<PAGE> 1
FORM 10-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
[ x ] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended - December 31, 1996.
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to ________________.
Commission file number 0-26476
IGG INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
Nevada 33-0231238
State or other jurisdiction of (I.R.S. Employer
incorporation or organization Identification No.)
One Kendall Square Building 300
Suite 200
Cambridge, Massachusetts 02139
(Address of principal executive offices) Postal Code
(617) 621-3133
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Name of each exchange on which registered
None
Securities registered pursuant to Section 12(g) of the Act:
Title of each class
Common Stock
Securities registered pursuant to Section 15(d) of the Act:
Title of each class
None
Indicate by check mark whether the Registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the Registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90
days. YES [ x ] NO [ ]
<PAGE> 2
Indicate by check mark if disclosure of delinquent filers pursuant
to Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of the Registrant's knowledge, in definitive
proxy or information statements incorporated by reference in Part III
of this Form 10-K or any amendment to this Form 10-K. [ ]
The number of shares outstanding each of the Registrant's classes
of Common Stock, as of March 31, 1997 was 10,565,991.
Documents Incorporated by Reference
1. Form 10 Registration Statement, which became effective by
operation of law on September 18, 1995.
2. Form 10/A Registration Statement, as filed with the Commission on
April 15, 1996, amending the foregoing Form 10 Registration
Statement.
3. Form 10-K for the year ended December 31, 1995.
4. Form 10-Q for the period ending March 31, 1996.
5. Form 10-Q for the period ending June 30, 1996.
6. Form 10-Q for the period ending September 30, 1996.
7. Form S-8 Registration Statement, with became effective by
operations of law on May 14, 1996.
<PAGE> 3
PART I
ITEM 1. BUSINESS.
General
IGG International, Inc. (the "Company") is a biotechnology venture
whose research efforts are directed at products to improve plant
health, the treatment of human cancer, HIV, and diseases related to
immune system deficiencies.
The Company is researching and developing five principal products,
four of which are derived from naturally occurring substances: ELEXA,
a plant fungus; the GBC 590 and the Microorganism Substances (MMS-1 and
MMS-2). The fifth product is an active peptide which is a synthetic
compound. Patents for MMS-1 have been issued and all other patents are
currently pending for all products. See "Business - Patents." The
base products used to create the substances are widely available,
inexpensive to procure and can be converted into the final products on
a commercial scale using accepted and proprietary manufacturing
techniques. Management presently anticipates that all products will be
manufactured exclusively by the Company on a contract with
manufacturing facilities.
Potential risks associated with the development of the Company's
products are: 1) the products referred to herein may never be
developed; 2) anticipated future losses due to the cost of research and
development; 3) the absence of commercially viable products; 4) the
timing and cost associated with governmental regulation and approval;
5) absence of patent protection; 6) the risk of product liability
claims; and, 7) the uncertainty that the Company will ever operate
profitably. For all of the foregoing reasons, an investment in the
Company's securities is risky and purchasers should be aware that they
might loose their entire investment.
Prior to marketing any of the products, the Company must obtain
regulatory approval from the United States Food and Drug Administration
("FDA") and Environmental Protection Agency ("EPA"). The Company is
sufficiently funded for one year allowing it to complete the product
development process, obtain EPA approval, and market ELEXA. However,
the Company will seek additional financing through the private sale of
restricted securities to investors, enter into joint venture, licensing
or similar arrangements with large pharmaceutical companies to provide
the funding necessary for additional activities. There can be no
assurance that the Company will enter into any such arrangements,
obtain the appropriate regulatory approvals, or develop, manufacture,
market, or distribute commercially viable products.
To date, the Company's activities have consisted primarily of
research, development and testing. Such activities have resulted in
accumulated losses at December 31, 1996. The Company anticipates that
it will incur substantial losses in the foreseeable future as a result
of its continued research. There are no assurances that the Company
will be successful in completing its research and development, receive
FDA approval, implement manufacturing operations and commercially
market its human therapeutic products.
<PAGE> 4
Business Objective
The specific goal of the Company's business is to successfully
develop, test and obtain FDA approval of its products for human use and
EPA approval for ELEXA natural fungicide.
Glossary of Terms
Antigen A substance or entity, usually a protein, that
induces the production of antibodies. The
antigenicity of a compound depends on its
structure and molecular weight.
Auto-immune disease A disease in which auto-immunity is one of the
contributory factors. Such disease includes
Addison's disease and rheumatoid arthritis.
Cutaneous lesions Skin lesions.
Extravasate The process of passing out of a vessel into tissue.
Glycopeptide A compound formed from a peptide covalently linked
to a carbohydrate.
Glycoprotein Compounds in which carbohydrate side chains are
covalently linked to a protein. Common side
chains include D-galactose, D-mannose and N-acetyl-
D-glucosamine. Cell surface glycoproteins
play a role in cell recognition. Other
biologically important glycoproteins include
enzymes, hormones and antigens.
Granulomas Nodular inflammatory lesions.
Homocytotropic
Antibodies Cells that have an affinity to like cells.
Humoral Relating to extra cellular fluids in the body.
Ig (immunoglobulin) A protein of globulin type (usually gamma-
globulin) that possesses antibody activity.
Immune response The events that occur in humans and other
vertebrate animals when the body is invaded by
foreign protein. It is characterized by the
production of antibodies and may be stimulated by
an infectious organism or parasite (bacteria,
yeast, fungi, protozoa, etc.), transplanted
material, vaccine, sperm or even the host's own
tissue.
Immunegenecity The study of genetic aspects of the type and
formation of immunoglobulins (antibodies).
<PAGE> 5
Interferon-gammma Glycoprotein induced in different cell sites and
appropriate stimulus.
Interleukin-12 A protein synthesized and secreted by activated
macrophages that stimulates both immune and
inflammatory responses. Over-production of
interleukins can contribute to autoimmune disease
such as rheumatoid arthritis and multiple
sclerosis.
Lymphocyte A white cell arising from tissue of the lymphoid
systems. There are two types of lymphocytes: B
cells and T cells. These cells are capable of
being stimulated by an antigen to produce a
specific antibody to that antigen and to
proliferate to produce a population of such
antibody-producing cells.
Lymphokine Any of a number of soluble physiologically active
factors produced by T lymphocyctes in response to
specific antigens. Important in cell mediated
immunity, lymphokins include interferon,
macrophage arming factor, lymphocyte inhibition
factor, macrophage inhibition factor, chemotactic
factor and various cytotoxic factors.
Macrophage A motile white cell type found in vertebrate
tissue, including connective tissue, the spleen,
lymph nodes, liver, adrenal glands and pituitary,
as well as, in the endothelial lining of blood
vessels and the sinusoids of bone marrow, and in
the monocytes. They display phagocytic activity
and process antigens for presentation to
lymphocytes, which then prepare antigen-specific
antibodies.
Malignant Cancerous tumor.
MAP Kinase protein An enzyme that breaks down Microtubule Associate
Protein (protein that is inside cells - building
material).
Microbes Members of one of the following classes: bacteria,
fungi, algae, protozoa or viruses.
Microbial Relates to microbes.
Neoplastic Pertains to neoplasm (new tumor growth).
Nucleic acids Either of two types of macromolecule (DNA or RNA)
formed by polymerization of neuleotides. Neuleic
acids are found in all living cells and contain
the information (genetic code) for transfer of
<PAGE> 6
genetic information from one generation to the
next, as well as, for the expression of this
information through protein synthesis.
Nude mice Mice lacking an immune system.
Pathogenic Descriptive of a substance or organism that
produces a disease.
Phosphate A chemical group containing atoms of phosphorus
and oxygen.
Placebo An indifferent substance in the form of a medicine
given for the suggestive effect.
Polyclonal antibody An antibody produced in the normal immune response
to an antigen consisting of a number of closely
related, but not identical, proteins. The
variation in Polyclonal antibodies reflects the
facts that they are formed by a number of
different lymphocytes, in contrast to monoclonal
antibodies which are formed by a clone of
identical cells. Compare monoclonal antibody.
T-Cell A type of lymphocyte that matures in the thymus
gland. These cells are responsible for the
cellular immunity processes, such as direct cell
binding to an antigen, thus destroying it. T
lymphocytes also act as regulators of the immune
response as helper T cells, or suppressor T cells.
Tyrosine One of the 20 common amino acids that occur in
proteins. Tyrosine is a precursor of
noradrenaline, adrenaline, melanin, thyroid
hormone and various alkaloids.
Technical Background for International Gene Group, Inc. The Human
Therapeutic Subsidiary.
The following is a summary of certain theories related to the
Company's product development activities which are recognized in the
scientific community.
Cell Recognition and Adhesion
Cells recognize one another through pairs of complementary
structures on their surface. A structure on one cell carries encoded
biological information that a structure on another cell can decipher.
Previously, nucleic acids and proteins were recognized as the major
classes of biological materials involved in cell recognition.
Carbohydrates were not considered to be important in this intercellular
interaction. Recently, however, it has been theorized that the
majority of a cell's surface components contain carbohydrate structures
on the cell which change characteristics as the cell develops,
<PAGE> 7
differentiates and sickens. While to the foregoing has been theorized,
it has not been scientifically established that the foregoing is
correct and there is no assurance that the foregoing will ever be
scientifically established. The importance of carbohydrates in
cellular activity is underscored by studies showing that lectins (a
class of proteins found on cancer cells) can combine with carbohydrates
rapidly and selectively on the cell's surface membrane.
The adhesive capabilities of carbohydrates and lectins to bind
together were proven in a microbial adhesion study which serves as a
model for other forms of carbohydrate mediated cell recognition.
Because bacterial adhesion is so crucial to infection, medical
researchers are studying carbohydrates that may selectively inhibit
adhesion and act as molecular decoys, intercepting and binding to
pathogenic bacteria before they reach their tissue target. In 1990, M.
Mouricout showed that injections of glycopeptides taken from the blood
plasma of cows can protect newborn calves from lethal doses of E. coli.
The glycopeptides contain carbohydrates for which the E. coli bacteria
have affinities. The E. coli bacteria attach themselves to the
injected glycopeptides. The adhesion capabilities of the E. coli
bacteria is greatly reduced once the adhesion molecules on the E. coli
cell surface attach to the glycopeptides. This results in a measurable
decrease in the ability of the bacteria to attach to the intestines of
treated animals.
The Company has incorporated the foregoing theory into its
research on cell adhesion molecules and believes that cell adhesion
plays a key role in other diseases as well, such as the spread of
cancer cells throughout the body beginning at the primary tumor. For
example, the carbohydrates recognized by a specific lectin appear on
the cells of diverse tumors. It is theorized that some malignant cells
recruit the adhesion molecules that are part of the body's natural
defense mechanism to promote their own metastasis. If so, anti-
adhesive drugs will also be anti-metastatic drugs. While the foregoing
has been theorized by the Company, it has not been scientifically
established that the foregoing is correct and there is no assurance
that the foregoing will ever be scientifically established.
Cancer Metastasis
Metastasis is the transfer of neoplastic disease from one organ to
another not directly connected with it. This is the process by which
cancer spreads. Metastasis is the main cause of death for cancer
patients. Surgical removal of the primary cancer tumor does not
eliminate the threat of metastasis or the formation of additional
cancer tumors. Surgical process may cause the release of metastatic
cells into the blood stream.
The process of metastasis is initiated by the detachment of tumor
cells from the primary growth cell and is followed by their invasion of
surrounding tissues via the blood vessels. Once in blood circulation,
the tumor cells can travel to any and all of the body's distant organs
where they can arrest, extravasate, and proliferate to form new tumor
<PAGE> 8
colonies. It is accepted that the metastatic ability of tumor cells is
determined by unique cell properties and the ability to interact with
other tissue and blood cells.
A single isolated cancer tumor can be surgically removed.
However, once the cancer spreads to various organs, removal becomes
difficult or impossible. The Company believes by preventing the
ability of the cancer to metastasize, aggregate and form new tumor
colonies, the number of cancer deaths can be reduced. The foregoing is
based upon theory and there is no scientific evidence to support such
theory. Moreover, since different types of cancer cells appear to
share common "markers" which facilitate adhesion of infected cells, it
is possible that a treatment which prevents cellular adhesion in one
type of cancer (such as highly metastatic melanoma) could prove
ineffective in other types of cancer.
Human Immunodeficiency Virus and AIDS
The Human Immunodeficiency Virus (HIV), the virus that causes
AIDS, is currently recognized as one of the principal threats to human
health worldwide. HIV causes immune system dysfunction and permits the
onset of infections, such as pneumonia, which are the principal causes
of death.
The immune system has two principal responses in the fight against
infectious attacks. The first is the production of antibodies, protein
molecules which latch onto and neutralize foreign invaders such as
bacteria and viruses. Antibodies are believed to coat microbes in a
way that make them palatable to macrophage, scavenger cells which
destroy the invading cells. Each type of antibody acts on only a very
specific target molecule, known as an antigen. Thus, antibodies
designed to attack one type of infection are often ineffective against
others.
While antibodies are effective tools in the immunological system,
they cannot provide full protection against infectious attack. Some
diseases, such as tuberculosis, enter host cells before the antibodies
have an opportunity to attack. The Company has theorized that in order
to combat these invasions, the body also produces lymphocytes that
originate in the thymus, known as the T-cells. The Company has further
hypothesized that T cells recognize protein fragments on the surface of
infected cells, including viruses and mutated molecules in cancer
cells. The T-cells are believed to attack the infected cells and
inhibit the spread of the foreign invader. T-cells also appear to act
in concert with antibodies to lead the immunologic assault against
infection and disease by stimulating antibodies into an active state
and secreting lymphokines, molecules that promote antibody formation.
