Bioxytran, Inc. · OTC:BIXT
Bioxytran — Investor Presentation (March 2020)
52 slides from Bioxytran's investor presentation, Mar 12, 2020
Slide 1: David Platt contact details
DAVID PLATT david.platt@bioxytraninc.com (617) - 510 - 2539
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT This report contains forward - looking statements concerning, among other things, possible applications for marketing approval and other regulatory matters, clinical trials, plans for the development of BioXyTran and business strategies . These forward - looking statements
Slide 3: Mission Statement
MISSION STATEMENT BioxyTran’s mission is to develop effective drug treatments for hypoxia (oxygen deficiency) which delivers oxygen to tissues with the potential to improve a myriad of medical conditions. 3
Slide 4: The Drug For Perfusion Professionals
PART 1 - The Drug For Perfusion Professionals 4
Slide 5: The Ultimate Perfusion Molecule
The Ultimate Perfusion Molecule Separating HEME from GLOBIN Bonding to a Co - Polymer (Alpha Carbohydrate) Universal Challenge: Delivering oxygen to ischemic tissues and measuring the effect of increased oxygen levels Solution: - Create molecule 5,000 times smaller than a red blood cell - Eliminate
Slide 6: Limitations of Blood
Limitations of Blood - Blood Supplies can run out (Mass Casualty Events) - Needs refrigeration - It gets old after 30 days and freshest blood is preferred - Large size of blood – incapable of perfusing through clots The oxyhemoglobin dissociation curve (image - right) has a characteristic sigmoid sh
Slide 7: Acellular Oxygen Carriers
Acellular Oxygen Carriers RED BLOOD CELL SUBSTITUTES: Oxygen carriers that use different mechanism to carry oxygen » Hemoglobin - based Oxygen Carrier (HBOCs): Made from Heme » Perfluorochemical - based particles (PFCs): Chemical that can carry and release oxygen. 7
Slide 8: Hemoglobin-Based Oxygen Carriers (HBOCs)
Hemoglobin - Based Oxygen Carriers (HBOCs) Hemoglobin - based particles use the oxygen carrying capacity of Heme and bind oxygen that is not the Reactive Oxygen Species (ROS). 8
Slide 9: Perfluorocarbons
Perfluorocarbons The Oxygen dissociation curves for cell - free hemoglobin and for a perfluorocarbon emulsion. Oxygen is bound to cell - free hemoglobin in the same way as it is bound to native hemoglobin. In contrast, oxygen readily dissolves in, but does not bind to, perfluorocarbon liquids. The o
Slide 10: Ideal Oxygen Carrier
Ideal Oxygen Carrier Advantages of a Blood Substitute (recreating the functionality of blood) □ Universal compatibility - Eliminates cross matching errors □ Pathogen Free - Elimination of disease testing for HIV, Hepatitis, Malaria, or Syphilis □ Long Shelf Life - Blood only lasts 42 days - Substitu
Slide 11: Expected Safety Profile of the Drug
Expected Safety Profile of the Drug BXT - 25 BioxyTran Combines Heme with a Co - Polymer + Heme : An FDA approved material that identifies and delivers oxygen similar to red blood cells Co - polymer : FDA Approved sugar stabilizes Heme in blood and eliminates nitric oxide scavenging BXT - 25’s uniqu
Slide 12: Proof of Concept of BXT-25 in Animals
Proof of Concept of BXT - 25 in Animals • Absence of nitric oxide scavenging, no increased blood pressure in diabetic mice (Harvard Medical School, 2013) • No toxicity from replacing 90% of the blood in dogs with similar chemistry to BXT - 25: https://www.hindawi.com/journals/ccrp/2014/864237/ ( QTe
Slide 13: Hemorrhagic Shock in Dogs
Hemorrhagic Shock in Dogs http://downloads.hindawi.com/journals/ccrp/2014/864237.pdf The administration of 0.65 g/kg BXT - 25 significantly elevated pulmonary artery pressure. Plasma hemoglobin concentrations of BXT - 25 ranging from 0.3 to 1.1 g/ dL , in conjunction with colloid based fluid resusci
