SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-QSB [ X ] Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended March 31, 2004 Commission File No. 000-27237 GENETHERA, INC. (Exact name of small Business Issuer as specified in its Charter) Florida 66-0622463 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification Number) 3930 Youngfield Street, Wheat Ridge CO 80033 (Address of principal executive offices) (Zip Code) Issuer's telephone number, including area code: (303) 463-6371 Hand Brand Distribution, Inc. (Former name, former address and former fiscal year, if changed since last report) 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 [ X ] Yes [ ] No State the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 5,581,642 Shares of $.001 par value Common Stock outstanding as of March 31, 2004. PART 1 - FINANCIAL INFORMATION Item 1. Financial Statements GENETHERA, INC. AND SUBSIDIARY CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) THREE MONTHS ENDED MARCH 31, 2004 TABLE OF CONTENTS Page No. -------- Report of Independent Accountants 2 Consolidated Balance Sheet March 31, 2004 (unaudited) 3 Consolidated Statements of Operations for the Three Months Ended March 31, 2004 and 2003 (unaudited) 4 Consolidated Statements of Stockholders' Equity (Deficit) for the Three Months ended March 31, 2004 and 2003 (unaudited) 5 Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2004 and 2003 (unaudited) 7 Notes to Consolidated Financial Statements (unaudited) 8 1 REPORT OF INDEPENDENT ACCOUNTANTS To the Board of Directors GeneThera, Inc. Wheat Ridge, Colorado We have reviewed the accompanying consolidated balance sheet of GeneThera, Inc. and its wholly-owned subsidiary as of March 31, 2004, and the related consolidated statements of operations, stockholders' equity (deficit), and cash flows for the three-month periods ended March 31, 2004 and 2003. These financial statements are the responsibility of the Company's management. We conducted our review in accordance with standards established by the American Institute of Certified Public Accountants. A review of interim financial information consists principally of applying analytical procedures to financial data and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with generally accepted auditing standards, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion. Based on our review, we are not aware of any material modifications that should be made to the accompanying consolidated financial statements for them to be in conformity with accounting principles generally accepted in the United States of America. /s/ KANTOR, SEWELL & OPPENHEIMER, PA ------------------------------------ KANTOR, SEWELL & OPPENHEIMER, PA Certified Public Accountants Hollywood, Florida May 7, 2004 2 GENETHERA, INC. AND SUBSIDIARY CONSOLIDATED BALANCE SHEET MARCH 31, 2004 (UNAUDITED) Assets Current assets Cash $ 36,506 Prepaid expenses 90,000 ----------- Total current assets 126,506 Property and equipment, net 682,167 Other assets Deposits 5,278 Investment in subsidiary 39,146 Other assets 36,783 ----------- 81,207 ----------- $ 889,880 =========== Liabilities and Stockholders' Equity Current liabilities Accounts payable $ 61,040 Accrued expenses 509,227 Due to related company 349 Lease payable 6,090 Loan payable - related party 50,000 Notes payable 44,517 Convertible notes payable 214,777 ----------- Total current liabilities 886,000 Stockholders' equity Preferred stock, $0.001 par value, 20,000,000 shares authorized; no shares issued and outstanding -- Common stock $.001 par value, authorized 100,000,000 shares; 5,731,404 issued and outstanding 5,731 Additional paid in capital 5,439,533 Accumulated deficit (5,441,384) ----------- 3,880 ----------- $ 889,880 =========== See notes to financial statements. 3 GENETHERA, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three months ended March 31, 2004 2003 ----------- ----------- Revenues $ -- $ -- ----------- ----------- Expenses General and administrative expenses 115,380 24,542 Lab expenses 18,476 5,171 Insurance 11,084 2,731 Consulting 235,500 5,190 Professional fees 117,696 564 Salaries 54,724 55,500 Lease expense 34,321 17,078 Depreciation 25,541 7,633 ----------- ----------- 612,722 118,409 ----------- ----------- Loss from operations (612,722) (118,409) Other income (expenses) Loss on impairment of long lived assets (25,825) -- Interest expense (4,064) (1,550) ----------- ----------- Net loss $ (642,611) $ (119,959) =========== =========== Loss per common share Basic and dilutive $ (0.12) $ (0.06) Basic and diluted weighted average number of shares outstanding 5,446,885 2,029,171 See notes to financial statements. 