UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 2008
Commission File Number:
000-27237
GeneThera, Inc.
(Exact name of registrant as Specified in its Charter)
Nevada 65-0622463
(State or Other Jurisdiction of (Internal Revenue Service
Incorporation or Organization) Employer Identification Number)
5255 Marshall Street
Arvada, CO 80002
(Address of Principal Executive Offices) (Zip Code)
Registrant telephone number, including area code:
(303) 463-6371
Securities registered pursuant to Section 12(b)
of the Exchange Act:
NONE
Securities registered pursuant to Section 12(g)
of the Exchange Act:
Common Stock, $0.001 per share
Indicate by check mark whether the registrant:
(1) has filed all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was
Required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days:
Yes [X] No [ ]
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-
accelerated filer, or a smaller reporting company. See definitions
of large accelerated filer, accelerated filer, and smaller reporting
company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer [ ] Accelerated filer [ ]
Non-accelerated filer [ ] Smaller reporting company [X]
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act):
Yes [ ] No [X]
Indicate by check mark if the registrant is a well-known seasoned
user, as defined in Rule 405 of the Securities Act.
Yes [ ] No [X]
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) if the Act.
Yes [X] No [ ]
As of December 31, 2008, the registrant had 2,265,816 shares of
its common stock ($.001 par value) outstanding.
The issuer?s revenue for its most recent fiscal year was $10,822.00
The aggregate market value of the issuer?s voting stock held by non-
affiliates of the issuer as of December 31, 2008 was $2,250,000.
PART I.
ITEM 1. DESCRIPTION OF BUSINESS
GeneThera, Inc. (we or the Company), formerly known as Hand
Brand Distribution, Inc., was incorporated in November 1998, under
the laws of the State or Florida. We transferred our state of
incorporation under the laws of the State of Nevada in November
2007. This corporate action was finalized in January 2008. No
shareholder approval was obtained for the transfer of our state of
incorporation. The abovementioned corporate action protected the
best interest of our long-term shareholders? investments when our
Charter in Florida was in jeopardy. Our main focus was to guard
their investment in GeneThera. Our Common Stock currently trades on
the Pink Sheets OTC Over-The-Counter (PS) under the symbol GTHR.
Our executive offices are located at 5255 Marshall Street Arvada, CO
80002 and our telephone number is 303-463-6371.
For the fiscal year 2008 the Company had one subsidiary, GeneThera,
Inc., a Colorado corporation, (GeneThera).
BUSINESS OVERVIEW
GeneThera, Inc., a Nevada corporation, was formerly known as Hand
Brand Distribution, Inc., and was incorporated in November 1998
under the laws of the State of Florida. In January 2008, the
Company finalized the transfer of their State of Incorporation under
the laws of the State of Nevada. The Company, without the approval
from their shareholders, proceeded to change the state of
incorporation in order to protect the investments of their long-term
shareholders and its investors. The Company failed to file an
Information Statement on the Schedule 14C and a Current Report on
Form 8-K to notify the shareholders about the changes. The Company
was rushed to incorporate elsewhere due to its Charter being taken
by another entity which had nothing to do with GeneThera, Inc. It
was a corporate action done under pressure. We will always be
grateful for all the shareholders who noticed the purchase of our
Charter and notified us about it. We are not currently in any
regulatory or clinical trials for any of the tests we have developed
to date. The molecular tests developed by GeneThera are in a
validation phase. We currently have no sales, marketing or
distribution capability. GeneThera has no plans, in the immediate
future, to offer any veterinary services in the United States.
Our independent auditors have expressed some doubt about our ability
to continue as a going concern in their report on our consolidated
financial statements for the fiscal year ended December 31, 2007.
For the years ended December 31, 2008 and 2007, our operating losses
were $1,988,707 and $841,829 respectively. Our current liabilities
exceeded current assets by $1,866,660 and $1,633,398 for the years
ended December 31, 2008 and 2007, respectively.
Up until 2002, GeneThera, Inc. was a privately held Colorado
corporation (GeneThera Colorado). The Board of Directors at that
time determined it would be in the best interests of the Company to
become a publicly traded company in order to facilitate the business
goals and objectives of the Company. That led to negotiations with
the Board of Hand Brand Distribution to effect a reverse
acquisition. The negotiations were on an arms-length basis at the
time and results in the reverse acquisition being completed in
October 2003 with the distribution of shares to Dr. Milici for the
acquisition from him of GeneThera, Inc. A total of 9,270,000 (after
2:1) shares were issued as consideration for the sale of the
private corporation. GeneThera received all the assets of GeneThera
Colorado including all laboratory equipment, laboratory supplies,
research and development, processes, and intellectual property.
We are a biotechnology company that develops molecular assays and is
currently in the process of developing therapeutic vaccines for the
detection and prevention of food contaminating pathogens, veterinary
diseases, and diseases affecting human health. We are in the
development stage and have not generated significant revenues since
our organization. Since June 2005, we had research contracts with
Xpention Genetics, LLC for the development of a molecular test for
early detection of cancer in dogs and the development of a molecular
test for early detection of cancers in humans Stage 1. GeneThera
business is based on its Integrated Technology Platform (ITP) that
combines a proprietary diagnostic solution called Gene Expression
System (GES) with PURIVAX?, a highly efficient purification
technology. The first part of this platform is the ongoing
development of molecular diagnostic assays solutions using Real Time
Fluorogenic Polymerase Chain Reaction (F-PCR) technology to detect
the presence of infectious disease from the blood of live animals.
The second part of the ITP is the development of therapeutic
vaccines using RNA interference technology. It also allows for the
efficient, effectives, and continuous testing, management and
treatment of animal populations. These facts distinguish the
technology from any alternative testing and management methodology
available to agriculture today ? all of which require the
destruction of individual animals and even entire herds. Our
testing and data analysis processes also allow us not only to
separate infected from clean animals, but also to gain knowledge
vital to development of preventative vaccines.
To date, GeneThera has successfully developed the ability to detect
Chronic Wasting Disease, a disease affecting elk and deer in North
America. GeneThera has also successfully developed an assay for the
detection of Mad Cow Disease, a disease recently found in the United
States, but which has been in Europe for many years. Chronic
Wasting Disease and Mad Cow Disease are both in the family of
diseases called Transmissible spongiform Encephalopathy (TSE).
BUSINESS MODEL
DESCRIPTION OF TECHNOLOGIES
Summary. GeneThera animal disease assay development business is
based on its Integrated Technology Platform (ITP) that combines a
proprietary diagnostic solution called Gene Expression System (GES)
with PURIVAX?, a highly sophisticated purification system that
removes contaminating particles from biological fluids. The first
part of this platform is the ongoing development of molecular
diagnostic assay solutions using real time Fluorogenic Polymerase
Chain Reaction (F-PCR) technology to detect the presence of
infectious disease from the blood of live animals. The second part
of the ITP is the development of therapeutic vaccines using RNA
interference technology. Interference RNA technology is a new
technique that is based on the use of short RNA sequences
complementary to a specific target gene. Once the RNA sequence binds
to the gene, the gene is deactivated or ?silenced? and no longer
able to produce the specific protein. It also allows for the
efficient, effective, and continuous testing, management and
treatment of animal populations. These facts distinguish the
technology from any alternative testing and management methodology
available to agriculture today ? all of which require the
destruction of individual animals and even entire herds. Our
testing and data analysis processes also allow us not only to
separate infected from clean animals, but also to gain knowledge
vital to development of preventative vaccines.
Each individual assay utilizes the propriety Field collection System
(FCS) for the collection and transportation of blood samples to
GeneThera laboratory. This system consists of two (2) tubes. A 5ml
red cap tube containing 1ml anticoagulant solution and a 10ml white
cap tube containing 2ml of a cell lysing and RNA extraction
solution. One (1) ml of blood is collected from the animal and added
to the red cap tube and then the entire content of the red cap tube
is immediately transfer to the white cap tube. The FCS allows
GeneThera to maintain the integrity of each sample by the addition
of specific reagents to test tubes contained in the system.
GeneThera FCS is designed to be an easy-to-use method of gathering
blood samples from harvested or domesticated animals. It ensures
consistency of samples as well as increased assurance of each
sample?s integrity.
We are also continuing our research to develop vaccines for Chronic
Wasting Disease and Johnes disease. The Company will need the
approval of the USDA before the vaccines can be manufactured or
sold. The approval process for animal vaccines is time-consuming
and expensive. We anticipate that such approval, if it is obtained,
may require more than $5 million and may require more than one year
for each vaccine for which approval is sought. Currently, we do not
have the capital necessary to seek approval of any of our candidate
vaccines, and we cannot provide any assurance that we will be able
to raise the capital necessary for such approval on terms that are
acceptable to us, if at all. In addition, even if we are successful
in raising the capital necessary to seek approval of any vaccine,
there are no assurances that such an approval will be granted, or if
granted, whether we will be able to produce and sell such vaccines
following such an approval in commercial quantities or to make a
profit from such production and sales.
INTEGRATED TECHNOLOGY PLATFORM (ITP)
GeneThera integrated technology platform is the foundation for
fast-track rDNA vaccine development. At the present stage we are
working on the development of a recombinant DNA vaccine for
transmissible spongiform encephalopathy (TSE) and Johnnes disease.
Transmissible Spongiform Encephalopathy (TSE) is a group of
invariably fatal neurodegenerative diseases that include Scrapie in
sheep, Bovine Spongiform Encephalopathy (BSE) in cattle, Chronic
Wasting Disease (CWD) in elk and deer, and Kuru Disease and variant
Creutzfeld-Jacob Disease (vGCD) in humans. The pathological effects
of the disease occur predominantly in the CNS (central nervous
system) where the predominant hallmark is accumulation of an
abnormally folded isoform of the prion protein (PrPsc). Johnne?s
Disease is a chronic debilitating infectious disease of ruminants,
characterized by weight loss and, particularly in cattle, by profuse
diarrhea. The casual agent is a bacterium, Mycobacterium avium
subspecies paratuberculosis. Infected animals may show no sign of
the disease until years after the initial infection. Johnes is a
slow, progressive disease with worldwide distribution.
Both vaccine developments are in the in vitro or pre-clinical
stage. We expect to initiate experimental animal studies for
Johnnes disease in the next 12 months. A longer time frame (24
months) will be needed to initiate experimental animal studies for
TSE. ITP combines the following technologies: 1) gene expression
technology or GES; 2) viral DNA purification technology or PURIVAX?
technology; 3) genetically engineered Adenovirus(rAD) and
recombinant Adeno Associate Virus (rAAV) systems (vectors). This
integrated technology platform yields fast-track vaccine
development. Leveraging its ITP, GeneThera believes that it can
develop a prototype vaccine within four to six months versus the
current standard of 18 to 24. We estimate that the cost to bring
these vaccines to market is $2-5 million. There is no assurance
that we will be able to raise the capital necessary to bring a
vaccine to market and if the capital is raised, that we will be able
to over the government regulations involved in bringing such a
product to market. The GES applied modular unit system utilizes
robotics and is based on nucleic acid extraction in conjunction with
F-PCR technology to develop gene expression assays. Using GES
assays, vaccine efficacy can be measured quickly because it will be
unnecessary to wait for the antibody response to measure how well
the vaccine is working. F-PCR will allow effective quantification
of the precise number of viral or bacterial genetic particles
before, during and after vaccine injection(s). We anticipate that
the more effective the vaccine is, the stronger the decrease of the
infectious disease particles will be.
GES SYSTEM
GES is a proprietary assay development system. GES was developed in
2001. To date, the system has been used to develop our TSE
molecular assay. GES is a gene expression system to be used
solely in our laboratory and will not be marketed for commercial
sale. The core of GES is Fluorogenic Polymerase Chain Reaction
technology (F-PCR). GeneThera approaches the technical problems
related to the use of conventional PCR in molecular diagnostics
via our modular unit concept. Specifically, the modular unit
consists of an Automated Nucleic Acid Workstation (ANAW) and a
Sequence Detection System (SDS) that are integrated, allowing an
operator to perform the entire procedure of DNA extraction and F-
PCR analysis within a closed computerized system. This system
results in minimal intervention and non post-PCR manipulation.
GES is a molecular genetic base system that utilizes fluorogenic
Polymerase chain reaction (F-PCR). Fluorogenic PCR (F-PCR) is a
technology based on sequence specific hybridization between a
nucleic acid target and a fluorogenic probe, a short sequence of
DNA chemically treated to generate light at a specific wavelength,
complementary to the target sequence. The probe consists of an
oligonucleotide, a short synthetic DNA molecule, with two
fluorescent molecules ( a reporter and quencher dye) attached to
both ends of the oligonucleotide. Due to the unique design of the
Fluorogenic probe, the activity of the Taq Polymerase enzyme
allows direct detection of PCR products by the release of the
fluorogenic reporter during PCR. The reporter and the quencher
dye are linked at the end of the probe. When the probe is intact,
the proximity of the reporter dye to the quencher dye results in a
suppression of the reporter fluorescence. During PCR, if the
target of interest is present, the probe specifically anneals
between the forward and the reverse primer site. The nuclease
activity of the Taq DNA Polymerase cleaves the probe between the
reporter and the quencher only if the region binds to the target.
If the probe is not bound then no cleavage occurs. After cleavage,
the shortened probe dissociates from the target and the
polymerization of the DNA strand continues. This process occurs
in every cycle and does not interfere with the exponential
accumulation of the product. The cleavage of the oligonucleotide
between the reporter and the quencher dye results in an increase
of fluorescence of the reporter that is directly proportional to
the amount of the product accumulated. The specificity of this 5?
nuclease assay results from the requirement of sequence
complementary between probe and template in order for cleavage to
occur. Thus, the fluorogenic signal is generated only if the
target sequence of the probe is generated by PCR. No signal is
generated by non-specific amplification.