The Company has accepted the foregoing hypothesis in developing its
products, however, the foregoing has not been established by any
scientific evidence and there is no assurance that the same will be
established in the future.
<PAGE> 9
T-cells themselves are comprised of many populations two of which
are: CD4 (or helper) T-cells and CD8 (or killer) T-cells. Activated
CD4 T-cells produce large amounts of lymphokines to accelerate the
division of other T-cells and to promote inflammation. Activated CD8
T-cells develop the capacity to punch holes in target cells and secrete
chemicals that kill infected cells.
The HIV virus is believed to bind to CD4 T-cells and deplete their
number. The infectious characteristics of AIDS often set in after the
CD4 T-cell count drops below 200 parts per cubic millimeter. Without
the presence of sufficient CD4 T-cell counts, people with HIV are
particularly susceptible to secondary or opportunistic diseases.
Many theories, which have not been established by scientific data,
exist to explain why the CD4 T-cell count shrinks in people with HIV.
While it was originally thought that HIV decreases the number of CD4 T-
cells by infecting and killing them, most researchers now believe the
process is more complex. One theory suggests that the immune system
maintains the quantity of all immune cells rather than creating
specific cells that are lost. Under this theory, known as the
homeostatic mechanism, it is believed that the immune system monitors
the levels of T-cells and does not distinguish between those bearing
the CD4 protein and those bearing CD8. Consequently, when CD4 T-cells
die, the body detects the loss and causes the generation of new T-cells
until the total T-cell count is back to normal. The immune system does
that by producing both CD4 and CD8 T-cells. In effect, the addition of
CD8 cells suppresses the production of new CD4 cells. As the virus
continues to kill T-cells selectively and the immune system replaces
them generically, the population of CD4 T-cells declines. Again, the
Company has relied upon these theories in the development of its
products. There is no assurance that any of the foregoing theories are
scientifically correct, and accordingly, there is no assurance that any
of the Company's products will function as believed by the Company.
PRODUCTS
Complex Carbohydrate Substance (GBC 590)
Intracellular interactions play a key role in various steps of the
metastatic process. The Company has designed a natural complex
carbohydrate glycoprotein (GBC 590). The GBC 590 compound is designed
to recognize specific lectins which appear only on metastatic cells.
The substance acts as a molecular decoy, which attaches to the
metastatic cell and preventing the aggregation of the metastatic cells.
The elimination of the metastatic cells to create an emboli, only
single metastatic cells remain in the blood circulation. These
individual cells marked with the carbohydrate molecule can then be
destroyed by the body's immune system.
The GBC 590 substance was used in a controlled experiment. The
result of which were published in the Journal of the National Cancer
Instate. The experiment resulted in a complete inhibition of
metastatic mice melanoma cells in mice. Human melanoma cancer cells
can also be inhibited by the GBC 590. No/No nude mice, which lack an
<PAGE> 10
immune system and can not reject human cells, were injected with
metastatic human melanoma cells. The mice were subsequently injected
with the GBC 590. One control group was injected with a placebo and
the other with only the human melanoma cells. The results from the
experiment showed no evidence of the presence of melanoma cancer or
metastasis in the mice injected with the GBC 590 and human melanoma
cells. The control mice injected only with the melanoma cells showed
significant metastasis and numerous tumor colonies in the lungs. The
tests were performed at the Michigan Department of Public Health in
Lansing, Michigan.
The Company's GBC 590 substance may be an effective tool in
preventing metastasis. It appears that the substance could be
particularly beneficial when administered to patients both prior to and
following cancer surgery. In many cases when a primary cancer tumor is
surgically removed metastatic cells are released to the blood stream,
spreading the cancer throughout the body. By giving a patient the GBC
590 prior to and following the operation, the threat of spreading the
cancer by releasing the metastatic cells into the blood stream may be
reduced or eliminated.
In February 1995, in independent research paper was published in
the JNCI. The study used a compound similar to the Company's GBC 590
substance. The study showed almost 100% elimination of prostate cancer
metastases in rats. These independent scientific results indicates
that many forms of cancer may produce metastatic cells with the same
markers to which the Company's substance derived from the Complex
carbohydrate attaches. As a result, while the substance has only been
tested on melanoma and prostate cancer in animals, the product may or
may not have an application in treating other cell lines as well.
There are no assurances that injection with the Company's GBC 590
substance will prove effective in reducing or eliminating the spread of
cancer and that there have not been any studies or tests conducted to
support such intended effect.
Micro-organism (MMS-1)
The Company's Micro-organism Substance (MMS-1) has demonstrated
immune system stimulation. The substance active CD4 T cells and other
known immune system defense mechanism. Recent testing with MMS-1 also
demonstrated an increase of interferon gamma, a known immune modulator
which has demonstrated the ability to kill viruses and increase
lymphocyte activity when elevated. The tests to detect the level of
interferon were performed and repeated three times by a contract lab at
Wayne State University in Detroit. Interferon gamma is currently in
clinical trial by other companies to prolong live of AIDS patients.
In addition, MMS-1 is in tests at the University of Kentucky on
genetically engineered immune deficient mice, an approved model used in
Aids research known as Murine Acquired Immune Deficiency Syndrome
(MAIDS). The experiment will be conducted to evaluate the effect of
the substance at different stages of viral infection and to see the
effect of continued injections. The results of the experiment will be
published in major scientific journal.
<PAGE> 11
However, successful completion of the experiment in MAIDS model
will not indicate successes in human trail to reduce the HIV in humans
by activate the immune system and that there have not been any studies
or tests conducted to support such intended effect by the MMS-1 immuno-
stimolator.
Micro-organism (MMS-2)
MMS-2 has demonstrated the ability to inhibit metastasis in No/No
nude mice (Mice without an active immune system so they will not reject
human cells) injected with human melanoma cells. The test was
performed according to a research article in the International Journal
Cancer, 1991. Two groups of mice were injected intravenously with
melanoma human cancer cells. The test group was injected twice a week
with MMS-2. After 35 days group 1 was compared to test group 2 with
respect to tumor growth using the Wilcoxon Rank Sum Text. Multiple
comparisons were made across 5 days using Bonferroni's rule. The test
was conducted at an overall significance level of 0.05. MMS-1
significantly reduce the amount of cancer cells in the mice's lungs.
The Company is studying the results of its laboratory experiments
to determine the reason for the unique immunological response triggered
in these animals studies. However, there are no assurances that
injection with the Company's GBC 590 substance will prove effective in
reducing or eliminating the spread of cancer and that there have not
been any studies or tests conducted to support such intended effect.
Research
Research efforts will continue on the Complex Carbohydrate and
Micro-organism Substances to establish efficacy, and identify the
processes involved in carbohydrate based cellular interactions and
immune system modulation and stimulation. The Company intends to
conduct research at a leased facility. As of the date hereof, the
Company has not leased any facility and there is no assurance that any
facility will be leased in the future. Additional research needs
include experiments to complete the structural identification of the
Company's products. This research is important for intellectual
property protection, required for FDA approval and to gain a better
understanding of the responses triggered by the substances.
The Company is presently conducting research on a contract or
collaboration basis with many institutions throughout the world.
The Company intends to continue research in select areas on a
contract basis. In doing so, it will be able to consult with experts
in particular fields who have state of the art facilities and trained
personnel. All such research will continue to be conducted under
strict confidentiality agreements which prohibit use and disclosure of
the Company's products and prohibit publication of findings without the
consent of the Company.
<PAGE> 12
Agrichemical Technical Background Agricultural Glycosystems, Inc. Plant
Health Subsidiary.
The Company is commercializing products designed to improve a
plant's natural ability to resist disease. This approach is innovative
in contrast with the traditional fungicide chemicals which are toxins
that function as agents to kill fungus directly. These new
carbohydrate compounds are favorable since they are known to have low
toxicity and have very little impact on the environment.
The Company's lead product, ELEXA, has been designed to inhibit
fungal infections in a variety of plant species. ELEXA is a complex
carbohydrate that has significantly reduced fungal infection in
greenhouse and field studies without adversely impacting the plant
under test.
Results from greenhouse experiments demonstrate that ELEXA is
highly effective in controlling fungal diseases on cucumber, rice,
potato and tomato plants. The Company has also initiated multiple
field tests on grapes, tomatoes, potatoes, rice and other vegetable
crops to confirm ELEXA's efficacy under normal growing conditions.
These preliminary results also demonstrate very encouraging protection
levels. The results of field trials on grapes in particular showed
that ELEXA can provide a level of protection against fungal infestation
equal to or greater than that provided by a commonly used commercial
fungicide. An application for fungicide registration has been
submitted and accepted by the EPA, with approval anticipated in late
1997.
Fungicides are used to control fungi appearance and damage to
foliage, crops, plants, roots and in post-harvest storage of fruits and
vegetables. The world market for fungicides is estimated to be
approximately $6 billion.
The Company, together with the Governmental of Israel (Volcani
Institute), has identified a specific carbohydrate compound that
induces the natural response that allows a plant to resist disease.
This proprietary and patent pending technology has significance for the
following reasons:
* it is effective without toxic effects to the plant;
* many plants have developed resistance to current chemical
fungicides;
* because it stimulates the plant, resistance should be
minimized;
* many existing chemical fungicides have potential toxic
effects.
This proprietary technology induces the plants' defense responses,
which include:
* the synthesis and accumulation of anti-microbial
phytoalexins;
<PAGE> 13
* the production of enzymes capable of attacking surface
polymers of pathogens;
* the synthesis of proteins that inhibit degradative enzymes
produced by pathogens;
* the modification of plant cell walls.
The active components which induce defense responses in plants are
commonly referred to as "elicitors." ELEXA is a "carbohydrate
elicitor" capable of inducing one or more plant defense responses.
The mechanisms by which ELEXA induces the various defense
responses in plant cells remain partially unknown. Recent research has
demonstrated that ELEXA induces several rapid responses at the plant
cell surface that may be part of the signal transduction pathway.
The Company has an agreement with the Volcani Institute to co-
develop new agricultural products such as naturally derived, non-toxic
insecticides, as well as, safe and effective products for the home and
garden. The Company believes that ELEXA has the potential to achieve
a dominant position in both the post-harvest and home and garden
markets in the light of preliminary data which suggest that the product
controls fungal disease on post-harvest applications. In addition,
ELEXA will have appeal to consumers who are demanding less toxic
products for their home and garden use.
ELEXA (previously AGI 02-105F)
The Company's lead product, ELEXA, is a complex carbohydrate which
has been developed in conjunction with the Israeli Government's
Agricultural Research Organization Volcani Institute to inhibit fungal
infections in a variety of plants, fruits and vegetables. A number of
field studies have been undertaken in which the compound has been shown
to be highly effective in controlling disease without
adversely impacting the plants. The field studies were conducted by
commercial growers, on a variety of high value crops including
tomatoes, peppers, lettuce, strawberries and broccoli. Plants treated
with ELEXA achieved maximum yields.
The result of additional studies conducted by the Volcani
Institute were announced in September 1996. Undertaken in greenhouse
conditions, they demonstrated that ELEXA was highly effective in
controlling fungal diseases on cucumber, potato and tomato plants.
Seven days after treatment with a 0.1 per cent solution of ELEXA,
approximately 90 per cent of the crops were free of disease compared
with zero per cent for the non-treated control plants. ELEXA was
successfully tested against botrytis cinerea, downy mildew,
phytophthora infestans, coletotrichum spp. and pythium spp. Multiple
field tests have been initiated on grapes, tomatoes, potatoes, rice and
other vegetable crops to confirm ELEXA's efficacy under normal growing
conditions.
<PAGE> 14
In January 1997, the Company announced results of several recently
completed independent field test conducted on ELEXA. The results
strongly suggested that ELEXA can control damaging fungal diseases on
rice, cucumbers and potatoes. The results also confirmed the
previously announced positive results on controlling fungi on treated
grape vines as described below. The studies demonstrated the ELEXA can
provide a level of protection against fungal infestation equal to or
greater than the protection provided by a commonly used commercial
chemical fungicide.
The independent field test on grapes, the results of which were
published in October 1996, demonstrated ELEXA's efficacy in preventing
fungal attack on treated grape vines in a commercial Californian
vineyard. In this study, conducted under EPA Good Laboratory Practice
Standards, one-third of the grape vines were treated with a 0.1 per
cent concentration of ELEXA, one-third were treated with a commercial
fungicide frequently used to protect grapes from fungal attack, and
one-third remained untreated. After treatment, about 10.4 per cent of
the untreated grapes showed botrytis infection, a serious fungal
disease, compared with only 1.6 per cent of the vines treated with
ELEXA. About 2.5 per cent of the vines treated with the commercial
chemical fungicide were infected with botrytis. This study
demonstrated that ELEXA can provide a level of protection against
fungal infestation equal to the protection provided by a commonly used
commercial chemical fungicide.
In January 1996, the Company entered into an exclusive worldwide
licensing agreement with the Volcani Institute to commercialize ELEXA.
The Company is currently in the process of seeking regulatory approval
from the EPA. Production procedures have been scaled-up to meet the
demands projected for the next few years. Concurrently, the Company
plans to collaborate with major, multi-national chemical corporations
that can assist in expediting field and toxicity studies on the
compound in relation to crops such as wheat, soybeans, cotton, peanuts
and rice.
Manufacturing
The Company intends to retain exclusive responsibility for product
manufacturing in order to protect the integrity of the products and to
generate additional revenue, regardless of whether the products are
licensed or distributed directly by the Company. The Company has
identified several contract manufacturers as having suitable facilities
for manufacturing large quantities of the GBC 590, MMS-1, MMS-2 and
ELEXA.
