Attached files

file filename
EXCEL - IDEA: XBRL DOCUMENT - GENETHERA INCFinancial_Report.xls
EX-32.1 - CERTIFICATION OF THE PRESIDENT AND CHIEF EXECUTIVE OFFICER - GENETHERA INCgenethera10qexh321.htm
EX-31.2 - CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 - GENETHERA INCgenethera10qexh312.htm
EX-31.1 - CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 - GENETHERA INCgenethera10qexh311.htm
EX-32.2 - CERTIFICATION OF THE CHIEF FINANCIAL OFFICER - GENETHERA INCgenethera10qexh322.htm


SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
 
[x]    Quarterly Report pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

For the Quarterly Period Ended June 30, 2011

Commission File No. 000-27237


GENETHERA, INC.
(Exact name of small Business Issuer as specified in its Charter)
   
Nevada
65-0622463
   
(State or Other Jurisdiction of  Incorporation or Organization)
 (I.R.S. Employer Identification Number)
 
 
   
7577 W. 103rd Ave. Suite 212, Westminster, CO
80021
(Address of principal executive offices)
 (Zip Code)
   
Issuer's telephone number, including area code:
(303) 439-2085

 
Check whether the issuer (1) 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 issuer 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]
(Do not check if a smaller reporting company)
 
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):
 
Yes [ ]                                No [x]
 
State the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 25,446,513 Shares of $.001 par value Common Stock outstanding as of June 30, 2011 and Series A 4,600 Shares, and Series B 6,320,000 shares of $.001 par value Preferred Stock outstanding as of June 30, 2011.
 
 
 
 

 
 
PART 1 - FINANCIAL INFORMATION

Item 1.                            Financial Statements

GENETHERA, INC.
CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2011
UNAUDITED

 

 
 
TABLE OF CONTENTS

 

 
Page No.
   
Consolidated Balance Sheet and Parenthetical Table June 30, 2011
3-4
   
Consolidated Statements of Operations for June 30, 2011 and 2010
5
   
Consolidated Statements of Cash Flows for June 30, 2011 and 2010
6
   
Notes to Consolidated Financial Statements
7


 
 
 
 
 
 
1

 

 
GeneThera, Inc. - Consolidated Balance Sheets - Unaudited
 
   
   
June 30,
2011
   
December 31,
2010
 
ASSETS
           
Current assets
           
Cash
  $ 68     $ 7  
Accounts receivable-related party
    7,299       -  
Prepaid expenses
    8,567       2,656  
                 
Total current assets
    15,934       2,663  
                 
Property and equipment
               
Office and laboratory equipment
    729,227       729,078  
Less: Accumulated depreciation
    (726,197 )     (724,874 )
Total property and equipment
    3,030       4,204  
Other assets
    7,000       7,000  
                 
TOTAL ASSETS
  $ 25,964     $ 13,867  
                 
LIABILITIES & STOCKHOLDERS' DEFICIT
               
Current liabilities
               
Accounts payable
    629,180       608,333  
Accounts payable-related party
    -       31,513  
Accrued expenses
    1,436,635       1,292,975  
Notes payable
    10,800       10,800  
Convertible notes payable
    128,503       27,900  
Loan from shareholder
    645,419       645,419  
                 
Total liabilities
    2,850,537       2,616,940  
                 
Stockholders' deficit:
               
Series A preferred stock
    5       5  
Series B preferred stock
    6,320       6,320  
Common stock
    25,447       21,866  
Additional paid-in capital
    16,924,646       16,822,944  
Deficit accumulated during the development stage
    (19,780,991 )     (19,454,208 )
                 
Total stockholders' deficit
    (2,824,573 )     (2,603,073 )
                 
TOTAL LIABILITIES & STOCKHOLDERS' DEFICIT
  $ 25,964     $ 13,687  

 
See accompanying notes to unaudited consolidated financial statements.


