Full Press Release Details
Navy Secure IP across all core and non core therapeutic areas. Raise more money and make money to generate capital sufficient to generate proof of principal data in all three clinical areas. Selectively partner for products or sell indications US/CA Escalation Study Oxycyte Big Pharma Involvement Harvest Existing IP Multiply Approach Partner Agreement (s) $ $ $ Dividends Partner Payments Door Opening Payments Try to Sell/License Annuity 22 Oxygen Biotherapeutics will set the standard in mitigation of loss of life or health due to lack of oxygen: Build a continuous revenue stream with topical indications as early as 2009 TBI in phase 3 with a partner Completed 2 b Trial for SCD Secured surrounding IP for PFC and tissue oxygenation Full development pipeline 23 24 $5.5M in cash at hand at a burn rate of about $300k per month, plus about $1.5M for trials and development (1year) Further $20M required to execute strategic plan (3 products with proof of principal by Q4 2010) by December 2010 Money inflow: Potential partner payments Warrant execution Recapitalization, if needed A substantial and untapped market opportunity remains Clinical failures are understood and can be avoided in the future OBI has a new and focused management team Oxycyte is a best in class PFC based oxygen carrier No storage issues, non reactive, no significant AEs Regulatory path is understood A modest capital investment to reach proof of principal and substantial value generation within 2 3 years. 25 Value Proposition Our mission is to save the lives and improve the health of ischemic patients through the safe and efficient delivery of oxygen.
Blood flow and O 2 levels are reduced in SCD patients causing pain crisis First generation PFCs in animal models have indicated that PFCs could reverse the sickle effect. Estimated Start Date: Q1 2009 Estimated Completion: Q4 2009 Estimated Cost: $150k 19 20 * * * * 21 Focus on 3 strategic clinical areas in which we can succeed o Traumatic Brain Injury (TBI) o Wound Healing o Sickle Cell Disease (SCD) Bring a topical Wound Healing indication to market quickly Launch a topical Cosmetic/Acne indication with partners Complete 2 b safety/efficacy trials for TBI and SCD Joint development of a DCS (decompression sickness) indication with the U.S.
US Army Medical Research and Materiel Command Grant ID# 00351085 Delivery system designed for continuous 24hr delivery of O2 to the wound. H 2 O 2 Catalyst Pouch, activate by crushing Oxycyte Gel Semi permeable Membrane Rayon Mesh Copper Oxide Wound Cover, Non permeable Includes O 2 Color Indicator When color disappears, time to change bandage Cupronized Rayon Gauge Toxicity / Efficacy Topical Devices Gel Formulation of Oxcycyte for wound, burn healing, and treatment of Acne Oxcycyte to be tested as active ingredient in medical device and in combination with a release controlled H 2 0 2 Estimated Start Date: Q4 2008 Estimated Completion: Q4 2009 Estimated Cost: Approx. $300k Filed a patent for DIFT Deep Immersion Fluorocarbon Treatment of traumatic burn patients ( Patients are fully immersed in oxygenated Oxycyte) 18 Phase 2a Trial Sickle Cell Disease (SCD) / Acute Treatment of Pain Crisis SCD causes hemoglobin to crystallize and RBCs to become misshapen and unable to move through the microcirculation.
Patient enrollment is anticipated to begin in Q1 2009 . Studies will take place in the U.S. with a second study planned in Canada. Possible additional study in Switzerland. 16 Phase 2a Trial Traumatic Brain Injury (TBI) Phase 2 trial Dose Escalation Safety 45 severe closed head injury patients o 36 patients received standard of care o 9 patients with standard of care + ~200ml Oxycyte within two hours of injury No significant AEs in Oxycyte group o Platelets, hemoglobin and liver enzymes at or near normal Oxycyte patients o Total response in 7/9 patients (78%) no neurological damage Control group o 50% died. 30% had chronic neurological damage Determine the optimal dose for Oxycyte for patients on Extended Glasgow Outcome Scale Optimal dose level that will reduce thrombocytopenia and provides clinical benefit in TBI In depth research to find the correlation between thrombocytopenia and platelets Federal Grant: $1.95 M (2008 1012 ) ?