The Microorganism Substances are naturally occurring. The raw
materials are used as base components in a number of drug products and
are commercially available nationally and internationally. With the
proper equipment, the substances can also be produced through
fermentation, thereby eliminating the need to purchase the raw
materials.
<PAGE> 15
The raw materials used to manufacture ELEXA are inexpensive and
commercially available in abundant supply, both nationally and
internationally. The manufacturing process used in produce these
products involves a series of processing steps and separations.
The Company has not entered into any manufacturing agreement for
any of its compounds, and there is no assurance that any agreements
will be entered into in the future. The contract manufacturers
schedule time in their plant upon notice from the Company of needed
production.
Government Regulation
The Company's activities are subject to extensive federal, state,
county and local laws and regulations controlling the development,
testing, manufacture and distribution of medical treatments. Most of
the Company's products will be subject to regulation as therapeutics by
the United States Food and Drug Administration ("FDA"), Environmental
Protection Agency ("EPA"), as well as varying degrees of regulation by
a number of foreign governmental agencies. To comply with the FDA and
EPA regulations regarding the manufacture and marketing of the
Company's products, the Company may incur substantial costs relating to
laboratory and clinical testing of new products and for the preparation
and filing of documents in the formats required by the FDA. There are
no assurances that the Company will receive FDA approval necessary to
commercially market its products and that if the Company is successful
it will encounter delays in bringing its new products to market as a
result of being required by the FDA to conduct and document additional
investigations of product safety and effectiveness.
Federal Drug Administration Regulation
The FDA approved process consists of four steps that all new
drugs, antibiotics and biologicals must follow, they are:
1. investigational new drug application (IND)
2. clinical trials
3. new drug application (review and approval)
4. post-marketing surveys
On January 11, 1993, the FDA approved new procedures to accelerate
the approval of certain new drugs and biological products directed at
serious or life-threatening illnesses. These new procedures will
expedite the approvals for patients suffering from terminal illness
when the drugs provide a therapeutic advantage over existing treatment.
The Company believes that its products will fall under the FDA
guidelines for accelerated approval for drugs and biological products
directed at serious and life threatening disease because the Company's
products are targeted as potential treatments for cancer metastasis and
HIV and are non-toxic and no treatment exists to effectively prolong
the life of people once their cancer has metastasized.
<PAGE> 16
Federal Drug Administration Regulation
The FDA approved process consists of four steps that all new
drugs, antibiotics and biologicals must follow, they are:
1. investigational new drug application (IND)
2. clinical trials
3. new drug application (review and approval)
4. post-marketing surveys
On January 11, 1993, the FDA approved new procedures to accelerate
the approval of certain new drugs and biological products directed at
serious or life-threatening illnesses. These new procedures will
expedite the approvals for patients suffering from terminal illness
when the drugs provide a therapeutic advantage over existing treatment.
The Company believes that its products will fall under the FDA
guidelines for accelerated approval for drugs and biological products
directed at serious and life threatening disease because the Company's
products are targeted as potential treatments for cancer metastasis and
HIV and are non-toxic and no treatment exists to effectively prolong
the life of people once their cancer has metastasized.
The Company believes that the first step in the approval process,
IND approval, will take approximately six (6) months. The Company will
provide the FDA with the results of laboratory and animal research and
a comprehensive clinical trial program for the NCCG, MMS-1 and MMS-2
substances. The Company anticipates filing its IND for all of its
products within the next six months.
Upon successful completion of the IND phase, the Company will be
permitted to commence large scale clinical trials with its substances.
Clinical trials are conducted in three phases, normally involving
progressively larger numbers of patients. The Company, in conjunction
with its FDA consultant, will select key physicians and hospitals to
actively conduct these studies. Phase I clinical trials will be
concerned primarily with learning more about the safety of the drug,
though they may also provide some information about the safety of the
<PAGE> 17
drug, though they may also provide some information about
effectiveness. Phase I testing is normally performed on healthy
volunteers although for drugs directed at HIV/AIDS and cancer, testing
on infected people is permitted. The test subjects are paid to submit
to a variety of tests to learn what happens to a drug in the human
body; how it is absorbed, metabolized and excreted, what effect it has
on various organs and tissues; and what side effects occur as the
dosages are increased. The principal objective is to determine the
drugs' toxicity. Phase I trials generally involve 20-40 people at an
estimated cost of $10,000 per patient, taking six months to one year to
complete.
<PAGE> 17
Assuming the results of Phase I testing present no toxic or
unacceptable safety problems, Phase II trials may begin. In many cases
Phase II trials may commence before all the Phase I trials are
completely evaluated if the disease is life threatening and preliminary
toxicity data in Phase I shows no toxic side effects. In life
threatening disease, Phase I and Phase II trials are sometimes combined
to show initial toxicity and efficacy in a shorter period of time. The
primary objective of this stage of clinical testing is designed to show
whether the drug is effective in treating the disease or condition for
which it is intended. Phase II studies may take several months or
longer and involve a few hundred patients in randomized controlled
trials that also attempt to disclose short-term side effects and risks
in people whose health is impaired. A number of patients with the
disease or illness will receive the treatment while a control group
will receive a placebo. The cost per patient is estimated at $10,000.
At the conclusion of Phase II trials, the FDA and the Company will
have a clear understanding of the short-term safety and effectiveness
of the drugs and their optimal dosage levels. Phase III clinical
trials will generally begin after the results of Phase II are
evaluated. The objective of Phase III is to develop information that
will allow the drug to be marketed and used safely. Phase III trials
will involve hundreds, and sometimes thousands, of people with the
objective of expanding on the research carried out in Phase II. An
objective would be to discover optimum dose rates and schedules, less
common or even rare side effects, adverse reactions, and generate
information that will be incorporated into the drugs' professional
labeling, as well as, the FDA-approved guidelines to physicians and
others about how to properly use the drug.
Patient estimates for each phase of the clinical trial process are
as follows:
Application Phase I Phase II Phase III
Cancer
GBC 590 36 200 1,000
MMS-2 20 200 1,000
HIV/AIDS
MMS-1 20 200 1,000
TOTAL 60 600 3,000
The third step that is necessary prior to marketing a new drug is
the New Drug Application (NDA) submittal and approval. In this step,
all the information generated by the clinical trials will be received
and if successful, the drug will be approved for marketing.
The final step is the random surveillance or surveys of patients
being treated with the drug to determine its long-term effects. This
has no effect on the marketing of the drug unless highly toxic
conditions arise. The time required to complete the above procedures
averages seven years, however, there is no assurance that the Company
will ever receive FDA approval of any of its products.
<PAGE> 18
The regulatory process for ELEXA the plant fungicide product of
the subsidiary, Agricultural Glycosystems, Inc. is well underway. The
testing and documentation required by the Environmental Protection
Agency (EPA) to market this product was submitted in December 1996.
The nature of the chemistry and low toxicity of ELEXA, should result in
an expedited approval for marketing. The Company's anticipates that
this approval will be granted in late 1997. However, there are no
assurances that the EPA will grant approval without asking for
additional information.
Competition
The Company will encounter significant competition from firms
currently engaged in the biotechnology and agrichemical industries.
The majority of these companies will be substantially larger than the
Company, and have substantially greater resources and operating
histories. The Company is aware of other competitors seeking cures for
cancer and HIV, however, the Company is not aware of any competitors
seeking to produce the same products as the Company.
Product Liability Exposure
Because many of the Company's products may be used on human
patients, the Company may be exposed to product liability claims. The
Company has purchased product liability insurance for the GBC 590 Phase
I Clinical trials. There can be no assurance that available amounts of
coverage will be sufficient to adequately protect the Company in the
event of a successful product liability claim.
Patent Status and Protection of Proprietary Technology
The Company currently holds a patent on MMS-1, registered
trademarks and additional patents are pending on its technology,
products or product applications. Dr. Platt will own all patents and
patent applications. Dr. Platt has granted an exclusive, world-wide,
license to IGG to make, use, have made, sell, lease or otherwise
transfer products covered by the patent or patent applications.
Further, Dr. Platt granted to IGG the right to issue sublicenses. Dr.
Platt is entitled to a royalty of 2% of the net selling price of GBC
590 and MMS-1. The license may be terminated by Dr. Platt in the sixth
year if total royalty payments, in any calendar year are less than
$50,000. Because all products may require more than six years for FDA
approval, the license may be terminated prior to the sale of any
products, the granting of FDA approval, or the granting of any patents.
Further, IGG is responsible for payment of all costs connected with
obtaining the patents. ELEXA patents are owned by Volcani Institute
which granted an exclusive license to AGI, a subsidiary of the Company.
All products except for MMS-1 are patent pending. The absence of
patent and trademark protection represents a risk in that the Company
is not able to prevent other companies from developing similar
products. In addition, there can be no assurance that the technology
of the Company will be granted patent protection, or will not infringe
on patents owned by others. To the extent that the Company currently
<PAGE> 19
relies upon unpatented, proprietary technology, processes and know-how
and the protection of such intellectual property by confidentially
agreements, there can be no assurance that others may not independently
develop similar technology and know-how or that confidentiality will
not be breached. There is no assurance that any patents will ever be
granted.
Dependence Upon Key Personnel
The Company relies greatly in its efforts on the services and
expertise of David Platt, Ph.D., CEO, Secretary and Chairman of the
Board of the Company. The operation and future success of the Company
would be adversely affected in the event that David Platt is
incapacitated or the Company otherwise loses his services.
Uncertainties Associated with Research and Development Activities
The Company intends to continue its research and development
activities on its products and for the purpose of developing
proprietary products. Research and development activities, by their
nature, preclude definitive statements as to the time required and
costs involved in reaching certain objectives. If research and
development requires more funding than anticipated, the Company may
have to reduce product development efforts or seek additional
financing. There can be no assurance that the Company would be able to
secure any necessary additional financing or that such financing would
be available on favorable terms.
Marketing
Assuming the Company is able to obtain EPA and FDA approval of its
products, it intends to market the same through partnership agreements
with established multinational companies. Partners will be selected on
the basis of experience and the degree of financial success they
exhibit in the industry. There are no assurances that the Company will
obtain EPA or FDA approval for its products and there are no assurances
that the Company will be successful in entering into agreements with
established multinational companies.
Company's Office
The Company's offices are located at One Kendall Square Building
300, Suite 202, Cambridge, Massachusetts 02139 and its telephone number
is (617) 621-3133. The Company leases 1,810 square feet of space.
The annual base rental is $27,150.00 and the term of the lease is two
years. The lease rent is subject to adjustment upon the occurrence of
certain events. Research is being conducted at various institutions.
See "ITEM 1. Business." The Company believes that the existing offices
and research and productive capacity of the facilities are suitable and
adequate for the Company's operations. However, the office may be
expanded in 1997.
<PAGE> 20
Employees
The Company is a development stage company and currently has one
employee (office staff) other than its Officers and Directors. See
"Management." Management of the Company expects to hire employees,
consultants, attorneys and accountants as necessary.
ITEM 2. PROPERTIES.
The Company's offices are located at One Kendall Square Building
300, Suite 202, Cambridge, Massachusetts 02139 and its telephone number
is (617) 621-3133. The Company leases 1,810 square feet of space.
The annual base rental is $27,150.00 and the term of the lease is two
years. The lease rent is subject to adjustment upon the occurrence of
certain events. Research is being conducted at various institutions.
See "ITEM 1. Business." The Company believes that the existing and
research and productive capacity of the facilities are suitable and
adequate for the Company's operations. However, the office may be
expanded in 1997.
ITEM 3. LEGAL PROCEEDINGS.
No material legal proceedings are pending to which the Registrant
is a party or of which any of Registrant's property is the subject
matter. No legal proceedings are known to be contemplated by
governmental authorities.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
No matters were submitted during the fourth quarter of the
calendar year covered by this report to a vote of security holders.
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED
STOCKHOLDERS MATTERS.
(a) Market Information.
The Registrant's securities are traded over-the-counter on the
Bulletin Board operated by the National Association of Securities
Dealers, Inc. under the symbol IGGI. The table shows the high and low
bid of Registrant's Common Stock since August 14, 1995, when the
Registrant's securities began trading.
<PAGE> 21
Quarter Ended BID
1995 High Low
September 30 1 3/4 5/8
December 31 3 1/4 1 5/8
1996
March 31 4 7/8 3 1/2
June 30 4 2 1/2
September 30 3 1/2 1 3/4
December 31 3 7/8 2 3/4
1997
First Quarter 6 1/4 3 3/8
(b) Holders.
As of March 31, 1997, the Company has 270 holders of record of its
Common Stock. This number does not include those beneficial owners
whose securities are held in street name. The total number of
shareholder is estimated to be approximately 800.
(c) Dividends.
The Registrant has never paid a cash dividend on its Common Stock
and has no present intention to declare or pay cash dividends on the
Common Stock in the foreseeable future. The Registrant intends to
retain any earnings which it may realize in the foreseeable future to
finance its operations. Future dividends, if any, will depend on
earnings, financing requirements and other factors.
ITEM 6. SELECTED FINANCIAL DATA.
Selected Consolidated Financial Data
The selected financial data presented below has been derived from
the financial statements of the Company. The following table
summarizes certain financial information and should be read in
conjunction with "Management's Discussion and Analysis of Results of
Operations and Financial Condition" and the Financial Statements and
related notes included elsewhere in this Registration Statement. The
information shown below may not be indicative of the Company's future
results of operations.