4 GENETHERA, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) THREE MONTHS ENDED MARCH 31, 2003 (UNAUDITED) Additional Common Stock Paid in Subscription Accumulated Shares Amount Capital Receivable (Deficit) TOTAL ----------- ----------- ----------- ------------ ----------- ----------- Balance, January 1, 2003 1,960,000 $ 1,960 $ 691,040 $ -- (1,332,657) $ (639,657) Recapitalization on March 23, 2003 778,176 778 1,041,122 -- (1,034,354) 7,546 Net loss (119,959) (119,959) ----------- ----------- ----------- ------------ ----------- ----------- Balance, March 31, 2003 (Unaudited) 2,738,176 $ 2,738 $ 1,732,162 $ -- $(2,486,970) $ (752,070) =========== =========== =========== ============ =========== =========== See accompanying notes to financial statements. 5 GENETHERA, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) THREE MONTHS ENDED MARCH 31, 2004 (UNAUDITED) Additional Common Stock Paid in Subscription Accumulated Shares Amount Capital Receivable (Deficit) TOTAL ----------- ----------- ----------- ----------- ----------- ----------- Balance, January 1, 2004 (restated) 4,716,478 $ 4,716 $ 4,283,585 $ -- $(4,798,773) $ (510,472) Shares issued on conversion 934,926 935 830,528 -- -- 831,463 Issuance of shares to consultants for services rendered ($4.00) 30,000 30 119,970 120,000 Issuance of shares to consultants for services rendered ($4.11) 50,000 50 205,450 -- -- 205,500 Net loss (642,611) (642,611) ----------- ----------- ----------- ----------- ----------- ----------- Balance, March 31, 2004(Unaudited) 5,731,404 $ 5,731 $ 5,439,533 $ -- $(5,441,384) $ 3,880 =========== =========== =========== =========== =========== =========== See accompanying notes to financial statements. 6 GENETHERA, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) Three months ended March 31, 2004 2003 --------- --------- Cash flows from operating activities: Net loss $(642,611) $(119,959) --------- --------- Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization 25,541 7,633 Impairement of long lived assets 25,825 Consulting in exchange for common stock 325,500 -- (Increase) decrease in prepaid expenses (90,000) -- (Increase) decrease in other assets (2,470) (15,548) Increase (decrease) in accounts payable and accrued liabilities (153,257) 153,076 --------- --------- Total adjustments 131,139 145,161 --------- --------- Net cash provided by (used in) operating activities (511,472) 25,202 --------- --------- Cash flows from investing activities: Cash payments for the purchase of property (5,509) (1,944) --------- --------- Net cash used in investing activities (5,509) (1,944) --------- --------- Cash flows from financing activities: Principal payments on lease payable (12,625) (2,852) Principal payment on notes and loans payable (148,888) -- Proceeds from convertible notes 715,000 5,000 --------- --------- Net cash provided by financing activities 553,487 2,148 --------- --------- Net increase (decrease) in cash and cash equivalents 36,506 25,406 Cash and cash equivalents, beginning of year -- -- --------- --------- Cash and cash equivalents, end of year $ 36,506 $ 25,406 ========= ========= Supplemental disclosures of cash flow information: a) Cash paid during the period for: Interest expense $ -- $ 1,550 --------- --------- See notes to financial statements. 7 GENETHERA, INC. AND SUBSIDIARY NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) THREE MONTHS ENDED MARCH 31, 2004 NOTE 1 PRINCIPLES OF CONSOLIDATION Principles of Consolidation --------------------------- The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, GeneThera, Inc. (Colorado). All significant inter-company balances and transactions have been eliminated. The accounts of Family Health News have not been consolidated because the Company expects control over Family Health News to be temporary. NOTE 2 BASIS OF PRESENTATION The interim financial information included herein is unaudited; however, such information reflects all adjustments which are, in the opinion of management, necessary for a fair presentation of the Company's financial position, results of operations, changes in stockholders' deficit and cash flows for the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the first three months of the year are not necessarily indicative of the results of operations which might be expected for the entire year. The accompanying consolidated financial statements of the Company have been prepared in accordance with the instructions to Form 10-Q and, therefore, omit or condense certain footnotes and other information normally included in financial statements prepared in accordance with generally accepted accounting principles. It is suggested that these condensed financial statements should be read in conjunction with the Company's financial statements and notes thereto included in the Company's audited financial statements on Form 10-K for the fiscal year ended December 31, 2003. NOTE 3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Recent Accounting Pronouncements -------------------------------- The Financial Accounting Standards Board (FASB) issued SFAS No. 141, Business Combinations, which establishes revised standards for accounting for business combinations, eliminating the pooling method, and providing new guidance for recognizing intangible assets arising in a business combination. Additionally, SFAS No. 141 requires more prominent and more frequent disclosures in financial statements about a business combination. This statement is effective for business combinations initiated on or after July 1, 2001. The adoption of this pronouncement on July 1, 2001 did not have a material effect on the Company's financial position, results of operations or liquidity. 