EX-99.1 4 ex99-1.htm BIOXYTRAN, INC. CORPORATE PRESENTATION, DATED JANUARY 12, 2022

 

Exhibit 99.1

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 MIKE SHEIKH | mike.sheikh@bioxytraninc.com | (509) - 991 - 0245 Corporate Overview

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Forward Looking Statement This Descriptive Presentation (the “Presentation") has been prepared by Bioxytran, Inc (the “Company”) and recipients are not entitled to rely on the accuracy or completeness of the Presentation . Statistical information contained in this Presentation is based on information available to the Company that the Company believes is accurate . It is generally based on publications that are not produced for the purposes of securities offerings or economic analysis . The Company has not reviewed or included data from all sources and cannot assure prospective parties of the accuracy or completeness of the data included in this Presentation . Forecasts and other forward - looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue and market acceptance of products and services . The Company undertakes no obligation to update forward looking information to reflect actual results or changes in assumptions or other factors that could affect those statements . This Presentation has not been filed or reviewed by the Securities and Exchange Commission (“SEC”) or any securities regulatory authority of any state, nor has the SEC or any such authority passed upon the accuracy or adequacy of this Presentation . This Presentation does not constitute an offer to sell or solicitation of an offer to buy any securities . This Presentation does not purport to contain all information which may be material to a prospective party, and recipients of this Presentation should conduct their own independent evaluation and due diligence of the Company . Each recipient agrees, and the receipt of this Presentation serves as an acknowledgment thereof, that if such recipient determines to engage in a transaction with the Company, its determination will be based solely on the terms of the definitive agreement relating to such transaction and on the recipient’s own investigation, analysis and assessment of the Company and the transaction . The Company does not intend to update or otherwise revise this Presentation following its distribution . 2

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 3 Mission Statement Bioxytran is a clinical stage pharmaceutical company developing platform technologies in the fields of Glycovirology, Hypoxia and Degenerative Diseases to eliminate viruses and prolong lifespan using carbohydrate drug design. GLYCOVIROLOGY HYPOXIA DEGENERATIVE DISEASES

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Virology: • Covid - 19 • Influenza • Other virologic diseases Long term symptoms resulting from viral infections (long - hauler): • ARDS • Pulmonary Fibrosis Technology Overview ProLectin Rx – Glycovirology BXT - 25 – Hypoxia & Degenerative Diseases Ischemia: • Stroke • Alzheimer • Dementia • Traumatic Brain Injury Anemia Wound healing ProLectin - M is a licensed technology that targets COVID - 19 mild to moderate cases MDX - viewer is a licensed technology that uniquely allow the company to prove oxygen delivery to tissue. It will be used in clinical trials as a regulatory end - point 4 Oncology and Fibrosis • Cancer Metastasis • NASH • Other Fibrotic condition Platform Overlap

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 ProLectin Rx Glycovirology Version 2.01.01 5

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 New mutations Alpha, Delta, Omicron, ? Variants are complicating the vaccination strategy If herd immunity is unattainable Therapeutic treatments are the ONLY fall back position 80% Herd Immunity 80% level has not been reached World Population Vaccination Not everyone wants to get vaccinated Not everyone has access to vaccines Lower risk of death At risk population Minimize asymptomatic spread not likely to spread without showing symptoms Vaccinations Unknowns (risks) • Duration of protection • Effectiveness against variants • Frequency of boosters • Long Term consequences of Immune system 6 Lingering Effects of COVID - 19 Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 ProLectin - Rx Galectin Antagonists First line of defense against all mutations of Covid - 19 STATUS: SWIFT approval pathway - Phase 3 Ready Universal Universal pandemic therapeutic Tested Complete elimination of mild to moderate cases (phase I/II clinical trials) No limitation No exclusions for age or underlying medical conditions Efficient Eliminate contagion 7

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Treatment ProLectin - M Oral ProLectin - I Intravenous ProLectin - A Intravenous ProLectin - F Intravenous Combination MDX - Viewer End - to - End Solution Stage IV (long hauler) Fibrosis Elevated Galectin - 3 ~20 days ARDS Viral response 8

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 9 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 3 5 7 Viral Load (Log10(average(N1+N2) Copies/mL)) Time (days) Viral Load Vs. Time ProLectin - M Treated Patients PL-CIM-002 PL-CIM-004 PL-CIM-005 PL-CIM-008 PL-CIM-009 1 Galectin Antagonist use in Mild Cases of SARS - CoV - 2; Pilot Feasibility Randomised, Open Label, Controlled Trial (longdom.org) N1+N2 Copies/mL Day 1 3 5 7 PL - CIM - 002 137080 6970 13180 16340 PL - CIM - 004 4468590 101170 9660 510 PL - CIM - 005 159730 15630 410 600 PL - CIM - 008 N/A 2268630 60180 4890 PL - CIM - 009 N/A 2154530 783750 563430 Patient 9 appeared to be an anomaly. Additionally, Patient 8 had no PCR measurement of viral load on day 1, so day 1’s PCR measurement was assumed to equal day 3’s measurement. < 50 copies/ ul Patients Treated With ProLectin - M Experienced Reductions In Viral Load Source; Phase 1 Trial 1

