern. Management is engaged in ongoing financing discussions
with third party investors and existing shareholders to raise the necessary
funds for future research and development activities and general and administrative
expenses in the public and private equity markets. Although there is no assurance
that we will be successful with these initiatives, management expects to
secure the necessary financing as a result of the above ongoing discussions.
These
financial statements do not include any adjustments that may be necessary
should the Company be unable to continue as a going concern. The Companys
continuation as a going concern is dependent on its ability to obtain additional
financing as may be required and ultimately to attain profitability.
F-6
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
1 - GENERAL
(continued):
|
b.
|
Unaudited
interim financial information
|
The
accompanying unaudited financial statements of the Company and the Subsidiary
have been prepared in accordance with accounting principles generally accepted
in the United States for interim financial information and with the instructions
to Form 10-QSB and Item 310 of Regulation S-B. Accordingly, they do not include
all of the information and footnotes required by accounting principles generally
accepted in the United States for complete financial statements. For further
information, refer to the financial statements and footnotes thereto included
in the consolidated annual report on Form 10-KSB for the year ended September
30, 2007.
In
the opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included.
Operating results for the nine-month period ended June 30, 2008, are not
necessarily indicative of the results that may be expected for the year ended
September 30, 2008.
In
June 2006, the FASB issued Interpretation No. 48,
Accounting
for Uncertainty in Income Taxes
(
FIN
48
). FIN 48 clarifies the accounting
for uncertainty in income taxes recognized in an enterprises financial
statements in accordance with Statement of Financial Accounting Standards
No. 109,
Accounting for Income
Taxes
(
FAS
109
). This interpretation prescribes
a minimum recognition threshold a tax position is required to meet before
being recognized in the financial statements. FIN 48 also provides guidance
on derecognition of tax positions, classification on the balance sheet, interest
and penalties, accounting in interim periods, disclosure, and transition.
The Company adopted FIN 48 effective October 1, 2007. FIN 48 requires significant
judgment in determining what constitutes an individual tax position as well
as assessing the outcome of each tax position. Changes in judgment as to
recognition or measurement of tax positions can materially affect the estimate
of the effective tax rate and consequently, affect the operating results
of the Company. The Company had no unrecognized tax benefits as of October
1, 2007. The result of the implementation of FIN 48 did not have any impact
on the Companys financial statements. The Company recognizes interest
and penalties related to its tax contingencies as income tax expense. As
of October 1, 2007, the Company recorded $30,000 of penalties related to
tax contingencies.
As
of October 1, 2007, the Company is subject to Israeli income tax examinations
and to U.S. Federal income tax examinations for the tax years of 2004 through
2007. As of June 30, 2008, the Company did not record any change to its unrecognized
tax benefits.
F-7
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
1 - GENERAL
(continued)
:
|
d.
|
Recently
issued accounting pronouncements
|
|
1.
|
In
September 2006, the FASB issued Statement of Financial
Accounting Standards No. 157,
Fair
Value Measurements
(
SFAS
157
). SFAS 157 defines
fair value, establishes a framework and gives guidance regarding
the methods used for measuring fair value, and expands disclosures
about fair value measurements. SFAS 157 is effective for financial
statements issued for fiscal years beginning after November 15,
2007, and interim periods within those fiscal years (October 1, 2008,
for the Company). The FASB has also issued FSP No. FAS 157-2,
Effective
Date of FASB Statement No. 157
,
which defers implementation of SFAS 157 as it relates to non-financial
assets and non-financial liabilities that are recognized and disclosed
at fair value in the financial statements on a nonrecurring basis.
The Company is currently assessing the impact that SFAS 157 may have
on its results of operations and financial position.
|
|
2.
|
In
February 2007, the FASB issued Statement of Financial
Accounting Standards No. 159,
The
Fair Value Option for Financial Assets and Financial Liabilities
- Including an amendment of FASB Statement No.
115
(
SFAS
159
). SFAS 159 is expected
to expand the use of fair value accounting but does not affect existing
standards which require certain assets or liabilities to be carried
at fair value. The objective of SFAS 159 is to improve financial
reporting by providing companies with the opportunity to mitigate
volatility in reported earnings caused by measuring related assets
and liabilities differently without having to apply complex hedge
accounting provisions. Under SFAS 159, a company may choose, at its
initial application or at other specified election dates, to measure
eligible items at fair value and report unrealized gains and losses
on items for which the fair value option has been elected in earnings
at each subsequent reporting date. SFAS 159 is effective for
financial statements issued for fiscal years beginning after November 15,
2007, and interim periods within those fiscal years (October 1, 2008,
for the Company). If a company elects the fair value option for its
existing assets and liabilities, the effect as of the adoption date,
shall be reported as a cumulative-effect adjustment to the opening
balance of retained earnings. The Company is currently assessing
the impact that SFAS 159 may have on its financial position.
|
|
3.
|
In
December 2007, the FASB issued Statement of Financial Accounting
Standards No. 141 (revised 2007),
Business
Combinations
(
SFAS
141(R)
). SFAS 141(R) changes
the accounting for business combinations, including the measurement
of acquirer shares issued in consideration for a business combination,
the recognition of contingent consideration, the accounting for contingencies,
the recognition of capitalized in-process research and development,
the accounting for acquisition-related restructuring cost accruals,
the treatment of acquisition related transaction costs and the recognition
of changes in the acquirers income tax valuation allowance
and income tax uncertainties. SFAS 141(R) applies prospectively to
business combinations for which the acquisition date is on or after
the beginning of the first annual reporting period beginning on or
after December 15, 2008. Early application is prohibited. The Company
will be required to adopt SFAS 141(R) on October 1, 2009.
|
F-8
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
1 - GENERAL
(continued)
:
|
4.
|
In
December 2007, the FASB issued SFAS No. 160,
Noncontrolling
Interests in Consolidated Financial Statements, an Amendment of ARB
No. 51
(
SFAS
160
). SFAS 160 amends
ARB 51 to establish accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a subsidiary.
An ownership interest in subsidiaries held by parties other than
the parent should be presented in the consolidated statement of financial
position within equity, but separate from the parents equity.
SFAS 160 requires that changes in a parents ownership interest
while the parent retains its controlling financial interest in its
subsidiary should be accounted for similarly as equity transactions.
When a subsidiary is deconsolidated, any retained noncontrolling
equity investment in the former subsidiary should be initially measured
at fair value, with any gain or loss recognized in earnings. SFAS
160 requires consolidated net income to be reported at amounts that
include the amounts attributable to both the parent and the noncontrolling
interest. It also requires disclosure, on the face of the consolidated
income statement, of the amounts of consolidated net income attributable
to the parent and to the noncontrolling interests. SFAS 160 is effective
for fiscal years (including interim periods within those fiscal years)
beginning on or after December 15, 2008 (October 1, 2009 for the
Company). Earlier adoption is prohibited. The statement shall be
applied prospectively as of the beginning of the fiscal year in which
it is initially applied, except for the presentation and disclosure
requirement which shall be applied retrospectively for all periods
presented. The Company is currently evaluating the impact SFAS 160
will have on its consolidated financial statements.
|
|
5.
|
In
June 2007, the Emerging Issues Task Force (EITF) issued Issue No.
07-03,
Accounting for Nonrefundable Advance Payments for
Goods or Services Received to Be Used in Future Research and Development
Activities
(
EITF No. 07-03
). EITF No.
07-03 requires that nonrefundable advance payments for goods or services
that will be used or rendered for future research and development
activities be deferred and amortized over the period that the goods
are delivered or the related services are performed, subject to an
assessment of recoverability. The provisions of EITF 07-03 will be
effective for financial statements issued for fiscal years beginning
after December 15, 2007, and interim periods within those fiscal
years (October 1, 2008, for the Company). The provisions of EITF
No. 07-03 are applicable for new contracts entered into on or after
the effective date. Earlier application is not permitted. The Company
is currently evaluating the impact EITF 07-03 will have on its consolidated
financial statements.
|
F-9
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
1 - GENERAL
(continued)
:
|
6.
|
In
December 2007, the FASB ratified EITF Issue No. 07-01,
Accounting
for Collaborative Arrangements
(
EITF
07-01
). EITF 07-01
defines collaborative arrangements and establishes reporting requirements
for transactions between participants in a collaborative arrangement
and between participants in the arrangement and third parties. EITF
07-01 also establishes the appropriate income statement presentation
and classification for joint operating activities and payments between
participants, as well as the sufficiency of the disclosures related
to these arrangements. EITF 07-01 is effective for fiscal years beginning
after December 15, 2008 (October 1, 2009, for the Company). EITF
07-01 shall be applied using modified version of retrospective transition
for those arrangements in place at the effective date. An entity
should report the effects of applying this Issue as a change in accounting
principle through retrospective application to all prior periods
presented for all arrangements existing as of the effective date,
unless it is impracticable to apply the effects of the change
retrospectively. The Company is currently assessing the impact that
EITF 07-01 may have on its results of operations and financial position.
|
|
7.
|
In
March 2008, the FASB issued SFAS Statement No. 161
Disclosures
about Derivative Instruments and Hedging Activities
(
SFAS
No. 161
). The new standard
is intended to improve financial reporting about derivative instruments
and hedging activities by requiring enhanced disclosures to enable
investors to better understand their effects on an entitys
financial position, financial performance, and cash flows. It is
effective for financial statements issued for fiscal years and interim
periods beginning after November 15, 2008, with early application
encouraged (October 1, 2009, for the Company). The new standard also
improves transparency about the location and amounts of derivative
instruments in an entitys financial statements; how derivative
instruments and related hedged items are accounted for under SFAS
No. 133
Accounting for
Derivative Instruments and Hedging Activities
(
SFAS
No. 133
); and how derivative
instruments and related hedged items affect its financial position,
financial performance, and cash flows. The Company is currently evaluating
the effect SFAS No. 161 will have on its financial statement presentations.
|
|
8.
|
In
May 2008, the FASB issued SFAS No. 162,
The
Hierarchy of Generally Accepted Accounting Principles
.
The statement is intended to improve financial reporting by identifying
a consistent hierarchy for selecting accounting principles to be
used in preparing financial statements that are presented in conformity
with U.S. generally accepted accounting principles (GAAP). SFAS 162
is effective 60 days following the SECs approval of the Public
Company Accounting Oversight Board Auditing amendments to AU Section
411,
The Meaning of
Present Fairly in Conformity with Generally Accepted Accounting Principles
.
The Company does not expect the adoption of SFAS 162 to have
a material impact on its results of operations, financial position
or cash flows.
|
F-10
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - COMMITMENTS:
|
a.
|
On
December 13, 2007, the Company entered into a Share Purchase Agreement
effective as of November 26, 2007 with ARP Biomed, Ltd. (
ARP
).
The Share Purchase Agreement provided that subject to fulfillment
of certain closing conditions, including the receipt of an Israeli
tax ruling, ARP will sell to the Company 12.5% of the issued and
outstanding shares of the Subsidiary such that at closing the Company
will own 100% of the issued and outstanding shares of the Subsidiary.
In consideration for such sale, the Company originally agreed to
issue to ARP, at closing, 2,697,535 shares of its common stock, valued
at $1,348,768, calculated based upon the average of the closing price
for the period which is two days before and after November 26, 2007,
a warrant to acquire 1,123,973 shares of its common stock and an
additional warrant to acquire 449,589 shares of its common stock.
The Share Purchase Agreement was subsequently amended on August 11,
2008. (See Note 5).
|
|
b.
|
On
May 30, 2008, the Subsidiary entered into a Contract Manufacture
Agreement (
Contract
Manufacture Agreement
)
with Bio Products Laboratory (BPL). Under the terms of
the Contract Manufacture Agreement, the Subsidiary is engaging BPL
as its manufacturer of VitiGam from plasma derived from Vitiligo
donors. The Contract Manufacture Agreement further provides that
BPL will manufacture VitiGam utilizing its proprietary GAMMAPLEX
process and will supply the Subsidiary with VitiGam for its
immediate clinical testing needs and for future commercial sale.
In addition, the agreement provides that BPL will make available
to the Subsidiary technical, scientific and other data, including
specific support for its U.S. regulatory filings and future regulatory
approvals in other markets. Under the terms of the agreement, the
Subsidiary has agreed to pay to BPL certain manufacturing and service
fees as well as royalties for the manufacture of VitiGam.
|
NOTE
3 - STOCK BASED COMPENSATION:
The
following is a transaction that took place during the quarter ended June
30, 2008:
On
April 10, 2008, options to purchase 50,000 shares of the Companys common
stock were granted under the Companys 2007 Global Share Option Plan
to an employee. The options are exercisable at $0.37 per share (equivalent
to the traded market price on the date of grant) with one third vesting on
each of the first, second and third anniversary of the date of grant. The
fair value of these options on the date of grant was $12,332, using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0% for all years; expected volatility of 82%; risk-free
interest rates of 2.66%; and expected lives of 5.02 years.
NOTE
4 - LOSS PER SHARE:
The
total number of common stock options and warrants excluded from the calculations
of diluted net loss was 25,022,558 for the nine months ended June 30, 2008
(25,062,558 for the nine months ended June 30, 2007).
F-11
GAMMACAN
INTERNATIONAL, INC.
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
5 SUBSEQUENT EVENTS:
On
August 11, 2008, the Company entered into an Amendment Agreement with ARP
Biomed, Ltd. (
ARP
)
made as of June, 2008 (the
Amendment
Agreement
) amending, among
other things the Share Purchase Agreement dated November 26, 2007 between
the Company and ARP. The Share Purchase Agreement provided that subject to
fulfillment of certain closing conditions, including the receipt of an Israeli
tax ruling, ARP will sell to the Company 12.5% of the issued and outstanding
shares of the Subsidiary such that at closing the Company will own 100% of
the issued and outstanding shares of the Subsidiary. In consideration for
such sale, the Company originally agreed to issue to ARP, at closing, 2,697,535
shares of its common stock, a warrant to acquire 1,123,973 shares of its
common stock and an additional warrant to acquire 449,589 shares of its common
stock. According to the Amendment Agreement, the number of shares of common
stock issuable to ARP at closing and upon receipt of an Israeli tax ruling
has been increased to 3,389,902 shares of common stock and no warrants will
be issued. Subsequently, on August 13, 2008, the Company conducted a closing
of the Share Purchase Agreement as amended by the Amendment Agreement. The
acquisition is to be accounted for by the purchase method. The purchase price
will be allocated to in-process research and development.
F-12
|
|
|
|
|
|
|
|
|
Kesselman & Kesselman
|
|
Certified
Public Accountants (Isr.)
|
|
Trade
Tower, 25 Hamered Street
|
|
Tel
Aviv 68125 Israel
|
|
P.O
Box 452 Tel Aviv 61003
|
|
Telephone
+972-3-7954555
|
|
Facsimile
+972-3-7954556
|
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Shareholders of
GammaCan International, Inc.
(A Development Stage Company)
We have audited the accompanying consolidated balance sheets
of GammaCan International, Inc. (A Development Stage Company) and its subsidiary
(the
Company
) as of September 30, 2007 and 2006, and the
related consolidated statements of operations, changes in stockholders equity
and cash flows for each of the two years then ended and cumulatively, for
the period from October 1, 2003 to September 30, 2007. These financial statements
are the responsibility of the Companys management. Our responsibility
is to express an opinion on these financial statements based on our audits.
We did not audit the cumulative totals of the Company for the period from
October 6, 1998 (date of incorporation) to September 30, 2003, which totals
reflect a deficit of $15,640 accumulated during the development stage. Those
cumulative totals were audited by other independent auditors, whose report,
dated November 17, 2003, expressed an unqualified opinion on the cumulative
amounts but included an emphasis of a matter. Our opinion, insofar as it
relates to amounts included for that period is based on the report of the
other independent auditors.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement.
An audit includes examining, on a test basis, evidence supporting the amounts
and disclosures in the financial statements. An audit also includes assessing
the accounting principles used and significant estimates made by management,
as well as evaluating the overall financial statement presentation. We believe
that our audits provide a reasonable basis for our opinion.