<PAGE> 22
<TABLE>
<CAPTION>
December 31,
1996 1995 1994
<S> <C> <C> <C>
Statement of Operations and Accumulated Deficit Data:
Income $ -0- $ -0- $ -0-
Operating Expenses $ 2,300,147 $ 675,833 $ 168,347
Net Income (loss) $(2,300,147) $ (675,833) $ (168,347)
Net Loss per Share $ (0.20) $ (0.09) $ (0.03)
Balance Sheet Data:
Working Capital $ 272,315 $(289,948) $(102,338)
Total Assets $ 488,839 $ 308,337 $ 23,278
Long-term Debt $ -0- $ -0- $ -0-
Stockholders'
Equity (Deficit) $ 298,091 $(270,941) $ (98,452)
</TABLE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATION.
The following discussion should be read in conjunction with the
consolidated financial statements and notes thereto.
Results of Operations
As a development stage enterprise from the Company's date of
inception, the Company has had no production, marketing, product sales
or net income. Operations from inception through December 31, 1996
have consisted principally of research, product development and
testing, and capital acquisition.
In the years prior to 1996, the Company's operations were
primarily funded by sales of its common stock during 1995 and 1994, and
by personal loans and capital from the Company's two founders during
1993.
On March 7, 1995, the Company completed a reverse acquisition,
wherein the majority shareholders in International Gene Group, Inc.
transferred their stock to Alvarada, Inc. for majority control of the
Company. Subsequent to this combination, Alvarada, Inc. changed its
name to IGG International, Inc. As part of this transaction, $400,000
in debt securities were privately placed, resulting in net proceeds in
excess of $360,000 for operating needs. In the three months preceding
this transaction, Alvarada, Inc. had raised the $400,000 from a private
placement offering of eight "investment units," which consisted of
$400,000 of one-year promissory notes together with a block of common
stock shares. The proceeds raised from the private placement were
escrowed and released to the Company after the reverse acquisition.
The Company had the option of extending the maturity date on these
Promissory Notes until January 1, 1997 or converting these notes to
common stock within the same time frame. While the Company is required
to repay most of these notes under certain circumstances if it
completes an equity offering, the aforementioned option provides the
<PAGE> 23
Company with some flexibility in handling its only loans of material
consequences. During 1996, the Company converted $310,000 of these
notes to 248,000 shares of common stock at the rate of $1.25 per share.
Also, the Company converted $30,746 in accrued interest on these notes
to 24,597 shares of common stock at the rate of $1.25 per share. The
remaining notes' balance of $90,000 was paid in cash during 1996.
The Company is making presentations to various venture capital
sources to raise additional capital. The Company is also pursuing
possible strategic partnerships or collaborations with other companies
interested in its substances under development. During the year ended
December 31, 1996, the Company raised $1,999,581 additional capital
through the sale of 1,332,431 shares of common stock. During the year
ended December 31, 1995, the Company raised $507,166 additional capital
through the sale of 336,491 shares of common stock. As of March 27,
1997, the Company had raised an additional $1,800,000 in capital
through the sale of its common stock in the first three months of 1997,
including $2,100,000 raised as part of a private placement during late
1996 and early 1997. Included in the additional capital raised by the
Company in 1995 and 1996 was the sale of 684,874 shares of common
stock with a total subscription price of $815,000.
The majority of the funds raised have been or will be used for the
funding of toxicity studies, clinical testing and addition field
testing on the compounds under development by International Gene Group,
Inc. and Agricultural Glycosystems, Inc. Once the toxicity studies are
completed, the major expenses anticipated by the Company are associated
with regulatory procedures for human clinical testing of the Company's
products, including consulting fees, and general and administrative
expenses. In addition, positive field study results will lead to
marketing expenses for ELEXA, the fungicide produced by Agricultural
Glycosystems, Inc.
The Company has completed pre-clinical studies on its cancer
metastasis product, GBC-590, and has begun Phase I human clinical
trials in cancer patients at two testing centers in the United States,
M. D. Anderson Hospital in Houston Texas and Graduate Hospital in
Philadelphia, Pennsylvania. Regarding a second product, MMS-1, an
experiment conducted by the University of Kentucky during 1996 proved
the possible effectiveness of the compound as a potential treatment for
HIV. Animal studies of MMS-1 are expected to continue during 1997 and
clinical testing is currently expected in the first quarter of 1998.
The Company has allocated from current and future available funds
$1,700,000 for further research and development of the associated
products. The Company will explore new applications of its products
and continue research on additional products based on carbohydrate
chemistry currently under development.
The Company's subsidiary, Agricultural Glycosystems, Inc. (AGI),
is developing a natural fungicide and, having completed initial
successful field studies, will continue further field testing on
various plant species and diseases. This fungicide, which is known as
ELEXA, has proven to be effective in the field, without problems with
toxicity. During 1996, the Company completed toxicity tests based on
<PAGE> 24
protocols designed to satisfy the EPA. The Company currently expects
the EPA registration process to be completed in late 1997 or early
1998. Product marketing, contingent upon EPA approval, is expected to
begin as early as the fourth quarter of 1997. The Company has
allocated from current and future available funds $1,700,000 for
further research and development on AGI's natural fungicide product for
the next two years. The Company is also pursuing registrations in
other countries. This product, ELEXA, may be fully register and
approved for sale in Chile in late 1997.
On December 29, 1995, AGI entered into a licensing agreement with
the Government of Israel's Agricultural Research Organization
concerning shared technology. The licensing agreement requires that
AGI pay a three percent (3%) royalty on the net selling price of any
licensed products arising from the shared technology. As an additional
condition of this agreement, AGI will fund a research and development
program requiring payments over the next five years totaling
$1,573,000. In the first year, AGI will pay $327,000 and in the
following four years $332,000, $314,000, $300,000 and $300,000,
respectively. This agreement will be effective until the patents using
the licensed technology have expired or the agreement is terminated by
the parties involved. The funding of the first two years of the
required research and development program is included in the
aforementioned budgets. The Company paid $30,000 of the first year's
payment in 1995, and an additional $297,000 in 1996. The Company has
paid $100,000 in early 1997.
Apart from the previously mentioned promissory notes, the
Company's only other significant liability is accrued legal fees,
including fees assessed by one firm of $111,635 during 1994. The
Company's management believes that these charges are improper,
excessive and will be settled for a small fraction of the amount
stated.
The Company's balance sheet shows significant negative working
capital for the year ended December 31, 1995. While not an unusual
status for working capital in a development stage enterprise, this
situation is expected to be alleviated by additional shareholders'
capital raised subsequent to December 31, 1995, conversion of
promissory notes to common stock, and the ultimate settlement of the
aforementioned legal fees at an amount less than that currently
recorded.
As of December 31, 1996 the Company's current assets were
$463,063. This results in net working capital in excess of $270,000.
Cash in banks totaled $444,661 of the current assets with an additional
$1,100,000 being received in January and February 1997 as part of a
Private Placement Offering and another $1,000,000 received from a
Regulation S investment.
<PAGE> 25
Capital Resources and Liquidity
The need for sustained funding of the current research and
development programs drives the Company's efforts to raise additional
capital from qualified investors. The Company expects to privately
place additional common stock over the next year. A large portion of
the funds from future offerings will be used to complete the Company's
Phase I and II clinical studies on GBC-590 cancer treatment. In
addition the Company will conduct pre-clinical and clinical studies on
other human therapeutic products. AGI's natural fungicide, ELEXA, will
constitute the bulk of the Company's research and development
operations, and should ultimately enable the Company to produce and
market its products.
The Company's cancer metastasis product, now referred to as GBC-590,
has completed animal toxicity testing in 1996, and has received
FDA approval as an investigative new drug in 1996. The clinical Phase
I test sites have been selected and testing of the drug in humans began
in March 1997. The Company's HIV product, MMS-1, finished animal
studies at the University of Kentucky in 1996, and additional studies
began in primates in the first quarter of 1997.
Pending the successful completion of the phase one and two
clinical studies on humans and the initiation of fungicide sales, the
Company is conducting an additional private offering of its equity
securities during 1997. The proceeds from this offering are expected
to fund the marketing and licensing of the products under development,
clinical studies, additional pre-clinical and field research and the
Company's working capital needs. The Company is pursuing a European
private offering of preferred or common stock during 1997, as well.
The Company has no significant commitments for the purchase of
equipment, product manufacturing or marketing efforts at present. The
Company is leasing office facilities under a two-year lease terminating
in August 1997. The first year of the lease was prepaid and the future
payments on the second year of the lease in 1996 and 1997 are expected
to total $34,820.
The Company has no bank lines of credit or other commercial
financing sources at present and does not expect to obtain any. It is
not known whether additional funds could be borrowed from shareholders
or other sources.
Inflation and Changing Prices
To date, the impacts of inflation and changing prices on the
Company's operations have been minimal. The Company is currently
testing it products in the United States and Israel in accordance with
royalty and research agreements already in effect. During the research
and development phase of operations to satisfy regulatory requirements
for the products under development, the Company expects that
inflationary pressures in both countries will be minimal. The Company
is also beginning to explore European markets and has minimal funds in
foreign bank accounts.
<PAGE> 26
In the future, the Company will attempt to minimize the impact of
inflation on production and operating costs through quality and
productivity improvement programs. While the Company is in the pre-
production stage of operations, it is not particularly affected by
inflation.
Going Concern Qualification
The auditors of the consolidated financial statements of the
Company have stated that the financial statements have been prepared on
a going-concern basis for the years ended December 31, 1995 and 1996.
That basis of accounting contemplates the realization of assets and the
satisfaction of liabilities in the normal course of conducting business
operations. As shown in the consolidated financial statements,
operations for the year ended December 31, 1996 resulted in a net loss
of $2,300,147. The Company's future is dependent on its ability to
continue to obtain additional capital or adequate financing to fund
successive phases of human clinical testing of its products in order to
prove their efficacy and marketability, and to achieve a level of sales
adequate to support its operations.
The Company will continue to raise additional capital from
qualified investors. The Company is making presentations to various
venture capital sources to raise additional capital. The Company is
also pursuing possible strategic partnerships or collaborations with
other companies interested in its substances under development.
The Company's management believes that the human clinical testing
and field testing of its products during 1996 have proven their
efficacy and marketability, thereby facilitating the acquisition of
funds needed for continued operations from the sale of equity
securities to the public. The Company believes it will have ELEXA as
a marketable product, with sales beginning in either the United States
or Chile no later than the first quarter of 1998.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
Financial statements and supplementary data begin on the next page.
<PAGE> 27
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
TABLE OF CONTENTS
PAGE
ACCOUNTANTS REVIEW REPORT F-1
CONSOLIDATED BALANCE SHEETS F-2 - F-3
CONSOLIDATED STATEMENTS OF OPERATIONS F-4
STATEMENT OF SHAREHOLDERS' EQUITY F-5 - F-7
CONSOLIDATED STATEMENTS OF CASH FLOWS F-8 - F-10
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-11 - F-22
<PAGE> 28
Board of Directors
IGG International, Inc.
Cambridge, Massachusetts
Independent Auditor's Report
We have audited the accompanying consolidated balance sheet of IGG
International, Inc. (a development stage enterprise) as of December 31,
1995, and 1996, and the related consolidated statements of operations,
shareholders' equity (deficit) and cash flows for the years ended
December 31, 1994, 1995, and 1996 and for the period from December 8,
1992 (inception) through December 31, 1996. These financial statements
are the responsibility of the Company's management. Our responsibility
is to express an opinion on these financial statements based on our
audit.
We conducted our audit in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial statements
are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation. We believe
that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above
present fairly, in all material respects, the financial position of IGG
International, Inc. as of December 31, 1995 and 1996, and the results
of its operations and its cash flows for the years ended December 31,
1994, 1995 and 1996, and for the period ended December 8, 1992
(inception) through December 31, 1996, in conformity with generally
accepted accounting principles.
The accompanying consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. As shown
in the consolidated financial statements, the Company incurred a net
loss of $2,300,147 during the year ended December 31, 1996. As
discussed in Note 1, this condition raises substantial doubt that the
Company will be able to continue as a going concern. The financial
statements do not include any adjustments that might result from the
outcome of this uncertainty.
Williams & Webster, P.S.
Certified Public Accountants
Spokane, Washington
March 27, 1997
F-1
<PAGE> 29
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
December 31, December 31,
1995 1996
<S> <C> <C>
ASSETS
CURRENT ASSETS
Cash $ 250,490 $ 444,661
Prepaid rent 28,052 6,134
Other 10,788 12,268
_________ _________
TOTAL CURRENT ASSETS 289,330 463,063
PROPERTY AND EQUIPMENT, net of
accumulated depreciation 16,810 23,987
OTHER ASSETS
Deposits 2,197 1,789
_________ _________
TOTAL ASSETS $ 308,337 $ 488,839
========= =========
</TABLE>
The accompanying notes are an integral part of these
consolidated financial statements.
