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Infectech Inc ˇ 10SB12G/A ˇ On 12/13/00

Filed On 12/13/00 11:31am ET   ˇ   SEC File 0-26423   ˇ   Accession Number 1014897-0-241

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  As Of               Filer                 Filing     As/For/On Docs:Pgs              Issuer               Agent

12/13/00  Infectech Inc                     10SB12G/A              2:45                                     Walker Jody M/FA

Amendment to Registration of Securities of a Small-Business Issuer   ˇ   Form 10-SB
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10SB12G/A   Amendment to Registration of Securities of a          44    158K 
                          Small-Business Issuer                                  
 2: EX-27       Financial Data Schedule                                1      3K 


10SB12G/A   ˇ   Amendment to Registration of Securities of a Small-Business Issuer
Document Table of Contents

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11st Page
2Item 1. Description of Business
14Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations:
16Item 3. Description of Property
"Item 4. Security Ownership of Certain Beneficial Owners and Management
17Item 5. Directors, Executive Officers, Promoters and Control Persons
20Item 6. Executive Compensation
21Item 7. Certain Relationships and Related Transactions
22Item 8. Description of Securities
23Item 1. Market Price of and Dividends on the Registrant's Common Equity and Related Stockholder Matters
"Item 2. Legal Proceedings
"Item 3. Changes in and Disagreements With Accountants
"Item 4. Recent Sales of Unregistered Securities
25Item 5. Indemnification of Directors and Officers
43Item 1. Index to Exhibits
"Item 2. Description of Exhibits
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2 SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10SB/A AMENDMENT 4 General Form for Registration of Securities of Small Business Issuers Under Section 12(b) or (g) of the Securities Exchange Act of 1934 INFECTECH, INC. (Exact name of Small Business Issuer in its charter) DELAWARE 34-1760019 (State or other jurisdiction of (I.R.S. Employer incorporation or organization Identification No.) Suite Two, 87 Stambaugh Avenue, Sharon, PA 16146 (Address of principal executive offices) (Zip Code) Registrant's Telephone number, including area code: (724) 346-1302 Securities to be registered pursuant to Section 12(b) of the Act: None Securities to be registered pursuant to Section 12(g) of the Act: Common Stock, $.02 par value Forward-Looking Statements and Associated Risk. This Registration Statement, including the information incorporated herein by reference, contains forward-looking statements including statements regarding, among other items, Infectech's growth strategies, and anticipated trends in Infectech's business and demographics. These forward- looking statements are based largely on Infectech's expectations and are subject to a number of risks and uncertainties, certain of which are beyond Infectech's control. Actual results could differ materially from these forward-looking statements.
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3 ITEM 1. DESCRIPTION OF BUSINESS A. Infectech was incorporated in June 1989 under the laws of the State of Delaware. Drs. Felder and Ollar began discussions on obtaining patents for important bacterial pathogens that utilized paraffin as their sole carbon source. They believed a method could be found to identify these faster and the symptoms treated more efficiently and effectively, thereby reducing the time patients spent being diagnosed for these illnesses. Infectech engaged in research and obtaining patents which we successfully began to obtain with our first patent being issued in 1992. We conducted additional research over several years leading to the development of more patents related to the use of paraffinophilic (paraffin-eating) bacteria which would then be used in testing devices, so that the presence of harmful bacteria could be more quickly detected then by conventional methods. In 1995, Infectech began testing and research at a laboratory facility in Milford, PA under the direction of Dr. Ollar. From 1995 to the present, Infectech has maintained the laboratory at which Dr. Ollar conducts research on the existing technology and developing related applications. On November 19, 1996, the Articles of Incorporation were amended to increase the authorized shares from 120,000 to 20,000,000 and a 50 to 1 stock split was declared. Infectech has remained a development stage company engaged in research and development of diagnostic tests and therapeutics for infectious human diseases. Infectech has obtained 30 patents on this technology. Infectech's technology has extended to the field of environmental bio-remediation which is the nontoxic degradation of pollutants and other harmful substances utilizing the same bacteria used in the medical diagnostic kit. Infectech has also applied this technology to a cancer therapy known as apoptosis involving the destruction of harmful cancer cells. Infectech is registering our common stock under the Exchange Act of 1934 to be eligible for the quotation of our stock on the NASD Bulletin Board. The Infectech Method. Infectech's research regarding paraffin as a sole carbon source led to the concept that paraffin-coated glass slides may be used to grow, identify and perform antibiotic sensitivity assays on paraffinophilic bacteria. Paraffinophilic bacteria are bacteria that use paraffin as their sole food source. Infectech then developed a technology that employs a paraffin carbon source that enables viable or living paraffinophilic organisms to be separated from viable non-paraffinophilic bacteria and from non-viable or dead bacteria. In this method only viable paraffinophilic bacteria grow on the paraffin coated glass slides. Those living or viable bacteria found on the surface of the paraffin coated slides may be stained and examined microscopically to determine the presence of suspect pathogens, or disease carrying organisms. Having identified the disease-causing bacterium, providing a patient cure is the next step. In a manner similar to identification of the pathogen, tests are conducted with a separate series of tubes containing antibiotics. Macroscopic and microscopic examination of the paraffin-coated slides indicate those tubes where there is an absence of bacterial growth on the paraffin slide surface. Such absence means that the antibiotic in question was able to kill the pathogen at a particular concentration of antibiotic. Infectech's patented technology will enable the medical community to conduct antibiotic sensitivity testing upon a pathogen once it has been identified, thereby enabling a more rapid and effective treatment of bacterial infections. This enables the hospital or doctor to determine the most appropriate antibiotic to use as well as the most effective in treating the patient. Infectech's paraffin slide culture technology provides a simple and inexpensive method for isolating, identifying and performing antibiotic sensitivity testing of paraffinophilic pathogens in markets ranging from the largest metropolitan urban hospitals to modest third world field laboratories. Of particular benefit to small hospitals, medical centers and third world field laboratories is the potential of using a variety of body fluids and fecal matter to provide samples for identification. The convenience, efficiency, and safety of this method also provide enhanced safety to the patient because of the non- intrusive nature of gathering the samples.
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4 The IDENTIKIT TM process, from the perspective of the physician and the patient, will operate relatively simply. For example, a patient enters a hospital with serious burns. Since burn patients are at high risk for bacterial infection including Pseudomonas, a bacteria which causes pneumonia, blood poisoning and other life-threatening disease, the physician will order a sample of blood or sputum to be taken from the patient. The sample will then be added to a series of test tubes containing Infectech's patented growth media. Paraffin slides are then added to the tube, and, with respect to Pseudomonas, for example, within 24 hours (using the IDENTIKIT TM) a laboratory technician will be able to observe the growth of bacteria on the paraffin and perform biochemical tests on it which will enable the identification, specification and antibiotic sensitivity testing of the patient's strain of Pseudomonas. The physician will then be able to administer the most appropriate antibiotic treatment. Since 1997, Infectech has obtained over two dozen additional patents and has begun to use the Infectech technology at several research hospital facilities in the United States. Infectech has also developed applications of its technology in the non-medical use of environmental bio-remediation. In this application, the Infectech method is used to produce bacteria which feeds upon certain toxic pollutants. This allows the bio-remediation (or biological cleanups) of polluted areas and such harmful substances as TCE (tri- chloroethylene). Infectech has entered into a licensing agreement with a bio-remediation firm actively engaged in this field. Products. IDENTIKIT TM. Infectech intends to offer two types of IDENTIKITs TM, one utilizing non-genetic microbiology and one utilizing genetic and amplification technology. Both types of IDENTIKITs TM will be used for all applications outside of the body in a noninvasive technique and may be used without additional specialized equipment. Both types of IDENTIKITs TM can be used for identification, specification and antibiotic sensitivity testing. Both types of IDENTIKITs TM, non-genetic and genetic amplification technology can be tailored with design, composition and instructions intended to meet specific customer requirements in identifying one or more of the paraffinophilic, non-paraffinophilic and non- paraffinophic/hydrophobic (water repellent) microorganisms. The price of each kit will be dependent on the number of paraffinophilic microorganisms to be tested by the kit. For example, the cost of a kit designed to identify all known paraffinophilic microorganisms will exceed the cost of a kit specifically designed to identify one microorganism (e.g. an MAI IDENTIKIT TM). The Non-genetic Microbiology Identification (NMI) IDENTIKIT TM is of a standard design and suitable for identifying any number of paraffinophilic, nonparaffinophilic or nonparaffinophilic/hydrophobic microorganisms. This kit is suitable for 100 tests. The anticipated list price of the kit for this testing of one of the disease causing organisms is $200.00. The Non-genetic Microbiology Antibiotic Sensitivity (NMAS) IDENTIKIT TM is designed for determining the effectiveness of a drug or bacteria for a paraffinophilic microorganism. Any number of paraffinophilic microorganisms may be tested. This kit is also suitable for 100 tests and can be shipped from stock. The anticipated list price of the kit determining the effectiveness of a drug or bacteria is approximately $300.00. The Non-genetic Microbiology Antibiotic Sensitivity for NonParaffinophilic Hydrophobic Organisms (NMAS) IDENTIKIT TM is designed for determining antibiotic sensitivity for a specific nonparaffinophilic/hydrophobic microorganism. This kit is also suitable for 100 tests and can be shipped from stock. The anticipated list price of this kit is approximately $300.00. The Non-genetic Microbiology Antibiotic Sensitivity for Several Organisms (Paraffinophilic, Nonparaffinophilic, Nonparaffinophilic/hydrophobic) is designed for determining antibiotic sensitivity for several organisms (user's choice of organism). This kit is also suitable for 100 tests and will be approximately $500.00 list price. No additional research or development is necessary to complete the non- genetic paraffinophilic kits. Additional research is presently ongoing for the nonparaffinophilic and nonparaffinophilic/hydrophobic
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5 non-genetic kits. This research is currently being conducted at the VA Medical Center in New York City and at Infectech's laboratory in Milford, Pennsylvania. However, the manufacturing, marketing and sales will need to occur through a relationship with a large international corporation. See "Sales and Marketing." Once such relationship is established, sales of the non-genetic kit can begin in overseas markets and domestic experimental markets for use in laboratory research. With the exception of experimental markets, sales in the U.S. cannot occur until FDA approval is granted. Infectech has begun to obtain the requisite number of clinical trials at the VA Medical Center in New York. We intend to obtain the required clinical trials and to submit application for a 510-K (90 day) approval from the United States Food and Drug Administration. Genetic Based Probe/Amplification Technology for Identification (PATID) is designed to rapidly identify specific microorganisms. The kit is a genetic based system and components are specific for the type of organisms to be scanned for. One kit is suitable for 100 tests. Genetic Based Probe/ Amplification Technology for Antibiotic Sensitivity (PATAS) is designed to perform rapid antibiotic sensitivity testing for specific microorganisms. The kit genetic based procedure and components are specific for a type of organism to be assayed for antibiotic sensitivity testing. One kit is suitable for 100 tests. By using Infectech's non-genetic IDENTIKITs TM, physicians will be given better data earlier about their patients' conditions, freeing them to make more effective treatment decisions. The following chart illustrates comparisons of Infectech's method with conventional testing for two life-threatening diseases. [Enlarge/Download Table] Infectech Genetic Infectech IDENTIKIT Conventional Conventional Genetic Antibiotic Method of Antibiotic IDENTIKIT Sensitivity Identification Sensitivity Identification Testing Mycobacterium avium-intracellularae (MAI) 8-30 days An additional 18-25 days 4-21 days total 8 days Pseudomonas 24-48 hours An additional 24-48 hours 24 hours total 24 hours MAI is an infection which affects organs, often the respiratory and gastrointestinal tracts of AIDS patients and is often fatal. Pseudomonas is a disease-causing bacteria which affects cystic- fibrosis, burn unit patients and other persons suffering from immune deficiencies resulting in serious illness and death. Infectech believes that its patented testing method may be the only one available, which can be successfully used with amplification techniques for rapid antibiotic sensitivity testing. As a result, Infectech is presently performing experimentation to combine its patented method with amplification techniques in an easy-to-use amplification IDENTIKIT TM, resulting in even more accelerated identification and antibiotic sensitivity testing, as the following chart illustrates: [Download Table] Infectech Genetic Infectech IDENTIKIT Conventional Conventional Genetic Antibiotic Method of Antibiotic IDENTIKIT Sensitivity Identification Sensitivity Identification Testing MAI 8-18 days An additional 18-25 days 48-96 hours 48-72 hours Pseudomonas 24-48 hours An additional 24-48 hours 24 hours total 24 hours MD Diagnostics. In 1999, Infectech became interested in the use of the Internet for its diagnostics. Management believed that the Internet offered an excellent method of interpreting microbiology test results over distances for its own tests and other medical tests.