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 10 Viral Curve Comparison 1 A quantitative model used to compare within - host SARS - CoV - 2, MERS - CoV, and SARS - CoV dynamics provides insights into the pathogen esis and treatment of SARS - CoV - 2 (plos.org) 2 Galectin Antagonist use in Mild Cases of SARS - CoV - 2; Pilot Feasibility Randomised, Open Label, Controlled Trial (longdom.org) Historical control is taken from a mathematical model using longitudinal data across four different studies of symptomatic, untreated cases 1 Assumed symptom onset at a viral load of 6500 copies/mL (i.e. log10(3.81)) 1 Patients treated within 2 days of symptom onset (average 1.80 days) 2 Upper and lower bounds of the model are 95% confidence interval 1 0 1 2 3 4 5 6 0 2 4 6 8 10 Viral Load (Log10(average(N1+N2) Copies/mL)) Normalized Time (days) Viral Load Vs. Time ProLectin - M Vs. SARS - CoV - 2 Historical Control Average Untreated Average Treated Symptom Onset Randomization Patients With Day 1 Measurement < 50 copies/ul

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 ProLectin - M Treatment Results in SARS - CoV - 2 Spike Protein Specific Antibody Immunity Introducing Post Infection Immunization ProLectin – M clears the blood of viral load thereby reducing the strain on the Innate immune system so the Adaptive immune system can build a robust response toward future infection. 11

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Galectin Inhibitor Tags Virus For Elimination Copyright © Bioxytran 2022. All rights. 12 Theoretical Mechanism of Action Liver Filtration Galectin Inhibitor Virus Human Cells Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 https:// www.longdom.org /abstract/galectin - antagonist - use - in - mild - cases - of - sarscov2 - pilot - feasibility - randomised - open - label - controlled - trial - 61087.html Clinical Research 13 Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Proposed Phase 3 Clinical Trial Design Phase 3 Clinical Trial • 408 participants • Double Blind Randomized Controlled Trial (DBRCT) • Change in seropositivity at day 14 • Broad inclusion criteria (Vaccination status irrelevant) 14 Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Product Indication Discovery Preclinical Phase I Phase II Phase III Phase IV ProLectin - M Oral Virology – Mild to Moderate • Covid - 19 • Influenza • Other virologic diseases ProLectin - I Intravenous Virology – Severe cases • Covid - 19 • Influenza • Other virologic diseases ProLectin - A* + Oxysense Intravenous combination treatment ARDS resulting from viral infection ProLectin - F* Intravenous Oncology and Fibrosis: • Cancer Metastasis • Pulmonary Fibrosis • NASH • Other Fibrotic conditions Glycovirology Development Pipeline 15 Completed Planned

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Vaccines Immunomodulatory Oxygenation (Ventilators) Regenerative Medicine (Stemcells) ProLectin - Rx □ Unique Galectin Antagonist – Oral/IV Polysaccharide □ It’s not a vaccine, nor an antiretroviral drug Antiretrovirals ( Compete for polymorphism) Therapeutic Approaches for COVID - 19 Version 2.01.01 16 16

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 17 Competitive Landscape Oral COVID - 19 Therapeutics Drug Company Description Gov. Award Clinical stage Molnupiravir Merck Mutagenesis via RdRp – forced mutations induced apoptosis $2.2 billion EUA Paxlovid Pfizer 3CL protease inhibitor – Antiviral & Immune sensitization; Ritonovir – inhibitor enhancer $5.3 billion EUA Tollovir Todos Medical 3CL protease inhibitor – Antiviral & Anti - Cytokine activity n/a Phase 2/3 Tempol Adamis RNA - dependent RNA Polymerase (RdRp) via antioxidant & Anti - Cytokine activity n/a Phase 2/3 ProLectin - M Bioxytran Galectin antagonist – Entry Inhibitor n/a Phase 3

 

 

BXT - 25 – Hypoxia & Degenerative Diseases 18 18 Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 The Brain Stroke Epidemic A Challenge to Worldwide Healthcare, a $500 Billion Medical Indication Costs 19 Region Strokes Population Survivors Direct cost Indirect cost US 0.8 million 330 million 5.8 million $44 billion $22 billion EU (+GB) 1.1 million 515 million 3.4 million $28 billion $16 billion CN 2.5 million 1,402 million 7.5 million estimated $74 billion World (total) 12.2 million 7,700 million 33.0 million estimated $500 billion Global, regional, and national burden of stroke and its risk factors, 1990 – 2019: a systematic analysis for the Global Burden of Disease Study 2019 The Lancet Neurology, Vol 20, Issue 10, October 01, 2021