In our opinion, based upon our audits and the report of the other
independent auditors, the consolidated financial statements referred to above
present fairly, in all material respects, the consolidated financial position
of the Company as of September 30, 2007 and 2006, and the consolidated results
of their operations and their cash flows for each of the years then ended
and cumulatively, for the period from October 1, 2003 to September 30, 2007,
in conformity with accounting principles generally accepted in the United
States of America.
As discussed in Note 1m to the financial statements, effective
October 1, 2006 the Company changed its method of accounting for stock-based
payment to conform with FASB Statement of Financial Accounting Standards
No. 123 (revised 2004),
Share-based Payment
.
The accompanying financial statements have been prepared assuming
that the Company will continue as a going concern. As discussed in Note 1
to the financial statements, the Company has net losses for the period from
inception (October 6, 1998) through September 30, 2007 of $8,956,187 and
presently the Company does not have sufficient cash resources to meet its
requirements in the twelve months following October 1, 2007. These reasons
raise substantial doubt about its ability to continue as a going concern.
Managements plans in regard to these matters are also described in
Note 1a. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Kesselman & Kesselman
Tel Aviv, Israel
December 28, 2007
F-13
ARMANDO C. IBARRA
Certified Public Accountants
A Professional Corporation
|
|
|
Armando C. Ibarra, C.P.A.
|
|
Members of the California Society of Certified
Public Accountants
|
Armando Ibarra, Jr., C.P.A., JD
|
|
Members of the American Institute of Certified
Public Accountants
|
|
Members of the Better Business
Bureau since 1997
|
INDEPENDENT AUDITORS REPORT
To the Board of Directors of
San Jose International, Inc.
(A Development Stage Company)
We have audited the statements of operations, changes in stockholders equity
and cash flows for the period from October 6, 1998 (date of inception) through
September 30, 2003 of San Jose International, Inc. (A Development Stage Company).
These financial statements are the responsibility of the Companys management.
Our responsibility is to express an opinion on these financial statements
based on our audit.
We conducted our audits in accordance with auditing standards
generally accepted in the 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 audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present
fairly, in all material respects, the results of operations and cash flows
of San Jose International, Inc. for the period from October 6, 1998 (date
of inception) through September 30, 2003 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 Note 1 to the
financial statements, the Company has had significant losses since inception.
This condition raises substantial doubt as to its ability to continue as
a going concern. Managements plans regarding those matters are also
described in Note 1. These financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
|
|
|
/s/ Armando C. Ibarra, CPA-APC
|
|
|
|
Armando C. Ibarra, CPA-APC
|
November 17, 2003
Chula Vista, California
371 E Street, Chula Vista, CA 91910 Tel: (619) 422-1348
Fax: (619) 422-1465
F-14
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
A s s
e t s
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
4,048,583
|
|
$
|
538,738
|
|
Prepaid
expenses
|
|
|
9,851
|
|
|
|
|
Other
|
|
|
47,271
|
|
|
12,494
|
|
|
|
|
|
|
|
|
|
T
o t a l current assets
|
|
|
4,105,705
|
|
|
551,232
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FUNDS IN RESPECT OF EMPLOYEE RIGHTS
UPON RETIREMENT (Note 2)
|
|
|
49,281
|
|
|
21,071
|
|
|
|
|
|
|
|
|
|
LONG TERM DEPOSITS
(Note 3)
|
|
|
18,590
|
|
|
22,270
|
|
|
|
|
|
|
|
|
|
PROPERTY AND EQUIPMENT, NET
(Note
4)
|
|
|
26,338
|
|
|
25,247
|
|
|
|
|
|
|
|
|
|
T
o t a l assets
|
|
$
|
4,199,914
|
|
$
|
619,820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders equity
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
797,515
|
|
$
|
279,857
|
|
Payroll
and related accruals
|
|
|
130,223
|
|
|
49,242
|
|
|
|
|
|
|
|
|
|
T
o t a l current liabilities
|
|
|
927,738
|
|
|
329,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT
(Note
2)
|
|
|
71,338
|
|
|
31,531
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
(Note 5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS
EQUITY:
|
|
|
|
|
|
|
|
Preferred
stock, $0.0001 par value (20,000,000 shares authorized; none issued
and outstanding)
|
|
|
|
|
|
|
|
Common
stock, $0.0001 par value (100,000,000 authorized shares; 44,958,917
and 28,453,732 shares issued and outstanding as of September 30, 2007
and 2006, respectively)
|
|
|
4,495
|
|
|
2,845
|
|
Additional
paid-in capital
|
|
|
8,968,930
|
|
|
3,172,284
|
|
Warrants
|
|
|
3,203,600
|
|
|
861,474
|
|
Deficit
accumulated during the development stage
|
|
|
(8,956,187
|
)
|
|
(3,777,413
|
)
|
Services
not yet rendered
|
|
|
(20,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
T
o t a l stockholders equity
|
|
|
3,200,838
|
|
|
259,190
|
|
|
|
|
|
|
|
|
|
T
o t a l liabilities and stockholders
equity
|
|
$
|
4,199,914
|
|
$
|
619,820
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of
the financial statements.
F-15
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(US $, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
from
October 6,
1998* to
September 30
2007
|
|
|
|
|
|
|
|
|
Year
ended
September 30
|
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RESEARCH
AND DEVELOPMENT COSTS
(Note 10)
|
|
$
|
1,198,004
|
|
$
|
802,254
|
|
$
|
2,713,178
|
|
GENERAL
AND ADMINISTRATIVE EXPENSES
(Note 11)
|
|
|
4,090,163
|
|
|
1,263,070
|
|
|
6,378,874
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
|
5,288,167
|
|
|
2,065,324
|
|
|
9,092,052
|
|
FINANCIAL
INCOME
|
|
|
(152,088
|
)
|
|
(44,130
|
)
|
|
(216,921
|
)
|
FINANCIAL
EXPENSES
|
|
|
41,317
|
|
|
14,979
|
|
|
63,431
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
BEFORE TAXES ON INCOME
|
|
|
5,177,396
|
|
|
2,036,173
|
|
|
8,938,562
|
|
TAXES
ON INCOME
(Note 9)
|
|
|
1,378
|
|
|
28,622
|
|
|
30,000
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS OF THE COMPANY AND ITS CONSOLIDATED SUBSIDIARY
|
|
|
5,178,774
|
|
|
2,064,795
|
|
|
8,968,562
|
|
|
|
|
|
|
|
|
|
|
|
|
MINORITY
SHARE IN LOSSES OF A SUBSIDIARY
|
|
|
|
|
|
|
|
|
(12,375
|
)
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS FOR THE PERIOD
|
|
$
|
(5,178,774
|
)
|
$
|
(2,064,795
|
)
|
$
|
(8,956,187
|
)
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(0.14
|
)
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES USED IN COMPUTING BASIC AND DILUTED
LOSS PER COMMON SHARE
|
|
|
38,043,043
|
|
|
28,052,065
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Incorporation date, see Note 1a.
The accompanying notes are an integral part of
the financial statements.
F-16
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CHANGES
IN STOCKHOLDERS EQUITY
(US $, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Shares
|
|
Common
Stock
Amount
|
|
Warrants
|
|
Additional
paid-in
capital
|
|
Deficit
accumulated
during
the
development
stage
|
|
Services
not yet
rendered
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes
during the period from October 6, 1998 (date of incorporation) to
September 30, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock and warrants issued for cash
|
|
|
57,506,498
|
|
$
|
5,750
|
|
$
|
139,494
|
|
$
|
782,141
|
|
$
|
|
|
$
|
|
|
$
|
927,385
|
|
Contributed
capital
|
|
|
|
|
|
|
|
|
|
|
|
7,025
|
|
|
|
|
|
|
|
|
7,025
|
|
Cancellation
of shares at June 8, 2004
|
|
|
(32,284,988
|
)
|
|
(3,228
|
)
|
|
|
|
|
3,228
|
|
|
|
|
|
|
|
|
|
|
Gain
on issuance of subsidiary stock to third party
|
|
|
|
|
|
|
|
|
|
|
|
86,625
|
|
|
|
|
|
|
|
|
86,625
|
|
Stock
based compensation
|
|
|
|
|
|
|
|
|
|
|
|
62,600
|
|
|
|
|
|
|
|
|
62,600
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(514,086
|
)
|
|
|
|
|
(514,086
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2004
|
|
|
25,221,510
|
|
|
2,522
|
|
|
139,494
|
|
|
941,619
|
|
|
(514,086
|
)
|
|
|
|
|
569,549
|
|
Common
stock and warrants issued for cash on November 11, 2004, net of issuance
costs
|
|
|
978,000
|
|
|
97
|
|
|
367,892
|
|
|
766,630
|
|
|
|
|
|
|
|
|
1,134,619
|
|
Common
stock and warrants issued for cash on January 25, 2005, net of issuance
costs
|
|
|
32,000
|
|
|
3
|
|
|
12,037
|
|
|
24,760
|
|
|
|
|
|
|
|
|
36,800
|
|
Issuance
of warrants to consultants
|
|
|
|
|
|
|
|
|
|
|
|
34,592
|
|
|
|
|
|
|
|
|
34,592
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,198,532
|
)
|
|
|
|
|
(1,198,532
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2005
|
|
|
26,231,510
|
|
|
2,622
|
|
|
519,423
|
|
|
1,767,601
|
|
|
(1,712,618
|
)
|
|
|
|
|
577,028
|
|
Common
stock and warrants issued for cash on October 31, 2005, net of issuance
costs
|
|
|
666,666
|
|
|
67
|
|
|
72,410
|
|
|
365,670
|
|
|
|
|
|
|
|
|
438,147
|
|
Common
stock and warrants issued for cash on December 20, 2005, net of issuance
costs
|
|
|
1,555,556
|
|
|
156
|
|
|
269,641
|
|
|
804,998
|
|
|
|
|
|
|
|
|
1,074,795
|
|
Options
issued to employees and directors
|
|
|
|
|
|
|
|
|
|
|
|
163,517
|
|
|
|
|
|
|
|
|
163,517
|
|
Options
and warrants issued to non-employees
|
|
|
|
|
|
|
|
|
|
|
|
70,498
|
|
|
|
|
|
|
|
|
70,498
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,064,795
|
)
|
|
|
|
|
(2,064,795
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2006
|
|
|
28,453,732
|
|
|
2,845
|
|
|
861,474
|
|
|
3,172,284
|
|
|
(3,777,413
|
)
|
|
|
|
|
259,190
|
|
Common
stock and warrants issued for cash on February 27, 2007, net of issuance
costs
|
|
|
16,250,000
|
|
|
1,625
|
|
|
2,231,459
|
|
|
3,652,640
|
|
|
|
|
|
|
|
|
5,885,724
|
|
Common
stock issued as part of the prepayment of the convertible promissory
note*
|
|
|
33,753
|
|
|
3
|
|
|
|
|
|
13,498
|
|
|
|
|
|
|
|
|
13,501
|
|
Amendment
of warrants exercise price
|
|
|
|
|
|
|
|
|
110,667
|
|
|
(110,667
|
)
|
|
|
|
|
|
|
|
|
|
Stock
based compensation expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services
|
|
|
221,432
|
|
|
22
|
|
|
|
|
|
149,978
|
|
|
|
|
|
|
|
|
150,000
|
|
Services
not yet rendered **
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,000
|
)
|
|
(20,000
|
)
|
Options
issued to employees and directors
|
|
|
|
|
|
|
|
|
|
|
|
1,713,169
|
|
|
|
|
|
|
|
|
1,713,169
|
|
Options
and warrants issued to non-employees
|
|
|
|
|
|
|
|
|
|
|
|
378,028
|
|
|
|
|
|
|
|
|
378,028
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,178,774
|
)
|
|
|
|
|
(5,234,274
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2007
|
|
|
44,958,917
|
|
$
|
4,495
|
|
$
|
3,203,600
|
|
$
|
8,968,930
|
|
$
|
(8,956,187
|
)
|
$
|
(20,000
|
)
|
$
|
3,200,838
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* See Note 6
** See Note 8(v)
The accompanying notes are an integral part of
the financial statements.
F-17
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
C
ONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
September 30
|
|
Period from
October 6,
1998* to
September 30,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the period
|
|
$
|
(5,178,774
|
)
|
$
|
(2,064,795
|
)
|
$
|
(8,956,187
|
)
|
Adjustments
required to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Income
and expenses not involving cash flows:
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
8,311
|
|
|
4,299
|
|
|
15,203
|
|
Exchange
differences on long term deposits
|
|
|
310
|
|
|
(48
|
)
|
|
262
|
|
Common
stock issued for services
|
|
|
143,501
|
|
|
|
|
|
146,501
|
|
Minority
share in losses of a subsidiary
|
|
|
|
|
|
|
|
|
(12,375
|
)
|
Write
off of in process research and development
|
|
|
|
|
|
|
|
|
100,000
|
|
Employees
and consultants stock based compensation expenses
|
|
|
2,091,197
|
|
|
196,957
|
|
|
2,385,346
|
|
Increase
in liability for employee rights upon retirement
|
|
|
39,807
|
|
|
17,806
|
|
|
71,338
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Decrease
(increase) in prepaid expenses
|
|
|
(9,851
|
)
|
|
6,416
|
|
|
(9,851
|
)
|
Decrease
(increase) in other current assets
|
|
|
(29,592
|
)
|
|
9,535
|
|
|
(45,611
|
)
|
Increase
in current liabilities
|
|
|
598,639
|
|
|
155,065
|
|
|
926,738
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(2,336,452
|
)
|
|
(1,674,765
|
)
|
|
(5,378,636
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Increase
in long term deposits
|
|
|
(1,815
|
)
|
|
(17,019
|
)
|
|
(20,512
|
)
|
Funds
in respect of employee rights upon retirement
|
|
|
(28,210
|
)
|
|
(13,543
|
)
|
|
(49,281
|
)
|
Purchase
of property and equipment
|
|
|
(9,402
|
)
|
|
(19,277
|
)
|
|
(41,541
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(39,427
|
)
|
|
(49,839
|
)
|
|
(111,334
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock and warrants net of issuance costs
|
|
|
5,885,724
|
|
|
1,550,000
|
|
|
9,538,553
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
5,885,724
|
|
|
1,550,000
|
|
|
9,538,553
|
|
|
|
|
|
|
|
|
|
|
|
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
3,509,845
|
|
|
(174,604
|
)
|
|
4,048,583
|
|
BALANCE
OF CASH AND CASH EQUIVALENTS
AT BEGINNING OF PERIOD
|
|
|
538,738
|
|
|
713,342
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
|
$
|
4,048,583
|
|
$
|
538,738
|
|
$
|
4,048,583
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental information on financing activities not involving
cash flow issuance costs paid by a grant of warrants to third parties
who assisted in securing subscription agreements totaled $37,058 for the
year ended September 30, 2006.
* Incorporation date, see Note 1a.
The accompanying notes are an integral part of
the financial statements.
F-18
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:
|
|
|
|
a.
|
General:
|
|
|
|
|
GammaCan International, Inc. (A Development
Stage Company) was incorporated on October 6, 1998, under the laws
of the State of Delaware, under the name of San Jose International,
Inc. Unless the context indicates otherwise, references to the
Company
refer to GammaCan International, Inc. and its
Israeli subsidiary, GammaCan Ltd (the
Subsidiary
).
|
|
|
|
|
|
The Company is engaged in research and development
in the biotechnology field and is considered a development stage company
in accordance with Statement of Financial Accounting Standard (
SFAS
)
No. 7
Accounting and Reporting by Development Stage Enterprises
.
|
|
|
|
|
|
The Companys lead product candidate,
VitiGam, is an anti-cancer immunotherapy derived entirely from
the plasma of donors with vitiligo, a benign skin condition affecting
up to 2% of the general population. The Company is developing VitiGam to
treat melanoma. The Company has demonstrated that plasma from individuals
with vitiligo contains anti-melanoma activities, and the Company is
seeking to develop VitiGam for the treatment of Stage III and
Stage IV melanoma.
|
|
|
|
|
|
The accompanying financial statements have
been prepared assuming that the Company will continue as a going concern.