8 GENETHERA, INC. AND SUBSIDIARY NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) THREE MONTHS ENDED MARCH 31, 2004 NOTE 3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - continued SFAS 142, Goodwill and Other Intangible Assets provides guidance on accounting for the acquisition of intangibles, except those acquired in a business combination, which is subject to SFAS 141, and the manner in which intangibles and goodwill should be accounted for subsequent to their initial recognition. This statement is effective for all fiscal years beginning after December 15, 2001. The adoption of SFAS 142 on April 1, 2002 did not have a material effect on the Company's financial position, results of operations, or liquidity. SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets provides implementation guidance regarding when and how to measure an impairment loss, and expands the presentation to include a component of an entity, rather than strictly a business segment. SFAS 144 also eliminates the current exemption to consolidation when control over a subsidiary is likely to be temporary. This statement is effective for all fiscal years beginning after December 15, 2001. The adoption of SFAS 144 on April 1, 2002 did not have a material effect on the Company's financial position, results of operations or liquidity. Earnings per Share ------------------ Basic earnings per share are computed based on the weighted average number of common shares outstanding during each year. Diluted earnings per share are computed based on the weighted average number of common shares outstanding during the period, plus the dilutive effect of potential future issuances of common shares relating to convertible notes. NOTE 4 PROPERTY AND EQUIPMENT Property and equipment consisted of the following: March 31, 2004 --------- Computers $ 38,030 Telephone System 5,118 Furniture & fixtures 1,465 Laboratory equipment 811,019 --------- 855,632 Less accumulated depreciation (173,465) --------- $ 682,167 ========= Depreciation expense for the three months ended March 31, 2004 and 2003 was $25,541 and $7,633, respectively. 9 GENETHERA, INC. AND SUBSIDIARY NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) THREE MONTHS ENDED MARCH 31, 2004 NOTE 5 CONVERTIBLE NOTES PAYABLE March 31, 2004 --------- Various convertible notes payable to individuals, with interest ranging from 8-10%; due at various dates from April 14, 2003 through June 18, 2004; convertible into shares of common stock at prices of $0.25 - $0.50 per share $ 214,777 Less: current portion (214,777) --------- Total long-term convertible notes payable $ 0 ========= For the three months ended March 31, 2004 and 2003, interest expense related to the convertible notes payable amounted to $4,064 and $0, respectively. NOTE 6 STOCKHOLDERS' EQUITY Common Stock ------------ During the three months ended March 31, 2004, the Company issued 934,926 shares of common stock pursuant to conversion rights exercised by holders. On January 16, 2004, the Company issued 30,000 shares pursuant to a one-year agreement with a consultant for a total of $120,000, based on the closing price on January 14, 2004. The Company charged one-fourth, or $30,000 to operations and the remaining $90,000 has been capitalized and prorated over the life of the agreement. On January 26, 2004, the Company issued 50,000 shares for a total of $205,500 based on the closing price on date of issue. These shares were issued to a consultant for services rendered and resulted in an immediate charge to operations. NOTE 7 UNCONSOLIDATED SUBSIDIARY On January 14, 2002, the board of directors voted to sell the stock of The Family Health News, Inc., subject to stockholder approval. This has not been accomplished as of March 31, 2004. The subsidiary has not been consolidated because the Company considers control to be temporary. 10 GENETHERA, INC. AND SUBSIDIARY NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) THREE MONTHS ENDED MARCH 31, 2004 NOTE 8 GOING CONCERN UNCERTAINTY These financial statements are presented assuming the Company will continue as a going concern. For the years ended December 31, 2003 and 2002, the Company showed operating losses of $2,431,761 and $627,984, respectively. The accompanying financial statements indicate that current liabilities exceed current assets by $759,494 for the three months ended March 31, 2004. In addition, the Company is in default for payments on notes payable in the amount of $94,517, including accrued interest. 