To perform GES, specific laboratory equipment is needed. This
involves some substantial initial costs to set up the laboratory
operations. We have performed this substantial set up and are fully
operational to perform GES. We currently have the entire specific
equipment necessary to further development. However, the use of F-
PCR represents a great advantage over other available systems
because of its greater sensitivity, speed, and accuracy.
The Automated Nucleic Acid Workstation is a highly flexible robotic
system that extracts and purifies acids from a variety of complex
samples, preparing them for F-PCR analysis. Data management system
software includes a database to manage all run phases and record
sample processing.
The Sequence Detection System detects the fluorescent signal
generated by the cleavage of the reporter dye during each PCR cycle.
This process confers specificity without the need of post-PCR
hybridization. Most importantly, the SDS offers the advantage of
monitoring real-time increases in fluorescence during PCR
processing. Specifically, monitoring real-time progress of the PCR
completely changes the approach to PR-based quantitation of DNA and
RNA, most particularly in improving the precision in both, detection
and quantitation of DNA and RNA targets.
GeneThera currently faces limited competition in the use of F-PCR
technology and the modular unit concept for commercial testing of
either infectious disease is animals or food pathogen contamination.
Currently, most labs utilize conventional microbiology,
immunological or conventional PCR methods for either veterinary
diseases or food pathogen contamination detection. Specific to
microbiology and immunological techniques, the drawbacks of these
approaches are:
1. the antibodies-based culture media used to detect the presence
of infectious diseases has a low level of sensitivity;
2. high background due to non-specific binding of antibodies
3. and/or culture contamination; sample preparation and storage
creates artifacts; and long, cumbersome protocols necessary to
perform these tests.
A major technical limitation of conventional PCR is the risk of
contaminating a specimen with the products of previously amplified
sequences. Known as cross-contamination, this phenomenon represents
a constant challenge to any lab using conventional PCR. Managing
these challenges is cumbersome and difficult to streamline.
Fluorogenic PCR (F-PCR) attempts to overcome these drawbacks by
making it possible for PCR to efficiently test large numbers of
samples even when major laboratory facilities are not readily
available. A novel methodology, F-PCR allows quantitative and
qualitative detection of specific nucleic acid sequences in a
sensitive, accurate, and rapid fashion.
PURIVAX? TECHNOLOGY
GeneThera has developed a large-scale process for highly purified
and high viral titer (viral concentration) Adenovirus and AAV
genetically engineered viruses. This technology enables GeneThera
to develop Adenovirus and AAV-based recombinant DNA vaccines for
veterinary diseases and food pathogens.
GeneThera?s PURIVAX? is a purification system that dramatically
improves biological purity and viral titer of recombinant Adenovirus
and AAV vectors. PURIVAX? is intended to completely eliminate toxic
side effects associated with Adenoviruses and AAV vectors, thereby
making it possible to develop highly immunogenic and safe
recombinant DNA vaccines. Importantly, recombinant DNA (rDNA)
vaccine technology represents a powerful fool for an innovative
vaccine design process known as genetic immunization.
Recombinant Adenovirus (rAD) and AAV (rAAV) vectors are the ideal
candidates for a gene delivery system. These viruses can
efficiently deliver genetic material to both dividing and non-
dividing cells, thereby overcoming some of the obstacles encountered
with first generation retroviral vectors.
Equally important, rAD and rAAV are engineered virus genomes that
contain no viral gene. One of the key features for rAD and rAAV is
their ability to infect a large variety of cells. However, two
technical challenges had to be overcome to fully utilize rAD and
rAAV in the development of rDNA vaccines:
1. lack of large scale purification system; and
2. low viral titer
Traditional technologies and first generation chromatography
processes are limited both in terms of purity and yield. And, due
to the limitation of these purification technologies, adequate viral
titers cannot be achieved. We believe that the result is that there
is currently no efficient system to deliver immunogenic genetic
sequences into cells.
This is the significant of GeneThera PURIVAX?, rAD and rAAV system
for rDNA vaccine development. Succinctly stated, it is designed to
be able to achieve both high purity and high viral titer (up to
10e16 viral particles/eulate) based on its propriety multi-resin
anion exchange chromatography system. GeneThera believes that
biological contaminants such as endogenous retrovirus, bacterial,
mycoplasma, non-specific nucleic acids, lipids, proteins,
carbohydrates and endotoxins are eliminated during the purification
process.
DEVELOPMENTS TO DATE:
GeneThera is a biotechnology company that develops molecular tests
and DNA vaccines for animal diseases. Listed below is a description
of the different stages of development achieved for the different
projects the company is currently working on.
CWD/BSE TEST
GeneThera has developed a molecular test for the detection of
Chronic Wasting Disease (CWD). This test measures the level of RNA
of a genetic marker, EDRF that is found to be at low levels in
animals affected by the disease. The same marker is also found at
low levels in animals infected with BSE. Chronic Wasting Disease and
Mad Cow Disease is both in the family of diseases called
Transmissible Spongiform Encephalopathy (TSE). We have analyzed a
total of 300 samples of elk and deer blood obtained from CWD free
animals, suspected CWD positive depopulated herds, and
experimentally infected animals. Samples were collected using the
FCS and processed according to our protocol for extraction of total
RNA from blood.
Our results have shown that both the clinical stage experimentally
infected sample (CWD+) and one of the samples (#54) from the
suspected CWD+ herd have a dramatic reduction in the level of
expression of EDRF in blood. The remaining samples obtained from the
same depopulated herds? shows a profile of the level of expression
of the EDRF gene identical to our negative control (CWD-).
These results suggest 1) a correlation between the presences of
clinic signs of CWD and a significant reduction of the level of
expression of EDFR in blood; 2) the indication that the down
regulation of EDRF in blood may represent an early sign of CWD
infection at a preclinical stage.
We believe that EDRF is a very useful genetic marker to detect the
presence of TSE in the blood of infected live animals. We also
believe that EDRF is an indicator of the presence of Transmissible
Spongiform Encephalopathy (TSE) at an early stage of infection prior
to the detection of the disease in the brain. However, additional
studies are required to determine the time course correlation
between the reduction in the level of expression of the EDRF gene
and pre-clinical and clinical signs of TSE.
JOHNES?S TEST
GeneThera has developed a molecular test for the detection of
Johnes disease, in blood. Johnes disease is a bacterial disease
caused by Mycobacterium Paratuberculosis (MAP) in blood; which
affects primarily dairy cows. Blood from uninfected cows was
spiked with different concentrations of MAP. The Bacterial DNA was
isolated using standard DNA extraction procedures and analyzed using
the Real Time PCR technology. Using this methodology, we can detect
the presence of twenty (20) bacterial particles from 1ml of blood.
We believe our test will be very useful for early diagnosis of MAP
infected cows. However, we have not yet tested blood from naturally
infected Johnes animals. Additional studies are therefore necessary
to determine the efficacy of our test in naturally infected animals.
PRODUCTS UNDER DEVELOPMENT:
DNA VACCINES
We are currently developing two (2) DNA vaccines. One vaccine
targets Johnes disease; the other is related to TSE. GeneThera
approaches to develop these vaccines are based on the use of
PURIVAX? technology, genetically engineered Adenoviral and AAV, and
silencing RNA technology (iRNA). Phase 1 clinical trial has been
successfully completed and is in the process of initiating Phase 2
trials.
DISEASE DNA VACCINE
GeneThera is developing a vaccine for Johnes disease using
Adenoviral genetically engineered virus and PURIVAX? technology. To
date, we have modified the Adenovirus by inserting a gene of the MAP
bacterium responsible for triggering the infection in blood cells.
Using PURIVAX? the genetic construct has been purified and
characterized.
TSE DNA VACCINE
The company strategy to develop a TSE vaccine is based on the use of
iRNA technology. To date, we have isolated a specific sequence of
the prion protein gene. Our initial experiments indicate that our
system is capable to generate a reduction in the expression of the
prion protein gene of about seventy percent. Our next step will be
to genetically alter the Adenovirus by inserting this specific
sequenced and characterize the construct using PURIVAX. The
vaccine is still in an in vitro or preclinical stage.
So far, none of our molecular tests of vaccine have been validated
or approved by any regulatory agency in the United States or abroad.
These tests and vaccines still require extensive validation and
lengthy approval process. These procedures are extremely time
consuming and expensive. There is no guarantee that none of the
tests or vaccines that GeneThera is developing will be successfully
validated or approved by any regulatory agency. GeneThera have
limited financial resources. Therefore, the company may not be able
to undertake any of the necessary steps to secure a successful
validation or approval of any of the molecular tests or vaccines.
FUTURE DEVELOPMENT PLANS
It is GeneThera intention to continue with the research and
development and validation of the molecular tests and DNA vaccines.
Future plans comprises in initiating validation procedures for both,
TSE and Johnes disease molecular test. These validation protocols
will be performed in Italy and Mexico. At the present time, we do
not plan to initiate any validation protocol in the United States.
In parallel, we will continue R&D phases for both the Johnes
disease and TSE DNA vaccine. We plan initiating an experimental
animal protocol to determine the safety of our vaccines. We estimate
that the experimental animal protocol may take up to a year. We
project to initiate the experimental animal studies within 12-24
months.
MARKET STRATEGY
GeneThera goal is to focus on the international market for the
commercialization of its animal testing platform. We are in the
process of setting up an animal testing laboratory in Monterrey
Mexico. The company has no plans, in the immediate future, to offer
any Veterinary Services in the United States.
However, if GeneThera decides to initiate animal testing in the
United States, commercialization of its diagnostic tests will not
require approval process from the USDA. All tests will be done
utilizing the blood of animals that can be collected in the field
using the Company proprietary Field Collection System (FCS). The
collected blood is then sent to GeneThera laboratory for testing.
Since all of the testing is done in house, meaning tested at
laboratories operated by GeneThera and using GeneThera developed
testing methods, the USDA deems GeneThera test to be under the
category of Veterinary Services. The regulations on Veterinary
Services are much different that that of third party testing.
Veterinary Services specifically mentioned by GeneThera are tests
developed and performed in house. The USDA through APHIS
regulates Veterinary Biologicals (vaccines bacterins, antisera,
diagnostic kits and other product of biological origin) APHIS
regulates veterinary biologics available for the diagnosis
prevention and treatment of animal disease to ensure the products
are pure, safe, potent and effective. GeneThera molecular tests are
not diagnostics kits and therefore do not fall under the Veterinary
Biologics category.
SALES AND MARKETING
We currently have no sales, marketing, or distribution capabilities
and we do not anticipate having the resources in the foreseeable
future to allocate to the sales and marketing of any products that
we may develop. Our success will depend, in part, on our ability to
either (i) enter into or maintain collaborative relationships with
third parties for the marketing, sales, and distribution of products
that we develop, if any, or (ii) hire and retain our own sales and
marketing capabilities. Initially, we plan to market products that
we develop and for which we obtain regulatory approval through
marketing, licensing, distribution, or other arrangements with
collaborative partners. We believe that this approach will both
increase market acceptance of any products that we develop and
enable us to avoid expending significant funds to develop a sales
and marketing organization.
COMMERCIAL PRODUCTS
RESEARCH AND DEVELOPMENT SERVICES
Molecular, Cellular, Viral Biology Research, and Consulting
Services. We provide independent research services to scientists in
academia, the pharmaceutical industry, and the biotechnology
industry. Primarily, we focus on technology relevant to animal and
human immunotherapy. Our services are supported by more than 50
years of cumulative experience in research and development for both
government and industry by GeneThera?s senior scientists. We intend
to develop a commercial-scale implementation of Adenovector
Purification Process to support R&D material production.
Furthermore, we intend to evaluate and test commercially available
expression vectors and incorporate them into our vector repertoire.
These technologies are well established within the repertoire of
GeneThera scientific staff. We cannot provide any assurance,
however, that we will be able to successfully offer these services
or that, if offered, we can provide them profitably.
We intend to offer the following research and development services.
Molecular Biology services consisting of:
Synthetic eDNA Construction
Prokaryotic Expression Vector Construction & Development
e.coli Expression Strain Evaluation
Pilot Scale Fermentation
Mammalian Expression Vector Construction & Development
Baculovirus Expression
Protein Isolation
Protein Engineering: Complement Determining Region Conjugated
Proteins
Monoclonal Antibody Production Chimerization & Humanization
Vector design for Prokaryotic Expression of Antibody Fragments (Fab)
and Single Chain
Antibody (ScFv)
Pilot Scale-up Development
Process Purification & Characterization
Assay Development & Quality Control Pharmaceutical Dosage and
Formulation
Molecular Biology Potential Agreement Structure, which refers to the
following stages or options available to a potential customer
interested in developing a gene/protein expression system for
research purposes.
Stage 1 ? cDNA Construction & Expression Vector Development Stage in
which a specific gene sequence is cloned in an expression vector and
screened by restriction enzyme analysis.
Stage II in which the expression vector is grown into bacteria and
the protein produced is purified by chromatography techniques.
Stage III, Assay for the protein stability and activity in which
protein activity is determined by testing the recombinant protein
using a specific stabilizing buffer. The recombinant protein is
tested against a substrate. The substrate is the target protein
that is deactivated by the recombinant protein.
Stage IV ? Quantification of protein yield per each cell line used
for protein expression. Each type of cell line responds differently
to each recombinant protein. Therefore, various cell lines that
express the highest quantity of a specific recombinant protein are
then used for large-scale recombinant protein production.