The Company has net losses for the period from inception (October 6,
1998) through September 30, 2007 of $8,956,187, as well as negative
cash flow from operating activities. Presently, the Company does not
have sufficient cash resources to meet its requirements in the twelve
months following October 1, 2007. These factors raise substantial doubt
about the Companys ability to continue as a going concern. Management
is in the process of evaluating various financing alternatives as the
Company will need to finance future research and development activities
and general and administrative expenses through fund raising in the
public or private equity markets. Although there is no assurance that
the Company will be successful with those initiatives, management is
confident that it will be able to secure the necessary financing as
a result of ongoing financing discussions with third party investors
and existing shareholders.
|
|
|
|
|
|
These financial statements do not include
any adjustments that may be necessary should the Company be unable
to continue as a going concern. The Companys continuation as
a going concern is dependent on its ability to obtain additional financing
as may be required and ultimately to attain profitability.
|
F-19
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
|
|
|
|
|
b.
|
Accounting principles
|
|
|
|
|
|
The consolidated financial statements
have been prepared in accordance with generally accepted accounting
principles in the United States of America (
U.S. GAAP
).
|
|
|
|
|
c.
|
Use of estimates in the preparation
of financial statements
|
|
|
|
|
|
The preparation of the financial
statements in conformity with U.S. GAAP 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 financial statement date and the reported expenses during the
reporting periods. Actual results could differ from those estimates.
|
|
|
|
|
d.
|
Functional currency
|
|
|
|
|
|
The currency of the primary economic
environment in which the operations of the Company are conducted is
the U.S. dollar (
$
or
dollar
).
|
|
|
|
|
|
Most of the Companys research
and development costs are incurred in dollars. A significant part of
the Companys capital expenditures and most of its financing is
in dollars. Thus, the functional currency of the Company is the dollar.
|
|
|
|
|
|
Transactions and balances originally
denominated in dollars are presented at their original amounts. Balances
in foreign currencies are translated into dollars using historical
and current exchange rates for non-monetary and monetary balances,
respectively. For foreign transactions and other items reflected in
the statements of operations, the following exchange rates are used:
(1) for transactions exchange rates at transaction dates or
average rates and (2) for other items (derived from non-monetary balance
sheet items such as depreciation) historical exchange rates.
The resulting transaction gains or losses are carried to financial
income or expenses, as appropriate.
|
|
|
|
|
e.
|
Principles of consolidation
|
|
|
|
|
|
The consolidated financial statements
include the accounts of GammaCan International, Inc. and its Israeli
subsidiary GammaCan Ltd. All material inter-company transactions and
balances have been eliminated in consolidation.
|
|
|
|
|
f.
|
Property and equipment
|
|
|
|
|
|
Property and equipment are recorded
at cost and depreciated by the straight-line method over the estimated
useful lives of the assets.
|
|
|
|
Annual rates of depreciation are
as follows:
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
|
Computers and peripheral
equipment
|
33
|
|
|
|
Office furniture and equipment
|
6-15
|
|
F-20
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
|
|
|
g.
|
Deferred taxes
|
|
|
|
|
|
Deferred taxes are determined utilizing the
assets and liabilities method based on the estimated future tax effects
of differences between the financial accounting and tax bases of assets
and liabilities under the applicable tax laws. Deferred tax balances
are computed using the tax rates expected to be in effect when those
differences reverse. A valuation allowance in respect of deferred tax
assets is provided if, based upon the weight of available evidence,
it is more likely than not that some or all of the deferred tax assets
will not be realized. The Company has provided a full valuation allowance
with respect to its deferred tax assets.
|
|
|
|
|
|
Regarding the Subsidiary, paragraph 9(f) of
FAS 109,
Accounting for Income Taxes
, prohibits
the recognition of deferred tax liabilities or assets that arise from
differences between the financial reporting and tax bases of assets
and liabilities that are measured from the local currency into dollars
using historical exchange rates, and that result from changes in exchange
rates or indexing for tax purposes. Consequently, the abovementioned
differences were not reflected in the computation of deferred tax assets
and liabilities.
|
|
|
|
|
h.
|
Research and development
|
|
|
|
|
|
Research and development costs are expensed
as incurred.
|
|
|
|
|
|
Acquisition of in process research and development
and the costs of registration of patents that have not yet reached
technological feasibility, have no alternative future use, are expensed
as incurred.
|
|
|
|
|
i.
|
Cash equivalents
|
|
|
|
|
|
The Company considers all short term, highly
liquid investments, which include short-term deposits with original
maturities of three months or less from the date of purchase that are
not restricted as to withdrawal or use and are readily convertible
to known amounts of cash, to be cash equivalents.
|
|
|
|
|
j.
|
Comprehensive loss
|
|
|
|
|
|
The Company has no other comprehensive loss
components other than net loss for the reported periods.
|
|
|
|
|
k.
|
Loss per share
|
|
|
|
|
|
Basic and diluted net losses per share of
common stock are computed by dividing the net loss for the period by
the weighted average number of shares of common stock outstanding during
the period. Outstanding stock options and warrants have been excluded
from the calculation of the diluted loss per share because all such
securities are anti-dilutive for all periods presented. The total number
of common stock options and warrants excluded from the calculation
of diluted net loss was 25,062,558 for the year ended September 30,
2007 (5,917,775 for the year ended September 30, 2006).
|
F-21
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
|
|
|
l.
|
Impairment in value of long-lived assets
|
|
|
|
|
|
The Company reviews long-lived assets, to
be held and used, for impairment whenever events or changes in circumstances
indicate that the carrying amount of the assets may not be recoverable.
In the event the sum of the expected future cash flows (undiscounted
and without interest charges) of the long-lived assets is less than
the carrying amount of such assets, an impairment loss would be recognized,
and the assets are written down to their estimated fair values.
|
|
|
|
|
m.
|
Stock based compensation
|
|
|
|
|
|
Until September 30, 2006, the Company accounted
for employees share-based payment under the intrinsic value model
in accordance with Accounting Principles Board Opinion No. 25 -
Accounting
for Stock Issued to Employees
(
APB 25
)
and related interpretations. In accordance with Statement of Financial
Accounting Standards No. 123 -
Accounting for Stock-Based
Compensation
(
FAS 123
), as amended by
Statement of Financial Accounting Standards No. 148,
Accounting
for Stock-Based Compensation - Transition and Disclosure
,
the Company disclosed pro forma information, assuming the Company had
accounted for employees share-based payments using the fair value-based
method defined in FAS 123.
|
|
|
|
|
|
Effective October 1, 2006, the Company adopted
Statement of Financial Accounting Standards No. 123 (revised 2004),
Share-based
Payment
(
FAS 123(R)
). FAS 123(R) supersedes
APB 25 and related interpretations and amends Statement of Financial
Accounting Standards No. 95,
Statement of Cash Flows
(
FAS
95
). FAS 123(R) requires awards classified as equity awards
be accounted for using the grant-date fair value method. The fair value
of share-based payment transactions is recognized as expense over the
requisite service period, net of estimated forfeitures. The Company
estimated forfeitures based on historical experience and anticipated
future conditions.
|
|
|
|
|
|
|
|
|
In March 2005, the Securities and Exchange
Commission issued Staff Accounting Bulletin No. 107 (
SAB 107
).
SAB 107 provides supplemental implementation guidance on FAS 123(R),
including guidance on valuation methods, inventory capitalization of
share-based compensation cost, income statement effects, disclosures
and other issues. SAB 107 requires share-based payment to be classified
in the same expense line items as cash compensation. The Company has
applied the provisions of SAB 107 in its adoption of FAS 123(R).
|
|
|
|
|
|
The Company elected to recognize compensation
cost for an award with only service conditions that has a graded vesting
schedule using the accelerated method based on multiple option award
approach
.
|
F-22
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
|
|
|
|
FAS 123(R) applies to all awards granted or
modified after the Statements effective date. In addition, compensation
cost for the unvested portion of previously granted awards that remain
outstanding on the Statements effective date shall be recognized
on or after the effective date, as the related services are rendered,
based on the awards grant-date fair value as previously calculated
for the pro-forma disclosure under FAS 123.
|
|
|
|
|
|
The Company elected to adopt the modified
prospective application transition method, as permitted by the Statement.
Under such transition method, upon the adoption of FAS 123(R), the
Companys financial statements for periods prior to the effective
date of the Statement are not restated.
|
|
|
|
|
|
Costs incurred in respect of stock based compensation
for years ended September 30, 2007 and 2006 were $1,713,169 and $163,517,
respectively.
|
|
|
|
|
|
The Company accounts for equity instruments
issued to third party service providers (non-employees) in accordance
with the fair value based on an option-pricing model or when more reliability
is based on the fair value of the services received, pursuant to the
guidance in EITF 96-18
Accounting for Equity Instruments That
Are Issued to Other Than Employees for Acquiring, or in Conjunction
with Selling Goods or Services
. The fair value of the options
granted is revalued over the related service periods and recognized
using the accelerated method.
|
|
|
|
|
|
The Company recorded stock compensation of
$508,028 and $33,440 during the years ended September 2007 and 2006
respectively, related to consulting services.
|
|
|
|
|
|
The following table illustrates the pro-forma
effect on net loss and loss per common share assuming the Company had
applied the fair value recognition provisions of FAS 123 to its stock-based
employee compensation:
|
|
|
|
|
|
|
|
Year ended
September 30
2006
|
|
|
|
|
|
|
|
|
|
|
Net loss as reported
|
|
$
|
(2,064,795
|
)
|
Add
back: Stock based employee compensation expense included in net loss
as reported
|
|
|
163,517
|
|
Deduct:
pro forma stock based employee compensation expense determined under
fair value method for all awards
|
|
|
(1,107,201
|
)
|
Recognize
the reversal of the pro forma stock based employee compensation expense
determined under fair value method due to forfeiture of awards granted
to employees
|
|
|
79,676
|
|
|
|
|
|
|
Pro forma net loss
|
|
$
|
(2,928,803
|
)
|
|
|
|
|
|
Net loss per common share:
|
|
|
|
|
Basic and diluted loss per shares - as
reported
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
Basic
and diluted loss per shares - pro forma
|
|
$
|
(0.10
|
)
|
|
|
|
|
|
F-23
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
The fair value of each option grant is estimated
on the date of grant using the Black Scholes option-pricing model with
the following weighted average assumptions:
|
|
|
|
|
|
|
|
For options
granted in
year ended September 30
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
Expected option life (years)
|
|
5.47-7.88
|
|
7.85
|
Expected stock price volatility
|
|
85.0%-89.9%
|
|
80.0%-85.1%
|
Risk free interest rate
|
|
4.23%-4.68%
|
|
4.5%
|
Expected dividend yield
|
|
0.0%
|
|
0.0%
|
|
|
|
|
|
n.
|
Newly issued and recently adopted
accounting pronouncements:
|
|
|
|
|
|
|
1)
|
In September 2006, the Securities and Exchange
Commission issued Staff Accounting Bulletin No. 108,
Considering
the Effects of Prior Year Misstatements when Quantifying Misstatements
in Current Year Financial Statements
(
SAB 108
),
which provides interpretive guidance on the consideration of the effects
of prior year misstatements in quantifying current year misstatements
for the purpose of a materiality assessment. SAB 108 is effective for
fiscal years ending after November 15, 2006 (September 30, 2007 for
the Company). The Company adopted SAB 108 in these financial statements
and accordingly, follows SAB 108 requirements when quantifying financial
statement misstatements. The adoption of SAB No.108 did not result
in corrections of the Companys financial statements.
|
|
|
|
|
|
|
2)
|
In July 2006, the FASB issued FASB Interpretation
No. 48
Accounting for Uncertainty in Income Taxes - an interpretation
of FASB Statement 109
(
FIN 48
). FIN 48
prescribes a comprehensive model for recognizing, measuring and presenting
in the financial statements tax positions taken or expected to be taken
on a tax return. This Interpretation also provides guidance on derecognition,
classification, interest and penalties and disclosure requirements
for uncertain tax positions. FIN 48 is effective for fiscal years beginning
on or after December 15, 2006 (October 1, 2007, for the Company). The
provisions of FIN 48 shall be applied to all tax positions upon initial
adoption of this Interpretation. Only tax positions that meet the more
likely than not recognition threshold at the effective date may be
recognized or continue to be recognized upon adoption of this Interpretation.
The cumulative effects, if any, of applying this Interpretation will
be recorded as an adjustment to retained earnings. The Company is currently
assessing this standard effect on its financial statements in future
periods.
|
|
|
|
|
|
|
3)
|
In September 2006, the FASB issued Statement
of Financial Accounting Standard No. 157,
Fair Value Measurements
(
FAS
157
). FAS 157 defines fair value, establishes a framework
for measuring fair value in accordance with generally accepted accounting
principles, and expands disclosures about fair value measurements.
FAS 157 will apply whenever another standard requires (or permits)
assets or liabilities to be measured at fair value. The standard does
not expand the use of fair value to any new circumstances. FAS 157
is effective for financial statements issued for fiscal years beginning
after November 15, 2007, and interim periods within those fiscal years
(October 1, 2008, for the Company). The Company is currently assessing
this standard effect on its financial statements in future periods.
|
F-24
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
|
|
|
|
|
4)
|
In February 2007, FASB issued SFAS 159,
The
Fair Value Option for Financial Assets and Financial Liabilities
.
This
standard permits companies to choose to measure many financial assets
and financial liabilities at fair value. Unrealized gains and losses
on items for which the fair value option has been elected are reported
in earnings. This statement will be effective for fiscal years beginning
on or after November 15, 2007 (October 1, 2008, for the Company).
The Company is currently evaluating the impact that the adoption
of SFAS 159 will have on its consolidated financial statements.
|
|
|
|
|
|
|
5)
|
In June 2007, the Emerging Issues Task Force
(EITF) issued EITF 07-3,
Accounting for Nonrefundable
Advance Payments for Goods or Services to Be Used in Future Research
and Development Activities
(EITF 07-3).
EITF
07-3 addresses the diversity which exists with respect to the accounting
for the non-refundable portion of a payment made by a research and
development entity for future research and development activities.
The EITF concluded that an entity will defer and capitalize non-refundable
advance payments made for research and development activities until
the related goods are delivered or the related services are performed.
EITF 07-3 is effective for interim or annual reporting periods in fiscal
years beginning after December 15, 2007 (October 1, 2008 for the Company).
The Company is currently evaluating the impact of adopting EITF 07-03
on its financial statements and results of operations.
|
|
|
|
|
|
|
6)
|
In December 2007, the FASB issued SFAS No.
141 (revised 2007),
Business Combinations
(
SFAS
141(R)
). SFAS 141(R) expands the definition of a business
and a business combination, requires the fair value of the purchase
price of an acquisition, including the issuance of equity securities
to be determined on the acquisition date, requires that all assets,
liabilities, contingent consideration, contingencies and in-process
research and development costs of an acquired business be recorded
at fair value at the acquisition date, requires that acquisition costs
generally be expensed as incurred, requires that restructuring costs
generally be expensed in periods subsequent to the acquisition date,
and requires changes in accounting for deferred tax asset valuation
allowances and acquired income tax uncertainties after the measurement
period to impact income tax expense. SFAS 141(R) applies prospectively
to business combinations for which the acquisition date is on or after
the beginning of the first annual reporting period beginning on or
after December 15, 2008 (October 1, 2009 for the Company). Early application
is prohibited. The Company is currently evaluating the impact SFAS
141(R) will have on its consolidated financial statements.
|
F-25
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
|
|
|
|
|
|
7)
|
In December 2007, the FASB issued SFAS No.
160,
Noncontrolling Interests in Consolidated Financial Statements,
an Amendment of ARB No. 51
(
SFAS 160
).
SFAS 160 amends ARB 51 to establish accounting and reporting standards
for the noncontrolling interest in a subsidiary and for the deconsolidation
of a subsidiary. An ownership interest in subsidiaries held by parties
other than the parent should be presented in the consolidated statement
of financial position within equity, but separate from the parents
equity. SFAS 160 requires that changes in a parents ownership
interest while the parent retains its controlling financial interest
in its subsidiary should be accounted for similarly as equity transactions.