F-2
<PAGE> 30
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
December 31, December 31,
1995 1996
<S> <C> <C>
LIABILITIES AND SHAREHOLDERS
EQUITY (DEFICIT)
CURRENT LIABILITIES
Accounts payable $ 9,011 $ 62,648
Professional fees payable 136,297 128,100
Accrued interest 33,970 -
Notes payable to
shareholders, net 400,000 -
_________ __________
TOTAL CURRENT LIABILITIES 579,278 190,748
_________ __________
COMMITMENTS AND CONTINGENCIES - -
MINORITY STOCK INTERESTS - -
SHAREHOLDERS' EQUITY (DEFICIT)
Preferred stock,
$.01 par value,
5,000,000 shares
authorized; no shares
issued and outstanding - -
Common stock, $.01 par
value, 25,000,000
shares authorized;
7,507,491 shares, and
9,462,641 shares issued
and outstanding at
December 31, 1995,
and 1996, respectively 75,075 94,626
Additional paid-in capital 536,246 3,082,822
Stock options and warrants - 303,052
Deficit accumulated during
development stage (882,262) (3,182,409)
_________ __________
TOTAL SHAREHOLDERS' EQUITY
(DEFICIT) (270,941) 298,091
_________ __________
TOTAL LIABILITIES AND SHARE-
HOLDERS' EQUITY (DEFICIT) $ 308,337 $ 488,839
========= ==========
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-3
<PAGE> 31
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Operations have been formatted to fit across two pages.
This is page 1 of page 2.)
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
Year Ended Year Ended
December 31, December 31,
1994 1995
<S> <C> <C>
REVENUES $ - $ -
__________ __________
GENERAL AND
ADMINISTRATIVE EXPENSES
Professional fees 134,185 83,832
Officers' salaries - 115,000
Depreciation 1,901 3,201
Amortization-debt
issuance costs - 31,697
Other 26,602 258,596
__________ __________
Total 162,688 492,326
__________ __________
RESEARCH AND
DEVELOPMENT COSTS
Consultants, supplies
and testing 5,451 154,495
__________ __________
OPERATING LOSS (168,139) (646,821)
__________ __________
OTHER INCOME (EXPENSES)
Interest expense (225) (35,970)
Interest income 17 6,958
Loss on disposal of assets - -
__________ __________
Total other income(expenses) (208) (29,012)
__________ __________
NET LOSS $ (168,347) $ (675,833)
========== ==========
NET LOSS PER COMMON SHARE $ (0.03) $ (0.09)
========== ==========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 5,779,699 7,290,615
========== ==========
The accompanying notes are an integral part of these consolidated
financial statements.
F-4
<PAGE> 32
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Operations have been formatted to fit across two pages.
This is page 2 of page 2.)
Period from
December 8, 1992
(inception)
Year Ended through
December 31, December 31,
1996 1996
<C> <C>
$ - $ -
___________ ___________
179,609 404,438
222,200 337,200
10,740 16,906
- 31,697
705,576 1,012,743
___________ ___________
1,118,125 1,802,984
1,045,027 1,263,210
___________ ___________
(2,213,152) (3,066,194)
___________ ___________
(103,517) (139,712)
18,289 25,264
(1,767) (1,767)
___________ ___________
(86,995) (116,215)
___________ ___________
$(2,300,147) $(3,182,409)
=========== ===========
$ (0.26) $ (0.57)
=========== ===========
8,700,146 5,545,332
=========== ===========
</TABLE>
F-4
<PAGE> 33
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Shareholders' Equity have been formatted to fit across
two pages. This is page 1 of page 2.)
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
For the year ended December 31, 1996,
and from December 8, 1992 (inception)
<TABLE>
<CAPTION>
Common Stock
Number
of shares Amount
<S> <C> <C>
Balances - December 8, 1992 - $ -
Issuance of shares to officers in
consideration of services provided
and additional cash contributed
during 1993, net average cost
of $.076 per share 578,165 5,782
Net loss for the year ended
December 31, 1993 - -
___________ __________
Balances - December 31, 1993 578,165 5,782
Common stock issued for cash
at $.244 per share 40,916 409
Common stock issued for
recruiting a director with
cash paid of $.001 per share 200,134 2,001
Cash paid by shareholders
for a minority interest in
International Gene Group, Inc.
prior to the reverse
acquisition of Alvarada Inc. - -
Shares issued in 9-for-1 stock
dividend to shareholders as
of January 1, 1994 5,001,871 50,019
Additional paid-in capital from
original shareholders during
the year - -
Net loss for the year ended
December 31, 1994 - -
___________ __________
Balances - December 31, 1994 5,821,086 $ 58,211
___________ ___________
The accompanying notes are an integral part of these consolidated
financial statements.
F-5
<PAGE> 34
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Shareholders' Equity have been formatted to fit across
two pages. This is page 2 of page 2.)
Deficit
Stock Accumulated Total
Additional Options During the Shareholders'
Paid-in and Development Equity
Capital Warrants Stage (Deficit)
<C> <C> <C> <C>
$ - $ - $ - $ -
37,905 - - 43,687
- - (38,082) (38,082)
_________ _________ __________ ____________
37,905 - (38,082) 5,605
9,591 - - 10,000
(1,801) - - 200
52,500 - - 52,500
(50,019) - - -
1,590 - - 1,590
- - (168,347) (168,347)
_________ _________ __________ ____________
$ 49,766 $ - $ (206,429) $ (98,452)
_________ _________ __________ ____________
</TABLE>
F-5
<PAGE> 35
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Shareholders' Equity have been formatted to fit across
two pages. This is page 1 of page 2.)
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
For the year ended December 31, 1996,
and from December 8, 1992 (inception)
<TABLE>
<CAPTION>
Common Stock
Number
of shares Amount
<S> <C> <C>
Balances - December 31, 1994
(carryforward) 5,821,086 $ 58,211
Recapitalization of the Company
through the reverse
acquisition of Alvarada, Inc. 1,349,914 13,499
Common stock issued for cash at
$2.50 per share, net of costs
of $7,500 88,200 882
Common stock issued for cash at
$1.19 to $1.25 per share, net
of costs of $2,500 248,291 2,483
Net loss for the year ended
December 31, 1995 - -
__________ _________
Balances - December 31, 1995 7,507,491 75,075
__________ _________
Common stock issued for the
conversion of notes payable
at $1.25 per share,
including accrued interest 272,596 2,726
Common stock issued to extend
notes payable at one share
per $5.00 of note, valued
at $1.25 per share 80,000 800
Common stock issued for services
valued at $2.00 per share 2,400 24
__________ _________
Balances - December 31, 1996 7,862,487 $ 78,625
(carryforward) __________ _________
The accompanying notes are an integral part of these consolidated
financial statements.
F-6
<PAGE> 36
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Shareholders' Equity have been formatted to fit across
two pages. This is page 2 of page 2.)
Deficit
Stock Accumulated Total
Additional Options During the Shareholders'
Paid-in and Development Equity
Capital Warrants Stage (Deficit)
<C> <C> <C> <C>
$ 49,766 - $ (206,429) $ (98,452)
(17,321) - - (3,822)
212,118 - - 213,000
291,683 - - 294,166
- (675,833) (675,833)
_________ _________ ___________ __________
536,246 - (882,262) (270,941)
_________ _________ ___________ __________
338,020 - - 340,746
99,200 - - 100,000
4,776 - - 4,800
__________ _________ ___________ __________
$ 978,242 $ - $ (882,262) $ 174,605
__________ _________ ___________ __________
</TABLE>
F-6
<PAGE> 37
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Shareholders' Equity have been formatted to fit across
two pages. This is page 1 of page 2.)
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
For the year ended December 31, 1996,
and from December 8, 1992 (inception)
<TABLE>
<CAPTION>
Common Stock
Number
of shares Amount
<S> <C> <C>
Balances - December 31, 1996
(carryforward) 7,862,487 $ 78,625
Common stock issued for cash
at $1.25 to $2.50 per share,
net of costs of $60,826 1,142,431 11,424
Common stock issued as part of a
Private Placement at $2.50 per
share with warrants attached 190,000 1,900
Common stock issued for common
stock of International Gene
Group, Inc. minority interests 173,449 1,734
Common stock issued for adjustment
in share prices 33,774 338
Stock options for 215,206 shares
of common stock issued for
consulting and professional
services valued at $1.50 to
$2.69 per share - -
Stock options exercised 60,500 605
Net loss for the year
ended December 31, 1996 - -
__________ ________
Balances - December 31, 1996 9,462,641 $ 94,626
========== ========
The accompanying notes are an integral part of these consolidated
financial statements.
F-7
<PAGE> 38
(In order to transmit these documents to the SEC via EDGAR, IGG
International, Inc., a development stage enterprise, Consolidated
Statements of Shareholders' Equity have been formatted to fit across
two pages. This is page 2 of page 2.)
Deficit
Stock Accumulated Total
Additional Options During the Shareholders'
Paid-in and Development Equity
Capital Warrants Stage (Deficit)
<C> <C> <C> <C>
$ 978,242 $ - $ (882,262) $ 174,605
1,513,157 - - 1,524,581
473,100 - - 475,000
(1,734) - - -
(338) - - -
- 424,052 - 424,052
120,395 (121,000) - -
- - (2,300,147) (2,300,147)
___________ _________ ___________ ___________
$ 3,082,822 $ 303,052 $(3,182,409) $ 298,091
=========== ========= =========== ===========
</TABLE>
F-7
<PAGE> 39
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
December 8,
(inception)
through
Years ended December 31, December 31
1994 1995 1996 1996
<S> <C> <C> <C> <C>
Cash flows from
operating activities:
Interest received $ 17 $ 5,267 $ 18,289 $ 23,573
Cash paid for
services and
administration (45,508) (621,233) (1,710,906) (2,414,665)
Interest paid (225) (2,000) (3,517) (5,742)
_________ _________ ___________ ___________
Net cash used in
operating activities (45,716) (617,966) (1,696,134) (2,396,834)
_________ _________ ___________ ___________
Cash flows from
investing activities:
Purchase of equipment (1,291) (16,125) (19,684) (42,660)
Loans to shareholders - (40,000) - (40,000)
Repayment of share-
holder loans - 40,000 - 40,000
Deposits paid, net - (2,197) 408 (1,789)
Net cash used in
acquisition - (3,822) - (3,822)
________ _________ ___________ ___________
Net cash used in
investing activities $ (1,291) $(22,144)$ (19,276) $ (48,271)
________ _________ ___________ ___________
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-8
<PAGE> 40
IGG INTERNATIONAL, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF CASH FLOWS (CONTINUED)
<TABLE>
<CAPTION>
December 8,
(inception)
through
Years ended December 31, December 31
1994 1995 1996 1996
<S> <C> <C> <C> <C>
Cash flows from
financing activities:
Short-term borrowing $ - $ 398,000 $ - $ 398,000
Payments on short-
term borrowing - - (90,000) (90,000)
Proceeds from
issuance of
common stock 61,700 517,166 2,060,407 2,682,960
Payment of capital
acquisition fees - (10,000) (60,826) (70,826)
Capital contributed
by shareholders 1,329 - - 1,329
Debt issuance costs - (31,697) - (31,697)
________ _________ __________ ___________
Net cash provided by
financing activities 63,029 873,469 1,909,581 2,889,766
________ _________ __________ ___________
Net increase in cash 16,022 233,359 194,171 444,661
Cash-beginning balance 1,109 17,131 250,490 -
________ _________ _________ ___________
Cash-ending balance $ 17,131 $ 250,490 $ 444,661 $ 444,661
======== ========= ========== ===========
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-9
<PAGE> 41
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
CONSOLIDATED STATEMENTS OF CASH FLOWS (CONTINUED)
<TABLE>
<CAPTION>
December 8,
(inception)
through
Years ended December 31, December 31
1994 1995 1996 1996
<S> <C> <C> <C> <C>
Reconciliation of net
loss to net cash used in
operating activities:
Net loss $(168,347) $(675,833) $(2,300,147) $(3,182,409)
_________ _________ __________ ___________
Adjustments:
Operating items paid in
common stock
Interest on notes - - 130,746 130,746
Consulting services
stock options
for services - 57,867 424,052 424,052
Amortization of debt
issuance costs - 31,697 - 31,697
Amortization of
debt discount - 2,000 - 2,000
Loss on disposal - - 1,767 1,767
Depreciation 1,901 3,201 10,740 16,906
Increase
in accounts payable 121,730 23,578 45,440 190,748
Increase in other
assets (1,000) (8,527) (1,480) (11,007)
Decrease (increase)
in prepaid rent - (28,052) 21,918 (6,134)
Increase (decrease)
in accrued interest - 33,970 (33,970) -
Consulting and professional
services paid by - - 4,800 -
issuance of stock - - 1,074 1,074
_________ _________ ___________ ___________
Total Adjustments 122,631 57,867 604,013 785,575
_________ _________ ___________ ___________
Net cash used in
operating activities $(45,716) $(617,966) $(1,696,134) $(2,396,834)
========= ========= ========== ===========
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements
F-10
<PAGE> 42
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION
IGG International, Inc. ("the Company"), formerly Alvarada, Inc.,a
Nevada corporation, is a successor by reverse acquisition (Note 7) to
International Gene Group, Inc., a Michigan corporation. The Company is
a development stage enterprise formed for the research and development
of pharmaceutical products based on carbohydrate chemistry.
International Gene Group, Inc. will continue as a subsidiary of IGG
International, Inc. In June 1995, the Company incorporated a new
subsidiary, Agricultural Glycosystems, Inc. in the state of Michigan.
The Company is the sole shareholder in this subsidiary. Agricultural
Glycosystems, Inc. will develop agricultural applications for products
that are also based upon carbohydrate chemistry and these products will
be either licensed from or jointly developed with the Government of
Israel's Agricultural Research Organization. IGG International, Inc.
and Agricultural Glycosystems, Inc. maintain an office in Cambridge,
Massachusetts.
PRINCIPLES OF CONSOLIDATION
The Company's financial statements include the accounts of the Company,
its majority owned subsidiary, International Gene Group, Inc., and its
wholly owned subsidiary Agricultural Glycosystems, Inc. All material
intercompany transactions and accounts have been eliminated in the
consolidated financial statements.