 
2

 

GeneThera, Inc. – Balance Sheets – Parenthetical

 
   
2011
   
2010
 
Balance Sheets - Parenthetical
           
Series A Preferred Stock, Par Value
  $ 0.001     $ 0.001  
Series A Preferred Stock, Shares Authorized
    20,000,000       20,000,000  
Series A Preferred Stock, Shares Issued and Outstanding
    4,600       4,600  
Series B Preferred Stock, Par Value
  $ 0.001     $ 0.001  
Series B Preferred Stock, Shares Authorized
    30,000,000       30,000,000  
Series B Preferred Stock, Shares Issued and Outstanding
    6,320,000       6,320,000  
Common Stock, Par Value
  $ 0.001     $ 0.001  
Common Stock, Shares Authorized
    300,000,000       300,000,000  
Common Stock, Shares Issued and Outstanding
    25,446,513       21,865,913  

See accompanying notes to unaudited consolidated financial statements.


 
3

 
 
GeneThera, Inc. - Consolidated Statements of Operations - Unaudited


   
Three Months
Ended June 30,
2011
   
Three Months
 Ended June 30,
 2010
   
Six Months
 Ended June 30,
 2011
   
Six Months
 Ended June 30,
2010
 
Expenses
                       
Other compensation
    -       -       2,400       -  
Consulting
    -       -       -       25,550  
General and administrative expenses
    113,283       17,902       176,747       28,985  
Payroll expenses
    69,750       69,750       139,500       139,500  
Depreciation
    662       2,140       1,323       4,280  
Settlement expense
    -       -       -       -  
Dividend payment
    -       -       -       -  
Laboratory expenses
    2,638       -       2,638       -  
                                 
Total operating expenses
    186,663       89,792       322,609       198,315  
                                 
Loss from operations
    (186,663 )     (89,792 )     (322,609 )     (198,315 )
Other income (expenses)
                               
Beneficial conversion expense
    -       -       -       -  
Interest expense
    (2,583 )     -       (4,174 )     -  
Gain on settlements
    -       -       -       -  
Other income (expenses), net
    -       -       -       -  
                                 
Total other income (expenses)
    (2,583 )     -       (4,174 )     -  
                                 
Net loss
    (188,916 )     (89,792 )     (326,783 )     (198,315 )
                                 
Loss per common share - Basic  and diluted
    (0.01 )     (0.00 )     (0.01 )     (0.01 )
                                 
Weighted average common shares outstanding - Basic and diluted
    24,362,847       22,265,763       23,324,804       22,234,509  

See accompanying notes to unaudited consolidated financial statements.


 
4

 
 
GeneThera, Inc. – Consolidated Statements of Cash Flows - Unaudited

 
   
Six Months
Ended June 30,
2011
   
Six Months
Ended June 30,
2010
 
Cash flows from operating activities
           
Net loss
  $ (326,783 )   $ (198,315 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
   Stock-based compensation
    2,400       25,550  
   Depreciation and amortization
    1,323       4,280  
Changes in operating assets and liabilities:
               
   Prepaid expenses
    (5,911 )     (3,150 )
   Accounts payable - related parties
    (31,513 )     8,581  
   Accounts payable and accrued expenses
    331,884       156,474  
                 
     Net cash used in operating activities
    (28,600 )     (6,580 )
                 
Cash flows from investing activities
               
   Cash paid for purchase of property and equipment
    (149 )     -  
                 
     Net cash used in investing activities
    (149 )     -  
                 
Cash flows from financing activities
               
   Proceeds from issuance of stock
    28,810       -  
                 
Net cash provided by financing activities
    28,810       6,800  
Net increase in cash
    61       220  
                 
Cash  at the beginning of the period
    7       7  
Cash at the end of the period
  $ 68     $ 227  
                 
Supplemental disclosures of cash flow information:
               
Cash paid for interest
  $ -     $ -  
Cash paid for income taxes
  $ -     $ -  
Non-cash investing  and financing transactions:
               
Proceeds from convertible notes payable
    167,377          
Conversion of convertible notes payable to common stock
  $ 74,073     $ -  

 
[1]   Proceeds from convertible notes payable given to a related party to pay Company operating expenses, net of $7,299 not yet spent.