Slide 14: Harvard Study of Several New HBOCs
Harvard Study - Characteristics of Several New HBOC’s Directed by Warren M Zapol , MD: Emeritus Anesthetist - in - Chief at MGH, Reginald Jenney Professor of Anesthesia at Harvard Medical School, and was Chief Anesthesiologist at MGH form 1994 – 2008. Objective: test for hypertension in awake wild t
Slide 15: Methods (Blind Study)
Methods (Blind Study) Hb and metHb concentrations of whole blood and plasma will be determined when appropriate in all groups. Arterial blood gas tensions inclu di ng pH, etc., will be obtained. The changes of cytokine release (i.e. TNF - α, IL - 1β, IL - 6, and IL - 10 levels) and the expression of
Slide 16: BXT Molecule = Sample B
BXT - 25 Molecule = Sample B • Molecular Weight:68 - 500 KD •P50:38 torr •Source of the Hb:bovine • Modification:glutaraldehyde and proprietary carbohydrate •Half life:18 - 36 hrs diabetic mice •Tetrameric Hb (%):30% • metHb (%):<3% •Hill coefficient value: n=~2 •Viscosity:1.3 cp Acknowledgements •2
Slide 17: Systolic blood pressure in wild-type mice
Systolic blood pressure in awake wild - type (C57BL6) mice after infusion of murine whole blood (WB), Sample A, or Sample B BXT - 25 Hemopure Note: Results are hard to decipher due to scaling of the graph BXT - 25 and Whole Blood are highly correlated and Nitric Oxygen (NO) is not scavenged by this
Slide 18: Systolic blood pressure in diabetic mice
Systolic blood pressure in awake diabetic ( db / db ) mice after infusion of murine whole blood (WB) or Sample B BXT - 25 Notice how the ranges overlap on the majority of the points demonstrating the correlation Note: Results are hard to decipher due to scaling of the graph 18
Slide 19: Hypoxia Identified in Many Medical Conditions
Hypoxia Identified in Many Medical Conditions - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587513/ - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4356629/ - https://www.nature.com/articles/s12276 - 019 - 0235 - 1 - https://www.intechopen.com/books/hypoxia - and - human - diseases - https://www.in
Slide 20: BXT Stroke Treatment Characteristics
BXT - 25 Stroke Treatment Characteristics Subject to FDA approval and testing - Restores oxygen to the brain - Creates efficacy for both ischemic and hemorrhagic strokes - Results in no known side effects - Delivers viable treatment for first responders - Enables immediate treatment prior to diagnos
Slide 21: Blood Substitutes During Stroke
Blood Substitutes During Stroke Subject to FDA approval and testing Drug Development Stroke Cure Dissolve Clot Perfuse Clot Usage Window Expand tPA Window Available in Ambulance Treat Both AIS & HS Diffusion Pharmaceuticals Pre - Treatment Drug NO Effective (3 hrs ) 3 hrs NO YES YES Dia Medica Thera
Slide 22: WHO Preparing for Pandemic
WHO Preparing for Pandemic — The global mortality rate for COVID - 19 is 3.4%, WHO said on March 2. This virus causes more severe illness than the flu, but doesn't spread as efficiently, the director - general said . » Without a vaccine in hand efforts to contain the disease quarantining people is t
Slide 23: Defeating the Outbreak – A Simple Plan
Defeating the Outbreak – A Simple Plan □ Containing the disease takes time □ Developing a vaccine take time □ Learning how it transmitted takes time □ Antiretrovirals don’t stop mortality Primary Reason People Die From the Virus Fluid in the lungs Why does fluid in the lungs kill people? They cannot
Slide 24: ARDS and Late Stage Coronavirus Patients Affecting Perfusionists
ARDS and Late Stage Coronavirus Patients Affecting Perfusionists HEADLINES 2/24/20 CytoSorbents Enters Agreement with China Medical System Holdings Limited to Bring CytoSorb to Mainland China to Treat Critically - ill Patients with COVID - 19 Coronavirus Infection https://cytosorbents.com/cytosorben