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 The Golden Hour Dilemma 20 Time to Needle 2.5 hours Equivalent to 9 Years of Aging* Onset of symptoms Ambulance arrives at home Arrival and initial assessment and treatment in ER Thombolysis or PTCA/CABG Blockage Removed * Time Is Brain — Quantified, Jeffrey L. Saver, Stroke. 2006;37:263 – 266

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 21 Solution: BXT - 25 an Oxygen Bridge • BXT - 25 is a hemoglobin - based polymer; 5,000 times smaller than a red blood cell • It can be used both in Ischemic and Hemorrhagic Stroke • It can penetrate a blood - clot and reach the brain within 3 minutes • Reduction of average Time - to - Needle by 90% BXT - 25 polymer Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Copyright © Bioxytran 2022. All rights. Version 2.01.01 22 How It Works? BXT - 25 – Stabilized Oxygen - carrying Protein Erythrocyte Hemoglobin Heme Single O 2 molecule • Delivered as an IV solution • Universally compatible with all blood types • Non - immunogenic • Low viscosity • Stable at room temperature • 3 - year shelf - life in liquid formulation • Extended shelf - life in dry formulation

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Proprietary Manufacturing Process of BXT - 25 Collect controlled source Red blood cells Extract Hemoglobin Protein Purify and crosslink Extract Heme and reattach to a polymer BXT - 25 is mixed with a saline solution, to be IV - infused by an ER team Key Assays for BXT - 25 chemical and structural specifications are: Electron spray Ionization, Amino Acid Analysis, Gel Electrophoresis, Circular Dichroism, Reverse phase HPLC and Immunoblotting 23

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Proof of Concept of BXT - 25 in Animals Middle Cerebral Artery Blockage Model in Rats 24 Hypoxic area 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: (QTest Labs, Columbus OH, 2014) Oxygen delivery and brain recovery in stroke induced rats with similar chemistry to BXT - 25 (Harvard Medical School, 2013) https://www.hindawi.com/journals/ccrp/2014/864237/

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Limited Effective Treatment Options Our competition is tPA and similar drugs, aiming to dissolve, or remove, a clot. These are time - consuming and require an MRI since blood - thinners are fatal in hemorrhagic strokes. THERE ARE NO DRUGS AVAILABLE TO DELIVER OXYGEN TO THE BRAIN BXT - 25 is designed to support the oxygenation of the brain until the clot is dissolved by medication or removed by surgery Drug Company Description rtPA Genentech, Johnson & Johnson Thrombolytic agent used to break apart blood clot that causes ischemic stroke Abciximab Eli Lilly /Centrocor Platelet aggregation inhibitor Cerovive AstraZeneca Nitrone based neuro protectant Candesartan AstraZeneca Angiotensin receptor blocker (ARB) Ancrod Knoll Pharmaceuticals Anticoagulant that acts by breaking down fibrinogen 25

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 How Do We Measure Tissue Oxygen Level? Version 2.01.01 26

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 FDA Approved Companion Diagnostics OXYSENSE - A clinical end - point for measuring oxygen delivery to the brain in real - time Flat probe Treated Aneurysm Tissue/brain monitored parameters Mitochondrial NADH (ATP) Hb Saturation (O 2 ) Cerebral Blood Flow Tissue Reflectance 90 Brain metabolic score Tissue metabolic score Measures real time tissue oxygenation levels Assists in determining organ viability 27

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Degenerative Disease/Hypoxia Development Pipeline Treatment/Device Indication Discovery Preclinical Phase I Phase II Phase III Phase IV BXT - 101 Cancer Metastasis BXT - 102 NASH • Cirrhosis • Fibrosis BXT - 251+ Oxysense Organ Transplantation • Preservation agent • Organ monitoring BXT - 25 Stroke • Ischemic • Hemorrhagic BXT - 252 Wound Healing BXT - 253 Anemia BXT - 255 Traumatic Brain Injury 28 Completed Planned

 

 

Business Development & Strategy 29 29 Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Clinical Trial Strategy 2021 2022 Product Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 ProLectin - M ProLectin - I ProLectin - F ProLectin - A / BXT - 25 Phase I/II Pre - clinical Development Phase I/II Phase III 30 Pre - clinical Development Pre - clinical Development Pre - clinical Development Phase III Phase III Phase I/II Phase I/II