When a subsidiary is deconsolidated, any retained noncontrolling equity
investment in the former subsidiary should be initially measured at
fair value, with any gain or loss recognized in earnings. SFAS 160
requires consolidated net income to be reported at amounts that include
the amounts attributable to both the parent and the noncontrolling
interest. It also requires disclosure, on the face of the consolidated
income statement, of the amounts of consolidated net income attributable
to the parent and to the noncontrolling interests. SFAS 160 is effective
for fiscal years (including interim periods within those fiscal years)
beginning on or after December 15, 2008 (October 1, 2009 for the Company).
Earlier adoption is prohibited. The statement shall be applied prospectively
as of the beginning of the fiscal year in which it is initially applied,
except for the presentation and disclosure requirement which shall
be applied retrospectively for all periods presented. The Company is
currently evaluating the impact SFAS 160 will have on its consolidated
financial statements.
|
|
|
|
|
|
|
8)
|
In December 2007, the FASB ratified
EITF
Issue No. 07-01, Accounting for Collaborative Arrangements
(
EITF
07-01
)
.
EITF 07-01 defines collaborative arrangements
and establishes reporting requirements for transactions between participants
in a collaborative arrangement and between participants in the arrangement
and third parties. EITF 07-01 also establishes the appropriate income
statement presentation and classification for joint operating activities
and payments between participants, as well as the sufficiency of
the disclosures related to these arrangements. EITF 07-01 is effective
for fiscal years beginning after December 15, 2008 (October 1, 2009
for the Company). The Company is currently evaluating the impact
EITF 07-01 will have on its consolidated financial statements.
|
|
|
|
|
|
o.
|
Reclassifications
|
|
|
|
|
|
Certain figures in respect of
prior years have been reclassified to conform to the prior year presentation.
|
F-26
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 2 - EMPLOYEE RIGHTS UPON RETIREMENT
|
|
|
|
|
a.
|
Israeli labor laws and agreements
require payment of severance pay upon dismissal of an employee or upon
termination of employment in certain other circumstances. The Subsidiarys
severance pay liability to its employees, mainly based upon length
of service and the latest monthly salary (one months salary for
each year worked), is reflected by the balance sheet accrual under
the liability for employee rights upon retirement. The
Company records the liability as if it was payable at each balance
sheet date on an undiscounted basis. The liability is partly funded
by purchase of insurance policies. The amounts funded are included
in the balance sheet as funds in respect of employee rights upon
retirement. The policies are the Companys assets and under
labor agreements, subject to certain limitations, they may be transferred
to the ownership of the beneficiary employees.
|
|
|
|
|
b.
|
The severance pay expenses for
the years ended September 30, 2007 and 2006, were $39,807 and $17,806
respectively.
|
|
|
|
|
c.
|
Cash flow information regarding
the Companys liability for employee rights upon retirement:
|
|
|
|
|
|
|
1)
|
The Company expects to contribute to the insurance
policies $23,000 in respect of severance pay for the year ended September
30, 2008.
|
|
|
|
|
|
|
2)
|
Due to the relatively young age of the Companys
employees, benefit payments to employees reaching retirement age in
the next 10 years, are not material. The amounts were determined based
on the employees current salary rates and the number of service
years that will accumulate upon their retirement date. These amounts
do not include amounts that might be paid to employees who will cease
working for the Subsidiary before their normal retirement age.
|
NOTE 3 LONG TERM DEPOSITS
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
Bank Deposits (1)
|
|
$
|
11,723
|
|
$
|
12,034
|
|
Deposits in respect of vehicles lease agreements
(2)
|
|
|
6,867
|
|
|
10,236
|
|
|
|
|
|
|
|
|
|
|
|
|
18,590
|
|
|
22,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
See also Note 5a
|
|
|
|
|
|
|
(2)
|
See also Note 5b
|
F-27
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 4 PROPERTY AND EQUIPMENT, Net
|
|
|
|
a.
|
Composition of property
and equipment, grouped by major classifications, is as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
Office
furniture and equipment
|
|
$
|
24,316
|
|
$
|
14,287
|
|
Computers
and peripheral equipment
|
|
|
17,225
|
|
|
17,852
|
|
|
|
|
|
|
|
|
|
|
|
|
41,541
|
|
|
32,139
|
|
Less
- accumulated depreciation
|
|
|
15,203
|
|
|
6,892
|
|
|
|
|
|
|
|
|
|
|
|
$
|
26,338
|
|
$
|
25,247
|
|
|
|
|
|
|
|
|
|
|
|
|
|
b.
|
Depreciation expense
totaled $8,311 and $4,299 in the years ended September 30, 2007 and
2006, respectively.
|
NOTE 5 COMMITMENTS:
|
|
|
|
a.
|
On May 18, 2006, the Subsidiary entered into
a new lease agreement for its new office facilities, in Israel, which
commenced on August 10, 2006. The new lease agreement is for a period
of 36 months with an option to renew the lease for an additional 36
month period. The monthly lease payment is $2,236. The future lease
payments under the lease are $26,827 and $22,356 for the years ending
September 30, 2008 and 2009 respectively.
|
|
|
|
|
|
As security for its obligation under this
lease agreement the Company provided a bank guarantee in an amount
equal to six monthly lease payments, which is secured by a long term
bank deposit (See also Note 3).
|
|
|
|
|
|
On June 8, 2006, the Company entered into
a lease agreement for the office facilities, in the United States,
it currently occupies. The lease agreement was for a period of 12 months
with an automatic option to renew for another 60 days at the same monthly
rate plus an increase of 14.83%. The monthly lease payment was $1,800.
On June 6, 2007, the Company renewed the lease agreement for a period
of 12 months. The current monthly lease payments is $2,000. The future
lease payments under this lease are $16,000 for the year ending September
30, 2008.
|
|
|
|
|
|
Rental expenses, for all office facilities
used by the Company, for the years ended September 30, 2007 and 2006
were $43,219 and $18,307, respectively.
|
F-28
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 5 COMMITMENTS
(continued):
|
|
|
|
b.
|
The Subsidiary has entered into operating
lease agreements for vehicles used by its employees for a period of
3 years.
|
|
|
|
|
|
The lease expenses for the years ended September
30, 2007 and 2006 were approximately $45,766 and $39,328, respectively.
The future lease payments under the lease agreement are $28,443 and
$4,990 for the years ending September 30, 2008, and 2009 respectively.
|
|
|
|
|
c.
|
On December 13, 2005, the Subsidiary entered
into a Research and Licensing Agreement with Tel Hashomer Medical Research
Infrastructure and Services LTD. (
THM
and
THM
Agreement
), pursuant to which the Subsidiary provided THM
with $200,000 in funding for THM to conduct a research project relating
to the mechanism of action for IVIg, hyper-immune IVIg and use of IVIg
as an anti-cancer treatment. As of September 30, 2007, the Company
paid its obligation under the contract. According to the THM Agreement,
THM granted the Subsidiary an exclusive worldwide license to any resulting
technology and know-how as described in the above mentioned agreement.
See Note 13d in connection with an amendment to the THM Agreement.
|
|
|
|
|
d.
|
On January 30, 2007, the Subsidiary entered
into a Master Services Agreement with BioSolutions Services, LLC (
BioSolutions
),
an outside party, pursuant to which the Subsidiary will from time-to-time
engage BioSolutions for various projects to assist it with the commercialization
of its anti-cancer immunotherapy to treat metastatic cancer. The services
to be performed under the Master Services Agreement will be specified
in separate work orders, which will set forth the scope of the work,
schedule and costs.
|
|
|
|
|
|
Work Order # 1 relates to regulatory consulting
services to be provided by BioSolutions in connection with the application
for an IND with the US FDA for VitiGam. As compensation for the
services, the Subsidiary agreed to pay BioSolutions a cash fee of between
$170,000 to $290,000 based on several factors. The Company issued to
BioSolutions a warrant to purchase 434,783 shares of its common stock
at a purchase price of $0.45 per share vesting as follows: (1) 33%
upon signature of a definitive agreement with an IVIg manufacturer,
(2) 33% upon the IND filing and (3) 34% when the IND has been approved
by the FDA (See also Note 8m).
|
F-29
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 5 COMMITMENTS
(continued):
|
|
|
|
e.
|
On February 1, 2007, the Subsidiary entered
into a Cooperation and Project Funding Agreement with Israel-U.S. Binational
Industrial Research and Development (the
BIRD Foundation
)
and Life Therapeutics (
Life
), pursuant to which
the BIRD Foundation will provide the Subsidiary and Life with funding
of the lesser of $1,000,000 or 50% of expenditures on the development
of an anti-cancer immunotherapy to treatment for metastatic cancer
(the
Project
), which funding will be repaid to the
BIRD Foundation if the development work goes beyond a Phase II clinical
trial. The repayment of the funding will be due within twelve months
following the completion of the Project in an amount equal to the total
funding linked to the US Consumer Price Index.
|
|
|
|
|
f.
|
On September 6, 2007, the Subsidiary entered
into an Agreement for the Purchase of Blood Plasma with DCI Management
Group, LLC (
DCI
). Under the terms of the agreement,
DCI will collect plasma from vitiligo donors at DCI operated FDA-approved,
IQPP certified donor centers for the manufacture of VitiGam.
|
NOTE 6 CONVERTIBLE PROMISSORY NOTE:
|
|
|
|
On November 20, 2006, the Company
issued a convertible promissory note, in a principal amount of $350,000,
which bore annual interest at 8% payable on maturity of the note with
a maturity date of November 20, 2007. On May 15, 2007 (the
Prepayment
Date
) the Company repaid the principal amount of the note
and issued 33,753 shares of its common stock in exchange for the accrued
interest on the principal amount to that date.
|
|
|
|
|
As of the date of issuance, the
hybrid instrument was bifurcated into an option and a host debt contract.
The fair value assigned to the option, determined using Black Scholes
option-pricing model, was $109,075. As of the Prepayment Date, the
fair value allocated to the option, estimated by using the Black Scholes
option-pricing model was $93,273. The value was based on the following
assumptions: dividend yield of 0%; expected volatility of 87%; risk-free
interest rates of 5.0%; and expected lives of 0.52 years.
|
NOTE 7 STOCK HOLDERS EQUITY:
|
|
|
|
The Companys shares are
traded on the Over-The-Counter Bulletin Board.
|
|
|
|
|
The following are capital stock
transactions that took place during the years ended September 30, 2007
and 2006:
|
|
|
|
|
a.
|
On October 31, 2005, the Company entered into
a subscription agreement for the sale of 666,666 units at a purchase
price of $0.75 per unit for total consideration of $500,000. Each unit
consisted of one share of the Companys common stock and one common
stock purchase warrant. Each warrant entitles the holder to purchase
half a share of common stock exercisable for three years at an exercise
price of at $1.00 per share.
|
F-30
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 7 STOCK HOLDERS EQUITY
(continued):
|
|
|
|
|
In connection with the subscription agreement,
the Company paid a $50,000 cash fee to a third party which assisted
in securing the agreement and issued a three year warrant to acquire
66,666 shares of common stock exercisable at $1.50 per share.
|
|
|
|
|
|
The consideration was allocated to the shares
and warrants issued based on relative fair value. The value allocated
to the warrants estimated by using the Black Scholes option-pricing
model is $72,410 and was based on the following assumptions: dividend
yield of 0%; expected volatility of 80%; risk-free interest rates of
4.4%; and expected lives of 3 years.
|
|
|
|
|
b.
|
On December 20, 2005, the Company entered
into a subscription agreement for the sale of 1,333,334 units at a
purchase price of $0.75 per unit for total consideration of $1,000,000.
Each unit consisted of one share of the Companys common stock
and one common stock purchase warrant. Each warrant entitles the holder
to purchase one share of common stock exercisable for three years at
an exercise price of $1.20 per share.
|
|
|
|
|
|
In connection with the subscription agreement
the Company paid a $100,000 cash fee to third parties who assisted
in securing the agreement, as well as issued warrants to purchase 133,332
shares of common stock exercisable for three years. Warrants exercisable
for 66,666 shares of common stock are exercisable at $1.25 per share,
and warrants exercisable for 66,666 shares of common stock are exercisable
at $1.50 per share.
|
|
|
|
|
|
The consideration was allocated to the shares
and warrants issued based on relative fair value. The value allocated
to all warrants estimated by using the Black Scholes option-pricing
model is $235,527 and was based on the following assumptions: dividend
yield of 0%; expected volatility of 81%; risk-free interest rates of
4.4%; and expected lives of 3 years.
|
|
|
|
|
c.
|
On December 20, 2005, the Company entered
into a subscription agreement for the sale of 222,222 units at a purchase
price of $0.90 per unit for a total consideration of $200,000. Each
unit consisted of one share of the Companys common stock and
one common stock purchase warrant. Each warrant entitles the holder
to purchase half a share of common stock exercisable for three years
at an exercise price of $1.15 per share.
|
|
|
|
|
|
The consideration was allocated to the shares
and warrants issued based on relative fair value. The value allocated
to all warrants estimated by using the Black Scholes option-pricing
model is $34,114 and was based on the following assumptions: dividend
yield of 0%; expected volatility of 81%; risk-free interest rates of
4.4%; and expected lives of 3 years.
|
|
|
|
|
d.
|
On February 27, 2007, the Company completed
a private placement for the sale of 16,250,000 units at a purchase
price of $0.40 per unit for total consideration of $6,500,000. Each
unit consisted of one share of common stock and one share purchase
warrant. Each warrant entitles the holder to purchase one share of
common stock for a period of five years at an exercise price of $0.48.
The consideration was allocated to the shares and warrants issued based
on relative fair value. The fair value, net transaction costs allocated
to the warrants is $2,231,459, using the Black Scholes option-pricing
model and was based on the following assumptions: dividend yield of
0% for all years; expected volatility of 89%; risk-free interest rates
of 4.63%; and expected lives of 5 years. Transaction costs of $614,275
were paid.
|
F-31
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 7 STOCK HOLDERS EQUITY
(continued):
|
|
|
|
e.
|
On February 27, 2007, the exercise price of
1,333,334 warrants was reduced to $0.55. The warrants were issued on
December 20, 2005 as part of a subscription agreement for the sale
of 1,333,334 units at a purchase price of $0.75 per unit for total
consideration of $1,000,000. The increase in the fair value of the
warrants is charged in the Statement of Changes in Stockholders Equity
against the additional paid-in capital.
|
|
|
|
|
f.
|
On February 27, 2007, the exercise price of
333,333 warrants was reduced to $0.55. The warrants were issued on
October 31, 2005 as part of a subscription agreement for the sale of
666,666 units at a purchase price of $0.75 per unit for a total consideration
of $500,000. The increase in the fair value of the warrants is charged
in the Statement of Changes in Stockholders Equity against the
additional paid-in capital.
|
|
|
|
|
g.
|
On May 15, 2007, the Company issued 33,753
shares of its common stock in exchange for the interest accumulated
on the principal amount of a convertible promissory note issued by
the Company on November 20, 2006. See also Note 6.
|
|
|
|
|
h.
|
As to shares issued as part of stock based
compensation plan see Note 8.
|
NOTE 8 STOCK BASED COMPENSATION:
|
|
|
|
On August 17, 2004, the Companys
board of directors adopted the 2004 Employees and Consultants Stock
Option Plan (the
2004 Stock Option Plan
).
|
|
|
|
|
On February 26, 2007, the Companys
board of directors adopted the 2007 Global Share Option Plan (the
2007
Stock Option Plan
).
|
|
|
|
|
Under both plans 10,000,000 shares
have been reserved for the grant of options, which may be issued at
the discretion of the Companys board of directors from time to
time. Under these plans, each option is exercisable into one share
of common stock of the Company.
|
|
|
|
|
The options may be exercised after
vesting and in accordance with vesting schedules which will be determined
by the board of directors for each grant. The maximum term of the options
is 10 years.
|
|
|
|
|
The fair value of each stock option
grant is estimated at the date of grant using a Black Scholes option
pricing model. The volatility is based on a historical volatility,
by statistical analysis of the weekly share price for past periods.