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6 Infectech formed MD Diagnostics-com, Inc. in the state of Delaware on April 2000. MDD-com is developing a business plan that would offer medical diagnostic second opinions using specialists who would interpret a variety of medical tests, including CAT scans, EKGs and other tests. The MDD-com activities are not limited to Infectech- based medical technology and will be a resource for a wide range of medical tests. The Market. Markets for the Identikits TM include hospitals, clinical laboratories, medical research institutions, medical schools, pharmaceutical companies and physician's offices. There are over 9,000 hospitals and medical laboratories in the United States, all of which are logical customers for the Identikit TM products. It is anticipated that the Identikit TM can capture a large percentage of the worldwide market for identification of paraffinophilic pathogens due to its low cost and the rapidity with which an assay can be completed. At present, before FDA approval, both the non-genetic and the genetic amplification kit can be sold in overseas markets subject to regulatory requirements in a particular country, which vary. It can also be sold in domestic experimental markets for use in laboratory research. Marketing and Sales. Infectech is positioning itself to capture the market for MAI and Tuberculosis bacteria diagnosis and antibiotic sensitivity testing. Prior to the AIDS epidemic, MAI was a rare disease. After the advent of widespread AIDS infection, MAI was found to infect AIDS patients at a very high rate. According to the World Health Organization (Global Tuberculosis Control: March 1999) world health authorities have estimated that more than 70% of AIDS patients harbor an MAI infection. MAI affects the bone marrow, spleen, liver and lungs. It compromises the lymph nodes, thereby further destroying the patient's immune system. MAI also causes opportunistic infections among non-HIV infected children and the elderly. MAI is believed to be a major contributor to AIDS wasting syndrome. Based on in-house research, in addition to MAI, there are at least 20 other disease-causing paraffinophilic bacteria for which Infectech's Infectech method can be utilized. Infectech initially plans to market its products through licensing and distribution arrangements with large, well-established medical diagnostic companies. Infectech's markets will potentially include hospitals, clinical laboratories, medical research institutions, medical schools, pharmaceutical companies (antibiotic sensitivity testing methodology can be used to create new drugs to treat paraffinophilic microorganisms), and physicians' offices. Any contractual arrangements with others concerning the marketing and distribution of its products may result in a lack of control by Infectech over any or all of the marketing and distribution of such products. Although Infectech is currently engaged in preliminary efforts to establish such marketing arrangements, there can be no assurance that Infectech will be able to enter into any such arrangements on terms acceptable to Infectech, or at all. As part of its overall service to the technical medical community, Infectech is prepared to offer workshops and consultation in the general area of medical diagnostics. While these two activities are not large, they will produce minor amounts of revenue, but more importantly will serve as the focal point for the dissemination of information and training required for Infectech's. technology. Infectech's future growth and profitability will depend, in large part, on the success of its personnel and others in fostering acceptance by the medical community. Such acceptance will be substantially dependent on educating the medical community as to the distinctive characteristics and perceived benefits of Infectech's proposed products. There can be no assurance that Infectech's efforts or those of others will be successful, or that any of its products will receive the necessary acceptance by the medical community. Potential Markets for Infectech's Technology. Diagnostics. Infectech believes that significant demand exists for an inexpensive diagnostic test for pathogens that - does not need highly skilled manpower or technology to isolate and distinguish deadly bacteria - produces results rapidly and accurately, - limits pre-preparation requirements,
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7 - tests a broad range of specimens and - assays for antibiotic sensitivity to determine the optimal treatment method. Infectech believes that its patented slide culture technology meets these requirements. Infectech's technology provides for rapid and accurate identification of at least 20 life-threatening paraffinophilic pathogens. These pathogens include Pseudomonas, the major cause of death in intensive care and burn units and the second leading cause of death in cancer patients, Mycobacterium Avium Intracellular ("MAI"), the bacterial infection most often associated with AIDS in the developed world) and Mycobacterium Tuberculosis, a non-paraffinophilic hydrophobic pathogen that can be grown via Infectech's technology. Mycobacterium Tuberculosis is the causative agent of tuberculosis, the world's deadliest infection. Each year in the United States alone, more than 10,000,000 tests are conducted for Mycobacterium Tuberculosis, 5,000,000 tests are conducted for Pseudomonas and more than 1,000,000 tests are conducted for MAI. Using Infectech's patented slide-culture technology in combination with gene amplification methodologies, life-threatening bacteria can rapidly be identified. Using Infectech's proprietary baiting technology, the efficacy of potentially appropriate antibiotics (e.g., penicillin) to treat for these bacteria can be tested through rapid, inexpensive antibiotic sensitivity tests. Infectech believes that its patented testing method may be the only method available that can be successfully used with amplification techniques for rapid antibiotic sensitivity testing. According to the World Health Organization, approximately 1.7 billion people worldwide carry the Tuberculosis bacterium which equals approximately 1 in 3 persons in the world. Although the majority of these cases are in underdeveloped and developing countries, it is thought by experts that as many as 10 million Americans may be infected with TB. (Global Tuberculosis Control: March 1999) This widespread health problem indicates a huge need for diagnostic testing of those infected individuals. At an average testing cost of merely $.45 per individual, a potential global market of at least $200 million exists. Infectech is positioning itself to capture a significant share of the market for MAI and Tuberculosis bacteria diagnosis and bacteria sensitivity. Historically, the search for MAI and other members of the genus Mycobacterium Tuberculosis has been very difficult. These organisms grow slowly, and specimens require rigorous preparation to prevent overgrowth of other more rapidly growing organisms often found co-existing in specimens. Handling of mycobacterial specimens has required highly-trained technicians and specialized equipment. This is not true of Infectech's technology. The Identikit is a self-contained testing device which requires little preparation. The sample is simply added to the test tube. It is sealed and then examined. The examination can be performed by any laboratory technician who need only analyze the visual results on the test tube slide. In addition, Infectech's technology permits sampling of a variety of tissues, not just blood or sputum. Although MAI forms in the gastrointestinal tract, physicians using conventional methods are unable to detect the bacteria until they reach the bloodstream. Using Infectech's technology, physicians will be able to analyze fecal matter or urine to detect MAI where it begins, in the gastrointestinal tract thereby leading to earlier treatment of the disease. Management is of the opinion that the convenience, efficiency and safety of Infectech's patented slide culture technology will provide enhanced safety for patients because of the non-invasive nature of required procedures. Management believes that its slide-culture technology also can be used to detect the presence of non-paraffinophilic bacteria through use of non-paraffin-based carbon coatings in a clean-room environment and sampling of certain body fluids such as blood and spinal fluid. The Infectech patented technology of paraffin slide culture does not require the use of highly skilled manpower. Infectech's advantages in this user-friendly method are:
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8 1. Eliminates the need for many processing steps currently needed to decontaminate and concentrate specimens. Since only a few types of organisms grow on paraffin, overgrowth due to specimen contamination is not a problem. This avoids the need for highly-trained mycobacteriologists who are customarily required to manipulate the slow growing organisms. 2. The system eliminates the need for expensive and sophisticated machinery like centrifuges. 3. As a self-contained system, the Infectech technology can be used even in facilities in which electrical power and refrigeration are not available. The test media utilized can be stored in a dehydrated state at room temperature. In addition, Infectech has filed a patent for a method of inducing apoptosis, a method of controlled cell-death or cell "suicide", with hydrophobic hydrocarbons, notably paraffin. Many types of cancer therapy use drugs to kill cells. The use of paraffin to induce cell death has important advantages, since paraffin is non-toxic and its effect is local. Dr. Richard A. Lockshin, Ph.D., of St. John's University, President of the Cell Death Society, has agreed to collaborate with Infectech on electron microscopy work necessary on this project. Bio-remediation of Chlorine-contaminated Aquifers, Air and Soil. Infectech believes that its utility patent for use of Compound C in baiting paraffinophilic micro-organisms has broad application in environmental bio-remediation of chlorine compounds such as TriChloroEthylene. Infectech has granted a world wide exclusive license to use this technology for bio-remediation to a Hermitage Pennsylvania-based company, Bio-remedial Technologies, Inc. BRT received a $250,000 grant from the state of Pennsylvania to treat contaminated air streams containing styrene and other hazardous air pollutants identified by the United States Environmental Protection Agency, utilizing Infectech's patented technology in 1998. BRT continues to use the Infectech method in its TCE degradation. Veterinary Applications. Infectech intends to develop a kit to test for Johne's Disease (caused by Mycobacterium Paratuberculosis) in cattle, a possible cause of Crohn's Disease in humans. Federal Drug Administration approval is not required for this product. Proprietary Slide-culture Technology. Infectech has found that paraffin-coated slides can be used to grow, identify and perform antibiotic sensitivity assays on paraffinophilic bacteria. Infectech has developed a technology utilizing a paraffin carbon source that enables viable or living paraffinophilic organisms to be separated from viable non-paraffinophilic bacteria grown on the paraffin-coated glass slides. Living or viable bacteria can then be stained and examined microscopically to determine the present of suspect pathogens. Efficacy of an antibiotic can be tested on disease-causing bacteria in a manner similar to identification of the pathogen. Test tubes in which there is an absence of bacterial growth can be determined. Absence of bacterial growth indicates that the antibiotic was able to kill the pathogen at a particular concentration. Presence of bacterial growth can indicate lack of effectiveness of the antibiotics to treat for the pathogen. The technology also enables the user to determine appropriate concentration of the antibiotic. These features make Infectech's technology ideal for markets ranging from large urban hospitals to third-world field laboratories. Infectech believes that its technology can contribute to reducing healthcare costs and significantly improving patient care. Rapid Detection Advantage of Infectech's Slide-culture Technology. By using Infectech's technology, laboratories will be able to accurately identify and perform antibiotic sensitivity testing for multiple pathogens in less time than conventional methods and with greater accuracy. Using Infectech's technology, management anticipates that: Infectech's methods permit the sampling of a variety of tissue samples (not just blood or sputum) with minimal preparation. The significance of this may be seen, for example, in the current state of the art in identifying and treating MAI, the bacterial infection most often
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9 associated with AIDS patients in the developed world. Although MAI forms in the gastrointestinal tract, physicians normally cannot detect it until it reaches the bloodstream using conventional methods. Through analyzing fecal matter or urine, physicians using Infectech's methods can detect MAI where it begins in the gastrointestinal tract, leading to earlier treatment which can sometimes make the difference between life and death in an AIDS patient. Infectech's methods do not require specialized equipment or highly skilled personnel to perform the protocols, unlike the existing conventional methodologies. In fact, Infectech's methods may be automated, resulting in a faster, more precise and cheaper diagnostic process for the more than 9,000 hospitals and medical laboratories in the United States, and similar customers throughout the world. Infectech's solution can contribute to reducing health care costs, which are continually rising. Manufacturing. Before any sales of the Genetic Based Probe/Amplification Technology kits can occur, Infectech must reach an agreement with a large international corporation to manufacture, market and sell the product. Once this occurs, sales of the Genetic Based Probe/Amplification Technology kits can begin in overseas markets and domestic experimental markets for use in laboratory research. Infectech has entered into an exclusive, worldwide license and royalty agreement for the manufacture and distribution of the PARASLC/TM with Erie Scientific, Inc. The PARA SL/CTM is the paraffin-coated slide used solely as a central component of the IDENTIKIT TM. Erie is the largest manufacturer and distributor of medical glass slides in North America, and a wholly owned subsidiary of Sybron International Corporation. The license and royalty agreement calls for a net royalty of 15% to be paid to Infectech on all worldwide sales of the PARASLC/TM by Erie. In addition, Infectech has agreed to provide to Erie consulting services for the paraffin slide culture technology. To date, the production has been limited to several thousand slide units due to the developmental state of Infectech. Although Infectech is currently engaged in preliminary efforts to establish other manufacturing arrangements with respect to certain of its proposed products, there can be no assurance that the Company will be able to enter into any such additional arrangements, on acceptable terms or at all, or that any manufacturer will be able to meet any demand for such products on timely basis. Competition. Infectech believes that most existing methodologies for identification and antibiotic sensitivity testing of paraffinophilic bacteria are expensive and time-consuming. Infectech further believes that there is limited competition in the field of antibiotic sensitivity testing combined with amplification techniques for paraffinophilic microorganisms. While the principal components of Infectech's technology are patented, there can be no assurance that larger, better-financed companies will not enter the market or that others will not develop competing technologies. Currently, the market for manufacture and distribution of diagnostic kits for each of these pathogens is highly concentrated. The competitors for manufacture and sale of kits for growing the pathogen for tuberculosis on conventional solid media are Difco and Remel. Difco has been consolidated into Becton Dickinson, which holds the majority of the market for diagnostic tests for Tuberculosis using continuous monitoring methods, which are utilized, extensively in major urban U.S. areas. Similarly, the market for testing for Pseudomonas and MAI is concentrated in Becton Dickinson, which sells petri-dish- based diagnostic tests. Licensing/Transactions. On September 14, 1999, Infectech and BRT signed an exclusive licensing agreement for the licensing of certain intellectual property and patents relating to the application in bio- remediation fields. BRT is a company which specializes in the biodegradation of chlorinated compounds and hydrocarbons. Unlike other bio-remediation companies, BRT uses specially prepared microbes to degrade volatile organic compounds from air, ground water and soil. The term of the exclusive licensing agreement with BRT is for a period of ten years. BRT will utilize Infectech's intellectual property solely as it applies in the field of bio-remediation for the creation of
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10 microbes for the specific task of bio-remediation. Infectech shall receive a royalty of 15% per bio-remediation project during the licensing period. Infectech allows BRT the ability to maintain intellectual property protection for methodologies involved in degrading VOC air emission, and ground water and solid remediation. The technology will remain that of Infectech with the application or enhancement of BRT being additional. Infectech's management believes that there will be a likelihood of success based upon early in-house laboratory studies performed in conjunction with BRT which showed Infectech's methodology to be superior to any current competing procedure in degrading TriChloroEthylene (TCE). TCE is the most abundant groundwater contaminant in the United States. TCE is not utilized as a food or energy source by the microorganisms in the soil or groundwater. As a result, the chemical accumulates in the environment and generates a public health risk. BRT will require EPA approval for all site projects involving bio-remediation. The exclusive licensing agreement can be terminated early if - either the assets or stock of BRT are acquired; - BRT attempts to assign, sub-license, lease or otherwise transfer its license without prior express written approval by Company. - insolvency of BRT - disqualification of BRT to conduct business; - material adverse change in the financial condition of BRT - BRT defaults on any provision of the agreement and does not cure the default within 15 business days after written notice is received. On October 15, 1997 Infectech signed a letter of intent (LOI) with the Erie Scientific Company (a wholly owned subsidiary of Sybron International) for the development of Infectech's Paraffin Slide Culture (Para SL/Ctm) technology into a commercially marketable product for the detection and susceptibility testing of pathogenic Mycobacteria. If development efforts are completed and all the requisite pre- marketing regulatory approvals for any proposed products are obtained, Infectech will need to establish manufacturing and marketing capabilities, either directly or through contractual arrangements with others, such as joint venture, licensing or similar collaborative agreements in order to commercialize any such products. Infectech is currently engaged in preliminary efforts to establish manufacturing and marketing capabilities with respect to certain of its proposed products; however, there can be no assurance that Infectech will be able to enter into such arrangements or that it will be able to obtain the necessary financing to manufacture and market such products directly. Once a suitable manufacturing relationship is established, the non- genetic and genetic amplification IDENTIKITsTM are essentially ready for production.