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Business Strategy Business Development Strategy • Collaboration agreement with qualified partner’s • Out - license agreements with Big Pharma Intellectual Property (IP) • One issued US patent (US6245316B1) • Two international patents pending approval • Additional applications to strengthen our IP position are ongoing 31

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 • Johnson & Johnson – Oncology, Neuroscience, Immunology, Cardiovascular, Vaccines, HIV • Roche Holdings – Oncology, Neuroscience, Immunology, Hematology, Ophthalmology • Pfizer – Oncology, Neuroscience, Cardiovascular, Diabetes • Novartis – Oncology, Neuroscience, Immunology, Cardiovascular, Respiratory, Ophthalmology • Merck – Oncology, Neuroscience, Immunology, Cardiovascular, Respiratory, Diabetes, Vaccines • Sanofi Aventis – Oncology, Neuroscience, Immunology, Inflammation, Diabetes, Vaccines • AbbVie – Oncology, Neuroscience, Immunology, Virology • GlaxoSmithKline – Oncology, Immunology, Respiratory, HIV, Vaccines • Eli Lilly – Oncology, Neuroscience, Immunology, Diabetes, Pain • Gilead – Oncology, Respiratory, Hematology, Inflammation, HIV • Bristol Meyers Squibb – Oncology, Immunology, Cardiovascular, Hematology, Inflammation • Allergan – Neuroscience, Ophthalmology, Gastroenterology • AstraZeneca – Oncology, Cardiovascular, Respiratory • Biogen – Oncology, Neuroscience, Inflammation, Stroke , Pain • Amgen – Oncology, Cardiovascular, Hematology, Inflammation Virology Oncology Immunology Respiratory Inflammation Neuroscience Cardiovascular Hematology Stroke IDEAL PLATFORM DRUG FOR MANY BIG PHARMAS THERAPEUTIC AREAS Big Pharma Licensing Targets 32 Copyright © Bioxytran 2022. All rights. Version 2.01.01

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Use of Proceeds Current Round – S - 1     ProLectin - M   ProLectin - I     ProLectin - F     ProLectin - Rx* Estimated Project Cost in thousands USD*   $ 2,700     $ 1,650     $ 1,000     $ 5,350 Development & GLP     -       -       -       - Pre - Clinical     100       150       150       400 IND Submission     150       200       200       550 Clinical Trials     2,000       1,000       500       3,500 G&A     450       300       150       900 End Point     Phase III       Phase II/a       Phase II/a       Total * $2.6 million have previously been spent on proof - of - concept and GMP manufacturing of   ProLectin - M, - I, and - F Future Round     ProLectin - A   BXT - 25     Total Upcoming*     Estimated Project Cost in thousands USD*   $ 10,000     $ 10,000     $ 20,000     Development & GLP     3,150       3,150       6,300     Pre - Clinical     1,200       1,200       2,400     IND Submission     300       300       600     Clinical Trials     4,000       4,000       8,000     G&A     1,350       1,350       2,700     End Point     Phase II/a       Phase II/a       Total     33

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Management David Platt PhD, CEO, CSO, Chairman Carbohydrate chemistry expert, founded four publicly traded companies, raised $150m in public markets, created $1B in shareholder value, and led development of two drugs. Ola Soderquist CPA, MSA, MBA, CFO >30 years multi - industry financial experience. Mike Sheikh, EVP BD >10 years of business development in life sciences. Broker and Research Analyst. Veronika Tyukova MBA, PM Dir >15 years of PM in Hi - Tech, Manufacturing and Commercialization. Board of Directors Anders Utter MBA, Director Audit Committee Chair, >25 years of managerial finance and accounting in medical devices and manufacturing. Dale Conaway DVM, Director Veterinary Medical Officer, Federal Research. Alan Hoberman PhD, Director Executive Director of Site Operations and Toxicology at Charles River Laboratories. Hana Chen - Walden MD, Director >30 years experience in pharmaceutical regulatory affairs in US and Europe . Advisory Board Avraham Mayevsky PhD, Professor Emeritus Worldwide authority in the field of minimal invasive monitoring of tissue and organ physiology; and professor at the Faculty of Life Sciences, Bar - Ilan University, Israel. Alben Sigamani, MD Professor and Head of Clinical Research Narayan Health, Bangalore. >17 years of experience in clinical research Thomaskutty Alumparambil, C.C.P > 30 years of clinical experience that includes heart, lung, and liver transplants. The Team 34

 

 

Copyright © Bioxytran 2022. All rights. Version 2.01.01 Copyright © Bioxytran 2021. All rights. Bioxytran, Inc. 75 2 nd Ave., Suite 605 Needham MA, 02494 (617) - 454 - 1199 www.bioxytraninc.com info@bioxytraninc.com Mike Sheikh mike.sheikh@bioxytraninc.com (509) - 991 - 0245 Version 2.01.01