The expected term is the length of time until the expected dates of
exercising the options, based on estimated data regarding employees exercise
behavior.
|
|
|
|
|
In connection with the completion
on February 27, 2007 of a private placement by the Company (See Note
7d), the officers, directors, and employees holding a total of 5,600,000
options, agreed to restrictions on resale of the shares underlying
the options until the first anniversary of the effective date of the
initial registration statement that was filed pursuant to the private
placement.
|
F-32
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 8 STOCK BASED COMPENSATION
(continued):
|
|
|
|
The following are stock options
and warrants transactions made during the years ended September 30,
2007 and 2006, (See Note 13 as to grants of stock options subsequent
to September 30, 2007):
|
|
|
|
|
a.
|
On October 6, 2005, 350,000 options were granted
to an employee under the 2004 Stock Option Plan at an exercise price
of $0.93 per share which was equivalent to 90% of the traded market
price on the date of grant. Compensation costs calculated in accordance
with APB 25 totaled $35,000. The fair value of these options on the
date of grant is $283,262 using the Black Scholes option-pricing model
and was based on the following assumptions: dividend yield of 0%; expected
volatility of 80%; risk-free interest rates of 4.5%; and expected lives
of 7.59 years. These options were cancelled on May 17, 2007 (See also
Note 8s).
|
|
|
|
|
b.
|
On October 20, 2005, 30,000 options were granted
to an employee under the 2004 Stock Option Plan at an exercise price
of $1.35 per share which was equivalent to the traded market price
on the date of grant. The fair value of the above options on the date
of grant is $32,637 using the Black Scholes option-pricing model and
was based on the following assumptions: dividend yield of 0%; expected
volatility of 85%; risk-free interest rates of 4.5%; and expected lives
of 7.85 years. These options were cancelled on May 17, 2007 (See also
Note 8s).
|
|
|
|
|
c.
|
On December 21, 2005, 250,000 options were
granted to an employee under the 2004 Stock Option Plan. at an exercise
price of $1.34 per share which was equivalent to the traded market
price on the date of grant. The fair value of these options on the
date of the grant, is $269,449 using the Black Scholes option-pricing
model and was based on the following assumptions: dividend yield of
0%; expected volatility of 85%; risk-free interest rates of 4.5%; and
expected lives of 7.85 years. These options were cancelled on May 17,
2007 (See also Note 8s).
|
|
|
|
|
d.
|
On January 12, 2006, 50,000 options were granted
to an employee under the 2004 Stock Option Plan at an exercise price
of $1.10 per share which was equivalent to the traded market price
on the date of grant. The fair value of these options on the date of
the grant, is $44,163 using the Black Scholes option-pricing model
and was based on the following assumptions: dividend yield of 0%; expected
volatility of 85%; risk-free interest rates of 4.5%; and expected lives
of 7.85 years.
|
|
|
|
|
e.
|
On March 15, 2006, 50,000 options were granted
to a director under the 2004 Stock Option Plan at an exercise price
of $1.37 per share which was equivalent to the traded market price
on the date of grant. The fair value of these options on the date of
grant is $54,712 using the Black Scholes option-pricing model and was
based on the following assumptions: dividend yield of 0%; expected
volatility of 84%; risk-free interest rates of 4.5%; and expected lives
of 7.85 years. These options were cancelled on May 17, 2007 (See also
Note 8s).
|
F-33
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 8 STOCK BASED COMPENSATION
(continued):
|
|
|
|
f.
|
On April 17, 2006, 1,400,000 stock options
were granted to the then new CEO under the 2004 Stock Option Plan at
an exercise price of $1.29 per share which was equivalent to 90% of
the average closing price of the common stock of the Company on the
30 days immediately preceding the date of grant. Compensation costs
calculated in accordance with APB 25 totaled $434,000. The fair value
of these options on the date of grant is $1,832,296 using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0%; expected volatility of 83%; risk-free interest
rates of 4.5%; and expected lives of 7.85 years. These options were
cancelled on May 17, 2007 (See also Note 8s).
|
|
|
|
|
g.
|
On May 4, 2006, 500,000 (100,000 for each
of its five board members) options were granted under the 2004 Stock
Option Plan at an exercise price of $1.29 per share which was equivalent
to 90% of the average closing price of the common stock of the Company
on the 30 days immediately preceding the date of grant. Compensation
costs calculated in accordance with APB 25 totaled $105,000. The fair
value of these options on the date of grant is $605,909 using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0%; expected volatility of 82%; risk-free interest
rates of 4.5%; and expected lives of 7.85 years These option were cancelled
on May 17, 2007 (See also Note 8s).
|
|
|
|
|
h.
|
During September 2006, 50,000 options were
forfeited due to the departure of a scientific advisor. Expenses in
respect of options forfeited due to non-performance were reversed.
|
|
|
|
|
i.
|
On October 12, 2006, 50,000 options were granted
under the 2004 Stock Option Plan to a then new member of the Scientific
Advisory Board, an outside party, at an exercise price of $0.65 per
share, which was equivalent to the traded market price on the date
of grant. These options vest according to the following vesting schedule:
|
|
|
|
|
|
|
|
|
1)
|
On the first anniversary of the grant date,
25% of the options vest;
|
|
|
|
|
|
|
|
|
2)
|
On the last day of each of the 36 months following
the first anniversary of the grant date, the remaining options vest
in equal monthly installments.
|
|
|
|
|
|
The fair value of these options as of September
30, 2007 is $14,849, using the Black Scholes option-pricing model and
was based on the following assumptions: dividend yield of 0% for all
years; expected volatility of 85%; risk-free interest rates of 4.23%;
and expected lives of 5.47 years.
|
|
|
|
|
j.
|
On October 18, 2006 the Company entered into
a Strategic Alliance Agreement with UTEK Corporation (
UTEK
),
pursuant to which UTEK would assist the Company in identifying technology
acquisition opportunities. In consideration for the services being
provided to the Company by UTEK, the Company agreed to pay UTEK $120,000.
The Company had the option of paying UTEK $10,000 per month in cash
and instead issued UTEK an aggregate of 171,432 shares of common stock
of the Company which vest in 12 equal monthly instalments of 14,286
shares each.
|
F-34
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
|
|
|
|
|
NOTE 8 -
|
STOCK BASED COMPENSATION
(continued):
|
|
|
|
|
|
|
k.
|
On November 13, 2006, 150,000
options were granted under the 2004 Stock Option Plan to each of the
Companys two board members who joined the Board of Directors
on November 6, 2006 (totaling 300,000 options). The options are exercisable
at $0.45 per share (equivalent to the traded market price on the date
of grant), in accordance with the following vesting schedule:
|
|
|
|
|
|
|
|
|
1)
|
On the first anniversary commencing the grant
date, 25% of the options vest;
|
|
|
|
|
|
|
|
|
2)
|
On the last day of each of the 36 months following
the first anniversary of the grant date, the remaining options vest
in equal monthly installments.
|
|
|
|
|
|
|
|
The fair value of these options
on the date of grant is $111,859, using the Black Scholes option-pricing
model and was based on the following assumptions: dividend yield of
0%; expected volatility of 90%; risk-free interest rates of 4.65%;
and expected lives of 7.88 years.
|
|
|
|
|
|
|
l.
|
On December 5, 2006, 50,000 options
were granted under the 2004 Stock Option Plan to a then new member
of the Scientific Advisory Board, an outside party. The options are
exercisable at $0.50 per share (equivalent to the traded market price
on the date of grant) in accordance with the following vesting schedule:
|
|
|
|
|
|
|
|
|
1)
|
On the first anniversary commencing the grant
date, 25% of the options vest;
|
|
|
|
|
|
|
|
|
2)
|
On the last day of each of the 36 months following
the first anniversary of the grant date, the remaining options vest
in equal monthly installments.
|
|
|
|
|
|
|
|
The fair value of these options
as of September 30, 2007 is $15,789, using the Black Scholes option-pricing
model and was based on the following assumptions: dividend yield of
0% for all years; expected volatility of 85%; risk-free interest rates
of 4.23%; and expected lives of 5.47 years.
|
|
|
|
|
|
|
m.
|
On January 30, 2007, warrants
to acquire 434,783 shares of common stock of the Company were granted
to an outside consultant. The warrants are exercisable for a period
of five years at an exercise price of $0.45 per share. Since the warrants
only vest if certain performance conditions are met (See also Note
5d), no compensation was recorded this period.
|
|
|
|
|
|
|
n.
|
On February 15, 2007, 100,000 options
were granted under the 2004 Stock Option Plan to an employee. The options
are exercisable at $0.45 per share, (equivalent to the traded market
price on the date of grant) in accordance with the following vesting
schedule:
|
|
|
|
|
|
|
|
|
1)
|
On the first anniversary commencing the grant
date, 25% of the options vest;
|
|
|
|
|
|
|
|
|
2)
|
On the last day of each of the 36 months following
the first anniversary of the grant date, the remaining options vest
in equal monthly installments.
|
|
|
|
|
|
|
|
The fair value of these options
on the date of grant is $34,244, using the Black Scholes option-pricing
model and was based on the following assumptions: dividend yield of
0% for all years; expected volatility of 90%; risk-free interest rates
of 4.68%; and expected lives of 5.91 years.
|
F-35
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
|
|
|
|
|
NOTE 8 -
|
STOCK BASED COMPENSATION
(continued):
|
|
|
|
|
|
|
o.
|
On February 26, 2007, 785,000
and 400,000 options were granted under the 2004 Stock Option Plan and
the 2007 Stock Option Plan, respectively. The options were granted
to directors, officers and employees. The options are exercisable at
$0.53 per share (equivalent to the traded market price on the date
of grant) with one third vesting on each of the first, second and third
anniversaries of the grant date. The fair value of these options on
the date of grant is $412,685, using Black Scholes option-pricing model
and was based on the following assumptions: dividend yield of 0% for
all years; expected volatility of 89%; risk-free interest rates of
4.62%; and expected lives of 5.89 years.
|
|
|
|
|
p.
|
On February 26, 2007, 80,000 options
were granted under the 2004 Stock Option Plan to the Subsidiarys
Chief Scientist and a consultant, both outside parties. The options
are exercisable at $0.53 per share (equivalent to the traded market
price on the date of grant) with one third vesting on each of the first,
second and third anniversaries of the grant date. The fair value of
these options as of September 30, 2007 is $24,936, using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0% for all years; expected volatility of 85%; risk-free
interest rates of 4.23%; and expected lives of 5.47 years.
|
|
|
|
|
q.
|
On February 26, 2007, 1,075,000
options were granted under the 2007 Stock Option Plan to the Chairman
of the Board in his capacity as an outside consultant. The options
are exercisable at $0.53 per share (equivalent to the traded market
price on the date of grant) with one third vesting on each of the first,
second and third anniversaries of the grant date. The fair value of
these options as of September 30, 2007 is $335,080, using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0% for all years; expected volatility of 85%; risk-free
interest rates of 4.23%; and expected lives of 5.47 years.
|
|
|
|
|
r.
|
On March 22, 2007, warrants to
purchase 350,000 shares of common stock were granted to an outside
consultant. The warrants are exercisable for five years at an exercise
price of $0.53. The fair value of these warrants on the date of grant
is $179,470, using the Black Scholes option-pricing model and was based
on the following assumptions: dividend yield of 0% for all years; expected
volatility of 89%; risk-free interest rates of 4.62%; and expected
lives of 5 years.
|
|
|
|
|
s.
|
On May 17, 2007, 2,790,000 options
were granted under the 2007 Stock Option Plan at an exercise price
of $0.61, which was the fair market value at the close of business
on May 16, 2007, to directors, officers and employees of the Company
(total 9 individuals), upon the surrender and cancellation by each
of such directors, officers and employees of options, exercisable for
an aggregate 2,780,000 shares of common stock which were granted previously.
The additional fair value added due to the replacement of these options
is $177,881, using the Black Scholes option-pricing model and was based
on the following assumptions: dividend yield of 0% for all years; expected
volatility of 87%; risk-free interest rates of 4.68%; and expected
lives of 5.80 years.
|
F-36
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
|
|
|
|
|
NOTE 8 -
|
STOCK BASED COMPENSATION
(continued):
|
|
|
|
|
|
|
t.
|
On May 17, 2007, 20,000 options
were granted to an employee under the 2007 Stock Option Plan at an
exercise price of $0.61 per share with one third vesting on each of
the first, second and third anniversary of the date of grant. The fair
value of these options on the date of grant is $9,096, using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0% for all years; expected volatility of 87%; risk-free
interest rates of 4.68%; and expected lives of 5.80 years.
|
|
|
|
|
u.
|
On May 21, 2007, two Subsidiary
directors resigned from their positions and as part of accepting their
resignation, the Board of Directors extended the term of all options
granted to them (350,000 in total for both) until May 20, 2010. The
fair value of the unvested portion of the 350,000 options as of that
date, held by these directors, is $98,423, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 87%; risk-free interest
rates of 4.68%; and expected lives of 3 years.
|
|
|
|
|
v.
|
On June 1, 2007, the Company entered
into a Service Agreement with ROI Group, LLC (
ROI
),
pursuant to which ROI is to provide investor relations services for
a period of one year. In consideration for the services being provided
to the Company, the Company pays a monthly retainer of $9,500. In addition,
the Company issued 50,000 fully vested shares of common stock of the
Company and warrants to acquire 250,000 shares of common stock.
|
|
|
|
|
|
The warrants will expire on February
27, 2014 and are exercisable into 62,500 shares of common stock at
an exercise price of $0.75 which vested on August 31, 2007, 62,500
shares of common stock at an exercise price of $0.90 which vested on
November 30, 2007, 62,500 shares of common stock at an exercise price
of $1.10 which vest on February 28, 2008 and 62,500 shares of common
stock at an exercise price of $1.25 which vest on May 31, 2008.
|
|
|
|
|
|
The Company has valued the shares
issued to ROI based on the market value of the shares of the Company
on the date of issuance, which was $0.60. The value of the shares issued
assigned to services not yet rendered through September 30, 2007 are
presented as a separate line item (contra-equity). The fair value of
these warrants is $72,511, using the Black Scholes option-pricing model
and was based on the following assumptions: dividend yield of 0% for
all years; expected volatility of 85%; risk-free interest rates of
4.23%; and expected lives of 6.42 years.
|
F-37
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
|
|
|
|
|
NOTE 8 -
|
STOCK BASED COMPENSATION
(continued):
|
|
|
|
|
|
|
A summary of the status of the
stock options granted to employees and directors as of September 30,
2007, and changes during the year ended on this date, is presented
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
Number
of
options
|
|
Weighted
average
exercise
price
|
|
Number
of
options
|
|
Weighted
average
exercise
price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
|
$
|
|
For
options granted to
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees
and Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at beginning of year
|
|
|
2,830,000
|
|
$
|
1.24
|
|
|
350,000
|
|
$
|
1.17
|
|
Changes
during the year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted at
market price
|
|
|
4,395,000
|
|
|
0.57
|
|
|
380,000
|
|
|
1.31
|
|
Granted at
an exercise price less then market price
|
|
|
|
|
|
|
|
|
2,250,000
|
|
|
1.23
|
|
Forfeited
|
|
|
(2,780,000
|
)
|
|
1.24
|
|
|
(150,000
|
)
|
|
1.20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at end of year
|
|
|
4,445,000
|
|
|
0.58
|
|
|
2,830,000
|
|
|
1.24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at end of year
|
|
|
812,458
|
|
|
|
|
|
82,292
|
|
|
|
|
Weighted
average fair value of options granted during the year
|
|
$
|
0.49
|
|
|
|
|
$
|
1.19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents summary
information concerning the options outstanding as of September 30,
2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Range of
exercise
prices
$
|
|
Number
outstanding
|
|
Weighted
average
remaining
contractual
life Years
|
|
Weighted
average
exercise price
$
|
|
Aggregate
intrinsic value
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.45 to
0.61
|
|
4,395,000
|
|
|
9.53
|
|
|
0.57
|
|
|
28,000
|
|
|
0.93 to 1.37
|
|
50,000
|
|
|
8.00
|
|
|
1.10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,445,000
|
|
|
9.51
|
|
|
0.58
|
|
|
28,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-38
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 8 - STOCK BASED COMPENSATION
(continued):
|
|
|
The following table presents summary information
concerning the options exercisable as of September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Range of
exercise
prices
$
|
|
Number
exercisable
|
|
Weighted
average
remaining
contractual life
Years
|
|
Weighted
average
exercise price
$
|
|
Aggregate
intrinsic value
$
|
|
|
|
|
|
|
|
|
|
|
|
0.45 to
0.61
|
|
788,500
|
|
9.63
|
|
0.61
|
|
|
|
0.93 to 1.37
|
|
23,958
|
|
8.00
|
|
1.10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
812,458
|
|
9.58
|
|
0.61
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrecognized compensation as determined under
FAS 123R as of September 30, 2007 totaled $1,254,999, to be recorded
over the next 41 months.