Stage V ? Experimental animal model development for determination of
proper biological active concentration and stability and
determination of proper storage. A typical animal model is a mouse
model. Mice are divided into two groups: 1) normal control and 2)
mice injected with different concentrations of recombinant protein.
The biological activity is determined by immunological assays such
as an ELISA test or Western blot analysis.
Gene Therapy Testing Services. GeneThera offers GLP testing
programs for somatic cell, viral and naked DNA-based gene therapies.
Our scientists have over eight years experience in providing fully
integrated bio-safety testing programs for the cell and gene therapy
fields and have supported a number of successful BLA and IND
applications. To date, the Company has not generated any revenues
with regard to these services, and there is no assurance that we
will generate any revenues from such services.
Replication-Competent Viral Vector Testing. Sensitive in vitro cell
culture assays are used to detect replication-competent retroviruses
or adenoviruses. GeneThera intends to work with clients to provide
custom replication-competent virus detection assays for the
particular vector construct.
Complete Somatic Cell and Viral Vector Packaging and Producer Cell
Line Characterization. GeneThera offers all of the assays mandated
by regulatory authorities worldwide for the bio-safety analysis and
characterization of cells and cell lines used in gene therapy
products.
Vector Stock Characterization. Custom purity and potency testing is
available for gene therapy viral vector stocks.
Vector Purification Process Validation for Viral Clearance. Most
biopharmaceuticals require viral clearance studies to validate the
removal of potential contaminants, such as those from bovine
components or from helper viruses (adenovirus in AAV production).
GeneThera can provide custom design and performance of viral studies
for various vector purification processes.
Custom Bio-safety Testing Programs for Somatic Cell, Ex Vivo Cell,
and Tissue Therapies. GeneThera can guide our clients through the
unique process of designing and implementing a bio-safety testing
program that meets the needs of each specific project.
To date, we have not entered into any agreement for the provision of
any of the services described above with any customer. We are
currently pursuing agreements to provide some of these services to
potential customers. There is no assurance that any agreement will
be entered into for the provision of the Company?s services or that
the Company will generate significant revenues or profits from any
such agreement.
INTELLECTUAL PROPERTY
We do not own any patents on any of our technology and have not
filed any applications for patents in any country. We cannot give
any assurance that we will be able to file any patent applications
or that, if we file one or more applications for patents, any
patents will issue or that, if issued, the claims granted in any
such patents will afford us adequate protection against competitors
with similar technology.
We also depend upon the skills, knowledge, and experience of our
scientific and technical personnel, none of which is patentable. To
help protect our proprietary know-how which is not patentable, and
for inventions for which patents may be difficult to endorse, we
rely on trade secret protection to protect our interests.
COMPETITION
We face competition from many companies, universities, and research
institutions in the United States and abroad. Virtually all of our
competitors have substantially greater resources, experience in
product commercialization, and obtaining regulatory approvals for
their products, operating experience, research and development,
marketing capabilities, and manufacturing capabilities that we do.
We will face competition from companies marketing existing products
or developing new products for diseases targeted by our
technologies. The development of new products for those diseases
for which we are attempting to develop products could render our
product candidates noncompetitive and obsolete. Our current
competitors include Prionics AG, IDEXX Laboratories, Inc., and Bio-
Rad Laboratories, Inc.
Academic and government institutions are also carrying out a
significant amount of research in the field of veterinary health,
particularly in the fields of Chronic Wasting Disease and Mad Cow
Disease. We anticipate that these institutions will become more
aggressive in pursuing patent protection and negotiating licensing
arrangements to collect royalties for use of technology that they
have developed and to market commercial products similar to those
that we seek to develop, either on their own or in collaboration
with competitors. Any resulting increase in the cost or decrease in
the availability of technology or product candidates from these
institutions may affect our business.
Competition with respect to our veterinary technologies and
potential products is and will be based, among other things, on
effectiveness, safety, reliability, availability, price, and patent
protection. Another important factor will be the timing of market
introduction of products that we may develop and for which we may
receive regulatory approval. Accordingly, the speed with which we
can develop products, complete the required animal studies or trials
and approval processes and ultimately supply commercial quantities
of the products to the market is expected to be an important
competitive factor. Our competitive position will also depend upon
our ability to attract and retain qualified personnel, to obtain
patent protection or otherwise develop propriety products or
processes, and to secure sufficient capital resources for the often
substantial period between technological conception and commercial
sales.
Several attempts have been made to develop technologies that compete
with F-PCR. To our knowledge none of these technologies have
resulted to date in any product available on the market. The field
of biotechnology is very dynamic. The possibility that more
advanced technologies could be developed into products that may
compete with ours is very strong. However, it is very difficult to
predict the length of time necessary for this scenario to take
place.
MANUFACTURING
We do not currently manufacture any products and do not have any
facilities capable of manufacturing any products. If we are
successful in developing a vaccine for veterinary purposes, we
intend to contract with third parties or a collaborative partner to
assist with production. We currently do not intend to establish a
manufacturing facility to manufacture any products that we may
develop. In the event we do decide to establish a commercial
manufacturing facility, we will require substantial additional funds
and will be required to hire and train significant numbers of
employees and comply with the extensive federal and state
regulations applicable to such a facility. In additional, we would
be required to apply for a license from the United States Department
of Agriculture Animal and Plant Health Inspection Service to
manufacture any such vaccines at such facilities.
PRODUCT LIABILITY
The testing, manufacturing, and marketing of the Company proposed
products involves an inherent risk of product liability attributable
to unwanted and potentially serious health effects in animals that
may receive any vaccines that we may develop and market. To the
extent we elect to test, manufacture, or market veterinary vaccines
and other products, we will bear the risk of product liability
directly. We do not currently have product liability insurance.
There is no guarantee that we can obtain product liability insurance
at a reasonable cost, or at all, or that the amount of such
insurance will be adequate to cover any liability that we may be
exposed to. In the absence of such insurance, one or more product
liability lawsuits against us can be expected to have a material
adverse effect on our business and could result in our ceasing
operations.
GOVERNMENT REGULATION
Our unique approach to the testing for various animal diseases
allows us to begin commercialization of its diagnostic tests without
the need for a long and enduring approval process from the USDA.
All tests are done utilizing the blood of animals that can be
collected in the field using the Company proprietary Field
Collection System (FCS). The collected blood is then sent to our
laboratory for testing. Since all of the testing for the diseases
is done in house, meaning tested at laboratories operated by us
and using our developed testing methods, the USDA deems our test to
be under the category of Veterinary Services. The regulations on
Veterinary Services are much different than that of third party
testing. The USDA through APHIS regulates Veterinary Biological
(vaccines bacterins, antisera, diagnostic kits and other product of
biological origin) APHIS regulates veterinary biologics available
for the diagnosis prevention and treatment of animal disease to
ensure the products are pure, safe, potent and effective. GeneThera
molecular tests are not diagnostics kits and therefore do not fall
under the Veterinary Biologics category. The USDA, to our best of
our knowledge, does not regulate laboratory tests that are performed
in-house under the category of Veterinary Services.
In the event that we develop a vaccine based on our research, the
vaccine product and the facility at which commercial quantities of
the vaccine will be produced will be subject to comprehensive
regulation by the United States Department of Agriculture Animal
and Plant Health Inspection Service. Before any biological
product (which includes vaccines) can be prepared for commercial
sale, APHIS must approve and license the product and the facility at
which it is proposed to be manufactured. The approval process is
lengthy and expensive. We will be required to submit an application
containing, among other things, an outline of production for the
proposed product, characterization data, and protocols for animal
studies and trials of host animal immunogenicity, safety, efficacy,
back passage, shed/spread, interference, and other studies.
We do not have the capability to conduct our own studies and trials
of any candidate vaccine that we may develop and will rely on
collaborative partners to conduct all such studies. Currently, we
do not have any such agreements with any partner, and we cannot give
any assurance that we will be able to enter into such an agreement
on terms that are favorable to the Company, if at all. If we do
enter into one or more such agreements, we will not be able to
control the timetable for completing such studies. Furthermore, we
cannot give any assurance that any applications that we submit for
any vaccine products will be approved by APHIS. The failure to
receive such approval, or the receipt of approval following the
approval of a competing product, would have an adverse material
effect on the Company.
LICENSING
Through our third division, Licensing, we intend to manage the
marketing and sale of the vaccines developed by GeneThera Research
& Development division. As GeneThera does not intend to be a
vaccine manufacturer, we plan to use our Licensing division to
license the technology related to any vaccines that may be developed
and to manage the revenue potential available from the successful
development and validation of specific vaccines. We cannot provide
any assurance that we will develop any vaccines or that, if they are
developed, we will be able to license them successfully or that any
such license will provide significant revenues.
ITEM 1A RISK FACTORS
We encounter various risks related to our business and our industry.
While the Company is optimistic about its long term prospects, the
following risk factors should be considered in evaluating its
outlook.
There is a substantial doubt about GeneThera ability to continue as
an on going concern
GeneThera has had negligible revenues since inception. Because of
these circumstances, GeneThera will require additional working
capital to develop business operation. There is no assurance that
GeneThera will reach a level of revenues adequate to generate
sufficient cash flow from operation or obtain additional financing
necessary to support GeneThera operating expenses requirements
If a Loss of Key Personnel Will Occur This Event Could Adversely
Affect the Company
The Company depends to a large part on the efforts and continued
employment of Antonio Milici, M.D., Ph.D., our President, Chairman
of The Board, and Chief Executive Officer. The loss of the services
of Dr. Milici could adversely affect our business.
If the Company fails to attract and retain additional, high skilled
personnel operations will suffer.
Finding qualified personnel in the biotechnology industry is very
challenging. Smaller biotechnology companies there are always at a
disadvantage because of its limited financial resources. The Company
has been unable at this time to hire any additional qualified
personnel. If the Company is unable to hire additional personnel
this may result in a substantial delay of its Research and
Development and commercial operations.
If the Company fails to attract significant additional capital, the
Company may be unable to continue developing its products.
From the starting of its operation, GeneThera has obtained limited
funding to implement its business strategy. The Company does not
have sufficient funding to meet its operating needs throughout 2008.
Potential sources of additional funding could include strategic
relationships, public or private sales of shares of common stocks,
or other arrangements.
Rapid Growth May Place Significant Demands on our Resources
We expect significant expansion of our operations. Our anticipated
future growth will place a significant demand on our managerial,
operational and financial resources due to:
a) The need to manage relationships with various strategic partners
and other third parties;
b) Difficulties in hiring and retaining skilled personnel necessary
to support our business;
c) The need to train and manage a growing employee base; and
d) Pressures for the continued development of our financial and
information management systems.
If we have not made adequate allowances for the costs and risks
associated with this expansion or if our systems, procedures, or
controls are not adequate to support our operations, our business
could be harmed.
The Company may not be able to comply with Government regulations
The Company is subject to or affected by laws and regulations that
govern, for example: (i) the vaccination of animals for certain
diseases. The failure to comply with these laws and regulations, or
to obtain applicable of these governmental approvals, could result
in the imposition of penalties, cause delays in, or make impossible,
the marketing of our products and services.
The Company may be unable to compete against other more establish
biotech of pharmaceutical companies
The Company operates in a very competitive and difficult area.
Biotechnology is notoriously very difficult and risky business. The
Company competes with other more established and better funded
companies in the United States and overseas that are involved in the
development of similar products. Several of these companies have
significant greater financial resources as well greater production
and market capabilities. The field of Biotechnology requires
extensive research and development. Better funded competitors may
be able to develop and market superior or less expensive product
which will make the Company products less valuable or unmarketable.
The Company has no manufacturing capabilities
The Company does not have manufacturing capabilities for its DNA
vaccine technology. The Company solely relies on other companies to
manufactures vaccines that can meet Government Regulations.
Manufacturing of these products are very expensive and The Company
may not be able to secure the necessary funding to hire any of such
companies. If The Company is unable to produce these vaccines, then
The Company may never be able to initiate clinical trials. This will
seriously hamper the Company?s ability to commercialize any of its
DNA vaccine products
The Company has limited Government Regulatory Experience
The company has never successfully undertaken a clinical trial for
animal DNA vaccine. Our experience in this area is limited. The
Company has never obtained regulatory approvals for any of its
products.
Being Delisted from Over the Counter Bulletin Board (OTCBB)
Although by the time of our original Form 10-K filing, our company
was participant of the exchange list of OTCBB (Over the Counter
Bulletin Board), FINRA delisted our Company on June 19, 2008 by
putting a penalty symbol after our ticker symbol GTHA due to failing
to file our quarterly and annual reports according to their
standards. The Company paid FINRA $4,000 for an appeal hearing,
which was useless since FINRA already pre-determined our culpability
before the appeal was addressed on June 20th, 2008. The Company had
IT difficulties with their server. The Company does not change their
date/time of filing; therefore, the Company was asking to the SEC to
change the headline of the 10K filing. It could have been done but
the Office of Technology from the SEC opted to ignore the Company?s
request for such modification due to our 16:20 date and time status
on our computer screen. Even though, the filing of the 10K was done
by 16:20; FINRA concluded the filing was done by 20:20. The Company
learned that the server was down for more than 4 hours when finally
the server recovered its data; the date and time of the filing was
changed without the Company knowledge. Moreover, the Company
understood when they filed for an extension requested by their
auditors, that the Company had 15 calendar days to complete such
extension of filing. The fifteenth day came along and the filing was
completed and approved by the auditors. However, once the EDGAR was
completed, the Company server was having technical difficulties,
especially when their server went down. Regardless of such
explanation given to the SEC Technology Office requesting to change
the headline of the filing, no one was concerned to contact the
Company CFO Interim to let the Company know about the answer to
their updated request. When the appeal hearing was done, the FINRA
staff only spoke with the Company?s investor relations entity, Mr.