CASH AND CASH EQUIVALENTS
The Company considers all highly liquid debt instruments purchased with
a maturity of three months or less to be cash equivalents. Cash in
interest-bearing accounts as of December 31, 1995, and 1996 totals
$215,432 and $398,791, respectively. This includes over $100,000 and
$397,000, respectively, which is held by a single bank and could
represent a concentration of credit risk. The Company's management
believes such risk is minimal since these funds are in a "sweep"
account which is daily reinvested in government securities funds.
PROPERTY AND EQUIPMENT
Equipment is carried at cost. Depreciation is calculated on
accelerated methods over estimated useful lives ranging from 5 to 7
years. The company has made $3,900 in leasehold improvements which are
being amortized over the remaining life of the lease, which is not
expected to be renewed.
F-11
<PAGE> 43
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES continued
ADVANCES TO AND FROM OFFICERS
In recent years, the officers have, as necessary, advanced funds to the
Company. Most of these advances have been converted to additional
paid-in capital. At times, the officers have received advances from
the Company.
PATENTS
Amounts paid to secure patent rights are expensed as paid until the
products under development have passed testing and prove to be viable
per regulatory requirements.
DEBT ISSUANCE COSTS
Debt issuance costs consist of legal and other related costs incurred
in connection with the Company's private placement offering in early
1995. These costs were amortized over the remaining life of the one-
year promissory notes. Debt issuance costs of $31,697 were fully
amortized as of December 31, 1995.
RESEARCH AND DEVELOPMENT
Research and development costs, which consist primarily of expenses for
consultants, supplies and testing, are charged to operations as
incurred.
LOSS PER SHARE
Loss per share is computed using the weighted average number of common
shares outstanding or deemed to be outstanding during the period,
including any warrants which are exercisable and outstanding. The
computation of loss per share does not include common stock
equivalents, which are anti-dilutive.
STOCK SPLIT
In March 1995, the Company effected a 78.14-for-1 reverse stock split
for all shares outstanding at that date. All references in the
financial statements to issued and outstanding shares and per share
data reflect this reverse stock split.
INCOME TAXES
As of December 31, 1996, the Company had accumulated net operating
losses of approximately $3,000,000. These losses are available to
reduce taxable income and the corresponding future federal and state
income taxes. These losses may be carried forward for fifteen years,
with the earliest expiration year of 2008.
F-12
<PAGE> 44
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES continued
MINORITY INTEREST
At December 31, 1996, minority shareholders held an approximately three
percent interest in International Gene Group, Inc. No value for this
minority interest is shown on the accompanying balance sheet, as the
subsidiary had a shareholders' deficit at December 31, 1996. During
1996, minority shareholders representing three percent of the
outstanding minority interest, converted their 585 shares in
International Gene Group, Inc. into 173,449 shares of common stock in
IGG International, Inc. These conversions were at 296.49 shares in the
Company for each minority share, which is the same rate as the original
acquisition of the Company.
GOING CONCERN
The consolidated financial statements of the Company have been prepared
on a going-concern basis. That basis of accounting contemplates the
realization of assets and the satisfaction of liabilities in the normal
course of conducting business operations. As shown in the consolidated
financial statements, operations for the year ended December 31, 1996
resulted in a net loss of $2,300,147. The Company's future is
dependent on its ability to continue to obtain additional capital or
adequate financing to fund successive phases of human clinical testing
of its products in order to prove their efficacy and marketability, and
to achieve a level of sales adequate to support its operations.
The Company has completed a private placement offering in February 1997
which raised in excess of $1,500,000 to meet the Company's cash needs
for 1997. The Company is making presentations to various venture
capital sources to raise additional capital. The Company is also
pursuing possible strategic partnerships or collaborations with other
companies interested in its substances under development.
RESTATEMENT
The restatement of the financial statements has resulted in certain
changes in presentation which have no effect on the net losses or
shareholders' equity for December 31, 1995 or 1994, or the years then
ended.
F-13
<PAGE> 45
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 2. EQUIPMENT
The Company's equipment at December 31, 1995 and 1996 consists of the
following:
<TABLE>
<CAPTION>
December 31, December 31,
1995 1996
<S> <C> <C>
Computer, office equipment and
improvements $ 22,976 $ 39,822
Less: accumulated
depreciation (6,166) (15,835)
_________ _________
TOTAL $ 16,810 $ 23,987
========= =========
</TABLE>
NOTE 3. NOTES PAYABLE
In March 1995, the Company raised $400,000 from a private placement
offering of eight "investment units" from accredited investors who
through their investments became shareholders of the Company. This
offering was intended to provide a "bridge" loan for the research and
development activities of the Company, and was contingent on the
completion of the reverse acquisition (Note 7). Each investment unit
consisted of a $50,000 promissory note and 25,000 shares of common
stock. The promissory notes, which paid ten percent interest per
annum, have a maturity date of January 1, 1996 although this date was
extended at the Company's option for an additional year. During 1997,
the Company paid $90,000 in cash and $310,000 in common stock
conversion.
As a condition of extending the notes, the Company is obligated to
issue an additional 10,000 shares of common stock to the note holders
of each unit, resulting in a total of an additional 80,000 shares of
common stock being issued. In 1996, the Company elected to extend the
loan and issued the 80,000 shares valued at $1.25 per share. This
expense was treated as additional interest paid in the first quarter of
1996 totaling $100,000.
The Company has discounted the aforementioned promissory notes to a
value of $398,000. The discount of $2,000, based upon the stock's
assigned value of $.01, has been attributed to stock issued with the
investment units. The Company accrued interest payable on the
promissory notes at December 31, 1995 of $33,970.
F-14
<PAGE> 46
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 3. NOTES PAYABLE continued
Expenses associated with the private placement offering totaled
$31,697. These charges have been capitalized and were amortized over
the original period of the loans. These expenses include legal and
promotional costs associated with the debt offering and the related
reverse acquisition of Alvarada, Inc.
In January 1996, promissory note holders converted $310,000 of the
aforementioned promissory notes at the rate of $1.25 per common share
to 248,000 shares. The note holders also converted $30,746 in accrued
interest at the rate of $1.25 per common share into 24,597 shares.
During 1996, the Company repaid $90,000 of the remaining promissory
notes including interest.
NOTE 4. ACCOUNTS PAYABLE AND ACCRUED ATTORNEY FEES
In 1993 and 1994, the Company engaged the services of a Detroit,
Michigan law firm for the purpose of raising funds for the Company from
private investors. While ultimately unsuccessful in raising any
significant funds for the Company, the law firm billed the Company
$111,635 for its services in late 1994. This same amount is recorded
in full as an accrued liability on the Company's balance sheet at
December 31, 1995 and 1996.
The Company disputes the amount of the legal charges and expects to
settle this obligation for an amount less than the recorded liability.
As of March 27, 1997, the amount and timing of any settlement is
unknown. As of December 31, 1995 and 1996, the Company owed additional
legal and accounting bills totaling $24,662 and $16,464, respectively.
NOTE 5. SHAREHOLDERS' EQUITY
International Gene Group, Inc. was incorporated on December 8, 1992
with an authorized capitalization of 60,000 shares of no par common
stock. The Company did not begin its activities or issue stock until
early 1993. In 1993, the original shareholders received common stock
for services provided and contributed $43,687 in cash. In 1994, these
shareholders contributed an additional $1,590 in cash. During 1994,
the Company sold common stock by subscription agreements for a total of
$62,700.
F-15
<PAGE> 47
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 5. SHAREHOLDERS' EQUITY continued
As of March 7, 1995, the majority shareholders of International Gene
Group , Inc., controlling 19,633 shares of common stock, acquired
eighty-one percent control of Alvarada, Inc. through a reverse
acquisition in exchange for their stock (Note 7). The investment of
the remaining shareholders, controlling 1,278 shares of International
Gene Group, Inc., is recorded as minority interest in this subsidiary
(Note 1).
The acquisition is being accounted for as a reverse acquisition and the
subsequent capital structure of the continuing entity includes the
restated stock of Alvarada, Inc. at $.01 par value and a combination of
the companies' additional paid-in capital. After the reverse stock
split in 1995, the authorized capital stock of Alvarada, Inc.,
subsequently known as IGG International, Inc., was amended to include
thirty million (30,000,000) authorized shares of stock, consisting of
twenty-five million (25,000,000) shares of common stock with a par
value of $.01, and five million (5,000,000) shares of preferred stock
with a par value of $.01.
On March 31, 1995, in exchange for accepting a seat on the Board of
Directors, the Company agreed to issue Mr. James C. Czirr warrants to
purchase up to a total of 300,000 shares of the Company's common stock
exercisable at $.10 per share through March 2005. As of December 31,
1995, one hundred thousand of these warrants are considered outstanding
and exercisable. As of December 31, 1996, two hundred thousand of
these warrants are considered as outstanding and exercisable. These
outstanding warrants are considered as common stock equivalents. On
October 2, 1995, the Company agreed to give Mr. Czirr a one-quarter of
one percent (0.25%) royalty interest in all products licensed or
developed by Agricultural Glycosystems, Inc. and, in addition, 3,500
shares of common stock in the Company per month, to be distributed
under a benefit plan to be adopted, for his future efforts in
developing the Company.
In October 1996, the Company reached a final consulting agreement with
Mr. Czirr. Under this agreement, the warrants issued will be limited
to 200,000 outstanding warrants. Furthermore, Mr. Czirr also received
in 1996 45,500 shares of common stock under the
F-16
<PAGE> 48
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 5. SHAREHOLDERS' EQUITY continued
Nonqualifying Stock Option Plan adopted in May 1996. These shares were
distributed in 1996 and the company charged operations for consulting
expenses for $91,000. As part of this agreement, the royalty interest
in Agricultural Glycosystems, Inc.'s products was terminated.
Additional capital raised by the Company in 1995 includes $271,666 from
the down payment on a subscription for 684,874 shares of common stock
with a total subscription price of $815,000. The balance of this
agreement amounting to $543,334 was paid during 1996.
In June 1996, the Company granted 2,500 options per month for a period
of thirteen months to Mr. Richard Salter in consideration of consulting
services. The purchase price of common stock from these options is
$0.01 per share and will be considered vested and exercisable
immediately each month. Also, an additional grant of 2,500 shares per
month of restricted shares for the twelve months beginning with July
1996 and an additional grant of 40,000 shares were made by the company.
Consulting expenses were charged for the $145,000 for the 72,500
options granted under this agreement. Only 15,000 actual shares were
issued from the amount earned in 1996.
Furthermore, the Company granted Mr. David Sandberg, in consideration
for legal services, the right to purchase up to 10,000 shares of common
stock at $0.01 per share based on warrants issued for reduction in
legal fees. As of December 31, 1996, the Company considers 3,598
shares earned by Mr. Sandberg under this agreement. The Company valued
these services at $7344 under variable pricing agreement with shares
being valued between $2.00 and $2.69, and are treated as stock options
until issued.
During 1996, the Company entered into a consulting agreement with Mr.
John Pool to provide European consulting services. Under this
agreement, Mr. Pool may earn up to 160,000 shares of restricted common
stock if he meets certain targets. As of December 31, 1996, 20,000
shares were considered earned but not issued, and were valued as stock
options at $2.00 per share for a total amount of $40,000.
F-17
<PAGE> 49
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 5. SHAREHOLDERS' EQUITY continued
In September 1996, the Company reached an agreement with Mr. Keith
Greenfield to issue common stock for his services in consulting and
negotiations. The Company agreed to issue 43,000 shares of restricted
common stock and 15,000 shares of common stock pursuant to the
Nonqualifying Stock Option Plan adopted in May 1996. All of these
shares were considered earned in 1996 and were valued at $2.00 per
share for a total increase in consultants expenses of $116,000. As of
December 31, 1996, this amount is considered to be outstanding stock
options.
On April 26, 1996, the Company entered into an agreement with Trinity
American Corporation granting Trinity warrants for 500,000 shares of
the Company's common stock. These warrants are exercisable at $5.00
per share for a term of 365 days or 100 days after the Securities and
Exchange Commission declares the registration statement effective,
registering the warrants and
NOTE 5. SHAREHOLDERS' EQUITY (continued)
underlying shares. These warrants were registered in late 1996 and
were declared effective in early 1997. The Company has extended the
exercise period to September 1, 1997.
As discussed above, the Company adopted a Nonqualifying Stock Option
Plan and registered 500,000 shares of common stock with the Securities
and Exchange Commission for the issuance under option agreements. The
exercise price of each option will be determined by the Board of
Directors of the Company and must be issued within ten years from May
1, 1996. The Company may issue these options to its officers,
directors, employees and consultants. As of December 31, 1996, 81,940
options were issued under this plan as consideration for $163,880 of
services and consulting expenses. Of that amount, 62,500 options were
tendered for common stock in 1996. The options issued under this plan
have exercise prices of $0.01.
During late 1996, the Company reached an agreement with some of its
researchers and consultants to limit their cash expenses. The
financial statements contain a provision for 15,608 options valued at
$1.50 per share with an exercise price of $.01 per share resulting in
consulting and research and development expenses being charged $23,412.
F-18
<PAGE> 50
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 5. SHAREHOLDERS' EQUITY continued
In November 1996, the Company began a Private Placement Offering of up
to 600,000 shares of common stock. As of December 31, 1996, 190,000
shares had been sold at $2.50. these shares include a attached warrant
to purchase one share for every four shares owned at $3.50. As of
December 31, 1996, the warrants outstanding under these sales totaled
47,500.