|
|
|
|
A summary of the status of the stock options
granted to non-employees as of September 30, 2007, and changes during
the year ended on this date, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
Number
of
options
|
|
Weighted
average
exercise
price
|
|
Number
of
options
|
|
Weighted
average
exercise
price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
For
options granted to Non-Employees:
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at beginning of year
|
|
|
100,000
|
|
|
1.15
|
|
|
150,000
|
|
|
1.15
|
|
Changes
during the year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted at
market price
|
|
|
1,255,000
|
|
|
0.53
|
|
|
|
|
|
|
|
Forfeited
|
|
|
|
|
|
|
|
|
50,000
|
|
|
1.15
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding at end of year
|
|
|
1,355,000
|
|
|
0.58
|
|
|
100,000
|
|
|
1.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at end of year
|
|
|
89,583
|
|
|
|
|
|
37,500
|
|
|
|
|
Weighted
average fair value of options granted during the year
|
|
$
|
0.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-39
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 9 - TAXES ON INCOME:
|
|
|
|
a.
|
Deferred income taxes:
|
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
In respect of:
|
|
|
|
|
|
|
|
Net operating loss carryforward
|
|
$
|
1,102,725
|
|
$
|
431,165
|
|
Research and development
expenses
|
|
|
215,522
|
|
|
145,840
|
|
Start-up costs
|
|
|
|
|
|
142,932
|
|
Other
|
|
|
11,036
|
|
|
6,209
|
|
Less - Valuation allowance
|
|
|
(1,329,283
|
)
|
|
(726,146
|
)
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
,
|
|
|
,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realization of deferred tax assets is dependent
upon sufficient future taxable income during the period that deductible
temporary differences and carryforwards are expected to be available
to reduce taxable income. As the achievement of required future taxable
income is uncertain, the Company recorded a full valuation allowance.
|
|
|
|
|
b.
|
Corporate taxation in the U.S.
|
|
|
|
|
|
Taxes on income included in the consolidated
statements of operations represent current taxes due to taxable income
of the US Company.
|
|
|
|
|
|
The applicable corporate tax rate for the
Company is 22%.
|
|
|
|
|
c.
|
Corporate taxation in Israel
|
|
|
|
|
|
The Subsidiary is taxed in accordance with
Israeli tax laws. Under the Income Tax (Inflationary Adjustments) Law,
1985, results for tax purposes are measured in real terms, in accordance
with the changes in the Israeli consumer price index (
CPI
).
|
|
|
|
|
|
The regular corporate tax rate in Israel for
2007 is 29%. The corporate tax rates for 2008 and thereafter are as
follows: 2008 27%, 2009 26% and for 2010 and thereafter 25%.
|
|
|
|
|
|
As of September 30, 2007, the Subsidiary has
an accumulated tax loss carryforward of approximately $3,348,267 (September
30, 2006 approximately - $1,724,661). Under Israeli tax laws, carryforward
tax losses are linked to the Israeli CPI. The Israeli loss carryforwards
have no expiration date.
|
|
|
|
|
d.
|
Reconciliation of the theoretical tax expense
to actual tax expense
|
|
|
|
|
|
The main reconciling items, between the statutory
tax rate of the Company and the effective rate are the non deductible
expenses and the provision of the valuation allowance in respect of
the Companys deferred income tax asset (see above).
|
F-40
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 10 - RESEARCH AND DEVELOPMENT COSTS:
|
|
|
|
|
|
|
|
|
|
Year ended
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical
trials
|
|
$
|
370,066
|
|
$
|
390,717
|
|
Consulting
fees
|
|
|
248,460
|
|
|
142,404
|
|
Salaries
and related expenses
|
|
|
400,705
|
|
|
155,116
|
|
Costs
for registration of patents
|
|
|
144,698
|
|
|
79,982
|
|
Compensation
costs in respect of warrants granted to consultants
|
|
|
33,941
|
|
|
33,440
|
|
Other
|
|
|
134
|
|
|
595
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,198,004
|
|
$
|
802,254
|
|
|
|
|
|
|
|
|
|
NOTE 11 - GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
|
|
|
|
|
|
|
Year ended
September 30
|
|
|
|
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payroll and related expenses
|
|
$
|
2,141,555
|
|
$
|
567,785
|
|
Consulting fees
|
|
|
945,643
|
|
|
83,113
|
|
Travel costs
|
|
|
152,243
|
|
|
99,417
|
|
Professional services
|
|
|
361,155
|
|
|
247,132
|
|
Insurance
|
|
|
69,501
|
|
|
57,481
|
|
Business development
|
|
|
212,299
|
|
|
94,786
|
|
Other
|
|
|
207,767
|
|
|
113,356
|
|
|
|
|
|
|
|
|
|
|
|
$
|
4,090,163
|
|
$
|
1,263,070
|
|
|
|
|
|
|
|
|
|
NOTE 12 - RELATED PARTIES - TRANSACTIONS:
|
|
|
|
a.
|
On March 1, 2005, the Company entered into
an agreement appointing a principal shareholder as Vice President of
Business Development, in consideration of a salary of $4,000 per month,
commencing February 2005 and ended July 2, 2005. Effective July 2,
2005, this individual served as the CEO of the Subsidiary and as acting
CEO of the Company, devoting approximately 70% of her time to the affairs
of the Company for a monthly salary of $6,475. On April 15, 2006, this
individual resigned from her position as the acting CEO of the Company,
and continued as the CEO of the Subsidiary. Payroll and related expenses
in respect of this individual for the years ended September 30, 2007
and 2006 was $111,841 and $111,609, respectively (see also Notes 12d
and 13b).
|
F-41
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 12 - RELATED PARTIES TRANSACTIONS
(continued):
|
|
|
|
b.
|
On April 16, 2006, the Company entered into
an employment agreement with its then new CEO pursuant to which the
CEO will serve as CEO of the Company, effective April 15, 2006. Under
the agreement, the CEO is entitled to an annual salary of $200,000
and an annual bonus of up to $200,000 upon achieving certain objectives.
Pursuant to a separate agreement between the Company and the CEO, the
Company agreed to indemnify the CEO for substantially all liabilities
he may incur as a result of his employment by or service to the Company.
Payroll and related expenses, including stock based compensation expenses,
in respect of the CEO for the years ended September 30, 2007 and 2006
was $1,205,028 and $593,641, respectively.
|
|
|
|
|
c.
|
On October 31, 2006, the Company entered into
a consulting agreement with Steven Katz
& Associates, Inc., (
SKA
), a company wholly-owned
by the Companys Chairman of the Board and President, engaging it
as a consultant. For the year ended September 30, 2007 the Company incurred
a total of $466,070 of consulting fees and a total of $158,953 of stock
based compensation expenses in respect of the services provided by SKA.
|
|
|
|
|
d.
|
On May 22, 2007, the CEO of the Subsidiary
was appointed as VP of Corporate Development of the Company. On the
same date, the CEO of the Company assumed the position of CEO of the
Companys Subsidiary.
|
NOTE 13 SUBSEQUENT EVENTS:
|
|
|
|
a.
|
On October 30, 2007, a director of the Company
resigned from his positions as member of the Companys Board of
Directors, Audit Committee and Compensation Committee and Chairman
of the Audit Committee. The departing director will continue to serve
the Company as a consultant. The Company also amended the departing
directors option agreements so that his 225,000 options previously
granted to him will continue to vest and be exercisable under the terms
of such agreements.
|
|
|
|
|
|
In connection with the foregoing resignation,
on October 30, 2007, a new director was appointed to fill the vacancy
on the Companys Board of Directors and was additionally appointed
to the Companys Audit Committee and Compensation Committee. In
connection with the appointment, the Company granted the new director
options to purchase a total of 225,000 shares of its common stock under
the 2007 Stock Option Plan at an exercise price of $0.41 per share,
one third vesting on each of the first, second and third anniversaries
of the new directors appointment. Further, the Company entered
into its standard form of indemnification agreement with the new director.
|
|
|
|
|
b.
|
On November 30, 2007, the employment agreement
with the related party serving as the VP of Corporate Development was
terminated. Subsequently a consulting agreement was entered into between
the Company and the related party pursuant to which the related party
will perform certain consulting services as requested from time to
time by the Company and will be compensated based on hours worked.
|
F-42
GAMMACAN INTERNATIONAL, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE 13 SUBSEQUENT EVENTS
(continued):
|
|
|
|
c.
|
On December 13, 2007, the Company entered
into a Share Purchase Agreement made as of November 26, 2007 with ARP
Biomed, Ltd. (
ARP
). The Share Purchase Agreement
provides that subject to fulfillment of certain closing conditions,
including the receipt of an Israeli tax ruling, ARP will sell to the
Company 12.5% of the issued and outstanding shares of our Subsidiary
such that at closing the Company will own 100% of the issued and outstanding
shares of our Subsidiary. In consideration for such sale, the Company
agreed to issue to ARP, at closing, 2,697,535 shares of its common
stock, a warrant to acquire 1,123,973 shares of its common stock and
an additional warrant to acquire 449,589 shares of its common stock.
|
|
|
|
|
|
In connection with the Share Purchase Agreement,
ARP and our Subsidiary agreed to enter into an amendment of the agreement
for the purchase and sale of intellectual property from ARP, which
amendment specifically delineates clarity of title and related issues
to certain intellectual property sold under the original agreement.
|
|
|
|
|
|
A member of our board of directors, is the
Chief Executive Officer of ARP and the Chief Scientist of the Subsidiary,
is an advisor to ARP.
|
|
|
|
|
d.
|
On December 23, 2007, the Subsidiary entered
into an Amendment to the THM Agreement (the
Amendment
)
with THM. The Amendment reduces the license fees payable under the
THM Agreement and clarifies, among other things, the nature of research
activities pursuant to the THM Agreement. Further, the research period
under the THM Agreement has been extended for a two year period, commencing
January 1, 2007, and the research funding for this period totals $500,000.
|
|
|
|
|
|
In connection with this Amendment, the Company
will issue to THM a five year warrant to acquire 500,000 shares of
the Companys common stock exercisable, commencing December 31,
2008, at $0.40 per share. Pursuant to certain conditions, the Company
will issue to THM an additional warrant to acquire 250,000 shares of
its common stock.
|
F-43
16,583,753 Shares
Common Stock
Prospectus
[
____________
]
, 2008
Until
[
__________
]
, 2008, all dealers that buy,
sell, or trade the common stock, may be required to deliver a prospectus,
regardless of whether they are participating in this offering. This is in
addition to the dealers obligation to deliver a prospectus when acting
as underwriters and with respect to their unsold allotments or subscriptions.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 24. Indemnification of Officers and Directors
Section
145 of the Delaware General Corporation Law provides as follows:
(a) A
corporation shall have power to indemnify any person who was or is a party
or is threatened to be made a party to any threatened, pending or completed
action, suit or proceeding, whether civil, criminal, administrative or investigative
(other than an action by or in the right of the corporation) by reason of
the fact that the person is or was a director, officer, employee or agent
of the corporation, or is or was serving at the request of the corporation
as a director, officer, 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 the person in connection with such action, suit or proceeding if the person
acted in good faith and in a manner the person 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
the persons conduct was unlawful. The termination of any action, suit
or proceeding by judgment, order, settlement, conviction, or upon a plea
of nolo contendere or its equivalent, shall not, of itself, create a presumption
that the person did not act in good faith and in a manner which the person
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
reasonable cause to believe that the persons conduct was unlawful.
(b) A
corporation shall have power to indemnify any person who was or is a party
or is threatened to be made a party to any threatened, pending or completed
action or suit by or in the right of the corporation to procure a judgment
in its favor by reason of the fact that the person is or was a director,
officer, employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise against
expenses (including attorneys fees) actually and reasonably incurred
by the person in connection with the defense or settlement of such action
or suit if the person acted in good faith and in a manner the person reasonably
believed to be in or not opposed to the best interests of the corporation
and except that no indemnification shall be made in respect of any claim,
issue or matter as to which such person shall have been adjudged to be liable
to the corporation unless and only to the extent that the Court of Chancery
or the court in which such action or suit was brought shall determine upon
application that, despite the adjudication of liability but in view of all
the circumstances of the case, such person is fairly and reasonably entitled
to indemnity for such expenses which the Court of Chancery or such other
court shall deem proper.
(c) To
the extent that a present or former director or officer of a corporation
has been successful on the merits or otherwise in defense of any action,
suit or proceeding referred to in subsections (a) and (b) of this section,
or in defense of any claim, issue or matter therein, such person shall be
indemnified against expenses (including attorneys fees) actually and
reasonably incurred by such person in connection therewith.
(d) Any
indemnification under subsections (a) and (b) of this section (unless ordered
by a court) shall be made by the corporation only as authorized in the specific
case upon a determination that indemnification of the present or former director,
officer, employee or agent is proper in the circumstances because the person
has met the applicable standard of conduct set forth in subsections (a) and
(b) of this section. Such determination shall be made, with respect to a
person who is a director or officer at the time of such determination, (1)
by a majority vote of the directors who are not parties to such action, suit
or proceeding, even though less than a quorum, or (2) by a committee of such
directors designated by majority vote of such directors, even though less
than a quorum, or (3) if there are no such directors, or if such directors
so direct, by independent legal counsel in a written opinion, or (4) by the
stockholders.
(e) Expenses
(including attorneys fees) incurred by an officer or director in defending
any civil, criminal, administrative or investigative action, suit or proceeding
may be paid by the corporation in advance of the final disposition of such
action, suit or proceeding upon receipt of an undertaking by or on behalf
of such director or officer to repay such amount if it shall ultimately be
determined that such person is not entitled to be indemnified by the corporation
as authorized in this section. Such expenses (including attorneys fees)
incurred by former directors
II-1
and officers or other employees and agents may be so paid upon
such terms and conditions, if any, as the corporation deems appropriate.
(f) The
indemnification and advancement of expenses provided by, or granted pursuant
to, the other subsections of this section shall not be deemed exclusive of
any other rights to which those seeking indemnification or advancement of
expenses may be entitled under any bylaw, agreement, vote of stockholders
or disinterested directors or otherwise, both as to action in such persons
official capacity and as to action in another capacity while holding such
office.
(g) A
corporation shall have power to purchase and maintain insurance on behalf
of any person who is or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise against any liability asserted against
such person and incurred by such person in any such capacity, or arising
out of such persons status as such, whether or not the corporation
would have the power to indemnify such person against such liability under
this section.
(h) For
purposes of this section, references to the corporation shall
include, in addition to the resulting corporation, any constituent corporation
(including any constituent of a constituent) absorbed in a consolidation
or merger which, if its separate existence had continued, would have had
power and authority to indemnify its directors, officers, and employees or
agents, so that any person who is or was a director, officer, employee or
agent of such constituent corporation, or is or was serving at the request
of such constituent corporation as a director, officer, employee or agent
of another corporation, partnership, joint venture, trust or other enterprise,
shall stand in the same position under this section with respect to the resulting
or surviving corporation as such person would have with respect to such constituent
corporation if its separate existence had continued.