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 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. 11 Item 2. Management's Discussion and Analysis or Plan of Operations The following discussion and analysis should be read in conjunction with the financial statements and notes thereto that appear elsewhere herein. RESULTS OF OPERATIONS Personnel and professional expenses (consulting and professional fees and salaries) increased from $5,190 for the prior three month period ending March 31, 2003 to $235,500 for the three month period ending March 31, 2004. Comparing the three month period ending March 31, 2003, to the three month period ending March 31, 2004, expenses increased substantially from $564 to $117,696. Based upon the Company's planned divestiture or closure of FHNI and the acquisition of GeneThera, the above discussion of FHNI's operations is not anticipated to be indicative of future operating results. GENETHERA PLAN OF OPERATION Background GeneThera is a development stage company (as such term is defined by the Securities and Exchange Commission ("SEC") and Generally Accepted Accounting Principles and has had negligible revenues from operations in the last two years. As a development stage company, its research and development expenditures have not been capitalized as of this date. The Company acquired 100% of the outstanding stock of GeneThera Inc., a Colorado corporation, for the issuance of 1,960,000 shares of the Company's common stock. 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 cattle and bison) diagnostics are in development. 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. 12 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 $1,000,000. 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 R&D serves is the source for both assay development and vaccine design/development. As assays for different diseases are developed, the Company plans 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 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. COMMERCIAL DIAGNOSTIC TESTING The Diagnostic Testing labs are the second division of the Company. The Company intends to locate 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. LICENSING Through our third division, Licensing, we intend to manage the marketing and sale of the vaccines developed by GeneThera's 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 assure you 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. 13 R&D SERVICES Molecular, Cellular, Viral Biology Research and Consulting Services: GeneThera Inc. is committed to providing global access to cutting edge biotechnology services to fellow scientists in academia, the pharmaceutical industry, and the biotechnology industry. Primarily, GeneThera's expertise focuses on technology relevant to animal and human immunotherapy. GeneThera is dedicated to furnishing dependable, high quality, cost-effective and prompt client consulting services. These services are backed by the cumulative experiences of greater than 100 years of research and development in both government and industry by GeneThera's senior scientists. GeneThera develops a commercial-scale implementation of Adenovector Purification Process to support R&D material production. Furthermore, GeneThera evaluates and tests commercially available expression vectors and incorporates them into its vector repertoire. These technologies are well established within the repertoire of GeneThera's scientific staff. Research & Development Services: Molecular Biology: o Synthetic cDNA Construction o Prokaryotic Expression Vector Construction & Development o E. coli Expression Strain Evaluation o Pilot Scale Fermentation o Mammalian Expression Vector Construction & Development o Baculovirus Expression o Protein Isolation o Protein Engineering: Complement Determining Region Conjugated Proteins Monoclonal Antibody Production Chimerization & Humanization o Vector design for Prokaryotic Expression of Antibody Fragments (Fab) and Single Chain Antibody (ScFv) o Pilot Scale- up Development o Process Purification & Characterization o Assay Development & Quality Control Pharmaceutical Dosage and Formulation Molecular Biology Potential Agreement Structure Stage (I): cDNA Construction & Expression Vector Development Stage (II): Pilot Scale Expression & Protein Purification Stage (III): Assay Development & Quality Control Development Stage (IV): Bioprocess Development & Optimization Stage (V): Dosage & Formulation Gene Therapy Testing services GeneThera Services offers GLP testing programs for somatic cell, viral and naked DNA-based gene therapies. With over eight years experience in providing fully integrated bio-safety testing programs for the cell and gene therapy fields, we have supported a number of successful BLA and IND applications. 