Richard Dopkin. No one spoke with our IT specialist who knew about
our technical difficulties and how to retrieve the correct filing
done by 16:20. Moreover, FINRA did not care to speak with the
officers of GeneThera, even though, they were witnesses of the IT
difficulties. FINRA seized $4,000 from the Company without a fair
appeal hearing to the Company shareholders. No one from FINRA
cared to hear the essence of the appeal.
ITEM 2 DESCRIPTION OF PROPERTY
We leased a 5,730 square foot biotechnology laboratory located at
3930 Youngfield Street, Wheat Ridge, Colorado 80033 until March 6,
2009. The lease was on a month-to-month basis and the rent was
$4,000 per month. We relocated to Arvada, CO where we lease a 1,945
square foot office space. We are viewing other suitable laboratory
space near Arvada. We sub-lease 700 square foot of office space to
GTI Corporate Transfer Agents, LLC, a related party, located on unit
201. The lease is on a five-year basis and the rent is $2,000.00
per month effective February 26, 2009. We do not own any real
estate property. If we are able to develop assays for different
diseases, we intend to formalize the procedure into a commercial
application through a series of laboratories to be owned and
operated by GeneThera. Currently we do not have the funds to
purchase or construct any such laboratories and do not have
commitment from any party to provide the funds for a laboratory.
ITEM 3 LEGAL PROCEEDINGS
On or about July 23, 2004, Sisu Media sued the Company in Jefferson
County District court for breach of an alleged contract for website
services for which the plaintiff seeks compensatory damages, plus
costs, interest, and attorney fees in amounts to be determined at
trial. Trial was held on August 4, 2005, wherein the court
determined that Sisu Media was entitled to compensation based only
upon the breach of contract claim. Plaintiff claims in quantum
meruit and for unjust enrichment were dismissed. The court also
dismissed defendant GeneThera, Inc. claim of aiding and abetting a
breach of fiduciary duty by third party. Entry of judgment was
entered in favor of the plaintiff for approximately $49,000.00. On
February 9, 2006, the Company appealed this judgment. The Appeals
Committee decision was in favor of the plaintiff due to the
GeneThera legal counsel lack of preparedness. On July 19, 2007,
the Appeals Committee approved plaintiff?s attorney, specifying the
attorney fees and costs in the amount of $6,237.31 incurred in said
appeal against GeneThera. No judgment has been paid to the plaintiff
by the Company.
On or about September 21, 2006, MAG Capital, a California Limited
Liability Company (Mercator Momentum III, LP; Mercator Momentum Fund
LP; Monarch Pointe Fund, ltd; a British Virgin Islands Corporation),
served GeneThera, Inc., a Florida corporation, GTI Corporate
Transfer Agents, LLC, a Colorado limited liability company, Antonio
Milici, an individual, Tannya L. Irizarry, and Laura Bryan,
individuals with a summons with the Federal Court, which was
quashed. On October 11, 2006, the above entities filed a Superior
Court State Complaint against GeneThera et al. for breach of written
contract. The plaintiffs dropped the charges against GeneThera,
Inc., GTI Corporate Transfer Agents, LLC, Antonio Milici, Tannya L.
Irizarry and Laura Bryan. The plaintiffs charged the Company with
breach of written contract for which the Company litigation
counsel filed an appeal on February 19, 2008. The Company
litigation counsel also filed a $5 million suit against the
plaintiffs and a $50,000 law suit against the plaintiff?s legal law
firm for unethical procedure in approaching one of the defendants.
The Company lost the appeal. The Judge awarded legal fees for the
plaintiffs.
ITEM 4 SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
PART II.
ITEM 5 MARKET FOR COMMON EQUITY AND RELATED SHAREHOLDER MATTERS
Our common stock currently trades on the Pink Sheets Over the
Counter Bulletin Board under the symbol GTHR. The following sets
forth the rant of high and low bid quotations for the periods
indicated as reported by Yahoo Finance. Such quotations reflect
prices between dealers,without retail markup, markdown or
commission, and may not represent actual transactions.
Year
Quarter
High
Low
2008
Fourth
Third
Second
First
2007
Fourth
..03
..01
Third
..03
..02
Second
..05
..02
First
0.05
..03
2006
Fourth
$0.08
$0.02
Third
0.10
0.05
Second
0.33
0.08
First
0.28
0.06
2005
Fourth
$0.49
$0.10
Third
1.00
0.40
Second
1.05
0.54
First
1.25
0.92
2004
Fourth
1.94
0.88
Third
1.60
0.70
Second
2.85
0.90
First
4.39
2.05
* Source Yahoo Finance
There are no restrictions on the payment of dividends. There are
approximately 1,149 record holders of common stock as of December
31, 2008.
DIVIDENDS
On May 21, 2007, the Company issued a one time dividend payment in
the amount of .0004 per share.
ITEM 6 SELECTED FINANCIAL DATA
The following selected financial data should be read in conjunction
with Item 7. Management Discussion and Analysis or Plan of
Operation and Item 8. Financial Statements
Operating Data As of December 31,
2008 2007 2006 2005
Gross Profit 10,822 97,900 150,000 190,982
General and Administrative (981,910) (379,068) (739, 529) (896,696)
Consulting expense (713,515) (236,757) (444,420) (1,952,040)
Depreciation (69,647) (72,451) (77,014) (11,751)
Other income (expense) (0) (100) (0) (1,301,373)
_____________________ _____ _________ ___________
Net loss (1,754,250) (841,829) (1,482,571) (3,794,079)
Loss per share (4.180) (.02) (.07) (.17)
Balance sheet data:
Cash and Cash Equivalents 869 68,463 26,314 18,031
Total assets 221,786 364,305 394,607 473,396
Total liabilities 2,515,508 1,701,861 1,418,411 850,277
Stockholders Equity (Deficit)(2,293,722) (1,337,556) (1,023,804) (376,881)
ITEM 7 MANAGEMENT DISCUSSIONS AND ANALYSIS OF FINANCIAL CONDITIONS
AND RESULTS OF OPERATIONS
FORWARD-LOOKING AND CAUTIONARY STATEMENTS
Sections of this Form 10-K, including the Management Discussion
and Analysis or Plan of Operation, contain forward looking
statements within the meaning of Section 27A of the Securities Act
of 1933 (the Securities Act), Section 21E of the Securities and
Exchange Act of 1934 (the Exchange Act), and the Private
Securities Litigation Reform Act of 1995. These forward looking
statements are subject to risks and uncertainties and other factors
that may cause our actual results, performance or achievements to be
materially different from the results, performance or achievements
expressed or implied by the forward looking statements. You should
not unduly rely on these statements. Forward looking statements
involve assumptions and describe our plans, strategies, and
expectations. You can generally identify a forward-looking
statement by words such as may, will, should, would, could, plans,
goal, potential, expect, anticipate, estimate,
believe, intent, project, and similar words and variations
thereof. This report contains forward-looking statements that
address, among other things,
a) our financing plans, b) regulatory environments in which we
operate or plan to operate, and c) trends affecting our financial
condition or results of operations, the impact of competition, the
start-up of certain operations and acquisition opportunities.
Factors, risks, and uncertainties that could cause actual results to
differ materially from those in the forward-looking statements
(Cautionary Statements) include, among others,
* our ability to raise capital,
* our ability to execute our business strategy in a very competitive
environment,
* our degree of financial leverage,
* risks associated with our acquiring and integrating companies into
our own,
* risks relating to rapidly developing technology,
* regulatory considerations;
* risks related to international economies,
* risks related to market acceptance and demand for our products and
services,
* the impact of competitive services and pricing, and
* other risks referenced from time to time in our SEC filings.
All subsequent written and oral forward-looking statements
attributable to us, or anyone acting on our behalf, are expressly
qualified in their entirety by the cautionary statements. We do not
undertake any obligations to publicly release any revisions to any
forward looking statements to reflect events or circumstances after
the date oft his report or to reflect unanticipated events that may
occur.
You should read the following discussion of our results and plan of
operation in conjunction with the consolidated financial statements
and the notes thereto appearing elsewhere in this Form 10-K.
Statements in this Management Discussion and Analysis or Plan of
Operation that are not statements of historical or current objective
fact are forward-looking statements.
OVERVIEW
We have developed proprietary diagnostic assays for use in the
agricultural and veterinary markets. Specific assays for Chronic
Wasting Disease (CWD) (among elk and deer) and Mad Cow Disease
(among cattle) have been developed and are available currently on a
limited basis. E. coli (predominantly cattle) and Johnes disease
(predominantly cattle and bison) diagnostics are in development. We
are also working on vaccine solutions to meet the growing demands of
today?s veterinary industry and tomorrow?s agriculture and
healthcare industries. The Company is organized and operated both
to continually apply its scientific research to more effective
management of diseases and, in so doing, realize the commercial
potential of molecular biotechnology.
We have not generated significant operating revenues and, as of
December 31, 2008 we had incurred a cumulative net loss from
inception of $17,556,670. Our ability to generate substantial
operating revenue will depend on our ability to develop and obtain
approval for molecular assays and developing therapeutic vaccines
for the detection and prevention of food contaminating pathogens,
veterinary diseases, and diseases affecting human health.
Our independent auditors have expressed some doubt about our ability
to continue as a going concern in their report on our consolidated
financial statements for the fiscal year ended December 31, 2007.
For the years ended December 31, 2008 and 2007, our operating losses
were $1,988,707 and $841,829, respectively. Our current liabilities
exceeded current assets by $1,866,660 and $1,633,398 for the years
ended December 31, 2008 and 2007, respectively.
Although we completed equity financing with gross proceeds of
approximately $1.1 million in 2005, we will require significant
additional funding in order to achieve our business plan. Over the
next 12 months, in order to have the capability of achieving our
business plan, we believe that we will require at least $5,000,000
in additional funding. We will attempt to raise these funds by both
means of one or more private offerings of debt or equity securities
and revenues generated by our Project in Mexico. At this time, we
have commitments for additional capital funds. This amount may
exceed an additional $1,000,000 depending on cost involved in the
further development and commercialization of our products. In such
event, we may need immediate additional funding. Our capital
requirements will depend on many factors including, but not limited
to, the timing of further development of assays to detect the
presence of infectious disease from the blood of live animals, our
hiring of additional personnel, the applications for, and receipt
of, regulatory approvals for any veterinary vaccines that we may
develop, and other factors. Our ability to raise capital will
increase our ability to implement our business plan.
Over the next 12 months, we expect significant purchases and/or
sales of plant or equipment and significant changes in the number of
our employees for any off balance sheet arrangements that will have
current and future effect on our financial condition.
We also expect to spend a significant amount of our capital on
research and development activities for commercialization relating
to development and vaccine design/development. When we are able to
develop assays for different diseases, we intend to formalize the
procedure into a commercial application through a series of
laboratories to be owned and operated by GeneThera. To date, we
have introduced our diagnostic solution for Chronic Wasting Disease
(CWD) and Mad Cow Disease, on a very limited basis. We anticipate
that significant funds will be spent on research and development
throughout the life of the Company, as this is the source for new
products to be introduced to the market. Our plan is to seek new
innovations in the biotechnology field. We may be successful in
developing or validating any new assays and, when we are successful
in developing and validating any such assays, we may be able to
successfully commercialize them or earn profits from sales of those
assays. Furthermore, we may be able to design, develop, or
successfully commercialize vaccines as a result of our research and
development efforts.
RECENT DEVELOPMENTS
The Company is in continued negotiations with the Italian government
to open a laboratory facility in Northern Italy for the validation
and testing of its live animal test for TSE. The parties are
currently discussing space requirements and personnel needs. The
Italian Project is also impatiently awaiting the completion of the
funding for this venture.
The Company has begun to form an entity with a Mexican company to
jointly own and operate a laboratory facility in Monterrey, Mexico
for express purposes of testing cattle for TSE. The entity is
currently being legally formed. The Mexico Project is also
enthusiastically waiting for the completion of the funding for this
enterprise.
The Company signed an Investor Relations agreement with The Mezey
Howarth Group, Inc., in March 2007. The Company terminated its
Investor Relations arrangement with The Mezey Howarth Group, Inc.
due to false press releases generated by J. Wade Mezey on June 18,
2007. This entity owes the Company $120,000 for which GeneThera will
pursue through litigation due to their failure in reimbursing the
Company for line of credit pre-paid fees, which was never approved
and/or materialized.
In March 2006, the Company opened a line of credit with Imperial
Capital Holdings, LLC on the advice of the Company?s consulting
financial advisor, Mr. Gary Rasmussen, who is also the primary
beneficiary of Imperial. The Company was not aware of the
relationship but, more importantly, after the CEO of the Company
learned that Red Sea Management was the managing company of Imperial
Capital, the CEO opted not to use the line of credit, requesting
from the SEC to grant a withdrawal. The withdrawal was approved on
April 13, 2007.
In 2008 GeneThera signed an agreement for the rights to an
exclusive license wit he of University of New Mexico for the
development and commercialization of E-Coli 0157-h7 vaccine. This
option expires in August 2009. It is the company?s intention to
have the final agreement finalized before the due date of the
exclusive right.
RELATED PARTY TRANSACTIONS
GTI Corporate Transfer Agents, LLC is the Company transfer agent.
After the death of the original Managing Director, Ms. Juanita Pagan
in March 2006, Ms. Tannya L. Irizarry became the Managing Director
of GTI Corporate Transfer Agents, LLC.
RESULTS OF OPERATIONS
Year Ended December 31, 2008 Compared to Year Ended December 31,
2007
For the year ended December 31, 2008, the Company reported a net
loss of $1,988,707, or less than $0.05 per share, and $97,900 of
revenue as compared with a net loss of $841,829, or $0.02 per share,
and $97,900 of revenue for the twelve months ended December 31,
2007.