(i) For
purposes of this section, references to other enterprises shall
include employee benefit plans; references to fines shall include
any excise taxes assessed on a person with respect to any employee benefit
plan; and references to
serving at the request of the corporation shall include any service
as a director, officer, employee or agent of the corporation which imposes
duties on, or involves services by, such director, officer, employee or agent
with respect to an employee benefit plan, its participants or beneficiaries;
and a person who acted in good faith and in a manner such person reasonably
believed to be in the interest of the participants and beneficiaries of an
employee benefit plan shall be deemed to have acted in a manner not opposed
to the best interests of the corporation as referred to in this section.
(j) The
indemnification and advancement of expenses provided by, or granted pursuant
to, this section shall, unless otherwise provided when authorized or ratified,
continue as to a person who has ceased to be a director, officer, employee
or agent and shall inure to the benefit of the heirs, executors and administrators
of such a person.
(k) The
Court of Chancery is hereby vested with exclusive jurisdiction to hear and
determine all actions for advancement of expenses or indemnification brought
under this section or under any bylaw, agreement, vote of stockholders or
disinterested directors, or otherwise. The Court of Chancery may summarily
determine a corporations obligation to advance expenses (including
attorneys
fees).
We
intend to indemnify our officers and directors to the extent permitted by
the Delaware General Corporation Law.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers and controlling persons 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.
Item 25. Other Expenses of Issuance and Distribution
The
following is an itemization of all expenses (subject to future contingencies)
incurred or expected to be incurred by us in connection with the issuance
and distribution of the securities being offered hereby, excluding the underwriters
discounts and commissions (items marked with an asterisk (*) represent estimated
expenses):
II-2
|
|
|
|
SEC Registration Fee
|
|
$
|
248.47
|
Legal Fees and Expenses*
|
|
|
25,000.00
|
Blue Sky Fees (including
counsel fees)*
|
|
|
5,000.00
|
Accounting Fees and Expenses*
|
|
|
10,000.00
|
Transfer Agent and Registrar
Fees*
|
|
|
1,000.00
|
Printing and Engraving Expenses*
|
|
|
3,000.00
|
Miscellaneous*
|
|
|
5,751.53
|
|
Total
|
|
$
|
50,000,000
|
Item 26. Recent Sales of Unregistered Securities
Set
forth below in chronological order is information regarding the numbers of
shares of capital stock sold by us, the number of options and warrants issued
by us, and the principal amount of debt instruments issued by us since June
1, 2005, the consideration received by us for such shares, options and
debt instruments and information relating to the section of the Securities
Act or rule of the Securities and Exchange Commission under which exemption
from registration was claimed. None of these securities was registered under
the Securities Act. Except as otherwise indicated, no sales of securities involved
the use of underwriters and no commissions were paid in connection with the
sale of any securities.
Each
of such transactions was exempt from registration under the Securities Act
by virtue of the provisions of Section 4(2) and/or Section 3(b) of the Securities
Act. Each purchaser of the securities described below has represented that
he/she/it understands that the securities acquired may not be sold or otherwise
transferred absent registration under the Securities Act or the availability
of an exemption from the registration requirements of the Securities Act,
and each certificate evidencing the securities owned by each purchaser bears
or will bear upon issuance a legend to that effect.
The
information below gives affect to all stock splits, reverse stock splits
and stock dividends to date.
In
June 2005 we granted options to purchase up to 50,000 shares of our common
stock at an exercise price of $1.15 per share, to each of the following:
Shmuel Levi, Yair Aloni, Jean-Pierre Elisha Martinez and Lior Soussan-Gutman.
In
June 2005 we granted options to purchase up to 100,000 shares of our common
stock at an exercise price of $1.15 per share to an employee. These options
were forfeited during 2005 due to the employee resignation.
In
June 2005 we granted options to purchase up to 50,000 shares of our common
stock at an exercise price of $1.15 per share to each of three members
of our Scientific Advisory Board (
SAB
).
The options granted to one of the three SAB members were forfeited during
2006 due to the member's resignation.
On
October 6, 2005 we granted options to purchase up to 350,000 shares of our
common stock at an exercise price of $0.93 to Chaime Orlev. These options
were subsequently cancelled on May 17, 2007.
On
October 20, 2005 we granted options to purchase up to 30,000 shares of our
common stock at an exercise price of $1.35 to an employee. These options
were subsequently cancelled on May 17, 2007.
On
October 31, 2005, we entered into a subscription agreement for the sale of
666,666 units at a purchase price of $0.75 per unit for a total consideration
of $500,000. Each unit consisted of one share of our common stock and
a warrant to purchase half a share of our common stock, exercisable for three
years, at an exercise price of $1.00 per share. Subsequently, on February
27, 2007, the exercise price of the warrants was reduced to $0.55 per
share. This transaction was made in reliance on the exemption from the registration
requirements provided in Regulation S under the Securities Act. In connection
with the subscription agreement, we paid a $50,000 cash fee to a third
party which assisted in securing the agreement and we issued a three year
warrant to acquire 66,666 shares of our common stock at $1.50 per share.
On
December 20, 2005, we entered into a subscription agreement for the sale
of 1,333,334 units at a purchase price of $0.75 per unit for a total
consideration of $1,000,000. Each unit consisted of one share of our
common stock and a warrant to purchase one share of common stock exercisable
for three years at an exercise price of $1.20 per share. Subsequently,
on February 27, 2007, the exercise price of the warrants was reduced to $0.55
per share. The purchaser was an accredited investor as defined
in Rule 501(a) of Regulation D under the Securities Act. This transaction
was made in reliance on the exemption from the registration requirements
provided in Section 4(2) of the Securities Act and Regulation D thereunder.
In connection with the subscription agreement we paid a $100,000 cash
fee to third parties who assisted in securing the agreement, as well as issued
warrants to purchase 133,332 shares of common stock exercisable for three
years. Warrants exercisable for 66,666 shares of common stock are exercisable
at $1.25 per share, and warrants exercisable for 66,666 shares of common
stock are exercisable at $1.50 per share.
On
December 20, 2005, we entered into a subscription agreement for the sale
of 222,222 units at a purchase price of $0.90 per unit for a total consideration
of $200,000. Each unit consisted of one share of our common stock and
a warrant to purchase half a share of common
II-3
stock exercisable for three years at
an exercise price of $1.15 per share. This transaction was made in reliance
on the exemption from the registration requirements provided in Regulation
S under the Securities Act.
On
December 21, 2005 we granted options to purchase up to 250,000 shares of
our common stock at an exercise price of $1.34 to an employee. These
options were subsequently cancelled on May 17, 2007.
On
January 12, 2006 we granted options to purchase up to 50,000 shares of our
common stock at an exercise price of $1.10 to an employee.
On
March 15, 2006 we granted options to purchase up to 50,000 shares of our
common stock at an exercise price of $1.37 to Josef Neuhaus. These options
were subsequently cancelled on May 17, 2007.
On
April 17, 2006 we granted options to purchase up to 1,400,000 shares of our
common stock at an exercise price of $1.29 to Patrick Schnegelsberg.
These options were subsequently cancelled on May 17, 2007.
On
May 4, 2006 we granted options to purchase up to 100,000 shares of our common
stock at an exercise price of $1.29 to each of the following: Shmuel
Levi, Yair Aloni, Jean-Pierre Elisha Martinez, Lior Soussan-Gutman and Josef
Neuhaus. These options were subsequently cancelled on May 17, 2007.
On
October 12, 2006, we granted options to purchase up to 50,000 shares of our
common stock at an exercise price of $0.65 to a then new member of our
Scientific Advisory Board.
On
October 18, 2006 we entered into a Strategic Alliance Agreement with UTEK
Corporation (
UTEK
),
pursuant to which UTEK would assist us in identifying technology acquisition
opportunities. As consideration for the services being provided to us by
UTEK, we issued UTEK an aggregate of 171,432 shares of our common stock which
vested in 12 equal monthly installments of 14,286 shares each.
On
November 13, 2006, we granted options to purchase up to 150,000 shares of
our common stock under our 2004 Stock Option Plan at an exercise price of $0.45
to each of Steven Katz and Albert Passner, our then two new additions to
our board of directors.
On
December 5, 2006, we granted options to purchase up to 50,000 shares of our
common stock under our 2004 Stock Option Plan at an exercise price of $0.50
to a then new member of our Scientific Advisory Board.
On
January 30, 2007, we granted warrants to purchase 434,783 shares of our common
stock exercisable for five years at an exercise price of $0.45 to our
regulatory consultant.
On
February 15, 2007, we granted options to purchase up to 100,000 shares of
our common stock under our 2004 Stock Option Plan at an exercise price of $0.45
to an employee.
On
February 26, 2007, we granted options to purchase 2,340,000 shares of our
common stock at an exercise price of $0.53 to our directors, officers,
employees and consultants. Of the
II-4
options granted, 865,000 were granted
under the 2004 Stock Option Plan and 1,475,000 were granted under the 2007
Stock Option Plan.
On
February 27, 2007, we completed a private placement for the sale of 16,250,000
units at a purchase price of $0.40 per unit, for total consideration
of $6,500,000. Each unit consisted of one share of common stock and one
share purchase warrant. Each warrant entitles the holder to purchase one
share of common stock for a period of five years at an exercise price of $0.48
per share. In connection with the private placement, T.R. Winston & Company,
LLC acted as placement agent and received aggregate commissions of $487,500.
On
March 22, 2007, we granted warrants to purchase 350,000 shares of our common
stock exercisable for five years at an exercise price of $0.53 to a consultant.
On
May 15, 2007, we prepaid the principal amount of a convertible note issued
on November 20, 2006, in the amount of $350,000. The accumulated interest
on the principal amount, in the amount of $13,501, was converted into
33,753 shares of our common stock.
On
May 17, 2007, we granted options to purchase 2,790,000 shares of our common
stock under the 2007 Stock Option Plan at an exercise price of $0.61
to our directors, officers and employees. These options were issued upon
the surrender and cancellation by each of such directors, officers and employees
of options, exercisable for an aggregate of 2,780,000 shares of our common
stock at exercise prices ranging from $0.93 to
$1.37, which were granted previously.
On
May 17, 2007, we granted options to purchase 20,000 of our common stock under
the 2007 Stock Option Plan to an employee at an exercise price of $0.61
per share.
On
June 1, 2007, we entered into a services agreement with ROI Group, LLC, pursuant
to which we issued them 50,000 shares of our common stock and consulting
warrants exercisable for an aggregate of 62,500 shares of common stock at
an exercise price of $0.75 which vested on August 31, 2007, 62,500 shares
of common stock at an exercise price of $0.90 which vested on November
30, 2007, 62,500 shares of common stock at an exercise price of $1.10
which vest on February 28, 2008 and 62,500 shares of common stock at an exercise
price of $1.25 which vest on May 31, 2008. The warrants are exercisable
from their respective date of vesting through February 27, 2014.
On
October 30, 2007 we granted to a new director options to purchase a total
of 225,000 shares of our common stock under the 2007 Stock Option Plan at
an exercise price of $0.41 per share.
II-5
On
December 23, 2007, our subsidiary, GammaCan Ltd., entered into an Amendment
of the Research and Licensing Agreement (the
Amendment
)
with Tel HaShomer-Medical Research Infrastructure and Services LTD.
(
THM
)
originally entered into on December 13, 2005 (the
Research and Licensing Agreement
).
On February 11, 2008, the Amendment was amended and restated to make immaterial
changes thereto. In connection with the Amendment, we issued to THM a five
year warrant to acquire 500,000 shares of our common stock exercisable,
commencing December 31, 2008, at $0.40 per share. In addition, within
30 days of the acceptance by the FDA of each new IND application that results
from work pursuant to a research project (excluding INDs pertaining to
VitiGam), we will issue to THM a warrant to acquire 250,000 shares
of our common stock at an exercise price equal to the closing price of
our common stock on the date of issuance of such warrant. The warrants
are subject to adjustment for, among other things, stock splits, stock
dividends, distributions and reclassifications. On March 31, 2008, the
Research and Licensing Agreement, as amended, was terminated resulting
in, among other things, the cancellation of the warrant to acquire 500,000
shares of our common stock.
On March
19, 2008, options to purchase 600,000 shares of our common stock were granted
under our 2007 Stock Option Plan to our new Chief Financial Officer. The
options are exercisable at
$0.40 per share (equivalent to the traded market price on the date of grant)
with one third vesting on each of the first, second and third anniversary of
the date of grant.
On April 10, 2008, we granted options to purchase 50,000 shares of our common stock under our 2007 Global Share Option Plan to an employee. The options are exercisable at $0.37 per share which was the fair market value at the close of business on April 10, 2008 with one third vesting on each of the first, second and third anniversary of the date of grant.
On August 13, 2008, we issued 3,389,902 shares of our common stock issued to ARP Biomed Ltd.
Item 27. Exhibits
(a)
The following exhibits are filed herewith:
Number
|
|
Exhibit
|
|
|
|
3.1
|
|
Certificate of Incorporation,
incorporated by reference to the Registration Statement on Form 10-SB
filed with the Commission on June 4, 2001.
|
|
3.2
|
|
Certificate of Amendment to
Certificate of Incorporation dated May 28, 2004 incorporated by reference
to Current Report on Form 8-K filed with the Commission on June 8,
2004.
|
|
3.3
|
|
Certificate of Amendment to
Certificate of Incorporation dated August 19, 2004 incorporated by
reference to Current Report on Form 8-K filed with the Commission on
August 27, 2004.
|
|
3.4
|
|
Certificate of Amendment to
Certificate of Incorporation dated December 27, 2007 incorporated by
reference to the Annual Report on Form 10-KSB filed with the Commission
on December 28, 2008.
|
|
3.5
|
|
By-Laws, incorporated by reference
to the Registration Statement on Form 10-SB filed with the Commission
on June 4, 2001.
|
|
4.1
|
|
2004 Employees and Consultants
Stock Compensation Plan, incorporated by reference to Current Report
on Form 8-K filed with the Commission on September 1, 2004.
|
|
4.2
|
|
2007 Global Share Option Plan
incorporated by reference to the Annual Report on Form 10-KSB filed
with the Commission on December 28, 2008.
|
|
5.1
|
|
Opinion of Reitler Brown & Rosenblatt
LLC incorporated by reference to the Registration Statement on Form
SB-2 filed with the Commission on August 1, 2007.
|
|
10.1
|
|
Sale of Intellectual Property
Agreement dated as of June 11, 2004 between GammaCan, Ltd. and ARP
Biomed, Ltd., incorporated by reference to Current Report on Form 8-K
filed with the Commission on June 22, 2004.
|
|
10.2
|
|
Services Agreement dated August
17, 2004 between GammaCan, Ltd. and Prof. Yehuda Shoenfeld, M.D., incorporated
by reference to Current Report on Form 8-K filed with the Commission
on September 1, 2004.
|
|
10.3
|
|
Consulting agreement between
GammaCan Ltd. and PBD Ltd., dated as of November 4, 2004, incorporated
by reference to Form 8-K dated as of November 4, 2004
|
|
10.4
|
|
Employment Agreement between
GammaCan, Ltd. and Vered Caplan, dated as of June 21, 2005, incorporated
by reference to Current Report on Form 8-K filed with the Commission
on June 27, 2005.
|
|
II-6
10.5
|
Employment Agreement
between GammaCan, Ltd. and Chaime Orlev, dated as of September 6, 2005,
incorporated by reference to Current Report on Form 8-K filed with
the Commission on September 12, 2005.
|
|
10.6
|
Research and Licensing
Agreement dated December 13, 2005 between Gammacan Ltd and Tel Hashomer
Medical Research Infrastructure and Services Ltd., incorporated by
reference to Current Report on Form 8-K filed with the Commission on
December 19, 2005.
|
|
10.7
|
Employment Agreement
between GammaCan, Ltd. and Patrick Schnegelsberg, dated as of April
16, 2006, incorporated by reference to Current Report on Form 8-K filed
with the Commission on April 19, 2006.
