Bioxytran, Inc. · OTC:BIXT
Bioxytran — Investor Presentation (September 2023)
42 slides from Bioxytran's investor presentation, September 2023
Slide 1: Galectin Antagonists in Long-COVID
Galectin Antagonists in Long-COVID 1 Copyright © Bioxytran 2022. All rights. Version 2.01.01 1
Slide 2: Forward Looking Statement
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
Slide 3: What is Long-COVID?
What is “Long-COVID”? Terminology Long COVID, Long Haulers, Long-term COVID, Post-COVID conditions (PCC), Post-acute sequelae of SARS-CoV-2 infection (PASC), Post COVID-19 Syndrome (PCS) An Insidious COVID that Lingers • Lack of return to the usual state of health • Not explained by an alternative d
Slide 4: 1 in 5 with COVID have Long COVID
Long Covid: Disabling America • 651-1002 million estimated cases worldwide • Lost work days: 1.6 million full-time equivalent workers • $3.7 trillion3 estimated economic burden • 7.5%4 of people report having long-COVID 1 in 5 with • Quality of life decreases5 COVID have Long COVID • CDC estimates t
Slide 5: Long Covid Symptoms
Long Covid Heart Chest Tightness Head Chest Pain Symptoms Palpitations Tinnitus Earache Sore throat The Most commonly reported Sinus pain Lungs Dizziness symptoms of ongoing Loss of taste and/or smell Breathlessness symptomatic COVID-19 and Cough Symptoms of depression Symptoms of anxiety post-COVID
Slide 6: Mapping ACE2 (72 Tissues)
Mapping ACE21 (72 Tissues) ACE2 Facilitates Viral Spread to Organs Residual infection in affected tissues lead to Long-COVID symptoms 1https://www.frontiersin.org/articles/10.3389/fmed.2020.594495/full Copyright © Bioxytran 2022. All rights. Version 2.01.01 6
Slide 7: Long-COVID Theories
Long-COVID Theories Viral Persistence Organ Damage Microclots Autoimmune response Dysbiosis Copyright © Bioxytran 2022. All rights. Version 2.01.01 7
Slide 8: Viral Persistence/Pathogen Remnants
8 Viral Persistence/Pathogen Remnants • Evidence that there’s active virus in tissues up to 9 months after infection1 • Paxlovid treatment lowers incidence of long-COVID2 (9.43 lowered to 7.11 per 100) • Ongoing viral replication/viral reservoirs might drive Long-COVID • Persistence of viral remnant
Slide 9: Tissue Damage and Microclots
9 Tissue Damage and Microclots • Galectin-3 is a DAMP and promotes coagulation • Galectins promote fibrosis/scarring and are being studied as antifibrotics • ProLectin-I blocks various galectins including 1 and 3 1https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4357586/ 2https://www.sciencedirect.com/s
Slide 10: Microclots
10 Microclots A central role for amyloid fibrin microclots in long COVID/PASC: origins and therapeutic implications1 • Microclots formed by aberrant amyloid fibrin triggered by the spike protein. • Microclots present novel antigens that lead to production of autoantibodies, exacerbating symptoms. Fl
Slide 11: Autoimmunity
11 Autoimmunity • Inflammation or autoimmunity might drive Long- COVID symptoms • Galectins are drivers of inflammation and are implicated in autoimmunity • Prolectin-I may have a beneficial effect in reducing autoimmune reactivity • Iwasaki says galectin-1 is elevated in long-COVID2 https://www.med
Slide 12: Dysbiosis/Reactivation
12 Dybiosis/Reactivation • Disruption of flora and subsequent reactivation of latent viruses (EBV) may cause long-COVID symptoms • ProLectin has not been tested against EBV yet, but has demonstrated broad-spectrum activity with other viruses Copyright © Bioxytran 2022. All rights. Version 2.01.01 12
Slide 13: Heterogeneous Disease = Clinical Trial Challenge
Heterogeneous Disease = Clinical Trial Challenge Testing Long COVID & Determining Endpoints § No validated tests/diagnostics § No industry guidance on endpoints Short Long-Haulers: 9 months Long Long-Haulers: Over 9 months Copyright © Bioxytran 2022. All rights. Version 2.01.01 13
Slide 14: Inspiration For Glycovirology