General and Administrative Expenses: General and administrative
expenses decreased to $981,910 for the twelve months ended December
31, 2008 compared to $379,068 for the same period in 2007. This
decline was due to a decrease in personnel.
Consulting Expenses: Consulting expenses decreased to $713,515 for
the twelve months ended December 31, 2008 compared to $236,757 for
the same period in 2007. The decrease is attributable to the
discontinuation of use of marketing consultants traditionally paid
in stock of the Company.
Depreciation and Amortization Expense: Depreciation and
amortization expenses decreased to $69,647 for the twelve months
ended December 31, 2008 compared to $72,451 for the same period in
2007 primarily due to no new equipment being purchased.
Year Ended December 31, 2006 Compared to Year Ended December 31,
2005
For the year ended December 31, 2006, the Company reported a net
loss of $1,482,571, or $0.07 per share, and $150,000 of revenue as
compared with a net loss of $3,794,079, or $0.017 per share, and
$190,982 of revenue for the twelve months ended December 31, 2005.
General and Administrative Expenses: General and administrative
expenses decreased to $739,529 for the twelve months ended
December 31, 2006 compared to $896,696 for the same period in 2005.
The decrease was attributable to the decrease in employees in 2006
due to budget constraints.
Consulting Expenses: Consulting expenses decreased to $444,420 for
the twelve months ended December 31, 2006 compared to $1,952,040 for
the same period in 2005. This decrease is primarily attributed to
the elimination of marketing consultants traditionally paid in stock
of the Company.
Depreciation and Amortization Expense: Depreciation and
amortization expenses increased to $77,014 for the twelve months
ended December 31, 2006 compared to $11,751 for the same period in
2005 primarily due to equipment purchased to expand the lab.
LIQUIDITY AND CAPITAL RESOURCES
We had a cash balance of $48 as of December 31, 2008 and cash
balance of $196 as of December 31, 2007. Our current cash balance
is not sufficient to fund our business objectives and we will need
significant additional capital over the next 12 to 18 months in
order to fund our planned operations. We may be unable to secure
any additional financing on terms that are acceptable to us, if at
all.
Since we completed the reverse merger with Hand Brand Distribution,
Inc., we have financed our operations, in large part, by private
placements of our common and preferred stock and promissory notes
convertible into our common stock. We have raised an aggregate of
$2,613,900 through such sales, including the sale of approximately
$1.1 million of our preferred stock in January 2005.
We will require significant additional funding in order to achieve
our business plan. Specifically, we intend to spend significant
funds on validating and testing our products, seeking necessary
regulatory approvals and focusing on international expansion. Over
the next 12 month, in order to have the capability of achieving our
business plan, we believe that we will require at least $5,000,000.
We will attempt to raise these funds by means of one or more private
offerings of debt or equity securities or both. We may not be able
to secure the financing that we believe is necessary to implement
our strategic objectives and, even if additional financing is
secured, we may not achieve our strategic objectives. As of the
date of this Report, we do not have any firm commitments from any
investors for any additional funding.
Our longer term working capital and capital requirements will depend
upon numerous factors, including revenue and profit generation, pre-
clinical studies and clinical trials, the timing and cost of
obtaining regulatory approvals, the cost of filing, prosecuting,
defending, and enforcing patent claims and other intellectual
property rights, competing technological and market developments,
collaborative arrangements. Additional capital will be required in
order to attain such goals. Such additional funds may not become
available on acceptable terms and we cannot give any assurance that
any additional funding that we do obtain will be sufficient to meet
our needs in the long term.
CRITICAL ACCOUNTING POLICIES
In December 2001, the SEC requested that all registrants discuss
their most critical accounting policies in Management Discussion
and Analysis of Financial Condition or Plan of Operation. The SEC
indicated that a critical account policy is one which is both
important to the portrayal of the Company?s financial condition and
results and requires management?s most difficult, subjective or
complex judgments, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain. Our
significant accounting policies are described in Note 1 to our
consolidated financial statements included in this Report.
RECENTLY ISSUED ACCOUNTING STANDARDS
On December 16, 2004, the Financial Accounting Standard Board issued
SFAS No. 123 (revised 2004), Share-Based Payment, which is a
revision of SFAS No. 123. SFAS No. 123 GeneThera supersedes APB No.
25, and amends SFAS No. 95, Statement of Cash Flows. Generally,
the approach in SFAS No. 123 GeneThera is similar to the approach
described in SFAS No. 123. However, SFAS No. 123 GeneThera requires
all share based payments to employees, including grants of employee
stock options, to be recognized in the income statement based on
their fair values. Pro forma disclosure is no longer an
alternative. SFAS No. 123 GeneThera must be adopted no later than
July 1, 2005. The Company has adopted SFAS No. 123 GeneThera using
a modified retrospective method which includes the requirements of
the modified prospective method described above, but also permits
entities to restate based on the amounts previously recognized under
SFAS No. 123 for purposes of pro forma disclosures either (a) all
prior periods presented or (b) prior interim periods of the year of
adoption. In March 2005, the FASB issued FASB interpretation No.
47, Accounting for Conditional Asset Retirement Obligations (FIN
47). FIN 47 provides guidance relating to the identification of
and financial reporting for legal obligations to perform an asset
retirement activity. The Interpretation requires recognition of a
liability for the fair value of a conditional asset retirement
obligation when incurred if the liability fair value can be
reasonable estimated. FIN 47 also defines when an entity would have
sufficient information to reasonably estimate the fair value of an
asset retirement obligation. The provision is effective no later
than the end of fiscal years ending after December 15, 2005. The
Company will adopt FIN 47 beginning the first quarter of fiscal year
2006 and does not believe the adoption will have a material impact
on its consolidated financial position or results of operations or
cash flows.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and
Error Corrections (SFAS 154) which replaces Accounting Principles
Board Opinions No. 20 Accounting Changes and SFAS No. 3,
Reporting Accounting Changes in Interim Financial Statements ? An
Amendment of APB Opinion No. 28. SFAS 154 provides guidance on the
accounting for and reporting of accounting changes and error
corrections. It establishes retrospective applications, or the
latest practicable date, as the required method for reporting a
change in accounting changes and a correction of errors made in
fiscal years beginning after December 15, 2005 and is required to be
adopted by the Company in the first quarter of 2006. The Company is
currently evaluating the effect that the adoption of SFAS 154 will
have on its results of operations and financial condition but does
not expect it to have material impact.
In June 2005, the Emerging Issues Task Force, or EITF, reached a
consensus on Issue 05-6, Determining the Amortization Period for
Leasehold Improvements, which requires that leasehold improvements
acquired in a business combination or purchased subsequent to the
inception of a lease be amortized over the lesser of the useful life
of the assets or a term that includes renewals that are reasonable
assured at the date of the business combination or purchase. EITF
05-6 is effective for periods beginning after July 1, 2005. We do
not expect the provisions of this consensus to have a material
impact on the financial position, results or cash flows.
In February 2006, the FASB issued SFAS 155, Accounting for Certain
Hybrid Financial Instruments, which amends SFAS 133, Accounting for
Derivative Instruments and Hedging Activities, and SFAS 140,
Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities; a replacement of FASB Statement No.
125. SFAS 155 will be effective for the Company for all financial
instruments issued or acquired after the beginning of its fiscal
year ending December 31, 2006. The Company has not yet evaluated
and determined the likely effect of SFAS 155 on future financial
statements.
In June 2006, the FASB issued Interpretation No. 48, Accounting for
Uncertainty in Income Taxes ? An Interpretation of FASB Statement
No. 109, (FIN 48). FIN 48 clarifies the accounting for uncertainty
in income taxes recognized in an enterprise financial statements
in accordance with FASB Statement No. 109, Accounting for Income
Taxes. FIN 48 also prescribes a recognition threshold and
measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax
return that results in a tax benefit. Additionally, FIN 48 provides
guidance on de-recognition, income statement classification of
interest and penalties, accounting interim periods, disclosure, and
transition. This interpretation is effective for the Company for
its fiscal year ending December 31, 2007. The Company has not yet
evaluated the effect that the application of FIN 48 may have, if
any, on its future results of operations and financial condition.
In September 2006, the FASB issued SFAS No. 157, Fair Value
Measurements. This statement defines fair value, establishes a
framework for measuring fair value in generally accepted accounting
principles, and expands disclosures about fair value measurements.
This statement applies under other accounting pronouncements that
require or permit fair value measurements. SFAS No. 157 is
effective for the Company for its fiscal year beginning on July 1,
2008. The Company is currently assessing the impact the adoption of
SFAS No. 157 will have on its financial statements.
In September 2006, the Sec issued Staff Accounting Bulletin (SAB)
No. 108 in order to eliminate the diversity of practice surrounding
how public companies quantify financial statement misstatements. In
SAB 108, the SEC staff established an approach that requires
quantification of financial statement misstatements based on the
effects of the misstatements on each of the Company financial
statements and the related financial statement disclosures. SAB No.
108 is effective for the Company for its current fiscal year. The
adoption of SAB No. 108 did not have an impact on the Company
financial statements.
On February 15, 2007, the FASB issues SFAS No. 159, The Fair Value
Option for Financial Assets and Financial Liabilities; Including an
Amendment of FASB Statement No. 115. This standard permits an
entity to measure many financial instruments and certain other items
at estimated fair value. Most of the provisions of SFAS No. 115
(Accounting for Certain Investment in Debt and Equity Securities)
apply to all entities that own trading and available for sale
securities. The fair value option created by SFAS No. 159 permits
an entity to measure eligible items at fair value as of specified
election dates. Among others eligible items exclude (1) financial
instruments classified (partially or in total) as permanent or
temporary stockholders equity (such as a convertible debt security
with a non contingent beneficial conversion feature) and (2)
investments in subsidiaries and interests in variable interests that
must be consolidated. A for-profit business entity will be required
to report unrealized gains and losses on items for which the fair
value option has been elected in its statements of operations at
each subsequent reposting date. The fair value option (a) may
generally be applied instrument by instrument, (b) is irrevocable
unless a new elections date occurs, and (c) must be applied to the
entire instrument and not to only a portion of the instrument. SFAS
No. 159 is effective as of the beginning of the first fiscal year
that begins after November 15, 2007. The Company has not yet
evaluated the effect that the application of SFAS No. 159 may have,
if any, on its future results of operations and financial condition.
EMPLOYEES
As of December 31, 2008, we had a total of two full time
employees who devote substantial effort on our behalf. None of our
employees are represented by a collective bargaining unit. We
entered into an employment agreement with Antonio Milici, M.D.,
Ph.D., to serve as our Chief Executive Officer and Chief Scientific
Officer through January 7, 2012. In consideration for his services,
Dr. Milici will receive a base salary of $144,000 per annual plus
bonuses as may be determined by the Board of Directors in its sole
discretion. As part of his employment agreement, Dr. Milici is
subject to non-disclosure and non-competition obligations and has
transferred to the Company all of his interests in any idea,
concept, technique, invention or written work. We also entered into
an employment agreement with Tannya L. Irizarry to serve as our
Chief Administrative Officer through January 7, 2012. Ms.
Irizarry base salary is $90,000 per annum. The above salaries
have been accrued to be paid in common stock shares from the
Company. There are no employee issues at this time.
RESEARCH AND DEVELOPMENT
We anticipate that R&D will be the source for both assay development
and vaccine design/development. If we are able to develop assays
for different diseases, we intend to formalize the procedure into a
commercial application through a series of laboratories to be owned
and operated by GeneThera. To date, we have introduced our
diagnostic solution for Chronic Wasting Disease and Mad Cow Disease
on a very limited basis. We anticipate that R&D will be ongoing
during the life of the Company, as this is the source for new
products to be introduced to the market. Our plan is to seek new
innovations in the biotechnology field. We cannot assure you that
we will be successful in developing or validating any new assays or,
if we are successful in developing and validating any such assays,
that we can successfully commercialize them or earn profits from
sales of those assays. Furthermore, we cannot assure you that we
will be able to design, develop, or successfully commercialize any
vaccines as a result of our research and development efforts.
COMMERCIAL DIAGNOSTIC TESTING
In the event that we are able to develop assays for the detection of
diseases in animals, we intend to establish a series of diagnostic
testing laboratories geographically proximate to the primary sources
of individual diseases and/or according to specific available
operating efficiencies. The specific number of labs to be built and
operated will be based on assay demand (demand facilitated by the
number of specific disease assays GeneThera develops), our ability
to obtain the capital to build the labs, and our ability to
successfully manage them from our principal office.
PROPERTIES
We leased a 5,730 square foot biotechnology laboratory located at
3930 Youngfield Street, Wheat Ridge, Colorado 80033. The lease
expired in January 2007, and the rent was $4,000.00 per month. The
Company was on a month-to-month basis. Our new location is 5255
Marshall Street in Arvada, CO. The lease is for five years. The
monthly rent is $2,000. We sub lease 900 square feet to GTI
Corporate Transfer Agents, LLC. The monthly rent is $1,000. We are
viewing lab space suitable for our biotechnology research, which
will be adequate to meet our research requirements. We do not own
any real property. If we are able to develop assays for different
diseases, we intend to formalize the procedure into a commercial
application through a series of laboratories to be owned and
operated by GeneThera. Currently, we do not have the funds to
purchase or construct any such laboratories and do not have a
commitment from any party to provide the funds for a laboratory.
ITEM 8 FINANCIAL STATEMENTS
GENETHERA, INC.