|
|
10.9
|
8% Convertible Promissory
Note issued November 20, 2006 incorporated by reference to Current
Report on Form 8-K filed with the Commission on November 22, 2006.
|
|
10.10
|
Form of Securities
Purchase Agreement from the private placement that closed on February
27, 2007 incorporated by reference to Current Report on Form 8-K filed
with the Commission on March 1, 2007.
|
|
10.11
|
Form of Stock Purchase
Warrant from the private placement that closed on February 27, 2007
incorporated by reference to Current Report on Form 8-K filed with
the Commission on March 1, 2007.
|
|
10.12
|
Form of Lock Up
Agreement from the private placement that closed on February 27, 2007
incorporated by reference to Current Report on Form 8-K filed with
the Commission on March 1, 2007.
|
|
10.13
|
Form of Registration
Rights Agreement from the private placement that closed on February
27, 2007 incorporated by reference to Current Report on Form 8-K filed
with the Commission on March 1, 2007.
|
|
10.14
|
Agreement for the
Purchase and Sale of Blood Plasma between GammaCan Ltd. and DCI Management
Group, LLC incorporated by reference to Current Report on Form 8-K
filed with the Commission on October 5, 2007.
|
|
10.15
|
Form of Indemnification
Agreement between GammaCan International, Inc. and its directors and
officers incorporated by reference to the Annual Report on Form 10-KSB
filed with the Commission on December 28, 2008.
|
|
10.16
|
Share Purchase Agreement
made as of November 26, 2007 between GammaCan International, Inc. and
ARP BioMed, Ltd. incorporated by reference to Current Report on Form
8-K filed with the Commission on December 19, 2007.
|
|
10.17
|
Form of Amendment
to Sale of Intellectual Property Agreement effective as of November
26, 2007 between GammaCan, Ltd. and ARP BioMed, Ltd. incorporated by
reference to Current Report on Form 8-K filed with the Commission on
December 19, 2007.
|
|
II-7
10.18
|
Form of Warrant
to be issued to ARP BioMed, Ltd. under the Share Purchase Agreement
incorporated by reference to Current Report on Form 8-K filed with
the Commission on December 19, 2007.
|
|
10.19
|
Form of Additional
Warrant to be issued to ARP BioMed, Ltd. under the Share Purchase Agreement
incorporated by reference to Current Report on Form 8-K filed with
the Commission on December 19, 2007.
|
|
10.20
|
Form of Registration
Rights Agreement made as of November 26, 2007 between ARP BioMed, Ltd.
and GammaCan International, Inc. incorporated by reference to Current
Report on Form 8-K filed with the Commission on December 19, 2007.
|
|
10.21
|
Form of Lock-Up
Agreement made as of November 26, 2007 between ARP BioMed, Ltd. and
GammaCan International, Inc. incorporated by reference to Current Report
on Form 8-K filed with the Commission on December 19, 2007.
|
|
10.22
|
Form of Amendment
to Research and Licensing Agreement effective as of December 23, 2007
between GammaCan Ltd. and Tel HaShomer Medical Research Infrastructure
and Services Ltd. incorporated by reference to the Annual Report on
Form 10-KSB filed with the Commission on December 28, 2008.
|
|
10.23
|
Form of amended
and restated Amendment to Research and Licensing Agreement effective
as of December 23, 2007 between GammaCan Ltd. and Tel HaShomer
Medical Research Infrastructure and Services Ltd. incorporated by reference
to Quarterly Report on Form 10-QSB filed with the Commission on February
14, 2008.
|
|
10.24
|
Executive Employment Agreement between GammaCan
International, Inc. and Limor Zur-Stoller, dated March 11, 2008 incorporated
by reference to Current Report on Form 8-K filed with the Commission
on March 24, 2008.
|
|
|
10.25
|
Contract Manufacture Agreement between Bio
Products Laboratory and GammaCan Ltd. incorporated by reference to Current
Report on Form 8-K filed with the Commission on June 4, 2008.
|
|
|
10.26
|
Amendment Agreement dated as of June, 2008 between ARP Biomed Ltd. and GammaCan International, Inc. incorporated by reference to the Quarterly Report on Form 10-QSB filed with the Commission on August 14, 2008.
|
|
14
|
Code of Ethics incorporated
by reference to Form 10KSB for the year ended September 30, 2007 filed
with the Commission on January 13, 2005.
|
|
21.1
|
List of Subsidiaries.
|
|
23.1
|
Consent of Kesselman & Kesselman
certified public accountants (isr.) a member of PriceWaterhouse Coopers
International Limited.
|
|
23.2
|
Consent of Reitler
Brown & Rosenblatt LLC (included in Exhibit 5.1 hereto)
|
|
23.3
|
Consent of Armando
C. Ibarra, certified public accountants
|
|
|
II-8
Item 28. Undertakings
(a)
Insofar as indemnification for liabilities arising under the Securities Act
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 Securities 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 Securities Act and will be governed
by the final adjudication of such issue.
(b)
The Registrant hereby undertakes:
To
file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
|
|
|
|
(i)
|
To include any prospectus required by Section
10(a)(3) of the Securities Act of 1933;
|
|
|
|
|
(ii)
|
To reflect in the prospectus any facts or
events arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which, individually
or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of prospectus filed
with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than 20% change in the
maximum aggregate offering price set forth in the Calculation
of Registration Fee table in the effective registration statement.
|
|
|
|
|
(iii)
|
To include any material information with respect
to the plan of distribution not previously disclosed in the registration
statement or any material change to such information in the registration
statement;
|
provided, however, that paragraphs (b)1(i) and (a)(1)(ii) of
this section do not apply if the registration statement is on Form S-3, Form
S-8 or Form F-3, and the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed with
or furnished to the Commission by the registrant pursuant to Section 13 or
Section 15(d) of the Securities Exchange Act of 1934 that are incorporated
by reference in the registration statement.
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.
That,
for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrants annual report pursuant to section 13(a)
or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable,
each filing of an employee benefit plans annual report pursuant to
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 therein, and the offering of
such securities at that time shall be deemed to be the initial bona fide
offering thereof.
To
determine any liability under the Securities Act, treat the information omitted
from the form of prospectus filed as part of this registration statement
in reliance upon Rule 430A and contained in a form of prospectus filed by
the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities
Act as part of this registration statement as of the time the Commission
declared it effective.
For
the purpose of determining any liability under the Securities Act, to treat
each post-effective amendment that contains a form of prospectus as a new
registration statement relating to the securities offered
II-9
therein, and the offering of such securities at that time as
the initial bona fide offering thereof.
The
Registrant hereby undertakes that it will provide to the underwriters at
the closing specified in the underwriting agreement certificates in such
denominations and registered in such names as required by the underwriters
to permit prompt delivery to each purchaser.
II-10
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 for filing on Form S-1 and has duly caused this the Registration
Statement to be signed on its behalf by the undersigned, thereunto duly authorized,
in the city of New York, N.Y. on August 26, 2008.
|
|
|
|
|
|
GAMMACAN INTERNATIONAL, INC.
|
|
|
|
|
By:
|
/s/ Patrick NJ Schnegelsberg
|
|
|
|
|
|
|
|
Patrick NJ Schnegelsberg
|
|
|
|
Chief Executive Officer
|
Pursuant
to the requirements of the Securities Act of 1933, this Registration Statement
has been signed by the following persons in the capacities and on the dates
indicated.
|
|
|
|
|
Name
|
|
Position
|
|
Date
|
|
|
|
|
|
|
|
|
|
|
/s/ Patrick NJ Schnegelsberg
|
|
Chief Executive Officer (Principal Executive
Officer)
|
|
August 26, 2008
|
|
|
|
|
|
Patrick NJ Schnegelsberg
|
|
|
|
|
|
|
|
|
|
/s/ Limor Zur-Stoller
|
|
Chief Financial Officer (Principal Financial
and Accounting Officer)
|
|
August 26, 2008
|
|
|
|
|
|
Limor Zur-Stoller
|
|
|
|
|
|
|
|
|
|
/s/ Steven Katz
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Chairman of the Board of Directors and
President
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August 26, 2008
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Steven Katz
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*
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Director
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August 26, 2008
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Josef Neuhaus
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*
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Director
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August 26, 2008
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Albert Passner
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* By Steven Katz, Attorney-in-Fact
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/s/ Steven Katz
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Steven Katz
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Attorney-in-Fact
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II-11
EXHIBIT INDEX
Number
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Exhibit
|
|
|
|
3.1
|
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Certificate of Incorporation,
incorporated by reference to the Registration Statement on Form 10-SB
filed with the Commission on June 4, 2001.
|
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3.2
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Certificate of Amendment to
Certificate of Incorporation dated May 28, 2004 incorporated by reference
to Current Report on Form 8-K filed with the Commission on June 8,
2004.
|
|
3.3
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Certificate of Amendment to
Certificate of Incorporation dated August 19, 2004 incorporated by
reference to Current Report on Form 8-K filed with the Commission on
August 27, 2004.
|
|
3.4
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|
Certificate of Amendment to
Certificate of Incorporation dated December 27, 2007 incorporated by
reference to the Annual Report on Form 10-KSB filed with the Commission
on December 28, 2008.
|
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3.5
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By-Laws, incorporated by reference
to the Registration Statement on Form 10-SB filed with the Commission
on June 4, 2001.
|
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4.1
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2004 Employees and Consultants
Stock Compensation Plan, incorporated by reference to Current Report
on Form 8-K filed with the Commission on September 1, 2004.
|
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4.2
|
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2007 Global Share Option Plan
incorporated by reference to the Annual Report on Form 10-KSB filed
with the Commission on December 28, 2008.
|
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5.1
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|
Opinion of Reitler Brown & Rosenblatt
LLC incorporated by reference to the Registration Statement on Form
SB-2 filed with the Commission on August 1, 2007.
|
|
10.1
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Sale of Intellectual Property
Agreement dated as of June 11, 2004 between GammaCan, Ltd. and ARP
Biomed, Ltd., incorporated by reference to Current Report on Form 8-K
filed with the Commission on June 22, 2004.
|
|
10.2
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|
Services Agreement dated August
17, 2004 between GammaCan, Ltd. and Prof. Yehuda Shoenfeld, M.D., incorporated
by reference to Current Report on Form 8-K filed with the Commission
on September 1, 2004.
|
|
10.3
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|
Consulting agreement between
GammaCan Ltd. and PBD Ltd., dated as of November 4, 2004, incorporated
by reference to Form 8-K dated as of November 4, 2004
|
|
10.4
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|
Employment Agreement between
GammaCan, Ltd. and Vered Caplan, dated as of June 21, 2005, incorporated
by reference to Current Report on Form 8-K filed with the Commission
on June 27, 2005.
|
|
II-12
10.5
|
Employment Agreement
between GammaCan, Ltd. and Chaime Orlev, dated as of September 6, 2005,
incorporated by reference to Current Report on Form 8-K filed with
the Commission on September 12, 2005.
|
|
10.6
|
Research and Licensing
Agreement dated December 13, 2005 between Gammacan Ltd and Tel Hashomer
Medical Research Infrastructure and Services Ltd., incorporated by
reference to Current Report on Form 8-K filed with the Commission on
December 19, 2005.
|
|
10.7
|
Employment Agreement
between GammaCan, Ltd. and Patrick Schnegelsberg, dated as of April
16, 2006, incorporated by reference to Current Report on Form 8-K filed
with the Commission on April 19, 2006.
|
|
10.9
|
8% Convertible Promissory
Note issued November 20, 2006 incorporated by reference to Current
Report on Form 8-K filed with the Commission on November 22, 2006.
|
|
10.10
|
Form of Securities
Purchase Agreement from the private placement that closed on February
27, 2007 incorporated by reference to Current Report on Form 8-K filed
with the Commission on March 1, 2007.
|
|
10.11
|
Form of Stock Purchase
Warrant from the private placement that closed on February 27, 2007
incorporated by reference to Current Report on Form 8-K filed with
the Commission on March 1, 2007.
|
|
10.12
|
Form of Lock Up
Agreement from the private placement that closed on February 27, 2007
incorporated by reference to Current Report on Form 8-K filed with
the Commission on March 1, 2007.
|
|
10.13
|
Form of Registration
Rights Agreement from the private placement that closed on February
27, 2007 incorporated by reference to Current Report on Form 8-K filed
with the Commission on March 1, 2007.
|
|
10.14
|
Agreement for the
Purchase and Sale of Blood Plasma between GammaCan Ltd. and DCI Management
Group, LLC incorporated by reference to Current Report on Form 8-K
filed with the Commission on October 5, 2007.
|
|
10.15
|
Form of Indemnification
Agreement between GammaCan International, Inc. and its directors and
officers incorporated by reference to the Annual Report on Form 10-KSB
filed with the Commission on December 28, 2008.
|
|
10.16
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Share Purchase Agreement
made as of November 26, 2007 between GammaCan International, Inc. and
ARP BioMed, Ltd. incorporated by reference to Current Report on Form
8-K filed with the Commission on December 19, 2007.
|
|
10.17
|
Form of Amendment
to Sale of Intellectual Property Agreement effective as of November
26, 2007 between GammaCan, Ltd. and ARP BioMed, Ltd. incorporated by
reference to Current Report on Form 8-K filed with the Commission on
December 19, 2007.
|
|
II-13
10.18
|
Form of Warrant
to be issued to ARP BioMed, Ltd. under the Share Purchase Agreement
incorporated by reference to Current Report on Form 8-K filed with
the Commission on December 19, 2007.
|
|
10.19
|
Form of Additional
Warrant to be issued to ARP BioMed, Ltd. under the Share Purchase Agreement
incorporated by reference to Current Report on Form 8-K filed with
the Commission on December 19, 2007.
|
|
10.20
|
Form of Registration
Rights Agreement made as of November 26, 2007 between ARP BioMed, Ltd.
and GammaCan International, Inc. incorporated by reference to Current
Report on Form 8-K filed with the Commission on December 19, 2007.
|
|
10.21
|
Form of Lock-Up
Agreement made as of November 26, 2007 between ARP BioMed, Ltd. and
GammaCan International, Inc. incorporated by reference to Current Report
on Form 8-K filed with the Commission on December 19, 2007.
|
|
10.22
|
Form of Amendment
to Research and Licensing Agreement effective as of December 23, 2007
between GammaCan Ltd. and Tel HaShomer Medical Research Infrastructure
and Services Ltd. incorporated by reference to the Annual Report on
Form 10-KSB filed with the Commission on December 28, 2008.
|
|
10.23
|
Form of amended
and restated Amendment to Research and Licensing Agreement effective
as of December 23, 2007 between GammaCan Ltd. and Tel HaShomer
Medical Research Infrastructure and Services Ltd. incorporated by reference
to Quarterly Report on Form 10-QSB filed with the Commission on February
14, 2008.
|
|
10.24
|
Executive Employment Agreement between GammaCan
International, Inc. and Limor Zur-Stoller, dated March 11, 2008 incorporated
by reference to Current Report on Form 8-K filed with the Commission
on March 24, 2008.
|
|
10.25
|
Contract Manufacture Agreement between Bio
Products Laboratory and GammaCan
Ltd.
incorporated by reference to Current Report on Form 8-K filed with the
Commission on June 4, 2008.
|
|
|
10.26
|
Amendment Agreement dated as of June, 2008 between ARP Biomed Ltd. and GammaCan International, Inc. incorporated by reference to the Quarterly Report on Form 10-QSB filed with the Commission on August 14, 2008.
|
|
14
|
Code of Ethics
incorporated by reference to Form 10KSB for the year ended September
30, 2007 filed with the Commission on January 13, 2005.
|
|
21.1
|
List of Subsidiaries.
|
|
23.1
|
Consent of Kesselman & Kesselman
certified public accountants (isr.) a member of PriceWaterhouse Coopers
International Limited.
|
|
23.2
|
Consent of Reitler
Brown & Rosenblatt LLC (included in Exhibit 5.1 hereto)
|
|
23.3
|
Consent of Armando
C. Ibarra, certified public accountants
|
II-14
Grafico Azioni Greater Cannabis (PK) (USOTC:GCAN)
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