Slide 25: ECMO Evolving as the Standard of Care in COVID
ECMO Evolving as the Standard of Care in COVID - 19 IS THERE A BETTER WAY? 25
Slide 26: BXT Solution for ARDS & Late Stage COVID-19 Patients
BXT - 25 Solution for Acute Respiratory Distress Syndrome (ARDS) & Late Stage COVID - 19 Patients Subject to FDA approval and testing - Restores oxygen the same as red blood cells - Results in no known side effects - Delivers viable treatment continually - Increase tissue oxygenation regardless of f
Slide 27: The Real Problem – Tissue Oxygenation & Real-time Monitoring
The Real Problem – Tissue Oxygenation & Real - time Monitoring - Late Stage Coronavirus Patients develop fluid in their lungs - Respirators force liquid levels of alveoli sacks lower so blood can get closer to O2 (Not very effective) - The blood is physically not close enough to the O2 to get oxygen
Slide 28: MDX Viewer: The Third Vital Sign
PART 2 – MDX Viewer The Third Vital Sign 28
Slide 29: The Problems in Diagnosing Severity of ARDS
The Problems in Diagnosing Severity of Acute Respiratory Distress Syndrome (ARDS) - Measuring disease state to triage patients (helps to decrease mortality in crisis) - Removing the constant need to check on the patient (Remote monitoring needed) - Need to increase tissue oxygenation and measure eff
Slide 30: Current Measuring Devices
Current Measuring Devices What are they really measuring? Thermometer Temp in Mouth, Ear, or Forehead Heart Rate – Pulse Heart beat in your wrist Respiratory Rate Stethoscope Breathing Sounds Blood Pressure Blood Pressure in your left arm Oxygen Saturation Pulse Oximeter Peripheral oxygen levels in
Slide 31: FDA Approved MDX Viewer Measures Hypoxia
FDA Approved MDX Viewer Measures Hypoxia FDA Approval Data https://www.accessdata.fda.gov/cdrh_docs/pdf6/K062977.pdf Tool for Facilitating Drug Approval Potential Endpoints □ Tissue Metabolic Score □ Brain Metabolic Score Approved Device Status Facilitates Defining Endpoint 31
Slide 32: MDX Monitoring for Acute Hypoxia
Light Source Unit Panel Computer Detection Unit Electronics And Embedded Computer System Power Supply Systemic vital parameters (probe 2) Photoplethysmographic analysis Parameters: 1. Pulse oximetry 2. Heart rate B D C F Core Temperature Systemic vital parameters (probe 3) G E MDX Monitoring for Acu
Slide 33: Clinical Unmet Need
BioXyTran.. Clinical Unmet Need Ne Compartment (Oxygen level (mmHg) Monitored Parameter —— < Respiratory Syste 100 End-Tidal CO, (ET-CO,) See en Electrocardiogram (ECG) — lar Syste Cardiac Output (CO) 0 ‘Systemic Blood Pressure (BP) Macro-circulation, — ——SystemicH Saturation (Sa0,) Microcirculatory
Slide 34: Continuous Real-time In-vivo Tissue Spectroscopy
Continuous Real - time In - vivo Tissue Spectroscopy 34
Slide 35: Mitochondrial NADH/Fp Redox State
Mitochondrial NADH/ Fp Redox State Conversion of Glucose to ATP 35
Slide 36: Technology
Technology The MDX-Viewer consists of three components: od Bedside Unit | Main unit: contains the light source, optical detectors and the main signal processing components. phe Fiber Probe oe i Monitor unit: displays the tissue monitored Distal ana parameters and contains the MDX-Viewer ™ : coeeeene
Slide 37: The Next Generation Viewer
The Next Generation Viewer 37
Slide 38: Competitive Environment Next Generation
Competitive Environment 38 Next Generation
Slide 39: Potential Applications
Potential Applications (Human Diseases Associated with Mitochondrial Dysfunction) 39
Slide 40: Hypoxia Science Research Won the Nobel Prize in 2019
Hypoxia Science Research Won the Nobel Prize in 2019 2019 NOBEL PRIZE WINNERS William Kaelin Jr., Sir Peter Ratcliffe, and Gregg Semenza Discovery: how cells adapt to changing oxygen levels □ BioxyTran has the only FDA approved device to measure tissue oxygenation □ Its MDX Viewer can quantify hypox