 
See accompanying notes to unaudited consolidated financial statements.
 

 
5

 
 
GENETHERA, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2011
UNAUDITED


Note 1- Basis of presentation

The accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America and the rules of the Securities and Exchange Commission, and should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s most recent Annual Financial Statements filed with the SEC on Form 10-K. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim period presented have been reflected herein. The results of operations for the interim period are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements which would substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal period, as reported in the Form 10-K, have been omitted.

Note 2- Going Concern

As shown in the accompanying consolidated financial statements, GeneThera had an accumulated deficit and a working capital deficit as of March 31, 2010. These conditions raise substantial doubt as to GeneThera 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 GeneThera viability, through private or public equity offering, and/or debt financing, and/or through the acquisition of new business or private ventures. The financial statements do not include any adjustments that might be necessary if GeneThera is unable to continue as a going concern.

Note 3 – Shareholders’ equity

On August 23, 2011, the Company increased its authorized shares to 300,000,000 of common stock, par value $.001 per share. Shares issued prior to August 23, 2011 have been retroactively restated to reflect the impact of the change in par value per share.

During 2011, the Company issued 1,600,000 shares valued at $28,810 for cash.

During 2011, the Company issued 1,780,600 shares for conversion of promissory notes totaling $74,073.

During 2011, the Company issued 200,000 shares valued at $2,400 for services.
 
 
 
6

 

Item 2.      Management's Discussion and Analysis and Results of Operation

The following discussion and analysis should be read in conjunction with the financial statements and notes thereto that appear elsewhere herein.

FORWARD-LOOKING AND CAUTIONARY STATEMENTS

Sections of this Form 10-Q, including the Management's Discussion and Analysis or Plan of Operation, contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), Section 21E of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995, as amended. 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, plan, goal, potential, expect, anticipate, estimate, believe, intend, project, and similar words and variations thereof. This report contains forward-looking statements that address, among other things,

*
Our financing plans,
*
Regulatory environments in which we operate or plan to operate, and
*
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 of this report or to reflect unanticipated events that may occur.
 
 
 
7

 

RESULTS OF OPERATIONS

Gross profits for the six-month period ended June 31, 2011 were $0 compared to $0 for the same period last year. Personnel (salaries) stayed the same from $69,750 for the prior three month period ending June 30, 2011 to $69,750 for the six month period ending June 30, 2010.  Professional expenses (consulting fees) comparing the six month period ending June 30, 2011, to the six month period ending June 30, 2010, stayed from $0 to $0 with the decrease attributable to stock issued for consulting and professional services received throughout the quarter.

LIQUIDITY AND CAPITAL RESOURCES

The Company had a cash balance of $68 as of June 30, 2011. Accounts receivable as of June 30, 2011 was $0. It is estimated that it will require outside capital for the remainder of fiscal year 2011 for the commercialization of GeneThera molecular assays as well as the development of their therapeutic vaccines. The Company intends to raise these funds by means of one or more private offerings of debt or equity securities or both and also generating revenue from Mexico.  Currently the company is in discussions with one group to obtain financing through either debt and/or equity.  No definitive agreements have been signed.  There are no guarantees whether the Company will be able to secure such a financing, and if the financing is secured, there are no guarantees whether the Company can achieve the goals laid out in its business plan fully. We will require significant additional funding in order to achieve our business plan.

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.

Item 3.      GeneThera Plan of Operation

Background

In November 2007, GeneThera, Inc. reincorporated in the State of Nevada due to a third party which purchased the GeneThera Florida Charter in order to blackmail our Company for $80,000. We had a special meeting with three shareholders where it was unanimously resolved for GeneThera to transfer its Charter to the State of Nevada as soon as possible in order to recognize our new incorporation on our next SEC filing. The reinstatement was completed by January 2008. GeneThera has developed proprietary diagnostic assays for use in the agricultural and veterinary markets. Specific assays for Chronic Wasting Disease (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 Johne's disease (predominantly dairy cattle and bison) diagnostics are in development. GeneThera is making a pivotal shift from a Research and Development organization into a product marketing and revenue generating entity.  The company strategy that we maintained from inception to our recent reverse split (July, 2008) had been one of research only. We focused all our energies, talent, and resources to the incubation and growth of new ideas in the realm of genetically engineered disease detection and vaccination. We feel that with recent announcements the company is positioned to move from a developmental stage to a product oriented stage.
 
