EXECUTIVE INFORMATIONAL OVERVIEW $2 Billion and Could Reach $10 Billion in the Next 10 Years If All Applications Are Commercialized
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Synthetic Blood International, Inc. 3189 Airway Avenue, Building C Costa Mesa, California 92626 Phone: (714) 427-6363 Fax: (714) 427-6361 www.sybd.com Biomedical Product Development Opportunity Snapshot September 22, 2005 Synthetic Blood International, Inc. (“Synthetic Blood” or “the Company”) is a biomedical product development company specializing in creating innovative pharmaceuticals and medical devices in the fields of oxygen therapeutics and continuous biosensor monitors. The Company is developing a blood substitute and a liquid ventilation product as well as an implantable glucose monitor. These products are based on core technologies that include biomedical applications for perfluorocarbons (PFCs)† and medical and industrial applications for biosensors. PFCs are inert, organic compounds that have attracted interest in medicine primarily as vehicles for respiratory gas transport and as contrast media in tissue imaging studies. PFC emulsions have been used for tissue oxygenation and thus have been referred to frequently as “blood substitutes” and “therapeutic oxygen carriers.” Synthetic Blood’s lead candidate, Oxycyte™, is being developed as an alternative to transfused blood for use in surgical and similar medical situations. Oxycyte™ is an oxygen-carrying intravenous emulsion that can carry three to four times more oxygen than hemoglobin (a red respiratory protein of red blood cells that transports oxygen as oxyhemoglobin from the lungs to the tissues). A substitute for blood is vitally important when there is no blood available, there is a limited blood supply, or there is insufficient time or resources to determine the blood type, or to test the blood to determine that it is free of infectious agents. Therapeutic oxygen carriers have shown promise in the treatment of such ischemic conditions as heart disease, cancer, stroke, traumatic brain injury, sickle cell anemia, decompression sickness (“the bends”), and carbon monoxide poisoning. Earlier stage candidates in the pipeline include Fluorovent™, a liquid ventilator providing oxygen exchange fluid for facilitating the treatment of lung conditions in adults and children, and a biosensor implant product that uses an enzyme process for measuring the glucose level in the bloodstream of diabetics. Recent Financial Data Ticker (Exchange) SYBD.OB (OTC.BB) Recent Price (09/22/05) $0.19 52-Week Range $0.19-0.41 Shares Outstanding 126.3 million Market Cap. $24.0 million Average 3-month volume 299,608 Insider Owners 31.5% Institutional Owners <1.0% EPS (qtr. ended 07/31/05) ($0.005) Employees 6 Key Points In January 2005, Synthetic Blood opened patient enrollment in a Phase II study of Oxycyte™ to evaluate its safety and efficacy in preventing tissue hypoxia in orthopedic surgical patients. Ultimately, the Company has a goal of filing a New Drug Application (NDA) to launch Oxycyte™ in 2008. PFC oxygen transport agents have a variety of potential medical applications, including use during surgery, for treating trauma and respiratory distress patients, after stroke and heart attack, and for organ preservation. Critical shortages of donor blood, which could reach four million units in the U.S. by 2030, combined with the increased risk of disease transmission (such as HIV and hepatitis), has created a global need for suitable blood replacement fluids. The current worldwide market for blood substitutes is estimated at EXECUTIVE INFORMATIONAL OVERVIEW $2 billion and could reach $10 billion in the next 10 years if all applications are commercialized. The Company has four U.S. patents and six non-U.S. patents covering the use and application of PFCs, and benefits from eight manufacturing process patents through an exclusive supply agreement. Synthetic Blood recently completed a private placement in July 2005, securing $1.15 million in immediate funds to support further clinical development of Oxycyte™. †BOLD WORDS ARE REFERENCED IN GLOSSARY ON PAGES 34-37. Contents Snapshot .......................................................................................................................................................1 Recent Financial Data...................................................................................................................................1 Key Points .....................................................................................................................................................1 Executive Overview.......................................................................................................................................3 Growth Strategy ............................................................................................................................................5 Intellectual Property ......................................................................................................................................6 Management and Board Members ...............................................................................................................7 Core Story .....................................................................................................................................................9 Blood Products and Technologies ...........................................................................................................9 Oxycyte™...............................................................................................................................................14 Fluorovent™...........................................................................................................................................22 Glucose Sensor......................................................................................................................................23 Key Points to Consider................................................................................................................................24 Historical Financial Results.........................................................................................................................25 Risks............................................................................................................................................................28 Recent Events.............................................................................................................................................33 Glossary of Lesser-Known Terms...............................................................................................................34 Executive Informational Overview Page 2 Executive Overview Synthetic Blood International, Inc. (“Synthetic Blood” or “the Company”) is a biomedical product development company specializing in creating innovative pharmaceuticals and medical devices in the fields of oxygen therapeutics and continuous biosensor monitors. The Company is developing a blood substitute and a liquid ventilation product as well as an implantable glucose monitor. These products are based on core technologies that include biomedical applications for perfluorocarbons (PFCs) and medical and industrial applications for biosensors. PFCs are inert, organic compounds that have attracted interest in medicine primarily as vehicles for respiratory gas transport and as contrast media in tissue imaging studies. PFC emulsions have been used for tissue oxygenation and thus have been referred to frequently as “blood substitutes” and “therapeutic oxygen carriers.” Synthetic Blood’s lead candidate, Oxycyte™, is being developed as an alternative to transfused blood for use in surgical and similar medical situations. Oxycyte™ is an oxygen-carrying intravenous emulsion that can carry three to four times more oxygen than hemoglobin. A substitute for blood is vitally important when there is no blood available, there is a limited blood supply, or there is insufficient time or resources to determine the blood type or to test the blood to determine that it is free of infectious agents. Therapeutic oxygen carriers have shown promise in the treatment of such ischemic conditions as heart disease, cancer, stroke, traumatic brain injury, sickle cell anemia, decompression sickness (“the bends”), and carbon monoxide poisoning. Earlier stage candidates in the pipeline include Fluorovent™, a liquid ventilator providing oxygen exchange fluid for facilitating the treatment of lung conditions in adults and children, and a biosensor implant product that uses an enzyme process for measuring the glucose level in the bloodstream of diabetics. Principal Product Oxycyte™ Oxycyte™, the Company’s most advanced candidate, is a PFC-based emulsion that has been demonstrated to be superior to other PFCs in animal screening tests. The product has successfully completed a Phase I clinical trial. In January 2005, Synthetic Blood opened patient enrollment in a Phase II study to evaluate the safety and efficacy of Oxycyte™ in preventing tissue hypoxia in orthopedic surgical patients, a procedure in which there is typically a moderate amount of blood loss but transfusions are not given. Oxycyte™ could have potential use in a variety of medical applications, including use as a blood substitute for trauma and surgical patients, for victims of stroke and heart attack, and in organ preservation. The potential market for a safe and effective blood substitute is significant, estimated to exceed $2 billion (Source: U.S. Blood Products Markets: Blood Substitutes and Expanders. Medical Data International (MDI), 1997). Many of the