AND SUBSIDIARY
(A Development Stage Company)
FINANCIAL STATEMENTS
FOR THE PERIOD FROM
OCTOBER 5, 1998 (INCEPTION) TO DECEMBER 31, 2008
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED FINANCIAL STATEMENTS
FOR THE PERIOD FROM
OCTOBER 5, 1998 (INCEPTION) TO DECEMBER 31, 2008
TABLE OF CONTENTS
Page No.
Independent Registered Public Accounting Firm?s Report 2
Consolidated Balance Sheets ? December 31, 2008 and 2007 4
Consolidated Statements of Operations for the
Period from October 5, 1998 (Inception) to December 31, 2008 6
Consolidated Statements of Changes in Stockholders? Equity
(Deficit) for the Period from October 5, 1998 (Inception) to
December 31, 2008 7
Consolidated Statements of Cash Flows for the
Period from October 5, 1998 (Inception) to December 31, 2008 10
Notes to Consolidated Financial Statements 11
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors
GeneThera, Inc.
Wheat Ridge, Co.
We have audited the accompanying balance sheets of GeneThera, Inc.
and subsidiary (the Company) as of December 31, 2008 and 2007 and
the related statements of operations, stockholders? deficit, and
cash flows for the years ended December 31, 2008 and 2007. 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. The cumulative financial
statements for the period October 5, 1998 (inception) to December
31, 2006, were audited by other accountants, whose report expressed
a qualified opinion regarding the Company?s ability to continue as a
going concern.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free
of material misstatement. The Company is not required to have, nor
were we engaged to perform an audit of its internal control over
financial reporting. Our audit included consideration of internal
control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for
the purpose of expressing an opinion on the effectiveness of the
Company internal control over financial reporting. Accordingly, we
express no such opinion. An audit also includes examining, on a test
basis, evidence supporting the amounts and disclosures in the
financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our audit
provides a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present
fairly, in all material respects, the financial position of the
Company as of December 31, 2008 and 2007, and the results of its
operations and changes in stockholders deficit and its cash flows
for the years ended December 31, 2008 and 2007, in conformity with
accounting principles generally accepted in the United States of
America.
The accompanying financial statements have been prepared assuming
that the Company will continue as a going concern. As discussed in
Note 9 of the financial statement, the Company?s accumulated deficit
from operations and its difficulties in maintaining sufficient
working capital raise substantial doubt about its ability to
continue as a going concern. Management plans concerning these
matters are also described in Note 9. The financial statements do
not include any adjustments that might result from the outcome of
this uncertainty.
W.T. Uniack & Co. CPA?s P.C.
Alpharetta, Georgia
April 15, 2009
Balance Sheet ? 4
Assets
2008
2007
Current Assets
Cash
$ 48
$ 196
Accounts receivable
821
68,267
Accounts receivable Related Parties
0
0
Prepaid expenses
0
0
Total Current Assets
869
68,463
Property and equipment
727,428
727,428
Accumulated Depreciation
(506,511)
(436,864)
Property and equipment, net
220,917
290,564
Other Assets
Deposits
0
5,278
Total Other Assets
0
5,278
Total Assets
$ 221,786
$ 364,305
Balance Sheet ? 5
Liabilities and Stockholder Equity
2008
2007
Current Liabilities
Accounts payable
$ 285,147
$ 582,869
Accrued expenses
1,582,382
968,702
Leases payable, current portion
0
0
Notes payable
0
150,290
Loan to shareholder
0
Total Current Liabilities
1,867,529
1,701,861
Loan to Shareholder
647,979
0
Total Liabilities
2,515,508
1,701,861
Stockholder Equity
Preferred stock, $.001 par value, 20,000,000 shares authorized;
Series A 4,600 shares issued and outstanding $.001 par value
5
5
Series B 7,320,000 shares issued and outstanding $.001 par value
7,320
3,000
Common stock $.001 par value, 100,000,000 shares authorized;
2,265,816 shares issued and outstanding
467
51,527
Additional paid in capital
16,096,984
15,017,704
Deficit accumulated during development stage
(18,398,498)
(16,409,792)
Total Stockholder Equity
(2,293,722)
(1,337,556)
Total Liabilities & Stockholder Equity
$ 221,786
$ 364,305
Stmt of Operations ? 6
For the period from
Year End December 31,
October 5, 1998
2008
2007
(inception) to
December 31, 2008
Income
Sales
$ 10,822
$ 97,900
$ 429,571
Research fees
0
0
188,382
Total income
10,822
97,900
617,953
Cost of sales
0
0
(30,352)
Gross profit
10,822
97,900
587,601
Expenses
Other compensation
0
0
3,283,009
Consulting
713,515
236,757
5,297,352
General and administrative expenses
981,910
379,068
4,489,529
Payroll expenses
234,000
235,350
2,103,269
Depreciation
69,647
72,451
472,763
Settlement expense
0
82,625
Dividend Payment
0
15,980
0
Lab expenses
457
223
294,974
Total expenses
1,999,529
939,830
16,079,235
Loss from operations
(1,988,707)
(841,929)
(15,491,634)
Other income (expenses)
Beneficial conversion expense
0
0
(1,987,991)
Interest expense
0
0
(46,758)
Gain on settlements
0
0
58,203
Other income (expenses), net
0
100
33,575
Net loss
$ (1,988,707)
$ (841,828)
$ (17,556,670)
Loss per common share Basic & Diluted
$ (4.180)
$ (0.017)
Weight Average Shares
475,797
50,475,480
Stmt of Changes in Stockholders ? 7
Stmt of Changes in Stockholders ? 8
Stmt of Changes in Stockholders ? 9
Stmt of Cash Flows ? 10
For the period from
Year End December 31,
October 5, 1998
(inception) to
2008
2007
December 31, 2008
Cash flows from operating activities:
Net loss
$ (1,988,707)
$ (841,829)
$ (16,904,538)
Adjustments to reconcile net loss to net
cash provided by (used in) operating activities:
Depreciation and amortization
69,647
72,451
$ 235,227
Compensation in exchange for common stock
854,340
439,727
$ 9,374,924
Beneficial conversion feature
$ 1,987,990
Changes in operating assets and liabilities
(Increase) Decrease in:
Accounts receivable
67,446
(61,467)
$ (821)
Accounts receivable Related Parties
0
17,390
$ 0
Reserve for Uncollectible
0
0
$ 90,000
Inventory
0
0
$ 0
Prepaid expenses
0
1,890
$ (2,000)
Other assets
5,278
0
$ 12,556
Increase in accounts payable
and accrued liabilities
963,937
353,752
$ 2,331,141
Total adjustments
1,960,648
823,743
14,029,017
Net cash used in operating activities
(28,059)
(18,086)
(2,875,521)
Cash flows from investing activities:
Cash payments for the purchase of property
0
0
(299,072)
Cash flows from financing activities:
Bank overdraft
0
Capital contributed as equipment
272,376
Principal payments on notes & leases payable
(240,119)
Payment of lease payable
0
(12,040)
132,383
Payment for Accrued Salaries
73,350
116,000
Proceeds from issuance of stock
178,200
15,000
2,072,082
Proceeds from loans payable
(150,290)
(58,262)
1,540,762
Proceeds from Subscription Receivables
0
100,040
Repurchase of Common Stock
0
(1,610)
Receipts of APIC
0
20,000
Payment of Preferred Dividends
0
(46,338)
Net cash provided by financing activities
27,910
18,048
3,965,576
Net increase (decrease) in cash
(149)
(38)
790,983
Cash, beginning of year
196
234
0
Cash, end of year
$ 47
$ 196
$ 47
Supplemental disclosures of cash flow information
Cash paid during the period for interest expense
$ 0
0
$ 46,758
Cash paid during the period for Taxes
$ 0
$ 0
$ 0
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization and Nature of Operations
The consolidated financial statements include GeneThera, Inc. and
its wholly owned subsidiary GeneThera, Inc. (Colorado) (collectively
the Company)
GeneThera, Inc., formerly known as Hand Brand Distribution, Inc.,
was incorporated in November 1995, under the laws of the State of
Florida. On February 25, 2002, GeneThera, Inc. acquired 100% of the
outstanding shares of GeneThera, Inc. (Colorado). A total of
16,611,900 shares of common stock were issued for the acquisition.
For accounting purposes, the acquisition has been treated as a
reversed merger and as a recapitalization of GeneThera, Inc.
(Colorado).
GeneThera, Inc. (Colorado) is a biotechnology company that develops
molecular assays for the detection of food contaminating pathogens,
veterinary diseases and genetically modified organisms.
Principles of Consolidation
The accompanying consolidated financial statements include the
accounts of GeneThera, Inc. (Florida) and GeneThera, Inc.
(Colorado). All significant inter company balances and transactions
have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of
revenues and expenses during the reporting period. Actual results
could differ from those estimates.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to
concentration risks are cash and accounts receivable. At various
times during the year, the Company had deposits in excess of the
federally insured limits. The Company maintains its cash with high
quality financial institutions, which the Company believes limits
these risks.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES ? continued
Related Party Transactions
GTI Corporate Transfer Agents, LLC is the Company transfer agent.
After the death of the original Managing Director, Ms. Juanita Pagan
sometime in March 2006, Ms. Tannya L. Irizarry became the Managing
Director (Interim) of GTI Corporate Transfer Agents, LLC.
Property and Equipment
Property and equipment are stated at cost. Equipment under capital
leases is stated at the present value of minimum lease payments.
Depreciation is calculated on a straight-line basis over the
estimated useful lives of the assets, which is 5 to 10 years.
Betterments, which extend the life of the asset, are capitalized,
and maintenance and repairs are expensed as incurred.
Impairment of Long Lived Assets
The Company reviews the recoverability of its long-lived assets to
determine whether events or changes in circumstances occurred that
indicate the carrying value of the asset may not be recoverable.
The assessment of possible impairment is based on the ability to
recover the carrying value of the asset from the expected future
cash flows of the related operations. If these cash flows is less
than the carrying value of such asset, an impairment loss is
recognized for the difference between the estimated fair value and
carrying value. The measurement of impairment requires management
to make estimates of these cash flows related to long-lived assets,
as well as other fair value determinations.
Revenue Recognition
Our Research and Development contracts are on a pre paid basis in
order to reflect our milestones during the research investigation.
Revenues from sales are recognized when services are completed.
Loss per Share
Basic loss per share for each year is computed by dividing loss for
the year by the weighted average number of common shares outstanding
during the year. Diluted loss per share includes the effects of
common stock equivalents to the extent they are dilutive. At
December 31, 2008 and 2007 all common stock equivalents were
Anti dilutive and therefore, diluted loss per share equaled basic
loss per share. The CEO exercisable option of 300,000 would be added
into the weighted average common shares if not anti dilutive in
calculating diluted loss per share.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - continued
Fair Value of Financial Instruments
The respective carrying value of certain on balance sheet financial
instruments approximated their fair value. These instruments
include cash, accounts receivable and accounts payable. Fair values
were assumed to approximated carrying values for these financial
instruments since they are short-term in nature and their carrying
amounts approximate fair values or they are receivable or payable on
demand.
Net Cash and Cash Equivalents
The Company considers all highly liquid debt instruments purchased
with an original maturity of three months or less to be cash
equivalents.
Recent Accounting Pronouncements
In March 2005, the FASB issued FASB interpretation No. 47,
Accounting for Conditional Asset Retirement Obligations (FIN
47). FIN 47 provides guidance relating to the identification of and
financial reporting for legal obligations to perform an asset
retirement activity. The Interpretation requires recognition of a
liability for the fair value of a conditional asset retirement
obligation when incurred if the liability fair value can be
reasonably estimated. FIN 47 also defines when an entity would have
sufficient information to reasonably estimate the fair value of an
asset retirement obligation. The provision is effective no later
than the end of fiscal years ending after December 15, 2005. The
Company will adopt FIN 47 beginning the first quarter of fiscal year
2006 and does not believe the adoption will have a material impact
on its consolidated financial position or results of operations or
cash flows.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and
Error Corrections (SFAS 154) which replaces Accounting Principles
Board Opinions No. 20 Accounting Changes and SFAS No. 3,
Reporting Accounting Changes in Interim Financial Statements: An
Amendment of APB Opinion No. 28. SFAS 154 provides guidance on the
accounting for and reporting of accounting changes and error
corrections. It establishes retrospective application, or the
latest practicable date, as the required method for reporting a
change in accounting changes and a correction of errors made in
fiscal years beginning after December 15, 2005 and is required to be
adopted by the company in the first quarter of 2006. The Company is
currently evaluating the effect that the adoption of SFAS 154 will
have on its results of operations and financial condition but does
not expect it to have a material impact.
In June 2005, the Emerging Issues Task Force, or EITF, reached a
consensus on Issue 05-6, Determining the Amortization Period for
Leasehold Improvements, which requires that leasehold improvements
acquired in a business combination or purchased subsequent to the
inception of a lease be amortized over the lesser of the useful life
of the assets or a term that includes renewals that are reasonably
assured at the date of the business combination or purchase. EITF
05-6 is effective for periods beginning after July 1, 2005. We do
not expect the provisions of this consensus to have a material
impact on the financial position, results of operations or cash
flows.
In February 2006, the FASB issued SFAS 155, Accounting for
Certain Hybrid Financial Instruments, which amends SFAS 133,
Accounting for Derivative Instruments and Hedging Activities, and
SFAS
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - continued
Recent Accounting Pronouncements - continued
140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities - a replacement of FASB Statement No.
125. SFAS 155 will be effective for the Company for all financial
instruments issued or acquired after the beginning its fiscal year
ending December 31, 2006. The Company not yet evaluated and
determined the likely effect of SFAS 155 on future financial
statements.