14 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. There is no assurance that any contracts will be signed or that the company will generate significant profits from these contracts. Business Model GeneThera's business is based on its Integrated Technology Platform (ITP) that combines a proprietary diagnostic solution called Gene Expression Assay (GEA(TM)) with PURIVAX(TM), 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. 15 Each individual assay utilizes the proprietary Field Collection System (FCS) for the collection and transportation of blood samples to GeneThera's 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's 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. 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. GeneThera has also successfully developed an assay for the detection of Mad Cow Disease, a disease recently found in the United States, but 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 Johnne's Disease are in the final stages of development. Vaccines for Chronic Wasting Disease and E.coli O157:H7 are in advanced stages of development. The Company will need the approval of the USDA before the vaccines can be sold. There are no assurances that such an approval will be granted, or if granted, whether the Company 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's integrated technology platform is the foundation for "fast-track" rDNA vaccine development. ITP is the assembly of GEA(TM) and PURIVAX(TM) rAD and rAAV systems. This integrated technology platform yields fast-track vaccine development. Leveraging its ITP, GeneThera can develop a prototype vaccine within 4 to 6 months versus the current standard of 18 to 24. The GEA(TM) 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 GEA(TM) assays, vaccine efficacy can be measured in real time. This means not having to wait for the antibody response to measure how well the vaccine is working. F-PCR allows effective quantification of the precise number of viral or bacterial genetic particles before, during and after vaccine injection(s). The more effective the vaccine is, the stronger the decrease of the infectious disease particles will be. GEA(TM) SYSTEM GEA(TM) is a proprietary assay development system. The core of GEA(TM) is Fluorogenic Polymerase Chain Reaction technology (F-PCR). GeneThera solves 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 fully 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 no post-PCR manipulation. 16 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 important, the SDS offers the advantage of monitoring real time increases in fluorescence during PCR. 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 no competition in the use of F-PCR technology and the modular unit concept for commercial testing of either infectious disease in 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 and/or culture contamination; 3. sample preparation and storage creates artifacts; and 4. 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) overcomes 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 very sensitive, highly accurate and rapid fashion. PURIVAX(TM)TECHNOLOGY GeneThera has developed a large-scale process for highly purified and high viral titer Adenovirus and AAV recombinant vectors. This technology enables GeneThera to develop Adenovirus and AAV based recombinant DNA vaccines for veterinary diseases and food pathogens. 17 GeneThera's PURIVAX(TM) is a multi-resin anion exchange chromatography system that dramatically improves biological purity and viral titer of recombinant Adenovirus and AAV vectors. PURIVAX(TM) completely eliminates 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 tool 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 transduce 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; 2. low viral titer Traditional technologies and first generation chromatography processes are inadequate both in terms of purity and yield. And, due to the limitation of these purification technologies, adequate viral titers cannot be achieved. The result is no efficient system to deliver immunogenic genetic sequences into cells. This is the significance of GeneThera's PURIVAX(TM), rAD and rAAV system for rDNA vaccine development. Succinctly stated, it is able to achieve both high purity and high viral titer (up to 10e16 viral particles/eulate) based on its proprietary multi-resin anion exchange chromatography system. Biological contaminants such as endogenous retrovirus, bacterial, mycoplasma, non-specific nucleic acids, lipids, proteins, carbohydrates and endotoxins are eliminated during the purification process. FIELD COLLECTION SYSTEM GeneThera's Field Collection System (FCS) is a commercial product designed to permit a standardized manner for drawing, stabilizing and handling blood samples intended for GeneThera's diagnostic assay testing. Each package is referred to as a "System" because it is just that. There are two different FCS packages: one for hunters and one for breeders or ranchers. GeneThera's 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. Common