Slide 41: Nobel Prize Laureates Theory
https://www.nobelprize.org/prizes/medicine/2019/press - release/ Nobel Prize Laureates Theory Predicts Cellular Interaction within the Tissue Micro - Environment Theory of the Cellular Universe This is the E=mc2 for cells Delivering Oxygen to Tissues Reduces Hypoxia: Reduced Hypoxia Improves the Con
Slide 42: When Two Scientists' Research Collide
When Two Scientist’s Research Collide 30 Years Researching Hypoxia Nobel Prize – Study of Hypoxia 30 Patents 10 Journal Articles 2 Textbooks 5 Public Companies 200 Animal Experiments 30 clinical trials Major Scientific Validation Embraced by Scientific & Medical Minds COMMERCIALIZATION 90 Years Sinc
Slide 43: Strategy for Successful Commercialization of BXT
Strategy for Successful Commercialization of BXT - 25 • Pursue functional claim of tissue oxygenation • Finalize development of MDX Viewer • Prioritize stroke application in near term • Explore a myriad of other applications/treatments • Build core team to scale future growth • Enhance IP value thro
Slide 44: BioxyTran Will Pursue a Functional vs. a Medical Claim
BioxyTran Will Pursue a Functional vs. a Medical Claim Most Drug Development Companies Pursue Medical Claims Example: Medical Claim (disease): The applicant claims the drug is for the treatment of ischemic stroke. The clinical endpoint for stroke is based on subjective cognitive tests. Functional Cl
Slide 45: BXT Optimizes Prior Technology
BXT - 25 Optimizes Prior Technology 45
Slide 46: Hemopure Research Supports Bioxytran's Value
Hemopure Research Supports Bioxytran’s Value • BXT - 25 delivers optimum oxygen type to tissues • Increases measurable oxygen tissue levels • Restores organ functionality • Mitigates Hemopure’s side effects (nitric oxygen scavenging) 46
Slide 47: BIXT Strategy: Add Molecule to Enhance Efficacy
BIXT Strategy: Add Molecule to Enhance Efficacy Celgene repurposed thalidomide which created a $74 billion purchase by Bristol Myers Squibb in 2019 - First approval in 1957 as a sedative – sleeping pill - Few years later marketed as anti - nausea/morning sickness drug - Pulled from market after 10K
Slide 48: Big Opportunities Potential for BXT
Big Opportunities Potential for BXT - 25 Johnson & Johnson – Oncology , Neuroscience , Immunology , Cardiovascular , Vaccines, HIV Roche Holdings – Oncology , Neuroscience , Immunology , Hematology , Ophthalmology Pfizer – Oncology , Neuroscience , Cardiovascular , Diabetes Novartis – Oncology , Neu
Slide 49: Licensing Zone
Licensing Zone • Complete safety studies in healthy human patients • Target coma patients for initial studies • Create credibility of third vital sign with influencers • Raise $10 million in equity related financing • Identify and approach key target licensees • Attract research coverage and institu
Slide 50: Bioxytran Plan for FDA Approval
Activities Month 1 - 3 Month 4 - 6 Month 7 - 9 Month 10 - 12 Month 13 - 15 Month 1 6 - 1 8 Month 19 - 21 Month 21 - 24 Development & Manufacturing Pre - Clinical & IND submission Phase I Phase II Phase III 8. Phase III • Stroke Patients (300) • National Institute of Health Stroke Score (NIHSS) Endpo
Slide 51: Leadership
Leadership MANAGEMENT David Platt, Ph.D/CEO Ph.D in Chemical Engineering, Hebrew University of Jerusalem; Weizmann Institute; Founder of five public Bio - Tech companies over a 25 year period with a combined market capitalization of more than $1.5 billion Elena Chekhova , Ph.D /Chief Scientist Ph.D
Slide 52: BioXyTran, Inc. contact
BioXyTran , Inc. 233 Needham St., Suite 300 Newton MA, 02464 (617) - 454 - 1199 www.bioxytraninc.com David Platt david.platt@bioxytraninc.com (617) - 510 - 2539