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11 On November 18, 1993, Infectech entered into an exclusive worldwide license and royalty agreement for the manufacture and distribution of the PARA SL/CTM with Erie Scientific, Inc. The PARA SL/CTM is the paraffin-coated slide used solely as a major component of the IDENTIKIT TM. Erie Scientific, Inc., is the largest manufacturer and distributor of medical glass slides in North American, and is a wholly owned subsidiary of Sybron International Corporation. The license and royalty agreement calls for a net royalty of 15% paid to Infectech of all worldwide sales of the PARA SL/CTM Erie. In addition, Infectech has agreed to provide to Erie consulting services for the IDENTIKIT TM. Patents and Proprietary Rights. Infectech has been issued and granted thirty (30) U.S. patents, including: [Enlarge/Download Table] Patent No. Issue Date Title 5,153,119* October 6, 1992 Method For Speciating And Identifying MAI (Mycobacterium Avium- Intracellular) 5,316,918 May 31, 1994 Method and Apparatus For Testing MAI (Mycobacterium Avium-Intracellulare) For Antimicrobial Agent Sensitivity 5,472,877 December 5, 1995 Apparatus For Determining The Presence Or Absence of MAI (Mycobacterium Avium- Intracellular) 5,569,592 October 29,1996 Apparatus For Testing MAI (Mycobacterium Avium- Intracellular) For Antimicrobial Agent Sensitivity 5,637,5011 June 10, 1997 Method And Apparatus For Automatically Testing The Antibiotic Sensitivity Of A Paraffinophilic Microorganism 5,639,675 June 17, 1997 A Method Of Identifying A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus*** 5,641,645 June 24, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus 5,654,194 August 5, 1997 A Method Of Identifying A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus 5,663,056 September 2, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism And An Associated Apparatus*** 5,668,010 September 16, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism Using Various Milieus And An Associated Apparatus
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12 5,667,169 October 14, 1997 A Method For Determining The Antimicrobial Agent Sensitivity Of A Nonparaffinophilic Microorganism And An Associated Apparatus 5,698,414 December 16, 1997 Method And Apparatus For Testing Paraffinophilic Microorganisms For Antimicrobial Agent Sensitivity 5,707,824 January 13, 1998 Method of Determining The Presence Or Absence Of A Paraffinophilic Microorganism*** 5,721,112 February 24, 1998 A Method Of Determining The Presence Or Absence Of A Nonparaffinophilic Microorganism In A Specimen And An Associated Apparatus 5,726,030 March 10, 1998 Method for automatically testing the antibiotic sensitivity of a nonparaffinophilic microorganism 5,750,363 May 12, 1998 Method for determining the antibiotic agent sensitivity of a nonparaffinphilic microorganism and an associated apparatus 5,776,722 July 7, 1998 Method of testing a body specimen taken from a patient for the presence or absence of a microorganism and a further associated method and associated apparatus 5,801,009 September 1, 1998 Method for determining the antimicrobial sensitivity of a paraffinophilic microorganism using various milous and an associated apparatus 5,804,406 September 8, 1998 Determining sensitivity of paraffinophilic microorganisms to antimicrobials 5,846,760 December 8, 1998 Method for determining a presence of a nonparaffinophilic hydrophobia microorganism in a body specimen and an associated apparatus 5,854,013 December 29, 1998 Method of determining presence or absence of a nonparaffinophilic microorganism in a specimen 5,854,014 December 29, 1998 Apparatus for testing paraffinophilic microorganisms for antimicrobial sensitivity 5,882,919 March 16, 1999 Apparatus for determining the presence or absence of a nonparaffinophilic microorganism in a specimen 5,882,920 March 16, 1999 Apparatus for determining the presence or absence of a nonparaffinophilic microorganism 5,891,662 April 6, 1999 Method for determining the antimicrobial agent sensitivity of a nonparaffinophilic hydrophobic microorganism 5,962,306 Method of determining the presence or absence of a nonparaffinophilic microorganism in a specimen and an associated apparatus. 5,989,902 Method for determining the antimicrobial agent sensitivity of a nonparaffinophilic hydrophobic microorganism and an associated apparatus.
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13 5,935,806 Method and apparatus for speciating and identifying MAI, (mycobacterium avium-intracellulare) and testing the same for antibiotic sensitivity 5,981,210 Method for determining a presence or absence of a nonparaffinophilic hydrophobic microorganism in a body specimen by using a DNA extraction procedure and a novel DNA extraction procedure 5,994,120 Method of bioremediating an organic hazardous substance
* Corresponding patents in Australia (parent and divisional) and Europe (parent and divisional); corresponding application in Canada *** Corresponding patent in South Africa as of November 27, 1996 1 Corresponding applications will be filed in AU/BR/CA/CH/EP/JP/MX/NZ/RF/SK 2 Corresponding applications will be filed in AU/BR/CA/CH/EP/JP/MX/NZ/RF/SK 3 Term of patent shall not extend beyond expiration of Patent 5,677,169 4 Term of patent shall not extend beyond expiration of Patent 5,654,194 Each of the above patents expire seventeen years after the date of grant. Infectech is presently allowing its patented technology to be used at the VA Medical Center of New York to perform research confirming the efficacy of the IDENTIKIT TM and to perform additional research with amplification techniques. It is anticipated that the technique will increase the rapidity with which both bacterial identifications and antibiotic sensitivities can be determined, reducing the time required by one or two orders of magnitude. The slide culture technology may be automated. Infectech is presently in negotiation with several diagnostic companies for the automation of the paraffin baiting method. Infectech has been granted a patent for the automation method. This will potentially lower the cost for identification and antibiotic sensitivity testing for MAI and for all other paraffinophilic microorganisms. There can be no assurance that any issued patents will provide Infectech with significant competitive advantages, or that challenges will not be instituted against the validity or enforceability of any patent owned by Infectech or, if instituted, that such challenges will not be successful. The cost of litigation to uphold the validity and prevent infringement can be substantial. Furthermore, there can be no assurance that others will not independently develop similar technologies or duplicate Infectech's technologies or design around the patented aspects of Infectech's technologies. While obtaining patents is deemed important to Infectech, patents are not considered essential to the success of its business. However, if further patents do not issue from present or future applications, Infectech may be subject to greater competition. Infectech also relies on a combination of non-competition and confidentiality agreements with its employees, licensing agreements, trademarks and trade secret laws to establish and protect proprietary rights to its technologies. There can be no assurance that trade secrets will be established, that secrecy obligations will be honored, or that others will not independently develop similar or superior technologies. Dependence on One or a Few Major Customers. Infectech does not expect that any single customer will account for more than ten percent of its business. Employees. Infectech employs four full time persons and six part time persons. Infectech shall employ additional individuals as required. Governmental Regulation. In order to gain broad acceptance, Infectech's diagnostic kits will require approval from the United States Food and Drug Administration ("FDA") and regulatory bodies outside of the United States. Infectech intends to apply for FDA
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14 approval based upon clinical testing programs conducted at major medical centers including the New York's VA Hospital, the University of West Virginia School of Medicine and the State University of New York School of Medicine. Data obtained from these institutions will enable Infectech to apply for FDA approval process testing kits through the 510-K application process.. No assurance can be given that Infectech will successfully develop or commercialize any proposed applications of its technology. With the exception of experimental markets, sales in the United States cannot occur until FDA approval is granted. FDA approval will take no less than one year. This includes 4-5 months of research, 4-5 months of clinical trials and the 2-3 months for review by the FDA. The research associated with the FDA approval will cost approximately $200,000. Regulatory requirements for the FDA include: Device Classifications - The device clarification is under 510K regulations for a non-invasive device. Investigational device exemptions - There would be no exemptions except for utilization of these devises used solely for experimental purposes. Clinical investigator monitoring - Infectech technology is being monitored for clinical investigation at the Bronx VA in New York. Institutional review board approval - The Infectech product reviewed at the VA Medical Center will have the Lutine review board method of approval. Premarket approval applications and conditions of approval - Medical articles have already been written by the University of West Virginia School of Medicine and articles are being prepared for peer-review journals by the VA Medical Center in New York and St. Vincent's Hospital in New York. Registration and Listing - will occur on completion of FDA testing at the VA medical Center. Labeling - The labeling will take approximately one month after the FDA approval for this noninvasive test. Manufacturing, including design controls - controlled by the Sybron Corporation and its Erie Scientific Division which is a wholly owned subsidiary of Sybron Corporation. Post-market obligations, including medical device reporting (MDR) and recalls - Infectech shall be governed by the FDA and its medical reporting apparatus. Import and export requirements - These will be fulfilled according to the jurisdiction of each foreign country in which Infectech intends to market its products. Penalties and legal remedies available to the FDA for violations of the Federal Device and Cosmetic Act and the regulations promulgated under its authority - These will be routine penalties and legal remedies available to the FDA for a noninvasive device under 510K regulations. These various FDA regulatory requirements bear certain inherent risks in any type of activity involving noninvasive medical devices unique to Infectech but are generally applicable to all providers of similar products in the medical diagnostics field. While Infectech does not have unique requirements, this field is highly regulated and subject to FDA oversight and monitoring which poses risk in this type of activity which would include the suspension of sales activities and distribution of the products should the government exercise those remedies. The broad range of actions the FDA can utilize would include the suspension of further production distribution and sales. In addition to working on obtaining the necessary governmental approvals to bring the product to market and looking for additional marketing arrangements through established distribution channels, the Company plans to perform contract experimental work testing for the efficacy of chemotherapeutic agents against paraffinophilic microorganisms. Infectech has no specific time-frame for performing experimental work for this testing. Infectech expects to begin clinical trials of its slide-culture technology in early 2001 and expects to receive approval of its technology from the FDA before the summer of 2002 through the 510-K application process. Infectech expects to begin marketing its test kits internationally during the first quarter of 2001.