 
 
8

 
 
GeneThera provides genetics-based diagnostic and is currently 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.

The Company believes it will require significant additional funding in order to achieve its business plan.  Over the next 12 months, in order to have the capability of achieving its business plan, the Company will require at least $5,000,000.  There are no guarantees whether the Company will be able to secure such a financing, and if the financing is secured, there are no guarantees whether the Company can achieve the goals laid out in its business plan fully.

RESEARCH AND DEVELOPMENT

We anticipate that research and development (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.  As of the date of this filing, we are in negotiation to establish one diagnostic testing laboratory outside of our Colorado facility.

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 produce significant revenues.
 
 
 
9

 
 
R&D 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, GeneThera expertise focuses on technology relevant to animal and human immunotherapy.  These services are backed by the cumulative experiences of greater than 50 years of research and development in both government and industry by GeneThera senior scientists. GeneThera intends to develop a commercial-scale implementation of Adenovector Purification Process to support R&D material production.  Furthermore, GeneThera intends to evaluate and test commercially available expression vectors and incorporate them into its 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.

Research & Development Services:

Molecular Biology:

Synthetic cDNA 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

Gene Therapy Testing Services. GeneThera offers GLP (Good Laboratory Procedure) testing programs for somatic cell, viral and naked DNA-based gene therapies.  Our scientists have over nine years experience in providing fully integrated bio-safety testing programs for the cell and gene therapy fields.  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.
 
 
 
10

 

Replication-Competent Viral Vector Testing.  Sensitive in vitro cell culture assays are used to detect replication-competent retroviruses or adenoviruses.  GeneThera can 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.

GeneThera is currently seeking contracts for these services and is in the final negotiation stage with a publicly traded company to perform these services on an annual basis.  There is no assurance that any contracts will be signed or that the company will generate significant revenues or profits from any such contracts.

BUSINESS MODEL

Summary.  GeneThera animal disease assay development business is based on its Integrated Technology Platform (ITP) that combines a proprietary diagnostic solution called Gene Expression Assay (GES) with PURIVAXTM, its system for analyzing large-scale DNA sequencing.  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, 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 proprietary Field Collection System (FCS) for the collection and transportation of blood samples to GeneThera laboratory.  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.
 
 
 
11

 

To date, GeneThera has successfully developed the ability to detect Chronic Wasting Disease, a disease affecting elk and deer in North America.  The release of commercialized Field Collection Systems and laboratory diagnostic testing occurred in October of 2003 as a marketing trial.  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.  The Field Collection Systems are available for purchase from the Company.  Chronic Wasting Disease and Mad Cow Disease are both in the family of diseases called Transmissible Spongiform Encephalopathy (TSE).  Diagnostic assays for E.coli O157:H7 and Johne's disease are in the final stages of development.

The Company, through GeneThera, is also developing vaccines for Chronic Wasting Disease and E.coli O157:H7.  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 two years 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.

Our recent developments include the progress we are making in regards to our Johne's disease validation trials scheduled to begin in collaboration with the Universidad National Autonoma de Mexico, a prominent state university in Mexico City. Our joint venture with Nutricion Avanzada, (the joint venture created a new company Applied Genetics. Applied Genetics is the marketing arm of GeneThera for the Mexican marketing of our Johne's disease testing service and subsequent Vaccine, (which is currently under development) has been in contact with several major ranchers throughout Mexico, and the overwhelming response from the ranchers has been an outcry for help in detecting and eliminating Johne's disease which is running rampant in their herds. Government approval and recommendation is expected to occur quickly once the validation trials are complete. The validation trials should be complete within 3-4 months from start. We will be conducting paid testing on a limited basis during the validation trials.