NOTE 6. RELATED PARTY TRANSACTIONS
In January 1994, the Company agreed that its founder, Dr. David Platt,
would receive an inventor's royalty from the Company of two percent of
net sales, in exchange for the licensed patent rights on substances
being developed, referred to as GBC-590 and MMS-1. The Company has
agreed to pay all of the costs to procure and maintain any patents
granted under this agreement.
The agreement includes a requirement that the royalties paid in the
sixth year of this agreement and all subsequent years meet a minimum
requirement of $50,000. If this requirement is not met, Dr. Platt may
terminate the agreement and retain the patent rights. The Company may
terminate the agreement on sixty days' notice.
As of March 31, 1995, the Company entered into an agreement with a
director and shareholder, Mr. James C. Czirr, to perform full time
consulting services at the rate of $8,000 per month plus reimbursable
expenses. In June 1995, Mr. Czirr's consulting contract was canceled
and he was removed from the Company's Board of Directors. As of
September 28, 1995, Mr. Czirr again became a consultant to the Company
and had his interests modified, as discussed in Note 5.
NOTE 7. ACQUISITION AND RECAPITALIZATION
On March 7, 1995, Alvarada, Inc. acquired International Gene Group,
Inc. by exchanging 5,821,086 shares of its issued and outstanding
common stock for 19,633 issued and outstanding shares of International
Gene Group, Inc. As a result of this exchange, Alvarada, Inc. acquired
approximately 94% of the outstanding common stock of International Gene
Group, Inc. The shares issued in this exchange are considered as being
issued from the earliest period
F-19
<PAGE> 51
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 7. ACQUISITION AND RECAPITALIZATION continued
presented, January 1, 1993, for the calculation of weighted average
shares outstanding. In the reverse acquisition, no adjustment of
assets of either company to "fair value" has been made, and goodwill
has not been recognized as a result of the acquisition.
Prior to the acquisition of International Gene Group, Inc., Alvarada,
Inc. had approximately 1,349,860 shares of common stock issued and
outstanding. As shares were reissued from the stock split and
acquisition, any fractional shares were rounded upward in accordance
with the agreements. As of March 28, 1995, Alvarada, Inc. changed its
name to IGG International, Inc.
ACQUISITION
The assets and liabilities of Alvarada, Inc. as of March 7, 1995, prior
to the acquisition of 94% of International Gene Group, Inc., consisted
of the following recorded at their historical amounts:
<TABLE>
<S> <C>
Cash $ 139
Cash in escrow-bridge loan 400,000
Debt issuance costs 31,697
_________
Total assets 431,836
_________
Accounts payable (5,000)
Accounts payable-debt issuance costs (31,458)
Promissory notes payable, net (398,000)
Shareholder loans (21,200)
_________
Total liabilities (435,658)
_________
Net liabilities acquired $ (3,822)
=========
</TABLE>
Alvarada, Inc. had an accumulated deficit during development stage of
$274,784 as of December 31, 1994. Prior to the reverse acquisition of
March 7, 1995, Alvarada, Inc. had a net loss of $1,548 from the
beginning of the year until this date. Prior to this acquisition,
during February 1995, shareholders contributed $500 for 6,399 shares of
common stock.
F-20
<PAGE> 52
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 8. LEASES
The Company leases office space in Cambridge, Massachusetts under a
two-year operating lease expiring on August 24, 1997. The Company
elected to pay the first year's rent in advance, which included the
base rent of $27,150, charges for common area maintenance and real
estate taxes of $11,670 and a security deposit of $2,263. The rent
paid under this agreement will be adjusted for actual common area
charges and real estate taxes. Also as of September 1995, the Company
was leasing a vehicle under an operating lease of $400 per month over
a forty-two month period. In June 1996, the Company leased an
additional automobile for two years at $481 per month. The Company
also leased a copier in May 1996, for three years at $285 per month.
Minimum future rental payments under non-cancelable operating leases
with remaining terms in excess of one year as of December 31, 1996 for
each of the next five calendar years in the aggregate are as follows:
Year ended December 31,
1997 $ 40,964
1998 $ 10,625
1999 $ 1,940
2000 $ -0-
The Company's subsidiary, Agricultural Glycosystems, rented office
space on a month-to-month basis in Malvern, Pennsylvania. The monthly
rental payment was $700 plus any additional services and was being
accounted for as an operating lease. This lease was terminated in July
1996. In connection with this lease, the Company paid a security
deposit of $650 in 1995. The Company also leases some office furniture
as needed on a month-to-month basis.
NOTE 9. LICENSING AGREEMENT
On December 29, 1995, the Company's subsidiary Agricultural
Glycosystems, Inc. (AGI) entered into a licensing agreement with the
Government of Israel's Agricultural Research Organization concerning
shared technology. The licensing agreement requires that AGI pay a
three percent (3%) royalty on the net selling price of any licensed
products arising from the shared technology. As an
F-21
<PAGE> 53
IGG INTERNATIONAL, INC
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 1994, 1995 and 1996
NOTE 9. LICENSING AGREEMENT continued
additional condition of this agreement, AGI will fund a research and
development program requiring payments over the next five years
totaling $1,573,000. In the first year of the licensing agreement, AGI
is obligated to pay $327,000 followed by successive annual payments of
$332,000, $314,000, $300,000 and $300,000, respectively. This
agreement will be effective until the patents concerning the licensed
technology have expired or the agreement is terminated by the parties
involved. The Company paid $30,000 of the first year's payment in
1995, and in 1996 the Company paid $297,000.
F-22
<PAGE> 54
ITEM 9. DISAGREEMENTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
There have been no disagreements on accounting and financial
disclosures from the inception of the Company through the date of this
Registration Statement.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT.
The officers and directors of the Company are as follows:
Name Age Position
David Platt, Ph.D. 42 Chief Executive Officer, Secretary
and Chairman of the Board of
Directors
Bradley J. Carver 35 President, Chief Financial Officer,
Treasurer and a member of the Board
of Directors
All directors hold office until the next annual meeting of
shareholders and until their successors have been elected and
qualified. The Company's officers are elected by the Board of
Directors at the annual meeting after each annual meeting of the
Company's shareholders and hold office until their death, or until they
resign or have been removed from office.
David Platt, Ph.D. - Chief Executive Officer, Secretary and Chairman of
the Board of Directors
Dr. Platt has been the Chief Executive Officer, Secretary and
Chairman of the Board of Directors since March 1995 and has been the
Chief Executive Officer, Secretary and the Chairman of the Board of
Directors of IGG since December 1992. Dr. Platt has been Chief
Executive Officer, Secretary and Chairman of the Board of Directors of
Agricultural Glycosystems, Inc., a wholly owned subsidiary of the
Company since its inception on June 23, 1995. From January 1991 to
November 1992, Dr. Platt was a research scientist with the Department
of Internal Medicine at the University of Michigan, Ann Arbor,
Michigan. From October 1989 to November 1991, Dr. Platt was a research
fellow with Dr. A. Raz. at the Michigan Cancer Foundation, Detroit
Michigan. From January 1989 to August 1989, Dr. Platt was a research
fellow under Dr. M. Wilcheck, Weizmann Institute of Science, Rehovot,
Israel. Dr. Platt received a Doctor of Philosophy degree (1989),
Masters of Science degree (1983), and Bachelor of Science degree (1978)
from the Hebrew University of Jerusalem, Israel and a Bachelor of
Engineering degree (1980) from Technion, Haifa, Israel.
<PAGE> 55
Bradley J. Carver - President, Chief Financial Officer, Treasurer and
a member of the Board of Directors
Mr. Carver has been President, Chief Financial Officer, Treasurer
and a member of the Board of Directors of the Company since March 1995
and has been the President, Chief Financial Officer, Treasurer and a
member of the Board of Directors of IGG since February 1993. Mr.
Carver has been President, Chief Financial Officer, Treasurer and a
member of the Board of Directors of Agricultural Glycosystems, Inc., a
wholly owned subsidiary of the Company since its inception on June 23,
1995. From June 1992 to October 1994, Mr. Carver has been a consultant
with Cyrowski and Associates, which is engaged in the business of
commercial real estate. From March 1991 to October 1994, Mr. Carver
has been a consultant with Circuit Master, Inc., a Michigan
corporation, which is a electronics design and engineering firm engaged
in the production of audio power amplifiers. From June 1991 to
September 1993, Mr. Carver was a consultant with EPI Medical Products,
a Michigan corporation, which is engaged in the production and
licensing of a patented device for disposal of hazardous medical waste
and surgical products. From January 1991 to March 1993, Mr. Carver was
a consultant with Capital Networks, Inc., a Michigan corporation, which
is a consulting firm for small business. From January 1989 to March
1991, Mr. Carver was a consultant with Lincoln Technical Services,
Inc., a Michigan corporation, which is engaged in the selection and
management of engineers for automotive clients. From December 1988 to
December 1990, Mr. Carver was the founder of Carver Nutritional
Products, which was engaged in production and sale of sports nutrition
products sold to professional and college sports teams. Mr. Carver
received a Bachelor of Arts degree in management from Michigan State
University in 1983.
ITEM 11. EXECUTIVE COMPENSATION.
(a) Cash Compensation.
The Company anticipates entering into employment agreements with
its officers in the near future. Directors do not receive compensation
for their services as directors and are not reimbursed for expenses
incurred in attending board meetings. The Company paid the following
salaries to its Officers in 1996:
David Platt, Ph.D. $ 96,000
Bradley Carver $ 80,000
and anticipates paying the following salaries in 1997:
David Platt, Ph.D. $ 105,000
Bradley Carver $ 105,000
Further, Dr. Platt will receive a royalty of 2% of the net sales
of GBC 590 and MMS-1 by the Company.
<PAGE> 56
Options to purchase 300,000 "restricted" shares of Common Stock at
an exercise price of $0.10 per share, expiring in March 2005, were
issued to James C. Czirr.
Mr. Czirr was removed as a Director by shareholder action on June
23, 1995 and as Vice President by action of the Board of Directors on
June 23, 1995. Mr. Czirr is currently a consultant to the Company.
(b) Compensation Pursuant to Plans.
The Registrant has no retirement, pension, profit sharing,
insurance and medical reimbursement plans covering its Officers or
Directors other than a non-qualified incentive stock option plan filed
on Form S-8 Registration Statement with the Commission. Currently,
options to purchase 77,500 shares have been issued and 62,500
exercised.
(c) Other Compensation.
Officers and Directors of the Registrant did not receive any other
compensation during the fiscal year ended December 31, 1996.
(d) Compensation of Directors.
The Registrant's Directors receive no compensation for their
services; however, they are reimbursed for travel expenses incurred in
serving on the Board of Directors.
(e) Termination of Employment and Change of Control Arrangements.
No compensatory plan or arrangement exists between the Registrant
and any Executive Officer, except as discussed herein.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT.
The following table sets forth the Common Stock ownership of each
person known by the Company to be the beneficial owner of five percent
or more of the Company's Common Stock, each director individually and
all officers and directors of the Company as a group. Each person has
sole voting and investment power with respect to the shares of Common
Stock shown, and all ownership is of record and beneficial.
<PAGE> 57
<TABLE>
<CAPTION>
Name and address Number of Percent
of owner Shares Position of Class
<S> <C> <C> <C>
David Platt, Ph.D. 2,964,950 Chief Executive Officer, 28.06%
One Kendall Square Secretary and Chairman
Building 300 of the Board of Directors
Cambridge, MA 02124
Bradley J. Carver 2,583,086 President, Chief 24.45%
One Kendall Square Financial Officer,
Building 300 Treasurer and member
Cambridge, MA 02124 of the Board
All officers and 5,548,036 52.51%
directors as a
group (2 persons)
</TABLE>
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
On January 7, 1994, IGG entered into a licensing agreement with
Dr. Platt, the Company's Chief Executive Officer and a member of the
Board of Directors to pay Dr. Platt a royalty of two percent (2%) of
the net sales of the Company's products. See "Business - Patent Status
and Protection of Proprietary Technology."
In June 1994, the Company issued 20,000,000 "restricted" shares of
Common Stock to Crosby Enterprises, Inc. in consideration of
$20,000.00; 10,000,000 "restricted" shares of Common Stock to Howard
Crosby in consideration of services rendered; and, 10,000,000
"restricted" shares of Common Stock to Robert Jorgensen for service
rendered.
In March 1995, the Company effected a 1 for 78.14 reverse stock
split of its common shares. Reference hereinafter is to post-split
shares.
On March 7, 1995, the Company issued 5,821,086 "restricted" shares
of Common Stock in exchange for 19,633 shares of IGG, which constituted
93.9% of the outstanding shares of IGG. There was no relationship
between Alvarada, Inc. and International Gene Group, Inc. prior to this
transaction.
On March 30, 1995, the Company entered into an agreement with Mr.
James C. Czirr, a former member of the Board of Directors of the
Company and Vice President, to pay Mr. Czirr a consulting fee of $8,000
per month. The Company has paid a total of $15,000.00 to Mr. Czirr and
terminated the consulting agreement.
On June 23, 1995, the shareholders removed Mr. James Czirr as a
member of the Board of Directors and the Board of Directors voted not
to fill his vacancy. Further, on June 23, 1995, Mr. Czirr was
terminated as Vice President of the Company. The Company has since
retained Mr. Czirr as a consultant to the Company.
<PAGE> 58
During 1996, the Company issued 1,342,431 shares of Common Stock
in consideration of $2,060,407 less associated expenses of $60,826.
These shares include 100,000 shares issued pursuant to a Regulation S
offering for a total of $200,000. Also included in this amount is
190,000 shares issued as part of a private placement of up to 600,000
shares. The Company received $475,000 for these 190,000 shares. The
stock offered per the private placement has warrants attached allowing
the purchaser to purchase one additional share, for $3.50, for every
four shares purchased, which expire in five years.