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15 Compliance with Environmental Laws. Infectech has no material costs or effects of compliance with federal, state or local environmental laws. Seasonal Nature of Business Activities. Infectech's business activities are not seasonal. Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations: Trends and Uncertainties. Demand for Infectech's products will be dependent on, among other things, market acceptance of Infectech's concept, the quality of its products, government approval and general economic conditions, which are cyclical in nature. Inasmuch as a major portion of Infectech's activities will be the receipt of revenues from the sales of its products, Infectech's business operations may be adversely affected by Infectech's competitors and prolonged recessionary periods. Capital and Source of Liquidity. Infectech requires substantial capital in order to meet its ongoing corporate obligations and in order to continue and expand its current and strategic business plans. Initial working capital has been obtained by the private sale of Infectech's common shares from November 1996 to present. For the nine months ended September 30, 1999, Infectech received proceeds from the issuance of common stock of $133,234 resulting in net cash provided by financing activities of $133,234 for the nine months ended September 30, 1999. For the nine months ended September 30, 1998, Infectech had proceeds from the issuance of common stock of $270,074. As a result, Infectech had net cash provided by financing activities of $270,074 for the nine months ended September 30, 1998. For the nine months ended September 30, 1999, Infectech had patent costs of $55,997, purchase of equipment of $2,450 and an increase in deposits of $51 resulting in net cash used in investing activities of $58,498. Infectech anticipates that costs associated with product testing and development will continue to increase. For the nine months ended September 30, 1998, Infectech received $200,000 from the redemption of certificate of deposit. Infectech purchased equipment for $4,505 and had patent costs of $179,554 for the nine months ended September 30, 1998. Infectech had an increase in deposits of $82 and had deferred merger and offering costs of $76,070 for that same period. As a result, Infectech had net cash used in investing activities of $60,211 for the nine months ended September 30, 1998. Infectech has a $10,500 line of credit, all of which was available at September 30, 1999. The line of credit is collateralized by the personal guarantee of a stockholder. On a long-term basis, liquidity is dependent on continuation and expansion of operation and receipt of revenues, additional infusions of capital and debt financing. Infectech believes that additional capital and debt financing in the short term will allow Infectech to increase its marketing and sales efforts and thereafter result in increased revenue and greater liquidity in the long term. However, there can be no assurance that Infectech will be able to obtain additional equity or debt financing in the future, if at all. Results of Operations. Since inception, Infectech has not received any material revenues from operations. Research and development expenses were $49,352 for the nine months ended September 30, 1999 versus $65,266 for the nine months ended September 30,, 1998. This decrease was due to research activities for its patents being shifted to work done internally in 1999. Wages increased to $86,592 for the nine months ended September 30, 1999 from $29,470 for the nine months ended September 30, 1998. This was the result from one employee working full time in research and development starting the later part of 1998. Legal and accounting decreased to $19,726 for the nine months ended September 30, 1999 versus $52,239 for the nine months ended September 30, 1998. The 1999 decrease was due to a change in law firms to a less costly firm and less usage during 1999.
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16 Consulting and professional fees increased to $116,059 for the nine months ended September 30, 1999 from $12,000 for the nine months ended September 30, 1998. This increase is due to increasing activity with consultants regarding marketing and commercialization of Infectech's product. Insurance expense decreased from $5,536 for the nine months ended September 30, 1998 to $51 for the nine months ended September 30, 1999 since Infectech discontinued life insurance coverage on its officers. Public relation expenses were $30,188 for the nine months ended September 30, 1999 versus -0- for the nine months ended September 30, 1998. This is due again to Infectech starting to market its product. Infectech incurred $30,614 in expenses for the nine months ended September 30, 1999 in connection with starting a subsidiary, MD- Diagnostics.com, Inc. to develop internet sites for medical diagnostics. Infectech had sales of $3,669 for 1998 versus -0- for 1997 and 1996. The revenue was due to a royalty payment earned in 1998. Research and development expenses increased to $92,004 for 1998 from $60,697 for 1997 and $17,500 for 1996. This was due to increasing research activities for its patents. Wages increased to $121,092 for 1998 from $24,568 for 1997 and $16,000 for 1996. This was the result from one employee working full time in research and development for 1998. Legal and accounting was $61,556 for 1998, $60,938 for 1997 and $80,711 for 1996. The 1998 and 1997 decrease was due to a change in law firms to a less costly firm. Travel expenses were $11,467 for 1998, $27,053 for 1997 and $9,310 for 1996. The increase travel expenses for 1997 was due to more trips to biotech companies and investment bankers. Consulting and professional fees increased to $183,466 for 1998 from $104,971 for 1997 and $43,360 for 1996. These increases are due to increasing activity with consultants regarding marketing and commercialization of Infectech's product. Plan of Operation. Infectech is in the development stage and has not conducted any significant operations to date and has received only minimal royalty revenues. Infectech may experience problems; delays, expenses and difficulties sometimes encountered by an enterprise in Infectech's stage of development, many of which are beyond Infectech's control. These include, but are not limited to, unanticipated problems relating to product development, testing, regulatory compliance, manufacturing costs, production and marketing problems, additional costs and expenses that may exceed current estimates and competition. Infectech has funding needs of approximately $1.2 million. Infectech shall seek equity or debt financing for intellectual Property ($30,000), research and development for Tuberculosis Pseudomonas ($814,400), legal expense for patents ($263,419) and internet research and development ($50,000). This does not include Infectech's working capital need. Research and development expenses will be dependent on the availability of funds. Infectech does not expect any additional purchases of plant and equipment. There are no expected significant changes in the number of employees. If Infectech obtained funding, support type of employees such as secretarial, etc, may be required. As of September 30, 1999, Infectech had working capital of $47,964. Infectech expects to use this capital to continue research and development of patents and for the costs associated with executing an initial public stock offering. Infectech believes that the net proceeds from equity financing together with revenues from operations, if any, will be sufficient to meet its anticipated cash needs for working capital and capital expenditures until approximately December 1999. There can be no assurance, however, that the net proceeds from equity financing will not be expended prior thereto due to unanticipated changes in economic conditions or other unforeseen circumstances. Unless growth in Infectech's revenues from operations substantially exceeds management's current expectations, by approximately December 1999, Infectech will be required to seek additional equity or debt financing to fund the costs of its operations, including continued development of its products. There can be no assurance that additional financing will be available or that, if available, such financing will be on acceptable terms to enable Infectech to complete development of or commercialize any of its proposed products or technologies.
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17 Infectech is not delinquent in any of its obligations even though Infectech has generated limited operating revenues. Infectech intends to market its products utilizing cash made available from the private and public sale of its securities. Infectech's management is of the opinion that revenues from the sale of its products and the proceeds of the sales of its securities will be sufficient to pay its expenses until its business plan can be fully implemented. Year 2000 Issues. To date, Infectech has had no material effects from the Year 2000 issues. ITEM 3. DESCRIPTION OF PROPERTY Infectech will operate out of two locations. The corporate headquarters will remain in Sharon, Pennsylvania and the clinical lab will continue in Milford, Pennsylvania. These offices consist of 3100 square feet. Infectech pays approximately $2,500 per month for use of these two locations. Infectech may consolidate operations to a single location once clinical testing is successfully completed. Also, Infectech will use the offices of Dr. Felder as its corporate headquarters. Dr. Felder will sublease a portion of his offices at a rate of approximately $550 per month to partially cover the cost of rent, office equipment, utilities and office personnel. Infectech retains the right to increase these payments in accordance with any rental time and increased need for office equipment, utilities and office personnel at both locations. ITEM 4. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The following tabulates holdings of shares of Infectech by each person who, subject to the above, at the date of this prospectus, holds of record or is known by Management to own beneficially more than 5.0% of the Common Shares and, in addition, by all directors and officers of Infectech individually and as a group. Each named beneficial owner has sole voting and investment power with respect to the shares set forth opposite his name. Shareholdings at Date of This Prospectus [Download Table] Percentage of Number & Class(1) Outstanding Name and Address of Shares Common Shares Mitchell S. Felder, M.D. (2) (3) 2,252,589 31.75% Suite 2 87 Stambaugh Avenue Sharon, PA 16146 Robert Ollar, Ph.D. (2) 1,697,322 23.92% 122 Cornelia Lane Milford, PA 18337 David Bernstein, Esq. (2) (3) 246,837 3.48% 33111 Seneca Drive Solon, OH 44139 Susan Felder (2) 382,967 5.40% Suite 2 87 Stambaugh Avenue Sharon, PA 16146 Stephen Lewis 100,000 1.41% 112 Mehard Avenue Greenville, PA 16125 Thomas Inman 0 0.00% 27 Garrett Lane Mercer, PA 16137 William Moder 0 0.00% Kerrwood Place, Suit 104 2500 Highland Road Hermitage, PA 16148
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18 All Directors & Officers as a group (7 persons) 4,679,715 65.96%
(1)Pursuant to Rule 13d-3 under the Securities Exchange Act of 1934, as amended, beneficial ownership of a security consists of sole or shared voting power (including the power to vote or direct the voting) and/or sole or shared investment power (including the power to dispose or direct the disposition) with respect to a security whether through a contract, arrangement, understanding, relationship or otherwise. Unless otherwise indicated, each person indicated above has sole power to vote, or dispose or direct the disposition of all shares beneficially owned, subject to applicable unity property laws. (2)Assumes exercise of all outstanding stock options. Includes for each of Dr. Felder, Dr. Ollar, Mr. Bernstein and Mrs. Felder, 42,535, 23,368, 37,978 and 29,167 shares, respectively, which such person has the right to acquire under options issued to him/her under the 1996 Stock Option Plan at a purchase price of $1.20 per share. (3)Includes for each of, Dr. Felder and Mr. Bernstein, 77,500 and 10,000 shares, respectively, for repayment of loans made to Infectech. Stock Options. The Corporation has issued options for the purchase of up to 828,852 shares of common stock to fourteen persons. The options are "non-qualified stock options" which are not qualified for treatment under Section 422 of the Internal Revenue Code of 1986, as amended. The term of the options has generally been up to ten years from the date of grant, and provide for vesting over a period of three years from the date of grant. The Corporation's 1996 Stock Option Plan provides for the issuance of options for the purchase of 1,182,750 shares of the Corporation's Common Stock to employees and consultants. In lieu of salary for past services, certain employees have received stock options to purchase up to 322,406 shares at a purchase price of $1.20 per share under the Stock Option Plan. Of the total 322,406 shares eligible for purchase pursuant to options, Dr. Felder, Dr. Ollar, Thomas Inman, William Moder II, David Bernstein, Steve Lewis, and Susan Felder have options to purchase a total of 227,200 shares. The remaining 95,116 shares eligible for purchase pursuant to options were distributed among 8 other employees. The Corporation's 1998 Stock Option Plan provides for the issuance of options for the purchase of 1,200,000 shares of the Corporation's Common Stock to employees and consultants. Currently no options have been issued under the 1998 Stock Option Plan. ITEM 5. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS. Board of Directors. The following persons listed below have been retained to provide services as director until the qualification and election of his successor. All holders of Common Stock will have the right to vote for Directors of Infectech. The Board of Directors has primary responsibility for adopting and reviewing implementation of the business plan of Infectech, supervising the development business plan, review of the officers' performance of specific business functions. The Board is responsible for monitoring management, and from time to time, to revise the strategic and operational plans of Infectech. Directors receive no cash compensation or fees for their services rendered in such capacity. The Executive Officers and Directors are: [Download Table] Name Position Term(s) of Office Mitchell S. Felder, M.D. age 47 CEO, President and Inception Treasurer and Director to present
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19 Robert A. Ollar, Ph.D. age 52 Executive Vice President Inception and Chief of Scientific to present Affairs and Product Development and Director Susan Felder age 46 General Manager and Director Inception to present David Bernstein, age 39 Corporate General Counsel and Director Stephen R. Lewis, age 40 Director 1995 to present
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Thomas Inman, age 45 Secretary and Controller June 1995 to present William J. Moder, III, age 48 Director Sept. 1998 to present