N. America/ Europe Civil Traumatic Brain Injury 4,980 Military Traumatic Brain Injury 200 Wound Treatment Burns 2,000(US); 700 ER, 45 Hospitalization Wound Treatment Topical 36,500 (US) Cosmetic Indications 9,200 (US) Sickle Cell Pain Crisis 260 (US), 1% Population India/Africa Decompression Sickness Ratio: 13.4 per 100,000 dives Heart Attack 4,260 Coronary Bypass Surgery 1,065 Stroke 2,360 (Global) Spinal Cord Injury 600 Organ Transplants 200 Severe Burned Body 18 11 In addition, the company could have income from wound treatment as early as: 2009 Revenue Scenario for 2013/14 Potential 20 % License Fee from Accessible Market $xx X Units of 150ml Oxycyte Compound Sold at $xx $xx TOTAL $xx Incidence In Thousands Dose Price Potential 4,950 Civil TBI $xx $xx Total Market X% Market Share $xx Accessible Market SCENARIO 2013/14 Civilian Traumatic Brain Injury #1 cause of loss in work force productivity Cancer and Heart Disease strike at older ages while TBI impacts younger people Major impairment in 50% of survivors: lost from work force We have an obligation to evaluate a potentially beneficial therapeutic intervention Military Blast Injury Largest killer in the war on terror, due to roadside bombs Number of TBI injuries swamping VA 50% of survivors of severe injury have major impairment Lost from active service No medical treatments available We have an obligation to evaluate a potentially beneficial therapeutic intervention Clinical Benefit in Phase 2a Study: 9 TBI Patients after Oxycyte versus 25 matched historical controls G=Good Recovery, M=Moderate Recovery, S=Severe Disability, V=Persistent Vegetative, D=Death Preclinical Animal Toxicity Phase I Phase II Phase II A Phase II DES Phase III Phase IV 15 Currently expanding phase II trials to include a sequential dose escalation safety and efficacy study of up to 40 patients US, and 40 patients Canada.
Applied Topically as a Therapeutic Agent Wound Healing, Dermatology, Cosmetics 8 Civil Candidate Indication Pre clinical Phase 2a Phase 1 Phase 2b Phase 3 OXY 1a Oxy 1b Oxy 2 Oxy 3 Oxy 4 Traumatic Brain Injury Traumatic Brain Injury Wound/Cosmetic Sickle Cell Disease Decompression Sickness Military Device, OTC first Trial in Caribbean Navy IND Oxy 5 Aortic / Myocardial Preservation 9 * * * 10 Indication Incidence in Thousands p.a.
Watson 1991 Dr. Leland Clark transfers his PFC patents to SYBD 1992 Company bases research on Dr. Clark s innovations 1996 Moved to own labs in Costa Mesa, CA 2002 Toxicity trials on Oxycyte completed 2006 Phase 2 A trials on Oxycyte/TBI completed 2007 Management change 2008 Company changes name to Oxygen Biotherapeutics, Inc., OTC OXBO 3 4 * * * * 5 Oxycyte A PFC based therapeutic O 2 carrier developed for clinical indications Oxycyte is a best in class PFC Forms Stable Emulsion Metabolically Inert Acceptable Organ Elimination Time Appreciable Residence Time in the Blood No HNCL Syndrome 5 PFCs HBOCs Superior safety profile Reported safety issues (Vasoconstriction, Hemostasis, GI) No supply issues Outdated human blood/ limited supply No animal hemoglobin Reformulated cow and pig blood Good half life Short half life No disease transmission/typing, cross matching Potential for disease transmission/antibody formation Carry 4 times more O 2 than RBCs 2 times faster than hemoglobin 50 times higher O 2 solubility and diffusability, and 50 times smaller than RBCs 6 * * * * DRAFT OXBO, 101508 7 7 Applied where tissues are at risk of inadequate oxygenation (Ischemic Tissue) IV Administration TBI, Stroke, Spinal Cord Injury, Sickle Cell Disease, Endothelial Cell Preservation . . .
Such statements made by the Company are based on knowledge of the environment in which it operates, but because of the factors previously listed, as well as other factors beyond the control of the Company, actual results may differ materially from the expectations expressed in the forward looking statements. 2 1990 Established as Synthetic Blood International, Inc., OTC SYBD; operations out of Antioch College in Yellow Springs, OH Company bases research on Dr.
1 RODMAN RENSHAW INVESMENT CONFERENCE New York, NY Nov. 12, 2008 Exhibit 99.1 The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward looking information made on the Company s behalf. All statements other than statements of historical facts which address the Company s expectations of source of capital or which express the Company s for the future with respect to financial performance or operating strategies, can be identified as forward looking statements.