In 1996, the Company adopted a Nonqualifying Stock Option Plan and
registered, pursuant to a Form S-8 Registration Statement 500,000
shares of stock for the compensation of directors, consultants and
employees as per the agreement. During 1996, the Company issued 62,500
shares qualifying as these S-8 shares. The Company considered shares
earned but not issued as options, and as of December 31, 1996 these
totaled 15,000 unissued shares. The Company had other stock for
services agreements which resulted in restricted shares being issued.
The Company issued 400 other shares for services in 1996, and
considered 139,706 shares as stock options outstanding awaiting the
issuance of the restricted shares.
In addition to the shares sold during 1996, the Company issued
shares for a number of other reasons. The Company elected to extend
due dates on notes payable for another year and issued 80,000 shares.
A majority of the Company's noteholders elected to convert their notes
and accrued interest into stock, whereby the Company issued 272,596
shares in consideration of $340,746 in notes and interest. The Company
also issued 173,449 shares to the minority shareholders of its
subsidiary International Gene Group, Inc., thereby increasing its
control of this subsidiary from 94% to 97%. Finally, the Company made
adjustments for changes in share prices and other matters which
resulted in 33,774 shares being issued in 1996.
In April 1996, the Company granted to Trinity American Corporation
warrants for up to a year (or 100 days after the Securities and
Exchange Commission declares the registration effective) to subscribe
for 500,000 new shares of Common Stock at $5.00 per share.
In June 1996, the Company granted 5,000 warrants per month,
exercisable at $0.01 per share, for a period of 13 months to Mr.
Richard Salter in consideration of consulting services. During the
period to June 30, 1996, warrants were similarly granted to Mr. David
Sandberg, exercisable at $0.01 per share upon to an aggregate of 10,000
shares, in consideration of legal services.
On September 30, 1996, warrants granted by the Company to James C.
Czirr, a former director, to subscribe for up to 200,000 shares of
Common Stock at $0.01 per share were outstanding and exercisable.
Enrico Petrillo, trading as Michaelangelo LLC, will render
consulting services in strategic planning, corporate finance and
partnering. In exchange for its services Michaelangelo will receive
210,000 shares of Common Stock or options to subscribe for such shares
<PAGE> 59
which will be exercisable immediately. It will also receive an
additional 420,000 shares (or options) upon the achievements by the
Company which the Company believes are indicative of Michaelangelo's
performance.
John Pool will act as director of European operations. In
exchange for his services, he will receive 20,000 shares of Common
Stock and a salary of $100,000 per annum to be paid following the
proposed fund raising but back-dated to August 1, 1996. He will
receive an additional 140,000 shares upon the achievement of certain
milestones against specific achievements in Europe.
On December 6, 1996, David Platt, Ph.D., the Company's Chairman of
the Board of Directors, signed a Confidentiality and Invention
Agreement with the Company. The Agreement provides that Dr. Platt
assigns all his rights, title and interest in any invention, data or
idea, made or conceived or reduced to practice either alone or jointly
with other to the Company. Further, that all rights thereto shall
remain the sole property of the Company and Dr. Platt agreed not to
disclose any information about the Company's confidential information.
In the first quarter of 1997, the Company completed another Reg.
S stock sale for $1,000,000 and issued 500,000 shares of Common Stock.
The Company also completed its Private Placement offering and related
stock sales for a total of $1,143,000 and issued 457,000 shares of
Common Stock.
The foregoing agreements and transactions were as favorable as
could have been obtained from an unaffiliated third party in a similar
transaction.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON
FORM 8-K.
(a) Financial Statements are contained in Item 8 of this Form 10.
(b) Reports on Form 8-K
No reports on Form 8-K have been filed during the last quarter of
the period covered by this report.
(c) Exhibits.
Exhibit
No. Description
3.1 Articles of Incorporation of Alvarada, Inc. (incorporated by
reference to Exhibit 3.1 to the Registrant's Registration
Statement on Form 10, SEC File No. 0-26476).
<PAGE> 60
3.2 Amendment to the Articles of Incorporation dated March 1,
1995 (incorporated by reference to Exhibit 3.2 to the
Registrant's Registration Statement on Form 10, SEC File No.
0-26476).
3.3 Amendment to the Articles of Incorporation dated March 3,
1995 (incorporated by reference to Exhibit 3.2 to the
Registrant's Registration Statement on Form 10, SEC File No.
0-26476).
3.4 Amendment to the Articles of Incorporation dated May 23, 1995
(incorporated by reference to Exhibit 3.4 to the Registrant's
Registration Statement on Form 10, SEC File No. 0-26476).
3.5 Bylaws of Alvarada, Inc. (incorporated by reference to
Exhibit 3.5 to the Registrant's Registration Statement on
Form 10, SEC File No. 0-26476).
3.6 Articles of Incorporation of International Gene Group
(incorporated by reference to Exhibit 3.6 to the Registrant's
Registration Statement on Form 10, SEC File No. 0-26476).
3.7 Bylaws of the Company of International Gene Group
(incorporated by reference to Exhibit 3.7 to the Registrant's
Registration Statement on Form 10, SEC File No. 0-26476).
3.8 Articles of Incorporation of Agricultural Glycosystems, Inc.
(incorporated by reference to Exhibit 3.8 to the Registrant's
Registration Statement on Form 10, SEC File No. 0-26476).
3.9 Bylaws of the Company of Agricultural Glycosystems, Inc.
(incorporated by reference to Exhibit 3.9 to the Registrant's
Registration Statement on Form 10, SEC File No. 0-26476).
4.1 Specimen Stock Certificate (incorporated by reference to
Exhibit 4.1 to the Registrant's Registration Statement on
Form 10, SEC File No. 0-26476).
10.1 Agreement and Plan of Reorganization (incorporated by
reference to Exhibit 10.1 to the Registrant's Registration
Statement on Form 10, SEC File No. 0-26476).
10.2 Licensing Agreement with Dr. Platt (incorporated by reference
to Exhibit 10.2 to the Registrant's Registration Statement on
Form 10, SEC File No. 0-26476).
10.3 Office Lease (incorporated by reference to Exhibit 10.3 to
the Registrant's Registration Statement on Form 10/A, SEC
File No. 0-26476).
10.4 Licensing Agreement with The Government of Israel
(incorporated by reference to Exhibit 10.4 to the
Registrant's Registration Statement on Form 10/A, SEC File
No. 0-26476).
<PAGE> 61
10.5 Incentive Stock Option Plan (incorporated by reference to
Exhibit 10.1 to the Registrant's Registration Statement on
Form S-8, SEC File No. 333-4764).
10.6 Employee Confidentiality and Invention Agreement between Dr.
David Platt and the Company.
24.1 Consent of Kevin J. Williams & Co., Certified Public
Accountants.
27 Financial Data Schedule.
<PAGE> 62
SIGNATURES
Pursuant to the requirements of Section 12 of the Securities
Exchange Act of 1934, the registrant has duly caused this Form 10-K to
be signed on its behalf by the undersigned, thereunto duly authorized,
in Cambridge, Massachusetts, on this 31st day of March, 1997.
IGG INTERNATIONAL, INC.
BY: /s/ Bradley J. Carver, President and Chief
Financial Officer
KNOW ALL MEN BY THESE PRESENT, that each person whose signature
appears below constitutes and appoints Bradley J. Carver, as true and
lawful attorney-in-fact and agent, with full power of substitution, for
his and in his name, place and stead, in any and all capacities, to
sign any and all amendments to this registration statement, and to file
the same, therewith, with the Securities and Exchange Commission, and
to make any and all state securities law or blue sky filings, granting
unto said attorney-in-fact and agent, full power and authority to do
and perform each and every act and thing requisite or necessary to be
done in about the premises, as fully to all intents and purposes as he
might or could do in person, hereby ratifying the confirming all that
said attorney-in-fact and agent, or any substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, this Form 10-K has been signed by the following persons in the
capacities and on the dates indicated:
Signatures Title Date
/s/ David Platt, Ph.D. Chief Executive Officer, March 31, 1997
David Platt, Ph.D Secretary and Chairman of
the Board of Directors
/s/ Bradley J. Carver President, Chief Financial March 31, 1997
Bradley J. Carver Officer, Treasurer and a
member of the Board of Directors
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
This schedule contains summary financial information extracted from the
financial statements at December 31, 1996 Audited and is qualified in its
entirety by reference to such financial statements.
</LEGEND>
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-END> DEC-31-1996
<CASH> 444,661
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 463,063
<PP&E> 39,822
<DEPRECIATION> 15,835
<TOTAL-ASSETS> 488,839
<CURRENT-LIABILITIES> 190,748
<BONDS> 0
0
0
<COMMON> 94,626
<OTHER-SE> 203,465
<TOTAL-LIABILITY-AND-EQUITY> 488,839
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 2,196,915
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 103,517
<INCOME-PRETAX> (2,300,147)
<INCOME-TAX> 0
<INCOME-CONTINUING> (2,300,147)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (2,300,147)
<EPS-PRIMARY> (0.26)
<EPS-DILUTED> (0.26)
</TABLE>
<PAGE> 1
IGG INTERNATIONAL, INC.
EMPLOYEE CONFIDENTIALITY AND INVENTION AGREEMENT
AGREEMENT, dated as of December 6, 1996, by and between IGG
International, Inc., a Nevada corporation with an address at One
Kendall Square, Building 300, Cambridge, MA 02139 (the "Company")
and DR. DAVID PLATT, an individual residing at 12 Appleton
Circle, Newton, MA ("Platt").
WHEREAS, the Employee is an employee of the Company; and
WHEREAS, the Company may, in the course of the performance
by the Employee of his employment, provide the Employee with
certain proprietary or confidential information;
NOW, THEREFORE, in consideration of the foregoing and of
other consideration the receipt and sufficiency of which are
hereby acknowledged, the Employee hereby agrees as follows:
1. The Company possesses certain confidential information
that has been created, discovered or developed by, or has
otherwise become known to, the Company (including without
limitation information created, discovered, developed or made
known to the Employee in the course of the Employee's employment
by the Company), or in which the Company has property rights
(whether by license, assignment or otherwise). All such
information is collectively referred to as "Confidential
Information," which term shall include without limitation trade
secrets, processes, formulae, data, know-how, discoveries,
developments, designs, improvements, inventions, techniques,
marketing plans, strategies, forecasts, new products, software,
software documentation, unpublished financial statements,
budgets, projections, licenses, prices, costs and customer and
supplier lists; provided however, that "Confidential Information"
shall not include information (i) in the public domain by
publication through no fault of the Employee, (ii) lawfully
received by the Employee from a third party who was under no
obligation of confidentiality with respect thereto, or (iii)
required by law to be disclosed, but only to the extent of such
required disclosure.
2. The Employee understands and agrees that all the
Confidential Information and rights relating thereto shall remain
the sold property of the Company. The Employee agrees not to
disclose to anyone outside the Company or use in any manner
whatsoever, either during or after the term of Employee's
employment by the Company (the "Term"), without the prior written
permission of the Company. The Employee agrees to return to the
Company all documents or other materials relating to the
Employee's work for the Company, and all copies thereof, upon the
termination of the Term.
<PAGE> 2
3. The Employee hereby assigns to the Company all his
right, title and interest in any invention, data or idea, made or
conceived or reduced to practice either alone or jointly with
others during the Term (collectively, "Inventions"). The
Employee specifically agrees that any Inventions shall be deemed
to be "work for hire" within the meaning of the patent and
copyright laws of the United States and any state, and the
Employee acknowledges and agrees that all Inventions shall be the
sole and exclusive property of the Company. In connection
therewith, the Employee agrees, upon the Company's request and at
the Company's expense, to execute a specific assignment of title
to the Company, and take any other actions or execute any other
documents, reasonably necessary to enable the Company to secure a
patent for or acquire any other rights in Inventions in the
United States or in foreign countries. The Employee hereby
designates the Company as his or her agent and attorney-in-fact,
to act for and on behalf of the Employee to execute and file such
documents as are needed to apply for, perfect or otherwise
acquire any rights in any Invention if the Employee is unable or
unwilling to do so.
4. The Company and the Employee each agrees to indemnify
and hold harmless the other from and against any and all claims,
losses or liabilities of or to any person or entity to which the
other party may become subject, arising out of or relating to the
acts or omissions of the indemnifying party, unless such claim,
loss or liability is a result of the other party's wilful
misconduct or negligence.
5. (a) The parties agree that any breach of this
Agreement by the Employee would cause irreparable harm to the
Company for which the Company would have no adequate remedy at
law and that, in such event, the Company shall have the right to
an injunction, specific performance or other equitable relief in
addition to any remedies available at law.
(b) This Agreement shall not be construed as an
employment or consulting contract and shall not be deemed to
create any right of continued employment.
(c) Each provision of this Agreement shall be treated
as a severable, separate and independent covenant and the
unenforceability of any provision shall have no effect on the
enforceability of the remainder of this Agreement.
(d) The terms of this Agreement shall survive the
termination of the Employee's employment by the Company and shall
inure tot he benefit of and be binding upon the parties hereto
and their respective successors, heirs and assigns.
(e) This Agreement will be governed in accordance with
the laws of the Commonwealth of Massachusetts.
<PAGE> 3
IN WITNESS WHEREOF, the parties have hereunto set their hand
and seals as of the date first above written.
/s/ David Platt
Accepted and agreed:
IGG INTERNATIONAL, INC.
BY: /s/ Bradley Carver, President