Resumes: Mitchell S. Felder, M.D., is a co-founder of Infectech, a founding member of Infectech's Scientific Advisory Board, and serves as Vice Chairman of Infectech's board of directors. Dr. Felder is a contributor to certain of the patent applications for Infectech's products, and has worked in Infectech's clinical medical effort. He received his M.D. degree from the University of Rome, Italy in 1983, and has been an attending Neurologist at the Horizon Hospital System in Greenville, Pennsylvania since 1997. Dr. Felder is married to Susan Felder and is a first cousin of Mr. Bernstein. Robert A. Ollar, Ph.D. is a co-founder of Infectech, a founding member of Infectech's Scientific Advisory Board, and has served as Chairman of the board of directors of Infectech since 1989. Dr. Ollar received his Ph.D. degree from the University of Surrey, England, United Kingdom in 1993. Prior to that, he received his Master of Science Degree majoring in Microbiology in 1984 from the University of Glasgow, Great Britain. Prior to that, he performed research at the Institute Pasteur Du Brabant in Brussels, Belgium. Dr. Ollar is the inventor of Infectech's slide culture technology. Dr. Ollar is presently an Assistant Professor of Neurology at the New York Medical College. Susan Felder has served as General Manager and director of Infectech since its inception in 1989. From 1978 to 1989 she had progressive analyst responsibilities with the Insurance Services Office, Inc. leading to the position of Computer Programmer which she held until 1989. From 1978 to 1979 she held the position of Marketing Research Analyst for the Continental Insurance Company. She received her B.A. in Economics from Rutgers College in 1976. She is the wife of Dr. Felder. David Bernstein, Attorney-at-Law, is Corporate Counsel for Infectech and is a director of Infectech. Mr. Bernstein is a sole practitioner practicing law in Cleveland, Ohio. Prior to engaging in sole practice, Mr. Bernstein was an attorney at Bekaert Corporation, a manufacturing company. He received his Juris Doctor of Law from The University of Akron in 1983 and his Bachelor's Degree in Accounting from Kent State University in 1980. Mr. Bernstein is a first cousin of Dr. Felder. Stephen R. Lewis has served as a director of Infectech since 1995. Mr. Lewis is an investment broker with, and shareholder of Butler Wick & Co., Inc. of Sharon, Pennsylvania since 1988. He received his Bachelor's Degree in Finance from Indiana University of Pennsylvania in 1983. Thomas L. Inman was the Corporate Controller for Infectech, having served from June 1995 to September 1999. Mr. Inman is the Secretary of Infectech. Since 1999, Mr. Inman is employed by the Mercer County Agency on Aging and was previously employed as an internal auditor for the County of Mercer in Pennsylvania from 1990 to 1999. William Moder, III is General Counsel for Infectech and has been a director of Infectech since September, 1998. Mr. Moder is an attorney engaged in private practice in Hermitage, Pennsylvania. He has advised
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Infectech as local counsel, primarily on contract issues. Prior to entering private practice, Mr. Moder was corporate counsel for First National Bank of Pennsylvania, a subsidiary of F.N.B. Corporation, for 14 years. He is a 1974 graduate of Edinboro University of Pennsylvania and earned his juris doctorate degree in 1980 from the University of Akron. The Corporation has not established any committees, other than the Compensation Committee and the Stock Option Plan Committee, which administers the issuance of options under the Corporation's 1996 and 1998 Stock Option Plans. The Compensation Committee is composed of Dr. Felder, Dr. Ollar, Mr. Shardy. and Mr. Moder. The Stock Option Plan Committee consists of Dr. Felder and Dr. Ollar Scientific Advisory Board. In July 1995 Dr. Ollar and Dr. Felder founded the Corporation's Scientific Advisory Board, which in addition to them consists of the following members: Nancy D. Connell, Ph.D., Assistant Professor, Dept. Of Microbiology and Molecular Genetics, UMDNJ/New Jersey Medical School Carl Gene Coin, M.D., Department of Radiology, University of Miami School of Medicine Joseph Giordano, M.D., Attending Internist, Sharon Regional Health System Vincent LaBombardi, Ph.D. Chief of the Department of Microbiology, St. Vincent's Hospital New York, New York; Assistant Professor of Microbiology, New York Medical College. Richard Steinfeld, M.D., Attending Internist, Sharon Regional Health System Benjamin M. Blumberg, Ph.D., Professor of Neurology, University of Rochester Medical School Joseph H. Kite, Jr., M.D., Professor of Microbiology; State University at Buffalo School of Medicine and Biomedical Sciences Jane Pascale, M.D., Assistant Professor of Microbiology; State University at Buffalo, NY Sheldon Brown, M.D., Assistant Professor of Medicine; Mt. Sinai School of Medicine, NY, NY; Attending Physician Infectious Diseases; Bronx V.A. Hospital Dale Pokorney, M.D., Assistant Professor of Dermatology, Case Western Reserve School of Medicine Pattisapu R.J. Gangadharam, Ph.D., Professor of Medicine, Microbiology and Pathology, Director of Mycobacteriology research, University of Illinois at Chicago Thomas Kelly, Ph.D., Professor of Microbiology Laboure College; Boston, MA David Sklansky*, Author of seven books on probability theory and wagers. Zsuzua (Susan), Polgar*, Women's World Chess Champion. Ms. Polgar and Mr. Sklansky do not have a scientific background. Each member of the Scientific Advisory Board has received an option to purchase six hundred fifty (650) shares of stock at $4.50 per share. Such options vest over a three-year period beginning on December 6, 1996, and expire without further vesting within ninety (90) days after each member's termination of Scientific Advisory Board service. ITEM 6. EXECUTIVE COMPENSATION No executive officer of Infectech, except for Dr. Robert Ollar, received any cash compensation for the fiscal year ended December 31, 1997. Dr. Ollar received cash compensation of $23,333 during fiscal year ended December 31, 1997. When operations allow, Dr. Ollar will receive a salary of $60,000 per year based on his full time work at
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Infectech's laboratory; and Dr. Felder will receive a salary of $60,000 per year based upon part-time work. Infectech retains the right to increase or decrease the cash compensation of its employees as necessitated by business conditions. In lieu of salary for past services, certain employees have received options to purchase up to 322,406 shares of Infectech's common stock at a price of $1.20 per share. [Enlarge/Download Table] Long Term Compensation Annual Compensation Awards (a) (b) (c) (d) (e) (f) (g) Name Securities And Other Annual Restricted Stock Underlying Principle Cal. Salary Bonus Compensation Award(s) Options Position Yr. ($) ($) ($) ($) (#) Dr. Felder 1998 0 0 75,175 CEO 1997 0 0 179,756 1996 0 0 0 0 Dr. Ollar 1998 $36,395 0 0 Executive 1997 $23,333 0 92,189 Vice Pres. 1996 $16,000 0 0 0 Aggregate Option Exercises in Last Fiscal Year and FY-End Option Values [Enlarge/Download Table] (a) (b) (c) (d) (e) Shares Number of securities underlying Value of Unexercised In-the Acquired Unexercised Options/SARs at Money Options at On Exercise Value FY-End (#) FY-End($) Name # Realized Exercisable/Unexercisable Exercisable/Unexercisable Dr. Felder 0 0 114,895/110,036 $47,833/$35,867 Dr. Ollar 6,250 7,438 55,209/30,730 $12,396/$39,666 Option in Last Fiscal Year (1998) Individual Grants [Enlarge/Download Table] (a) (b) (c) (d) (e) Number of Securities % of Total Underlying Options Exercise or Expiration Options Granted to Employees Base Price Date Name Granted (#) in Fiscal Year ($/Sh) Dr. Mitchell Felder 75,175 98% $1.20 2008 Dr. Robert Ollar 0 0% n/a n/a Employment Agreements. Dr. Robert Ollar is employed under an employment agreement for $20,000 per year. Other than Infectech's standard form of non-competition and confidentiality agreement, Infectech does not presently have any employment contracts in effect with the named executive officers of Infectech, including any compensatory plans or arrangements resulting from the resignation, retirement or other termination of the named executive officers of Infectech, other than the compensation arrangements discussed above. ITEM 7. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS Related Party Transactions. Prior to July 1995, all of Infectech's expenditures were funded by Dr. Mitchell Felder. Dr. Felder advanced Infectech $26,776 in 1993, $36,649 in 1994, $19,564 in 1995 and $36,189 in 1996. Advances from inception of Infectech to December 31, 1992 totaled $39,387. Under an agreement with Infectech, $64,833 of the amounts loaned was converted to common stock. In 1992, David Bertstein, a stockholder, provided legal services amounting to $12,000 in exchange for a non-interest bearing note payable due or before December 1, 1999. Mr. Bernstein has agreed to accept 10,000 Common Shares of Infectech as repayment of this debt upon completion of this offering.
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Infectech subleases a portion of its office space from Dr. Felder, President, at a rate of $550 per month to cover the cost of rent, office rent, computer equipment, utilities and office personal. These payments totaled $6,600 in 1999. William Moder serves as general counsel for Infectech. Mr. Moder is paid on an hourly basis for professional services at the rate of $50 per hour and is also given stock options in an equal amount, exercisable at a price of $1.20 per share. In 1998, Mr. Moder received $11,015 in cash and 11,015 stock options for legal services provided to Infectech. Infectech entered into a consulting agreement with Steven Lewis, a stockholder and director of Infectech. The term of the consulting agreement is one (1) year commencing May 18, 1998. Infectech has not extended the agreement and it expired May 18, 1999. Mr. Lewis shall be paid a $4,000 per month payable quarterly under the terms of the Agreement. Additionally, Mr. Lewis has received 30,000 stock options with an option price of $1.20 per share. The agreement provided that upon Infectech receiving $300,000 during its term, that Mr. Lewis would receive an additional 30,000 stock options at the option price of $1.20 per common share, which did not occur. During 1997 and 1996, Mr. Lewis was paid $31,347 and $18,360, respectively for his prior services to forfeiture, which number will be reduced by 16,137 Common Shares Mr. Lewis was never awarded the additional 30,000 stock options due to non-performance and termination of the contract. ITEM 8. DESCRIPTION OF SECURITIES Qualification. The following statements constitute brief summaries of Infectech's Certificate of Incorporation and Bylaws, as amended. All material portions of the Certificate of Incorporation and Bylaws have been discussed. Infectech is authorized to issue 20,000,000 shares of Common Stock, par value $.02 per share. As of the date hereof, there are 6,265,588 shares of Common Stock outstanding, excluding shares reserved for issuance upon the exercise of 828,852 issued and outstanding common stock options. The holders of the Common Stock are entitled to one vote per share with respect to all matters on which holders of Infectech's common stock are entitled to vote. Holders of the common stock have the right to dividends from funds legally available therefor, when, as and if declared by the board of directors and re-entitled to share ratably, in all of the assets of Infectech available for distribution to holders of shares of common stock upon liquidation, dissolution or winding up of the affairs of Infectech. Holders of common stock do not have preemptive, subscriptive or conversion rights. The common stock does not have cumulative voting rights and, therefore, holders of shares entitled to exercise more than 50% of the voting power are able to elect 100% of the Directors of Infectech. As a result, the existing shareholders of Infectech have the power to retain control over Infectech, despite any accumulation of common stock pursuant to this offering. Transfer Agent. Florida Atlantic Stock Transfer, Inc. of Tamarac, Florida currently acts as Infectech's transfer agent.
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PART II ITEM 1. MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS Infectech common shares are listed on the National Quotation Board ("pink sheets") under the symbol IFEC. Quarter ended High Bid Low Bid June 30, 1999 $2.00 $1.50 September 30, 1999 $1.50 $1.00 December 31, 1999 $1.00 $ .06 March 31, 2000 $2.90 $ .38 June 30, 2000 $1.75 $ .80 September 30, 2000 $1.00 $ .38 Infectech has never paid any cash dividends nor does it intend, at this time, to make any cash distributions to its shareholders as dividends in the near future. As of October 31, 2000, the number of holders of Infectech's common stock is 77. ITEM 2. LEGAL PROCEEDINGS Merger With Regal One Corporation ("Regal"). On April 7, 1998, the Corporation entered into a Plan and Agreement of Merger with Regal, a Florida Corporation, whose shares are listed on the OTC Bulletin Board under the symbol "RONE." Regal was to issue approximately 26,320,520 Common Shares to the Corporation's stockholders so that on the effective date of the merger, the shareholders of the Corporation would have owned in the aggregate 85% of the Common Shares of Regal, which upon closing will change its name to Infectech. A condition of the merger was that the Corporation raise a minimum of $300,000 prior to June 30, 1998. This condition was not met and the Corporation exercised its right to terminate the transaction. The Corporation filed for arbitration in Pennsylvania (AAA Case No. 55- 136-0131-98) to recover monies advanced to Regal One and other fees and costs. The matter has been amicably settled. ITEM 3. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS. During Infectech's two most recent fiscal years or any later interim period, there have been no changes in or disagreements with Infectech's principal independent accountant or a significant subsidiary's independent accountant. ITEM 4. RECENT SALES OF UNREGISTERED SECURITIES. During the first and second quarter of 1997 Infectech issued 522,450 Common Shares at $1.20 per share in cash to the following individuals and entities. Jean C. Harnett 46,250 James Gessler 10,000 James M. Holl & Steve D. Gurrera 10,000 Carl Shardy 42,000 David A. & Betty I. Geisel 5,000 Mark B. Jubelirer 10,000 John F. Loretta A. Hamley 3,000 Dale Pokorney 16,000 Martin M. Horowitz 50,000 Cathi Gurska 12,500 Samuel Bungo 7,000 Gary W. Podobruck 4,000 Beverly D. Beshore 20,000 Scott D. Payne 4,000 Karen Gagen 14,700 Richard J. Donatelli 2,500 M. Virginia Larimer 5,000 Charles O. & Lorraine A. Stepp 2,000 Alexis J. Loomis 10,000 Stacey B. Enck 5,000 Ian C. Horowitz 5,000 Annamarie Denis 5,000
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Ronald L. Susan D. Campbell 33,000 Patricia E. Loomis & James L. Gibson 10,000 Steven B. Bakst 40,000 Mitchell S. Felder 37,500 Scott A. Riley 18,000 Glenn B. Harnell 80,000 Allen D. Kidd 15,000 Marten C. Owens 15,000 Steve D. Gurrera 2,500 Christine & David Kirila 10,000 John A. & Joyce A. Mackey Custodians 10,000 These issuances were made in compliance with Rule 505, Regulation D of the Securities Act of 1933 by Registrant's management, consultants and selected broker/dealers. No commissions or other remuneration was paid to anyone. No general solicitation was utilized. The determination of whether an investor was accredited or non-accredited was based on the responses in the subscription agreement filled out by each investor. During the second quarter of 1998, Infectech issued 225,000 Common Shares for cash payments of $1.20 to the following: Bruno Melaragno 20,000 Anthony Melaragno 20,000 Carl Shardy 27,000 Dale Pokorney 10,000 John & Joyce Mackey, Custodians 10,000 Marten C. Owens 10,000 Peter Melaragno 20,000 Victor Melaragno 20,000 Ronald Campbell 10,000 Victor Melaragno, Custodian 10,000 Richard J. Donatelli 10,000 Steve D. Gurrera 3,000 Christine & David Kirila 10,000 A. William Senopole, Jr. 10,000 Aurelio Berardinelli 20,000 William E. Brest 15,000 These issuances were made in compliance with Rule 505, Regulation D of the Securities Act of 1933 by Registrant's management, consultants and selected broker/dealers. No commissions or other remuneration was paid to anyone. No general solicitation was utilized. The determination of whether an investor was accredited or non-accredited was based on the responses in the subscription agreement filled out by each investor. In January 1998, Infectech issued 121 Common Shares pursuant to option exercise at $.01 per Common Shares to Thomas A. Kelly, Ph.D. The Common Shares were issued to a sophisticated investor who had access to information on Infectech necessary to make an informed investment decision for cash consideration pursuant to an exemption from registration under Section 4(2) of the Securities Act of 1933. In the second and third quarters of 1998, Infectech issued Common Shares for option exercise at $.01 per Common Share as follows. Name Common Shares Cash Payment Thomas A. Kelly, Ph.D 1,017 $ 10.17 Robert A. Ollar, Ph.D. 6,250 $ 62.50 Jeffrey Lewis 49,825 $498.25 Dr. Kelly obtained the options during 1997 for his work with the scientific advisory board. Dr. Kelly also obtained options in 1997 and 1998 for services on the scientific advisory board. Dr. Ollar received options for scientific contributions to Infectech. Mr. Lewis was granted options for financial consulting services to Infectech in 1997 and 1998. The option price of $1.20 is based upon the previous private offering price. The Common Shares were issued to sophisticated investors who had access to information on Infectech necessary to make an informed investment decision for cash consideration or services pursuant to an exemption from registration under Section 4(2) of the Securities Act of 1933.