to each FCS are two test tubes, each containing a separate reagent. The process, as described in the packaging, ensures that each individual sample of blood will be stabilized, thereby increasing the integrity of that sample for diagnostic testing. Additionally, this common method of receiving blood samples at the GeneThera laboratory(s) increases the efficiency of handling the volume of samples received. We believe this will enable us to provide a fast, efficient process, capable of posting results within 24 hours of receipt at a low cost to the consumer. All testing using the FCS must be done by GeneThera and no third 18 parties can test the blood collected. The Company is currently offering the FCS for hunters, breeders, or ranchers directly through the Company on a limited basis. The Company intends to begin a marketing campaign through the addition of key personnel to achieve higher volumes of sales for the FCS. The Company projects that no capital will be needed to hire the additional personnel as they will be hired on a strictly commission based. FHNI DISCUSSION AND ANALYSIS FHNI has had a long history of losses and flat to negative growth in revenues. FHNI's business is not at the core of our ongoing business model. The Company's belief is that the GeneThera business holds greater promise for long-term growth and value. As a result, the Board of Directors is seeking to divest the Company of FHNI or to dissolve and liquidate FHNI's assets. As stated numerous times in this report, the Company has been unable to obtain financial information from FHNI. Management of FHNI has refused to provide the Company with the financial information necessary for the Company to discuss the financial condition and results of operations of FHNI, despite several attempts on the part of the Company to obtain such information. Liquidity and Capital Resources The Company had a cash balance of $36,506 as of March 31, 2004. It is estimated that it will require outside capital for the year 2004 for the commercialization of GeneThera's 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. As discussed in this filing, the Company has raised $715,000 through Convertible Notes to certain individuals in late 2003 and early 2004. These individuals have converted as of the date of this filing. Currently the company is in discussions with two groups 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. Convertible Notes To relieve its cash flow crisis, the Company has issued convertible notes to certain individuals. On December 12, 2002, the Company issued a convertible promissory note bearing interest at the rate of 8% per annum in the principal amount of Fifty Thousand Dollars ($50,000) to Fidra Holdings Ltd. Under the terms of the convertible promissory note, the holder of the note is entitled to convert all sums due under the December12 Note for $.50 per share. As of April 14, 2003, the December 12 Note has not been converted. 19 On December 24, 2002, the Company issued a Convertible Promissory Note bearing interest at the rate of 8% per annum in the principal amount of Ten Thousand Dollars ($10,000). Under the terms of the Convertible Promissory Note, the holder of the Note is entitled to convert all sums due under the December 24 Note for $0.50 per share. As of April 14, 2002, the December 24 Note has not been converted. On December 27, 2002, the Company issued a Convertible Promissory Note bearing interest at the rate of 8% per annum in the principal amount of One Thousand Dollars ($1,000). Under the terms of the Convertible Promissory Note, the holder of the Note is entitled to convert all sums due under the December 27 Note for $0.50 per share. As of April 14, 2003, the December 27 Note has not been converted. Between October 2003 and January 2004, the Company issued 2 separate Convertible Promissory Notes bearing interest at the rate of 8% per annum. An aggregate amount of Seven Hundred and Fifteen Thousand Dollars ($715,000) were raised. Under the terms of the Convertible Promissory Notes, the holder of the Note is entitled to convert all sums due under the Note for $1.00 per share with the notes maturing one year from the date the money is received by the Company. The Company received Thirty Thousand Dollars ($30,000) as of December 31, 2003 and the balance of Six Hundred Eighty-Five Thousand Dollars ($685,000) was received as of February 1, 2004. As of February 27, 2004, Six Hundred Ninety-Eight Thousand Dollars ($698,000) was converted into 698,000 shares, $17,000 still remains outstanding under the Note. FORWARD-LOOKING AND CAUTIONARY STATEMENTS Sections of this Form 10-qSB, 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, 20 * 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. ITEM 3. 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 and Chief Financial Officer. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that due to recent developments within FHNI which are beyond the control of the Company as more fully explained below, our disclosure controls and procedures are ineffective in timely alerting management to material information relating to us that is required to be included in our periodic SEC filings. In connection with the preparation and filing of this report, management of FHNI has refused to provide the Company with the financial information of FHNI necessary for the Company to prepare consolidated financial statements that include the financial condition and results of operations of FHNI, despite several attempts on the part of the Company to obtain such information. Consequently, the Company is prevented from being able to obtain the necessary financial information regarding FHNI. As is discussed elsewhere in this report, the Board of Directors of the Company is seeking to divest the Company of FHNI or to dissolve and liquidate FHNI's assets. There have been no significant changes in our internal controls or in other factors that could significantly affect internal controls 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. 21 PART II - OTHER INFORMATION Item 1. Legal Proceedings GeneThera Inc. has commenced a civil action against individuals Milton and Keith Dailey d/b/a "Hunting Lease Magazine" based upon a commercial transaction. The Company is seeking compensatory and exemplary damages. It is too early in the proceeding to determine any likelihood of an unfavorable outcome. Item 2. Changes in Securities None. Item 3. Defaults upon Senior Securities No defaults upon senior securities. Item 4. Submission of Matters to a Vote of Security Holders No matters were submitted to a vote of security holders as of March 31, 2004. Item 5. Other Information None. Item 6. Exhibits and Reports on Form 8-K. (A) Financial Statements Reference is made to the financial statements listed on the Index to Financial Statements in this Form 10-QSB. (B) Exhibits 99.1 Certification of the President and Chief Executive Officer 99.2 Certification of the Chief Financial Officer 1. Reports on Form 8-K 22 SIGNATURES In accordance with the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. GENETHERA, INC. Date: May 14, 2004 By: /s/ Antonio Milici ---------------------- Antonio Milici, M.D., Ph.D. Chief Executive Officer 23 CERTIFICATIONS I, Antonio Milici, Chief Executive Officer of Hand Brand Distribution, Inc. (the "Registrant"), certify that; (1) I have reviewed this quarterly report on Form 10-QSB of GeneThera, Inc.; (2) Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; (3) Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this quarterly report. (4) The Registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the Registrant and have: a) designed such disclosure controls and procedures to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the Registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; (5) The Registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the Registrant's auditors and the audit committee of Registrant's board of directors (or persons performing the equivalent functions): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the Registrant's ability to record, process, summarize and report financial data and have identified for the Registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal controls; and (6) The Registrant's other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other facts that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: May 14, 2004 By: /s/ Antonio Milici ---------------------- Antonio Milici, M.D., Ph.D. Chief Executive Officer CERTIFICATIONS I, Tannya L. Irizarry, Chief Financial Officer of Hand Brand Distribution, Inc. (the "Registrant"), certify that; (1) I have reviewed this quarterly report on Form 10-QSB of GeneThera, Inc.; (2) Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; (3) Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this quarterly report. (4) The Registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures(as defined in Exchange Act Rules 13a-14 and 15d-14) for the Registrant and have: a) designed such disclosure controls and procedures to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the Registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; (5) The Registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the Registrant's auditors and the audit committee of Registrant's board of directors (or persons performing the equivalent functions): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the Registrant's ability to record, process, summarize and report financial data and have identified for the Registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal controls; and (6) The Registrant's other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other facts that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: May 17, 2004 By: /s/ Tannya L. Irizarry -------------------------- Tannya L. Irizarry Chief Financial Officer