In June 2006, the FASB issued Interpretation No. 48, Accounting for
Uncertainty in Income Taxes - An Interpretation of FASB Statement
No. 109, (FIN 48). FIN 48 clarifies the accounting for uncertainty
in income taxes recognized in an enterprise's financial statements
in accordance with FASB Statement No. 109, Accounting for Income
Taxes. FIN 48 also prescribes a recognition threshold and
measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax
return that results in a tax benefit. Additionally, FIN 48 provides
guidance on de-recognition, income statement classification of
interest and penalties, accounting in interim periods, disclosure,
and transition. This interpretation is effective for the Company for
its fiscal year ending December 31, 2007. The Company has not yet
evaluated the effect that the application of FIN 48 may have, if
any, on its future results of operations and financial condition.
In September 2006, the FASB issued SFAS No. 157, Fair Value
Measurements. This statement defines fair value, establishes a
framework for measuring fair value in generally accepted accounting
principles, and expands disclosures about fair value measurements.
This statement applies under other accounting pronouncements that
require or permit fair value measurements. SFAS No. 157 is
effective for the Company for its fiscal year beginning on July 1,
2008. The Company is currently assessing the impact the adoption of
SFAS No. 157 will have on its financial statements.
In September 2006, the SEC issued Staff Accounting Bulletin (SAB)
No. 108 in order to eliminate the diversity of practice surrounding
how public companies quantify financial statement misstatements. In
SAB 108, the SEC staff established an approach that requires
quantification of financial statement misstatements based on the
effects of the misstatements on each of the Company?s financial
statements and the related financial statement disclosures. SAB No.
108 are effective for the Company for its current fiscal year. The
adoption of SAB No. 108 did not have an impact on the Company?s
financial statements.
On February 15, 2007, the FASB issued SFAS No. 159, The Fair Value
Option for Financial Assets and Financial Liabilities: Including an
Amendment of FASB Statement No. 115. This standard permits an
entity to measure many financial instruments and certain other items
at estimated fair value. Most of the provisions of SFAS No. 115
(Accounting for Certain Investments in Debt and Equity Securities)
applies to all entities that own trading and available-for-sale
securities. The fair value option created by SFAS No. 159 permits
an entity to measure eligible items at fair value as of specified
election dates. Among others, eligible items exclude (1) financial
instruments classified (partially or in total) as permanent or
temporary stockholders? equity (such as a convertible debt security
with a non-contingent beneficial conversion
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - continued
Recent Accounting Pronouncements ? continued
feature) and (2) investments in subsidiaries and interests in
variable interests that must be consolidated. A for-profit business
entity will be required to report unrealized gains and losses on
items for which the fair value option has been elected in its
statements of operations at each subsequent reposting date. The
fair value option (a) may generally be applied instrument by
instruments, (b) is irrevocable unless a new elections date occurs,
and (c) must be applied to the entire instrument and not to only a
portion of the instrument. SFAS No. 159 is effective as of the
beginning of the first fiscal year that begins after November 15,
2007. The Company has not yet evaluated the effect that the
application of SFAS No. 159, may have, if any, on its future results
of operations and financial condition.
NOTE 2 PROPERTY AND EQUIPMENT
Property and equipment at December 31, 2008 and 2007 consisted of
the following:
2008 2007
Office equipment $ 84,344 $84,344
Laboratory equipment 643,084 643,084
Total 727,428 727,428
Less: Accumulated depreciation (506,511) (436,864)
Net Property & Equipment $ 220,917 $ 290,564
Depreciation expense for the years ended December 31, 2008 and 2007
was $69,647 and $72,451, respectively.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELPOMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 4 LEASE OBLIGATIONS
Operating Leases
The Company leases its office, space under non-cancelable operating
leases, which have initial terms in a month-to-month basis. We sub-
lease 700 square foot office space to GTI Corporate Transfer Agents,
LLC located on the 3924 unit of our lease space reflected as 3930
Youngfield Street, Suite #2, Wheat Ridge, CO 80033. The Lease is on
a month-to-month basis and the rent is $500.00 per month. The rent
is paid out in Cash or Common Stock.
Total lease expense for the years ended December 31, 2008 and 2007
was $53,277 and $54,405 respectively.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 5 LOAN PAYABLE
The Company has an outstanding loan payable to a related party as
follows:
2008 2007
Loan payable with no interest, due on demand, unsecured.
$0 $ 150,290
Less current portion (0) (0)
Total Current loan payable ? related party $ 0 $ 150,290
There was no interest expense related to this obligation for the
years ended December 31, 2008 and 2007.
The Company has an outstanding loan payable to a share holder (Tony
Milici). Tony converted 180,000 preferred B stock to 1,800,000
common stock. The common stock was used to pay for consulting
resources and operation expenses.
Operation expense $20,566
Consulting resources $627,413
Total payable $647,979
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 6 STOCKHOLDERS? EQUITY (DEFICIT)
Common Stock Transactions
On December 31, 2008, the Company authorized 100,000,000 shares of
$.001 par value common stock; 2,265,816 are outstanding at December
31, 2008.
In January 2005, the Company issued 2,000 shares of common stock
valued at $2,200 pursuant to conversion rights exercised by a
holder.
In January 2005, the Company cancelled 15,204 shares of common stock
valued at $15,960 from a consultant. Accordingly, $15,960 for
consultant expense was charged to operations.
In January 2005, the Company cancelled 1,400 shares of common stock
valued at $1,610 from a consultant. Accordingly, $1,610 for
consultant expense was charged to operations.
In March 2005, the Company issued 1,475,000 shares valued at
$1,489,999 to a marketing consultant and resulted in an immediate
charge to operations.
In March 2005, the Company issued 175,000 shares valued at $182,000
to two consultants assisting the Company in the development of
operations in Mexico and resulted in immediate charges to
operations.
In March 2005, the Company issued 45,000 shares valued at $46,350 to
an officer in lieu of salary and resulted in an immediate charge to
operations.
In May 2005, the Company issued 45,000 shares valued at $27,000 to
an officer in lieu of salary and resulted in an immediate charge to
operations.
In May 2005, the Company issued 17,000 shares of common stock valued
at $12,580 pursuant to conversion rights exercised by a holder. In
June 2005, the Company issued 318,182 shares of common stock in
exchange for 1,400 of its Series A Preferred Stock.
In July 2005, the Company issued 15,000 shares of common stock
valued at $12,300 to employees and resulted in an immediate charge
to operations.
In July 2005, the Company issued 400,000 shares valued at $296,000
to a marketing consultant and resulted in an immediate charge to
operations.
In March 2006, the Company issued 40,000 shares valued at $7,200 in
settlement of a lawsuit previously filed by OR Surgical and resulted
in an immediate charge to operations.
In March 2006, the Company issued 90,000 shares valued at $12,600 to
two officers in lieu of salary and resulted in an immediate charge
to operations.
In May 2006, the Company issued 500,000 shares valued at $65,000 to
a marketing consulting group and resulted in an immediate charge to
operations.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 6 STOCKHOLDERS EQUITY (DEFICIT) - continued
Common Stock - continued
In May 2006, the Company issued 50,000 shares valued at $6,500 to
consulting services for lab work and resulted in an immediate charge
to operations.
In June 2006, the Company issued 750,000 shares valued at $82,500 to
officer of operations and resulted in an immediate charge to
operations.
In August 2006, the Company issued 2,130,000 shares valued at
$131,800 to consulting services of operations and resulted in an
immediate charge to operations.
In August 2006, the Company issued 625,000 shares valued at $37,500
to the line of credit fees of operations and resulted in an
immediate charge to operations.
In September 2006, the Company issued 3,041,667 shares valued at
$162,500 to consulting services of operations and resulted in an
immediate charge to operations.
In September 2006, the Company issued 600,000 shares valued at
$36,000 to lieu of salary and resulted in an immediate charge to
operations.
In September 2006, the Company issued 1,000,000 shares valued at
$50,000 to lieu of salary and resulted in an immediate charge to
operations.
In October 2006, the Company issued 2,400,000 shares valued at
$96,750 to consulting services of operations and resulted in an
immediate charge to operations.
In November 2006, the Company issued 678,000 shares valued at
$29,870 to consulting services of operations and resulted in an
immediate charge to operations.
In November 2006, the Company cancelled 200,000 shares valued at
$10,000 to consulting services.
In December 2006, the Company issued 1,100,000 shares valued at
$34,000 to consulting services of operations and resulted in an
immediate charge to operations.
In January 2007, the Company issued 1,100,000 shares valued at
$33,000 to consulting services of operations and resulted in an
immediate charge to operations.
In February 2007, the Company issued 400,000 shares valued at
$16,000 to consulting services of operations and resulted in an
immediate charge to operations.
In March 2007, the Company issued 836,500 shares valued at $40,960
to consulting services of operations and resulted in an immediate
charge to operations.
In April 2007, the Company issued 1,399,706 shares valued at $59,835
to consulting services of operations and resulted in an immediate
charge to operations.
In April 2007, the Company issued 1,440,000 shares valued at
$.05/share, $72,000 for lieu salary.
In May 2007, the Company issued 5,295,331 shares valued at $160,356
to consulting services of operations and resulted in an immediate
charge to operations.
In May 2007, the company issued 45,000 shares valued at S.03/share,
$1,350 for lieu of salary.
In June 2007, the company issued 1,216,964 shares valued at $43,225
to consulting services of operations and resulted in an immediate
charge to operations.
In July 2007, the company issued 534,928 shares valued at $10,699 to
consulting services of operations and resulted in an immediate
charge to operations.
In August 2007, the company issued 738,438 shares valued at $14,769
to consulting services of operations and resulted in an immediate
charge to operations.
In September 2007, the company issued 582,024 shares valued at
$11,640 to consulting services of operations and resulted in an
immediate charge to operations.
In October 2007, the company issued 1,211,347 shares valued at
24,226 to consulting services of operations and resulted in an
immediate charge to operations.
In November 2007, the company issued 523,526 shares valued at 10,471
to consulting services of operations and resulted in an immediate
charge to operations.
In December 2007, the company issued 727,349 shares valued at 14,547
to consulting services of operations and resulted in an immediate
charge to operations.
In January 2008, the Company issued 347 shares valued at $34,690 to
consulting services of operations and resulted in an immediate
charge to operations.
In February 2008, the Company issued 129 shares valued at $14,375 to
consulting services of operations and resulted in an immediate
charge to operations.
In February 2008, the Company issued 44 shares valued at $4,363 for
rent of the facility of operations and resulted in an immediate
charge to operations.
In March 2008, the Company issued 374 shares valued at $37,408 to
consulting services of operations and resulted in an immediate
charge to operations.
In March 2008, the Company issued 100 shares valued at $10,000 for
rent and yearly maintenance of the facility of operations and
resulted in an immediate charge of operations.
In April 2008, the Company issued 40 shares valued at $4,000 for
rent of the facility of operations and resulted in an immediate
charge to operations.
In April 2008, the Company issued 139 shares valued at $13,933 to
consulting services of operations and resulted in an immediate
charge to operations.
In May 2008, the Company issued 143 shares valued at $7,150 for rent
of the facility of operations and resulted in an immediate charge to
operations.
In May 2008, the Company issued 688 shares valued at $452,958 to
consulting services of operations and resulted in an immediate
charge to operations.
In June 2008, the Company issued 145 shares valued at $7,273 for
rent of the facility of operations and resulted in an immediate
charge to operations.
In June 2008, the Company issued 140 shares valued at $7,000 for
consulting services of operations and resulted in an immediate
charge to operations.
In July 2008, the Company issued 2,221 shares valued at $34,999 for
consulting services of operations and resulted in an immediate
charge to operations.
In November 2008, the Company issued 451,000 shares valued at
$226,190 for consulting services of operations and resulted in an
immediate charge to operations.
Reverse Stock Split
As of July 9, 2008, the Company did a reverse stock split of one
For five thousand (1:5000) reverse split of it common stock. After
the reverse split, the Company has 12,595 shares outstanding. All
Per Share amounts in the accompanying financial statements have been
adjusted for the reverse split.
Converted Stock
As of July 11, 2008, the Company converted 20,000 Preferred B Stock
to 200,000 Common Stock.
As of September 26, 2008, the Company converted 10,000 Preferred B
Stock to 100,000 shares of Common Stock.
As of October 20, 2008, the Company converted 150,000 Preferred B
Stock to 1,500,000 shares of Common Stock.
Preferred Stock
On December 31, 2008, the Company authorized 20,000,000 shares of
$0.001 par value preferred stock; 4,600 shares of Series A,
Convertible Preferred Stock (Series A) and 7,320,000 Shares of
Series B, Convertible Preferred Stock (Series B) were issued and
outstanding at December 31, 2008.
Preferred Stock (Series A) shall be convertible into Common Stock
any time at the holder?s sole discretion in part or in whole by
dividing the Purchase Price per Share by a price (the Conversion
Price) equal to 110% of the Market Value on the Closing Date.
Market Value on any given date shall be defined as the average of
the lowest three intra-day trading prices of the Company common
stock during the 15 immediately preceding trading days.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 6 STOCKHOLDERS EQUITY (DEFICIT) ? continued
Common Stock - continued
Pursuant to the Registrant's Certificate of Designation establishing
the Series B Preferred Stock, each share of the currently issued and
outstanding Series B Preferred Stock may be converted into ten (10)
fully paid and non-assessable shares of the Registrant common stock.
On all matters submitted to a vote of the holders of the common
stock, including, without limitation, the election of directors, a
holder of shares of the Series B Preferred Stock is entitled to the
number of votes on such matters equal to the number of shares of the
Series B Preferred Stock held by such holder multiplied by twenty
(20).