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During the first quarter of 1999, Infectech issued 111,000 common shares at $1.20 per common share cash payment (aggregate of $133,200) to the following: Robert Hudock 10,000 Common Shares James A. Hudock 10,000 Common Shares John Zullo 10,000 Common Shares Frank Shardy 19,000 Common Shares Victor Melaragno 10,000 Common Shares Anthony Melaragno 10,000 Common Shares Bruno Melaragno 20,000 Common Shares Aurelio Berarolineli 10,000 Common Shares John Demas, Sr. 12,000 Common Shares These issuances were made in compliance with Rule 504, Regulation D of the Securities Act of 1933 by Registrant's management, consultants and selected broker/dealers. No commissions or other remuneration was paid to anyone. The determination of whether an investor was accredited or non-accredited was based on the responses in the subscription agreement filled out by each investor. In March 1999, Infectech issued 3,334 Common Shares pursuant to option exercise at $.01 per Common Shares to June Pasacic for financial consulting services provided in 1996. The Common Shares were issued to a sophisticated investor who had access to information on Infectech necessary to make an informed investment decision for cash consideration or services pursuant to an exemption from registration under Section 4(2) of the Securities Act of 1933. ITEM 5. INDEMNIFICATION OF DIRECTORS AND OFFICERS Indemnification. Infectech shall indemnify to the fullest extent permitted by, and in the manner permissible under the laws of the State of Delaware, any person made, or threatened to be made, a party to an action or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he is or was a director or officer of Infectech, or served any other enterprise as director, officer or employee at the request of Infectech. The Board of Directors, in its discretion, shall have the power on behalf of Infectech to indemnify any person, other than a director or officer, made a party to any action, suit or proceeding by reason of the fact that he/she is or was an employee of Infectech. Insofar as indemnification for liabilities arising under the Act may be permitted to directors, officers and controlling persons of Infectech, Infectech has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by Infectech of expenses incurred or paid by a director, officer or controlling person of Infectech in the successful defense of any action, suit or proceedings) is asserted by such director, officer, or controlling person in connection with any securities being registered, Infectech will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issues. INDEMNIFICATION OF OFFICERS OR PERSONS CONTROLLING THE CORPORATION FOR LIABILITIES ARISING UNDER THE SECURITIES ACT OF 1933, IS HELD TO BE AGAINST PUBLIC POLICY BY THE SECURITIES AND EXCHANGE COMMISSION AND IS THEREFORE UNENFORCEABLE. Limitation on Liability and Indemnification Matters. The Certificate of Incorporation of the Corporation limits the liability of directors of the Corporation to the Corporation or its stockholders to the fullest extent permitted by Delaware law. Specifically, directors of the Corporation will not be personally liable for money damages for breach of a duty as a director, except for liability (i) for any breach of the director's duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the Delaware General Corporation Act, which relates to unlawful declarations of dividends or other distributions of assets to stockholders or the unlawful purchase of shares of the corporation, or (iv) for any transaction from which the director derived an improper personal benefit.
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PART F/S The following financial statements required by Item 310 of Regulation S-B are furnished below Independent Auditor's Report dated March 24, 1999 Balance Sheet as of December 31, 1998 and 1997 Statement of Operations for the Years ended December 31, 1998, 1997 and 1996 and the period from June 21, 1989 (inception) to December 31, 1998 Statement of Stockholders' Equity for the Years ended December 31, 1998, 1997 and 1996 and for the period from June 21, 1989 to December 31, 1998 Statement of Cash Flows for the Years ended December 31, 1998, 1997 and 1996 and for the period from June 21, 1989 to December 31, 1998 Notes to Financial Statements Balance Sheet as of September 30, 1999 Statement of Operations for the Nine Months ended September 30, 1999 and 1998 Statement of Cash Flows for the Nine Months ended September 30, 1999 and 1998 Notes to Financial Statements
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March 24, 1999 Board of Directors Infectech, Inc. Sharon, Pennsylvania Independent Auditors' Report We have audited the accompanying balance sheets of Infectech, Inc., a development stage enterprise, as of December 31, 1998 and 1997 and the related statements of operations, stockholders equity (deficit) and cash flows for each of the three years in the period ended December 31, 1998 and for the period from June 21, 1989 (inception) to December 31, 1998. These financial statements are the responsibility of Infectech's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Infectech, Inc. as of December 31, 1998 and 1997 and the results of its operations and its cash flows for each of the three years in the period ended December 31, 1998 and for the period from June 21, 1989 (inception) to December 31, 1998 in conformity with generally accepted accounting principles. /s/Hill Barth & King, Inc. Certified Public Accountants Sharon, Pennsylvania -1-
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BALANCE SHEETS INFECTECH, INC (A development stage enterprise) December 31, 1998 and 1997 [Download Table] DECEMBER 31, 1998 1997 A S S E T S CURRENT ASSETS Cash and cash equivalents $ 217,295 $ 295,489 Certificate of deposit 0 200,000 EQUIPMENT Medical equipment 43,517 37,013 Less accumulated depreciation 16,078 10,192 ---------- --------- NET EQUIPMENT 27,439 26,821 ----------- --------- OTHER ASSETS Deposit 1,669 1,456 Patent costs, net of accumulated amortization of $82,442 in 1998 and $51,686 in 1997 522,092 361,475 ---------- --------- TOTAL OTHER ASSETS 523,761 362,931 $ 768,495 $ 885,241 ========== ========== LIABILITIES AND STOCKHOLDERS EQUITY CURRENT LIABILITIES Accounts payable $ 33,006 $ 16,205 Accrued payroll taxes 522 363 Accrued state taxes 2,468 2,516 ---------- ---------- TOTAL CURRENT LIABILITIES 35,996 19,084 ---------- ---------- STOCKHOLDERS EQUITY - NOTES E, F, G AND H Common stock - $.02 par value per share: Authorized 20,000,000 shares; issued and outstanding 6,366,450 shares in 1998 and 6,033,200 shares in 1997 127,329 120,664 Additional paid-in capital 1,853,546 1,446,993 Deficit accumulated during the development stage (1,248,376) (701,500) ---------- --------- TOTAL STOCKHOLDERS EQUITY 732,499 866,157 ---------- --------- $ 768,495 $ 885,241 ========== ========== See accompanying notes to financial statements -2-
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STATEMENTS OF OPERATIONS INFECTECH, INC. (A development stage enterprise) Years ended December 31, 1998, 1997, 1996 and period from June 21, 1989 (inception) to December 31, 1998 [Download Table] PERIOD FROM JUNE 21, 1989 (INCEPTION) YEAR ENDED TO DECEMBER 31, DECEMBER 31, 1998 1997 1996 1998 ----- ----- ----- ---- OPERATING INCOME Sales $ 3,669 $ 0 $ 0 $ 3,669 OPERATING EXPENSES Research and development 92,004 60,697 17,500 206,011 Wages 121,092 24,568 16,000 177,404 Telephone 7,592 9,955 3,595 29,255 Office expense 9,746 7,541 2,328 22,675 Insurance 5,536 5,066 6,765 17,692 Legal and accounting 61,556 60,938 80,711 234,743 Travel 11,467 27,053 9,310 68,416 Payroll taxes 3,185 2,268 1,573 8,627 State and local taxes 4,796 3,777 2,584 11,692 Amortization 30,756 20,669 14,194 85,282 Depreciation 5,886 5,288 4,410 16,079 Rent 28,212 26,713 19,808 74,733 Consulting and professional fees 183,466 104,971 43,360 331,797 Miscellaneous 6,656 8,355 956 17,526 ------- ------- ------ -------- TOTAL OPERATING EXPENSES 571,950 367,859 223,094 1,301,932 -------- ------- ------- ---------- LOSS FROM OPERATIONS (568,281)(367,859)(223,094) (1,298,263) -------- ------- ------- --------- OTHER INCOME (DEDUCTION) Interest expense 0 0 (661) (661) Interest earned 21,405 21,634 2,833 50,548 -------- ------- ------- ---------- 21,405 21,634 2,172 49,887 ------- -------- ------ --------- NET LOSS $(546,876)$(346,225)$(220,922) $(1,248,376) ========= ======== ======= ========= Basic Earnings (Loss) per share $ (.09)$ .06)$ (.04) ========= ========= ========= See accompanying notes to financial statements -3-
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STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) INFECTECH, INC. (A development stage enterprise) Years ended December 31, 1998, 1997, 1996 and the period from June 21, 1989 (inception) to December 31, 1998 [Enlarge/Download Table] DEFICIT ACCUMULATED ADDITIONAL DURING RECEIVABLE COMMON PAID-IN DEVELOPMENT FROM SALE STOCK CAPITAL STAGE OF STOCK TOTAL ------ ---------- ----------- ------------ ------- Balance June 21, 1989 (inception) $ 0 $ 0 $ 0 $ 0 $ 0 Net loss 0 0 (98) 0 (98) -------- -------- ------- ------- ----- Deficit December 31, 1989 0 0 (98) 0 (98) Net loss 0 0 (388) 0 0 -------- -------- ------- ------- ----- Deficit December 31, 1990 0 0 (486) 0 (486) Net loss 0 0 (907) 0 (907) -------- -------- ------- ------- ----- Deficit December 31, 1991 0 0 (1,393) 0 (1,393) Issuance of 1,849,300 shares of stock in exchange for $20,000 in long-term loans 20,000 0 0 0 20,000 Issuance of 1,811,100 shares of stock in exchange for research and development 35,810 0 0 0 35,810 Issuance of 100,000 shares of stock for organization costs 2,000 0 0 0 2,000 Issuance of 105,000 shares of stock for out-of-pocket costs 2,100 0 0 0 2,100 Issuance of 134,600 shares of stock in exchange for legal services 13,000 0 0 0 13,000 Net loss 0 0 (67,027) 0 (67,027) ------ ------ ------- -------- ------- Balance (deficit) December 31, 1992 72,910 0 (68,420) 0 4,490 Net loss 0 0 (7,993) 0 (7,993) ------ ------ ------- -------- ------ Balance (deficit) December 31, 1993 72,910 0 (76,413) 0 (3,503) Net loss 0 0 (14,160) 0 (14,160) ------ ------ ------- -------- ------ Balance (deficit) December 31, 1994 72,910 0 (90,573) 0 (17,663) Conversion of long-term debt to additional paid-in capital 0 44,833 0 0 44,833 Transfer of costs in excess of par value upon change to $1 par value from no par value 7,090 (7,090) 0 0 0 Private placement of 500,000 shares of stock at $.20 per share 10,000 90,000 0 0 100,000 Private placement of 507,500 shares of stock at $.40 per share 10,150 192,850 0 0 203,000 Private placement of 25,000 shares of Stock at $.80 per share 500 19,500 0 0 20,000 Costs relating to sale of stock 0 (10,200) 0 0 (10,200) Issuance of 100,000 shares of stock at $.06 Per share 2,000 4,000 0 (6,000) 0 Net Loss 0 0 (43,780) 0 (43,780) -------- ------- -------- ------ -------- Balance (deficit) December 31, 1995 102,650 333,893 (134,353) (6,000) 296,190 Cancellation of 15,250 shares of stock (305) 305 0 0 0 Issuance of 87,500 shares of stock for debt 1,750 103,250 0 0 105,000 Collection of receivable 0 0 0 6,000 6,000 Private placement of 306,000 shares of stock At $1.20 per share 6,120 361,080 0 0 367,200 Costs relating to sale of stock 0 (36,000) 0 0 (36,000) Net loss 0 0 (220,922) 0 (220,922) ------- ---------- --------- ----- -------- Balance (deficit) December 31, 1996 110,215 762,528 (355,275) 0 517,468 Private placement of 522,450 shares of stock at $1.20 per share 10,449 616,491 0 0 626,940 Expense relating to stock options 0 67,974 0 0 67,974 Net loss 0 0 (346,225) 0 (346,225) --------- --------- --------- ----- --------- Balance (deficit) December 31, 1997 120,664 1,446,993 (701,500) 0 866,157 Private placement of 225,000 shares of stock at $1.20 per share 4,500 265,500 0 0 270,000
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Issuance of 57,213 shares of stock upon exercise of options at $.01 per share 1,144 (572) 0 0 572 Issuance of 51,037 shares of stock for services 1,021 65,372 0 0 66,393 Costs relating to sale of stock 0 (41,148) 0 0 (41,148) Expense relating to stock options 0 117,401 0 0 117,401 Net loss 0 0 (546,876) 0 (546,872) ------ -------- ---------- ---- -------- Balance (deficit) December 31, 1998 $127,329 $1,853,546 $(1,248,376) $ 0 $ 732,499 ========= ========== =========== ====== =========