The recent signing of our agreement with STC.UNM (the technology development arm of The University of New Mexico) for the genetic vaccine they have developed and patented for E.coli 0157:h7 has thrust GeneThera into the global spotlight. The vaccine acts on a genetic level to inhibit the growth and shedding of the deadly E.coli 0157:h7 bacteria from cattle. The vaccine has already passed initial animal trials and is now set to enter the clinical trial phase. We are currently seeking partnerships for the completion of the clinical trials and subsequent taking of the finished vaccine to market. Due to the specific genetic makeup of the vaccine, we expect the clinical trials to be completed within 9-12 months from start. This is 3 to 5 times faster than a standard vaccine might take. As of the beginning of 2011, GeneThera decided not to further pursue the development of the E.coli vaccine.
 
 
 
12

 
 
Item 4.      Controls and Procedures

As required by Rule 13a-15 under the Securities Exchange Act of 1934 (The Exchange Act), we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures within the 90 days prior to the filing date of this report.  This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer, Consulting Chief Financial Officer, and Controller. We concluded that our internal controls are ineffective. We will be working on them to improve its effectiveness.

There will be significant changes in our internal controls and in other factors that will definitely affect internal controls positively subsequent to the date we carried out our evaluation.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.  Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.

PART II - OTHER INFORMATION

Item 1.     Legal Proceedings

On or about May 11, 2009, Goldsmith Group, LLC filed a Complaint of Breach of Contract against GeneThera, Inc. for traveling done by Alvin Goldsmith from Goldsmith Group for trips not authorized by the Company. The Company was seeking to retain legal counsel due to the complexity of it since Goldsmith combined personal issues and another company in the Complaint. Goldsmith also filed a claim of Unduly Enrichment against GeneThera. The Company was not unduly enriched by anything Goldsmith claimed he did. There was no breach of contract as Alvin Goldsmith from Goldsmith Group LLC did job abandonment on February 18, 2009. Messner & Reeves Law Firm was retained as our legal counsel. The judgment by default was vacated.

Item 2.     Changes in Securities

None.

Item 3.     Defaults upon Senior Securities

No defaults upon senior securities.
 
 
 
13

 

Item 4.     Submission of Matters to a Vote of Security Holders

No matters were submitted to a vote of security holders as of June 30, 2009.
 
Item 5.     Other Information

None.

Item 6.     Exhibits and Reports on Form 10-Q

(A)
Financial Statements
     
  Reference is made to the financial statements listed on the Index to Financial Statements in this Form 10-Q.
     
(B)
Exhibits
 
     
 
31.1
Certification pursuant to section 302 of the Sarbanes-Oxley act of 2002
 
31.2
Certification pursuant to section 302 of the Sarbanes-Oxley act of 2002
 
32.1
Certification of the President and Chief Executive Officer
 
32.2
Certification of the Chief Financial Officer
 
101.ins
XBRL Instance
 
101.xsd
XBRL Schema
 
101.cal
XBRL Calculation
 
101.def
XBRL Definition
 
101.lab
XBRL Label
 
101.pre
XBRL Presentation
 
Signatures

Pursuant to the requirements of the Securities Act of 1933 the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Westminster, Colorado on this 18th day of November, 2011.
 
GENETHERA, INC.

By:
 s/ Antonio Milici
Name:
  Antonio Milici
Title:
 President and Chief Executive Officer

 
Pursuant to the requirements of the Securities Act of 1933 this Registration Statement has been signed by the following persons in the capacities indicated on November 18, 2011:
 
Signature
Title(s)
 
/s/ Antonio Milici
Antonio Milici
 
President, Chief Executive Officer
 
 
 
/s/ Tannya L Irizarry
Tannya L Irizarry
 
 
Chief Financial Officer (Interim)
 
 
 
 

14