On January 18, 2005, the Company issued 11,000 shares of its Series
A Preferred Stock to Mercator Momentum Fund, LP, Mercator Momentum
Fund III, LP and Monarch Pointe Fund, Ltd. (the Purchasers), for
$100 per share, or an aggregate of $1,100,000. The Company also
issued warrants to purchase an aggregate of 597,826 shares of common
stock at an exercise price of $0.92 per share, in consideration for
the aggregate proceeds of $1,100,000 to the Purchasers and Mercator
Advisory Group, LLC, an affiliate of the Purchasers. In connection
with the sale of the shares, the Company paid a due diligence fee of
$88,000 and legal expenses of $10,000 to Mercator Advisory Group,
LLC. All warrants expire on January 18, 2008.
In June 2005, 1,400 shares of Series A Preferred Stock were
cancelled and converted into 318,182 common shares of the company
In July 2005, 5,000 shares of Series A Preferred Stock were
cancelled and converted into 1,086,957 common shares of the company.
The adjustment to shareholder equity was due to the reclassification
in common stock in the amount of 49,658.
On May 5, 2006, GeneThera, Inc. (the Registrant) entered into a
subscription agreement and issued 1,500,000 shares of the
Registrant's Series B convertible, preferred stock, par value $0.001
per share (the "Series B Preferred Stock"), to Antonio Milici,
Registrant Chief Executive Officer and Chairman of the Board of
Directors. The Series B Preferred Stock was issued to Dr. Milici for
cash consideration of $.04, per share, or an aggregate of Sixty
Thousand ($60,000) Dollars.
On September 1, 2006, GeneThera, Inc. (the Registrant) entered into
a subscription agreement and issued 750,000 shares of the Registrant
Series B convertible, preferred stock, par value $0.001 per share
(the Series B Preferred Stock), to Tannya L. Irizarry, Registrant
Chief Administrative Officer. The Series B Preferred Stock was
issued to Ms. Irizarry for cash consideration of $.04, per share, or
an aggregate of Thirty Thousand ($30,000) Dollars.
In April 2007, the company issued 750,000 preferred B shares valued
at $.06/share to adjust 9/1/06 issued Preferred Stock. To Tannya L.
Irizarry, Registrant?s Chief Administrative officer.
On April 30, 2008, GeneThera, Inc. (the Registrant) entered into a
subscription agreement and issued 4,500,000 shares of the
Registrant's Series B convertible, preferred stock, par value $0.001
per share (the Series B Preferred Stock), to Antonio Milici,
Registrant's Chief Executive Officer and Chairman of the Board of
Directors. The Series B Preferred Stock was issued to Dr. Milici for
Accrued Salaries of $.04, per share, or an aggregate of One Hundred
and Eighty Thousand ($180,000) Dollars.
Warrants
The Company has warrants to purchase an aggregate of 597,826 shares
of common stock at an
exercise price of $0.92 per share outstanding at December 31, 2007.
Warrants expire on January 18th 2008.
Summary of Warrant activity
Warrants-Common Share Equivalents
Weighted Average Exercise Price
Warrants exercisable-Common share equivalents
Weighted Average Exercise Price
Outstanding December 31, 2004
Granted
597,826
$0.92
597,826
$0.92
Exercised
0
0
Outstanding December 31, 2005
597,826
$0.92
597,826
$0.92
Granted
0
0
Exercised
0
0
Outstanding December 31, 2006
597,826
$0.92
597,826
$0.92
Granted
0
0
Exercised
0
0
Outstanding December 31, 2007
597,826
$0.92
597,826
$0.92
(1) In January of 2005, we issued 597,826 warrants to MAG
Capital and three affiliated parties of MAG Capital as part of a
$1.1 million convertible note. The warrants carried a term of 3
years and subsequently expired in January of 2008.
Option grant summary
Options-Common Share Equivalents
Weighted Average Exercise Price
Options exercisable-Common share equivalents
Weighted Average Exercise Price
Outstanding December 31, 2003
0
Granted (2)
1,450,000
$0.25
1,450,000
$0.25
Exercised
0
0
Outstanding December 31, 2004
1,450,000
$0.25
1,450,000
$0.25
Granted (3)
1,280,000
$0.44
1,280,000
$0.44
Exercised
0
0
Outstanding December 31, 2005
2,730,000
$0.34
2,730,000
$0.34
Granted
0
0
Exercised
0
0
Outstanding December 31, 2006
2,730,000
$0.34
2,730,000
$0.34
Granted
0
0
Exercised
0
0
Outstanding December 31, 2007
2,730,000
$0.34
2,730,000
$0.34
Options outstanding Options exercisable
Range of Option Exercise Price
Options-Common Share Equivalents
Weighted Average Exercise Price
Weighted Average Remaining Contractual Life as of 12/31/2008
Options-Common Share Equivalents
Weighted average Exercise price
$0.25
1,780,000
$0.25
3.33
1,780,000
$0.25
$0.50
950,000
$0.50
2.25
950,000
$0.50
Total
2,730,000
$0.34
2,730,000
$0.34
Issued pursuant to 2004 Senior Officer Option Plan. These options
were subsequently recalculated after the Company?s reverse stock
split made effective in July 2008. Outstanding options under this
plan are now 290 at an exercise price of $1250.
Issued pursuant to 2005 Employee, Director, and Consultant Option
Plan. These options were subsequently recalculated after the
Company?s reverse stock split in July 2008. Outstanding options
under this plan after the split were 66 at $1250 and all expired in
September 2008.
Issued pursuant to 2005 Employee, Director, and Consultant Option
Plan. These options were subsequently recalculated after the
Company?s reverse stock split in July 2008. Outstanding options
under this plan after the split were 190 at $2500 and expire in
September 2010.
GENETHERA, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
NOTE 7 INCOME TAXES
The Company has no current or deferred income tax due to its
operating losses.
The Company has a federal net operating loss carry forward at
December 31, 2008 and 2007 of approximately $17,556,670 and
$16,409,792, respectively, subject to annual limitations prescribed
by the Internal Revenue Code, that are available to offset future
taxable income through 2025. A 100% valuation allowance has been
recorded to offset the net deferred taxes due to uncertainty of the
Company?s ability to generate future taxable income.
NOTE 08 CONTINGENCIES
The Company is involved in claims arising during the ordinary course
of business resulting from disputes with vendors and shareholders
over various contracts and agreements. While the ultimate outcome of
these matters has yet to be determined, management has included a
provision for these claims based on known facts and circumstances as
of December 31, 2008 in the amount of $55,000.
NOTE 9 GOING-CONCERN UNCERTAINTY
These financial statements are presented assuming the Company will
continue as a going concern. For the years ended December 31, 2008
and 2007, the Company showed operating losses of $1,988,707 and
$841,829, respectively. The accompanying financial statements
indicate that current liabilities exceed current assets by
$1,866,660 and $1,633,398 at December 31 2008 and 2007,
respectively.
These factors raise substantial doubt about its ability to continue
as a going concern. Management?s plan with regard to these matters
includes raising working capital and significant assets and
resources to assure the Company?s viability, through private or
public equity offering, and/or debt financing, and/or through the
acquisition of new business or private ventures.
NOTE 10 RESEARCH AND DEVELOPMENT COSTS
All research and development costs are charged to expense when
incurred. The following table illustrates the types of expenses
imbedded in the financial statements as costs related to laboratory
research, formulation, design and testing of products and processes
as related to the business plan.
2008 2007
Consulting $ 0 $ 0
Salaries 144,000 144,000
Lease expense 63,217 63,217
Depreciation 10,759 11,751
Lab expenses 457 223
Totals $ 218,433 $ 219,191
MARKETING CONSULTANT
In March 2007 we entered into a consulting agreement with The Mezey
Howarth Group (the Marketing Consultant) pursuant to which the
Marketing Consultant agreed to provide us with Investor Relations.
In June 2007, the marketing consultant was terminated. Currently,
the Company is in the process of signing a consulting agreement as a
marketing consultant with JR Dopkin & Associates from New York. On
February 29th, 2008, the Company signed a consulting agreement as a
marketing consultant with Jack Craig from Florida. They will both
work together as marketing/Investor Relations consultants.
ITEM 14 PRINCIPAL ACCOUNTING FEESAND SERVICES
AUDIT FEES
The aggregate fees billed for each of the last two fiscal years for
professional services rendered by our principal accountant for the
audit of the Company?s annual financial statements and review of
financial statements included in the registrant?s Form 10-Q was as follows:
2006 $15,000
2007 $26,500
AUDIT-RELATED FEES
The aggregate fees billed in each of the last two fiscal years for
assurance and related services by our principal accountant that are
reasonably related to the performance of the audit and not reported
in Audit Fees was $-0-.
TAX FEES
The aggregate fees billed in each of the last two fiscal years for
services rendered by our principal accountant for tax compliance,
tax advice, and tax planning was $-0-.
ALL OTHER FEES
The aggregate fees billed in each of the last two fiscal years for
products and services provided by our principal accountant other
than those described above was $-0-.
The Company?s audit committee, which consists of all directors,
approved the services described above.
ITEM 15 EXHIBITS, FINANCIAL STATEMENTS, SCHEDULES AND REPORTS
EXHIBITS
The following documents are filed herewith or have been included as
exhibits to previous filings with the SEC and are incorporated
herein by this reference:
EXHIBIT DESCRIPTION OF DOCUMENT
3.1 Articles of Incorporation of GeneThera, Inc., as amended
in the State of Nevada. (6)
3.2 Bylaws, as amended. (2)
3.3 State of Incorporation in the State of Nevada
10.1 Form of Common Stock Purchase Agreement among GeneThera,
Inc. and various original holders of the common stock of
GeneThera, Inc. (1)
10.2 Form of Letter Agreement between GeneThera, Inc. and
various original holders of the Common Stock of GeneThera,
Inc. (2)
10.3 Employment Agreement dated as of January 23, 2002 between
Antonio Milici, MD, PhD and GeneThera, Inc. (2)
10.4 Letter of Intent dated November 6, 2003 between Oncology
Sciences Corporation and GeneThera, Inc. (3)
10.5 Research Consulting Agreement between Xpention Genetics,
Inc. and GeneThera, Inc.
10.6 Placement Agent Agreement dated as of May 31, 2004 between
Invest Line Securities, LLC and GeneThera, Inc. (4)
10.7 Letter Agreement dated November 22, 2003 between NVO
Solutions, Inc. and GeneThera, Inc. (4)
10.8 Resolution Agreement dated August 2004 by and among John
Taggart, Family Health News, Inc., and GeneThera, Inc. 4)
10.9 GeneThera, Inc. 2004 Employee, Director, and Consultant
Stock Option Plan (6)
10.10 GeneThera, Inc. 2004 Senior Executive Officer Option Plan.
(6)
10.11 Subscription Agreement dated as of January 18, 2005 by and
between GeneThera, Inc., Mercator Advisory Group, LLC,
Mercator Momentum Fund, LP, Mercator Momentum Fund III,
LP, and Monarch Pointe Fund, Ltd. (5)
10.12 Registration Rights Agreement dated as of January 18, 2005
by and between GeneThera, Inc., Mercator Advisory Group,
LLC, Mercator Momentum Fund, LP, Mercator Momentum Fund
III, LP, and Monarch Pointe Fund, Ltd. (5)
10.13 Warrant to Purchase Common Stock issued to Mercator
Advisory Group, LLC. (5)
10.14 Warrant to Purchase Common Stock issued to Mercator
Momentum Fund, LP. (5)
10.15 Warrant to Purchase Common Stock issued to Mercator
Momentum Fund III, LP. (5)
10.16 Warrant to Purchase Common Stock issued to Monarch Pointe
Fund, Ltd. (5)
10.17 Industrial Multi-Tenant Lease dated December 4, 2001
between Youngfield Plaza LLC and GeneThera, Inc. (4)
10.18 Amendment to Industrial Multi-Tenant Lease dated December
12, 2004 between Youngfield Plaza LLC and GeneThera, Inc.
(6)
10.19 Strategic Alliance Agreement dated November 1, 2004
between G. Gekko Enterprises and GeneThera, Inc. (6)
10.20 Securities Purchase Agreement dated November 8, 2004
between G. Gekko Enterprises and GeneThera, Inc. (6)
10.21 Letter Agreement dated March 1, 2005 between 0711005 B.C.
Ltd and GeneThera, Inc. (6)
10.22 Mutual Release and Settlement Agreement dated March 1,
2005 between J.P. Turner & Company, L.L.C. and GeneThera,
Inc. (6)
21.1 List of Subsidiaries. (6)
31.1 Certification of Chief Executive Officer required by Rule
13a-14(a) or Rule 15d-14(a) of the Exchange Act
31.1 Certification of Chief Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act.
31.2 Certification of Chief Financial Officer required by Rule
13a-14(a) or Rule 15d-14(a) of the Exchange Act
32.2 Certificate of Chief Financial Officer furnished pursuant
to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act
and Section 1350 of Chapter 63 of Title 18 of the United
States Code (18 U.S.C. 1350)
99.1 Curriculum Vitae. (4)
(1) Incorporated by reference to our Current Report on Form 8-K,
as filed with the Commission on March 5, 2002.
(2) Incorporated by reference to our Annual Report on Form 10-Q,
as filed with the Commission on June 4, 2002.
(3) Incorporated by reference to our Annual Report on Form 10-Q,
as filed with the Commission on April 14, 2004.
(4) Incorporated by reference to our Registration Statement on
Form SB-2 (File No. 333-118937) and amendments thereto,
declares effective December 1, 2004.
(5) Incorporated by reference to our Current Report on Form 8-K,
as filed with the Commission on January 19, 2005.
(6) Incorporated by reference to our Registration Statement on
Form SB-2 (File No. 333-123138) filed on March 4, 2005.
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