See accompanying notes to financial statements
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STATEMENTS OF CASH FLOWS INFECTECH, INC. (A development stage enterprise) Years ended December 31, 1998, 1997, 1996 and the period from June 21, 1989 (inception) to December 31, 1998 [Enlarge/Download Table] PERIOD FROM JUNE 21, 1989 (INCEPTION) TO DECEMBER 31, 1998 1997 1996 1998 ----------- ---------- ---------- --------------- CASH FLOWS FROM OPERATING ACTIVITIES Net loss $(546,876) $(346,225) $(220,922) $(1,248,376) Adjustments to reconcile net loss to net cash used in operating activities: Amortization 30,756 20,669 14,194 85,282 Depreciation 5,886 5,288 4,410 16,079 Increase (decrease) in payables 16,801 (60,867) 71,089 31,212 Increase in accrued expenses 111 2,132 412 4,052 Expenses exchanged for capital 183,794 67,974 0 302,678 --------- -------- -------- --------- NET CASH USED IN OPERATING ACTIVITIES (309,528) (311,029) (130,817) (809,073) --------- -------- -------- --------- CASH FLOWS FROM INVESTING ACTIVITIES Purchase (redemption) of certificate of deposit 200,000 (200,000) 0 0 Purchase of equipment (6,504) (849) (22,328) (43,518) Patent costs (191,373) (108,549) (119,572) (605,374) Increase in deposits (213) (26) (1,430) (1,669) --------- --------- --------- --------- NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES 1,910 (309,424) (143,330) (650,561) --------- --------- --------- --------- CASH FLOWS FROM FINANCING ACTIVITIES Fees in connection with issuance of stock (41,148) 0 (36,000) (87,348) Proceeds from issuance of long-term debt 0 0 36,189 170,565 Proceeds from issuance of common stock 270,572 626,940 373,200 1,593,712 ---------- ---------- --------- ---------- NET CASH PROVIDED BY FINANCING ACTIVITIES 229,424 626,940 373,389 1,676,929 ---------- ---------- --------- ---------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (78,194) 6,487 99,242 217,295 CASH AND CASH EQUIVALENTS Beginning of period 295,489 289,002 189,760 0 --------- --------- ---------- --------- End of period $ 217,295 $ 295,489 $ 289,002 $ 217,295 ========== ========= ========== =========== CASH WAS PAID FOR Interest $ 0 $ 0 $ 661 $ 661 ========== ========= ========== =========== See accompanying notes to financial statements -5-
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NOTES TO FINANCIAL STATEMENTS INFECTECH, INC. (A development stage enterprise) December 31, 1998 and 1997 NOTE A - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Operations: These financial statements are those of a development stage company, Infectech, Inc., that was incorporated in 1989 to develop diagnostic tests for infectious diseases. A paraffin slide technology has been developed that greatly reduces the time required to identify bacteria and diagnose disease. This technology has been patented in the United States, major European countries and Australia. Infectech's operations have consisted primarily of incurring legal costs to obtain patents in the United States and foreign countries and conducting research and development activities. Cash and Cash Equivalents: Infectech considers highly liquid debt instruments purchased with maturity dates of three months or less to be cash equivalents. Infectech maintains deposits in savings, checking and transfer accounts in one bank located in Hermitage, Pennsylvania. Deposits at times may exceed federally insured amounts. Equipment: Equipment is stated at cost. Depreciation is computed on the straight- line method. Patent Costs: Patent costs are stated net of amortization. Amortization is computed on the straight-line method over a 17 year period. Infectech has capitalized only legal fees related to patent rights acquired; all other such costs have been expensed as incurred. Research and Development Costs: Research and development costs not directly reimbursable by others, totaling $35,810 in 1992, were charged to expense when stock was issued in exchange for patent rights. Research and development costs of $92,004 in 1998, $60,697 in 1997 and $17,500 in 1996 were charged to expense when incurred. 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. Revenue Recognition Substantially all revenues are recognized when finished products are delivered or services have been rendered, with appropriate provision for uncollectible accounts. Royalty income is recognized when earned. Long-Lived Assets In 1997, Infectech adopted SFAS 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of." The adoption of SFAS 121 had no impact on Infectech's financial position or on its results of operations. In accordance with SFAS 121, long-lived assets held and used by Infectech are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an assets may not be recoverable. For purposes of evaluating the recoverability of long- lived assets, the recoverability test is performed using undiscounted net cash flows estimated to be generated by those assets compared to the carrying value of the asset. NOTE B - LINE OF CREDIT Infectech has a $10,500 line of credit, all of which was available at December 31, 1998. The line of credit is collateralized by the personal guarantee of a stockholder.
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NOTES TO FINANCIAL STATEMENTS (CONTINUED) INFECTECH, INC. (A development stage enterprise) December 31, 1998 and 1997 NOTE C - LEASES WHERE COMPANY IS LESSEE Infectech has a three year operating lease for laboratory space, with a renewal option for an additional three years. Following is a summary of future minimum lease payments as of the lease inception: Year ending - December 31, 1999 $ 3,602 NOTE D - INCOME TAXES Following is a reconciliation between federal income taxes at statutory rates and actual taxes based on income before income taxes: [Download Table] YEAR ENDED DECEMBER 31, ------------------------------------- 1998 1997 1996 ---- ---- ---- Statutory taxes 35.0% (35.0%) (35.0%) Effect of valuation reserve 35.0 35.0 35.0 ------ ----- ------ .0% .0% .0% ======= ====== ======= The tax effects of temporary differences that give rise to significant portions of deferred tax assets are presented below: [Download Table] YEAR ENDED DECEMBER 31, ----------------------------------- 1998 1997 ---- ---- Deferred tax assets: Net operating loss $400,000 $215,000 Less valuation allowance (400,000) (215,000) --------- --------- NET DEFERRED TAX ASSETS $ 0 $ 0 Infectech has no significant deferred tax liabilities. At December 31, 1998, Infectech had unused net operating tax loss carryovers of approximately $1,179,000 available for federal income tax purposes for offset against future taxable income, $547,000 expiring in 2013, $325,000 expiring in 2012, $220,000 expiring in 2011, $43,800 expiring in 2010, $14,000 expiring in 2009, $8,000 expiring in 2008 and the balance expiring in the years 2004 through 2008. The utilization of the loss carryovers may be limited to a reduced annual amount after an ownership change as defined by Section 382 of the Internal Revenue Code. NOTE E - STOCK OPTIONS Infectech adopted a stock option plan, which provides for the issuance of up to 1,182,750 shares of common stock to key employees and directors and other individuals involved in Infectech. During 1998, the plan was amended to increase the number of shares by 1,250,000. A summary of Infectech's option plans at December 31, 1998 and December 31, 1997 and changes during the periods ending on those dates are shown below:
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[Download Table] DECEMBER 31, DECEMBER 31, 1998 1997 ---------------- ------------------ WEIGHTED WEIGHTED AVERAGE AVERAGE EXERCISE EXERCISE SHARES PRICE SHARES PRICE --------------- --------------- Employees Outstanding at beginning of period 203,921 $1.20 66,766 $1.20 Granted 146,638 .63 137,155 1.20 Options exercised (6,750) .01 0 .00 -------- ------- Outstanding at end of period 343,809 .98 203,921 1.20 ======== ===== ======= ===== Options exercisable At end of period 236,866 $ .84 0 $ .00 ========= ===== ======= ===== Nonemployees Outstanding at beginning of period 525,263 $2.14 158,330 $1.31 Granted 69,199 1.14 366,933 2.51 Options exercised (50,463) .01 0 .00 --------- ----- ------- ----- Outstanding at end of period 543,999 2.22 525,263 2.14 ======== ===== ======= ===== Options exercisable at end of period 198,200 $2.08 53,492 $ .00 All shares issued before 1998 vest in equal installments over a three year period on each anniversary date of the grant. The shares granted in 1998 vest immediately. The terms of the options are generally for 10 years. In addition, on December 9, 1995 one consultant to Infectech was granted a fully vested option to purchase $15,000 worth of stock at a price equal to one-half of the price any stock is sold in an initial public offering. Following is a summary on the status of options outstanding at December 31, 1998: [Download Table] OUTSTANDING OPTIONS EXERCISABLE OPTIONS WEIGHTED AVERAGE WEIGHTED REMAINING AVERAGE EXERCISE CONTRACTUAL EXERCISE PRICE NUMBER LIFE PRICE NUMBER EMPLOYEES $ .01 63,750 10 years $ .01 63,750 .20 60,000 10 years .20 20,000 1.20 217,120 10 years 1.20 119,688 NONEMPOYEES $ .01 15,000 10 years $ .01 11,666 .02 1,650 10 years .02 1,650 1.20 221,188 10 years 1.20 113,462 3.00 300,000 10 years 3.00 100,000 4.50 9,100 9 years 4.50 6,500 The Company charges expense for the fair value of the stock options issued to nonemployees. The fair value of each option granted to nonemployees is estimated on the grant date using the Black-Scholes model. The following assumptions were made in estimating fair value:
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Dividend yield 0 Risk-free interest rate 5% Expected life 10 years Expected volatility None Infectech applies APB Opinion 25 in accounting for its stock options for employees. Accordingly, compensation cost has been recognized only to the extent that the market value at grant date exceeded the option price. The amount of compensation cost recognized for 1998 was $83,300. No compensation cost was recognized for the plan in 1997. Had compensation cost been determined on the basis of fair value pursuant to FASB Statement No. 123, net loss would have been increased as follows: [Download Table] 1998 1997 1996 Net loss - As reported $(546,876) $(346,225) $(220,922) ========= ========= ========= Per Share $(.09) $(.06) $(.04) ========= ========= ========= Pro forma $(587,931) $(449,891) $(324,399) ========= ========= ========= Pro forma Per Share $(.10) $(.08) $(.06) ========= ========= ========= The independent contractors were granted options to purchase 57,459 and 60,146 shares from $.01 to $1.20 per share in exchange for services rendered during 1998 and 1997, respectively. Infectech recognized an expense of $34,667 for 1998 and $67,974 for 1997 equal to the value of this option. Following is a table listing the independent contractor and the options issued. Options Issued Independent Contractor 1998 1997 ---------------------- ---- ---- Steven Lewis 30,000 0 Jeff Lewis - 50,025 Tom Kelly 650 5,121 Sara Giordano 15,138 5,000 James Johnson 270 0 William Modor 10,401 0 Larry Sanata 1,000 0 ------- ------ TOTAL OPTIONS ISSUED 57,459 60,146 ======= ====== In addition, one independent contractor, Timothy Miles, was granted 50,000 common shares in exchange for services in 1998. Infectech recognized a $60,000 expense for the value of the shares issued during 1998. NOTE F - CONTROLLING INTEREST AND RELATED PARTY TRANSACTIONS Controlling Interest: Dr. Mitchell Felder and Dr. Robert Ollar own 63.0% and 66.6% of Infectech's outstanding common stock at December 31, 1998 and 1997, respectively. Related Party Transactions: Prior to July 1995, all of Infectech's expenditures were funded by a loan from Dr. Mitchell Felder. Infectech also utilizes office space provided by Dr. Felder at no charge to Infectech. Dr. Felder advanced Infectech $26,776 in 1993, $36,649 in 1994, $19,564 in 1995 and $36,189 in 1996. Advances from inception of Infectech to December 31, 1992 totaled $39,387. Under an agreement with Infectech, $64,833 of the amounts loaned were converted to common stock. At December 31, 1995, $56,811 was payable to Dr. Felder. Attorney David Bernstein provided legal services in exchange for common stock. Mr. Bertstein also provided legal services during 1992 in exchange for a $12,000 note payable.
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During 1996, $105,000 in loans from Dr. Felder and Attorney Bernstein were converted to 87,500 shares of common stock. Infectech has entered into a two-year consulting agreement with Steven Lewis, a stockholder and director of Infectech to provide consulting and advisory services to Infectech in consideration for cash payments equal to 5% of the gross proceeds to Infectech from a variety of financial transactions in which they may engage. During 1998, 1997 and 1996, $32,000, $31,347 and $18,360, respectively, was expensed under this agreement. NOTE G - NONCASH OPERATING, INVESTING AND FINANCING ACTIVITIES During the year ended December 31, 1992, Infectech issued common stock in exchange for $13,000 in legal fees incurred to Attorney Bertstein and $35,810 in research and development costs provided by Dr. Ollar and $2,100 in organization costs incurred by Dr. Ollar. Infectech also incurred $12,000 in long-term debt in exchange for legal services performed by Attorney Bernstein. Infectech also converted $20,000 in long-term debt to stock owed to Dr. Felder during 1992. Dr. Felder paid company expenses or loaned amounts to Infectech on a long-term basis as follows: Year Amount ----- ------- 1989 $ 2,522 1990 4,946 1991 8,914 1992 23,005 1993 26,776 1994 36,649 1995 19,564 1996 35,813 $158,189 ======== During the year ended December 31, 1995, $44,833 in noninterest bearing long-term debt was transferred to paid-in capital in exchange for a transfer of stock among Dr. Felder, Susan Felder, Attorney Bernstein and Dr. Ollar. During the year ended December 31, 1995, Infectech issued common stock to Steven Lewis in exchange for a $6,000 subscription receivable, which was repaid during 1996. During the year ended December 31, 1996, Infectech issued common stock to Dr. Felder and Attorney Bernstein in exchange for $105,000 in long- term debt. NOTE H - STOCK SPLITS AND STOCK OFFERING On November 19, 1996, the stockholders amended the articles of incorporation increasing the authorized shares from 120,000 to 20,000,000. In addition, a 50 to 1 stock split was declared increasing the outstanding shares to 5,117,250. On June 1, 1995, the stockholders amended the articles of incorporation increasing the authorized shares from 3,000 to 120,000 shares. In addition, a 40 to 1 stock split was declared increasing the outstanding shares to 120,000. At this time, the stockholders contributed 40,000 shares of stock back to Infectech. All per share amounts and number of shares have been restated to reflect the stock splits. On November 27, 1996, Infectech offered for sale 1,000,000 shares of common stock under a private placement. As of December 31, 1998, 903,450 shares have been issued. NOTE I - TERMINATION OF MERGER AGREEMENT On April 7, 1998, Infectech signed a merger agreement with Regal One Corporation, an inactive public company located in Las Vegas, Nevada. The agreement called for each share of Infectech, Inc. to be exchanged for 3.8483 shares of Regal One Corporation subject to adjustment for stock options and any additional shares issued under the private placement. After the merger, Infectech, Inc. stockholders would have
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owned approximately 85% of the combined company. The agreement was terminated in 1998. Infectech incurred approximately $56,000 in expenses in connection with this failed merger which were charged to operations during 1998.
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Infectech, Inc. and Subsidiary (A DEVELOPMENT STAGE ENTERPRISE) Consolidated Balance Sheet Unaudited Audited September 30 Dec. 31 ASSETS 1999 1998 ------------ ------- CURRENT ASSETS Cash and cash equivalents $ 81,466 $217,295 EQUIPMENT Medical equipment 45,967 43,517 Less accumulated depreciation 20,872 16,078 -------- -------- NET EQUIPMENT 25,095 27,439 OTHER ASSETS Deposit 1,721 1,669 Patent costs, net of accumulated amortization Of $110,438 in 1999 and $82,442 in 1998 550,093 522,092 ------- ------- TOTAL OTHER ASSETS 551,814 523,761 ------- ------- $658,375 $768,495 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES Accounts payable $ 28,413 $33,006 Accrued expenses 5,380 522 Accrued state taxes 0 2,468 ------- ------- TOTAL CURRENT LIABILITIES 33,793 35,996 ------- ------- STOCKHOLDERS' EQUITY Common stock - $.02 par value Authorized 20,000,000 shares issued and outstanding 6,480,784 shares in 1999 129,616 127,329 Additional paid-in capital 2,152,097 1,853,546 Deficit accumulated during the development stage (1,657,131) (1,248,376) --------- ---------- TOTAL STOCKHOLDERS' EQUITY (DEFICIT) 624,582 732,499 --------- ---------- $ 658,375 $ 768,495 ========= ========= See accompanying notes to consolidated financial statements
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Infectech, Inc. and Subsidiary Consolidated Statement of Operations (A DEVELOPMENT STAGE ENTERPRISE) (Unaudited) [Enlarge/Download Table] For the For the Period from Three Months Ended Nine Months Ended June 21, 1989 September 30, September 30, (Inception) to 1999 1998 1999 1998 September 30, 1999 -------- ------ ------- ------ -------------- OPERATING INCOME Sales & Royalties $ 7,290 $0 $ 7,290 $ 0 $ 10,959 OPERATING EXPENSES: Research and development 14,363 42,504 49,352 65,266 255,363 Wages 73,513 11,027 86,592 29,470 263,996 Telephone 1,656 1,021 8,106 6,980 37,361 Office expense 919 2,070 9,674 8,194 32,349 Insurance 0 266 51 5,536 17,743 Legal & accounting 3,785 12,000 19,726 52,239 254,469 Travel (77) 4,299 5,580 6,645 73,996 Payroll Taxes 617 819 1,917 2,495 10,544 State & local taxes 0 1,374 2,621 4,774 14,313 Amortization 9,470 11,933 27,995 23,051 113,277 Depreciation 1,686 1,648 4,794 4,320 20,873 Rent 6,293 8,304 14,739 20,609 89,472 Consulting & professional fees 101,341 12,398 116,059 12,000 447,856 Public relations 3,378 0 30,188 0 30,188 Royalties 1,822 0 1,822 0 1,822 Misc. operating expenses 6,211 1,801 11,420 5,911 28,946 MD-diagnostics.com expenses 0 0 30,614 0 30,614 ---------- ---------- ----------- ---------- ------------ TOTAL OPERATING EXPENSES 224,977 111,464 421,250 247,490 1,723,182 ---------- ---------- ----------- ---------- ------------ LOSS FROM OPERATIONS (217,687) (111,464) (413,960) (247,490) (1,712,223) OTHER INCOME (DEDUCTION) Interest expense 0 0 0 0 (661) Interest earned 1,144 3,022 5,205 18,503 55,753 ---------- ----------- ----------- ---------- ----------- NET LOSS $(216,543) $(108,442) $(408,755) $(228,987) $(1,657,131) ========== ========== =========== ========== =========== BASIC LOSS PER SHARE $ (.03) $ (.02) $ (.06) $ (.04) ========== ========== ========== ========== WEIGHTED AVERAGE SHARES 6,480,784 6,258,631 6,436,972 6,133,173 See accompanying notes to consolidated financial statements
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Infectech, Inc. and Subsidiary Consolidated Statement of Cash Flows (Unaudited) [Enlarge/Download Table] For the For the Period from Nine Months Nine Months June 21, 1989 Ended Ended (Inception) to Sept. 30, 1999 Sept. 30, 1998 Sept. 30, 1999 -------------- -------------- --------------- CASH FLOWS FROM OPERATING ACTIVITIES Net Loss ($408,755) ($228,987) ($1,657,131) Adjustments to reconcile net loss to net cash used in operating activities: Amortization 27,995 23,051 113,277 Depreciation 4,794 4,319 20,873 Increase (decrease) in payables (4,593) 2,077 26,619 Increase (decrease) in accrued expenses 2,390 1,141 6,442 Expenses exchanged for capital 167,604 0 470,282 -------- -------- ---------- NET CASH USED IN OPERATING ACTIVITIES (210,565) (198,399) (1,019,638) CASH FLOWS FROM INVESTING ACTIVITIES Redemption (Purchase) of certificate of deposit 0 200,000 0 Purchase of equipment (2,450) (4,505) (45,968) Patent costs (55,997) (179,554) (661,371) Increase (decrease) in deposits (51) (82) (1,720) Deferred merger & offering costs 0 (76,070) 0 ------- ------ -------- NET CASHED USED IN INVESTING ACTIVITIES (58,498) (60,211) (709,059) CASH FLOWS FROM FINANCING ACTIVITIES Fees in connection with issuance of stock 0 0 (87,348) Proceeds from issuance of long-term debt 0 0 170,565 Proceeds from issuance of common stock 133,234 270,074 1,726,946 -------- -------- --------- NET CASH PROVIDED BY FINANCING ACTIVITIES 133,234 270,074 1,810,163 NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (135,829) 11,464 81,466 CASH AND CASH EQUIVALENTS Beginning of Period 217,295 295,489 0 End of Period $ 81,466 $ 306,953 81,466 ========== ========== ========= CASH WAS PAID FOR Interest $ 0 $ 0 $ (661) ========== ========== ========= See accompanying notes to consolidated financial statements
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NOTES TO FINANCIAL STATEMENTS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1999 NOTE A - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Operations: These financial statements are those of a development stage company, Infectech, Inc., that was incorporated in 1989 to develop diagnostic tests for infectious diseases and one 95% owned subsidiary. The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with instructions to form 10-QSB. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary have been made for the fair presentation of the company's results for the nine month period ended September 30, 1999. These results are not necessarily indicative of the results that may be expected for the year ended December 31, 1999.
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PART III ITEM 1. INDEX TO EXHIBITS (2) Charter and by-laws (3) Instruments defining the rights of security holders (5) Voting Trust Agreement - Not Applicable (6) Material Contracts (7) Material Foreign Patents - Not Applicable (12) Additional Exhibits ITEM 2. DESCRIPTION OF EXHIBITS (2.1) Articles of Incorporation incorporated by reference to Form 10SB filed June 17, 1999 (2.1.1) Amendment to Articles of Incorporation dated July 4, 1995 incorporated by reference to Form 10SB filed June 17, 1999 (2.1.2) Amendment to Articles of Incorporation dated November 21, 1996 incorporated by reference to Form 10SB filed June 17, 1999 (2.2) Bylaws incorporated by reference to Form 10SB filed June 17, 1999 (3.1) Common Stock Certificate - to be filed by amendment (3.2) Preferred Stock Certificate - to be filed by amendment (6.1) License Agreement dated October 4, 1993, between Infectech and Erie Scientific Company incorporated by reference to Form 10SB filed June 17, 1999 (6.2) Investment and Licensing Agreement dated June 11, 1998 between Infectech and BioRemedial Technologies, Inc. incorporated by reference to Form 10SB filed June 17, 1999 (6.3) Consulting Agreement dated July 8, 1998, between Infectech and Breakthru Technologies, L.L.C. incorporated by reference to Form 10SB filed June 17, 1999 (6.4) Consulting Agreement dated September 24, 1998, between the Company and Timothy Miles d/b/a/ Little Pond Enterprises incorporated by reference to Form 10SB filed June 17, 1999 (6.5) Letter agreement together with Option Agreement and Research Agreement exhibits dated August 19, 1998, between Infectech and Brigham and Women's Hospital incorporated by reference to Form 10SB filed June 17, 1999 (6.6) Consulting Agreement dated September 15, 1998, between the Company and Merrill Weber & Co., Inc. incorporated by reference to Form 10SB filed June 17, 1999 (6.7) Letter Agreements dated April 14, 1997 and May 14, 1997 between Infectech and NEN Life Science, Inc. incorporated by reference to Form 10SB filed June 17, 1999 (6.8) Letter Agreement dated November 19, 1997, between Infectech and Starplex Scientific incorporated by reference to Form 10SB filed June 17, 1999 (6.9) Exclusive Licensing Agreement dated September 14, 1999 between Infectech and BioRemedial Technologies, Inc. (6.10) Consulting Agreement dated September 13, 1999 between the Company and Bridgeport Group, LLC
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SIGNATURES In accordance with Section 12 of the Securities Exchange Act of 1934, the registrant caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized. INFECTECH, INC. Mitchell Felder, M.C. Date: December 8, 2000 -------------------------------- By: Mitchell Felder, President

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