Inspiration For Glycovirology Adhesion Drug Entry Inhibitor • Common means of viral adhesion: surface lectins • Galectin Fold discovered on spike protein in a combining with carbohydrates conserved region • Carbohydrates can block surface lectins. • Interfere with spike protein activation • Galectin
Slide 15: Galectins Explained
Galectins Explained A Galectin is a protein that recognizes carbohydrates and modulates intra cellular and extracellular interactions primarily related to the immune system. In some cases, Galectins act as a glue bringing molecules such as surface receptors together. The major focus of research is o
Slide 16: Galectin Inhibition MOA
Galectin Inhibition MOA • Binding to the spike protein in Blood • Liver removes carbohydrates drug and virus. • Restoration of Adaptive immune system – peel off galectin plaque • Adaptive immune system creates long term immunity Copyright © Bioxytran 2022. All rights. Version 2.01.01 16
Slide 17: Neutralizing the Spike Protein
Neutralizing the Spike Protein How it Works No Sugar Shield Shielded in Sugar antibody Galectin Fold Ideal Binding Site Binding to the spike protein prevents viral entry Conserved binding site Common to all variants Immensely tighter bond to galectin fold vs tip (Prolactin-RX 99% binding affinity) A
Slide 18: Complex Carbohydrate Design Using Advanced NMR Spectroscopy Techniques
Complex Carbohydrate Design Using Advanced NMR Spectroscopy Techniques 1 Galectin approach to lower covid transmission - Drug Development for clinical use Copyright © Bioxytran 2022. All rights. Version 2.01.01 18
Slide 19: Galectin Antagonist Tags Virus For Elimination
Galectin Antagonist Tags Virus For Elimination Theoretical Mechanism of Action Virus Galectin Antagonist Liver Filtration Human Cells Approach used for the 1st Time in History of Drug Development Bioxytran Copyright ©Copyright © Bioxytran 2022. All rights. 2022. All rights. Version 2.01.01 19
Slide 20: Galectin Trouble-Maker
Galectin Trouble-Maker The Center of Inflammatory Feedback Loops • Gal-3 is a Pro-inflammatory Molecule • Inhibiting it blocks cycle of inflammation • Galectin is the KEY modulator of inflammatory molecules http://jpet.aspetjournals.org/content/351/2/336 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC
Slide 21: PCR Test Data (Blinded Phase 2)
PCR Test Data (Blinded Phase 2) • Cycle Threshold (Ct) values are used to assess infectivity of the patient using a nasal pharyngeal test. Lower values are a proxy for higher viral loads and increased infectivity. Values over 29 are considered PCR negative. Starting Ct values of patients were under
Slide 22: PCR Test Phase 2 Data
PCR Test Phase 2 Data • Day 3 – 14 out of 17 were PCR negative (88%) • Day 7 – 17 out of 17 were PCR negative (100%) n = 34 ProLectin-M Ct Values Unblinded Data n=34 • No toxicity signals • Randomized 1:1 • Double Blind Placebo Controlled Trial Actual results show tight grouping btw treated arm and
Slide 23: ProLectin-M vs Pfizer's Paxlovid
ProLectin-M vs Pfizer’s Paxlovid • Day 3 – 14 out of 17 were PCR negative (88%) • Day 20 PCR negative (30%) • Day 7 – 17 out of 17 were PCR negative (100%) n = 34 • Toxicity (Drug to Drug Interactions) • No toxicity signals • Limited to Underlying Medical • Randomized 1:1 Conditions • Double Blind P
Slide 24: Elimination of Viral Rebound
Elimination of Viral Rebound Paxlovid rebound was common after day 10 There were no rebounds within 14 days. 1Galectin approach to lower covid transmission - Drug Development for clinical use (medRxiv.org) Copyright © Bioxytran 2022. All rights. Version 2.01.01 24
Slide 25: Elimination of Viral Rebound
Elimination of Viral Rebound Frequency of COVID-19 symptoms in the Paxlovid rebound was common after day 10 study groups before and after treatment 1Galectin approach to lower covid transmission - Drug Development for clinical use (medRxiv.org) 2An Oral Galectin Inhibitor in COVID-19—A Phase II Rand
Slide 26: Clinical Trial Results Summary
Clinical Trial Results Summary Elimination of the viral load and symptoms within 5 days Reduction of infectivity Quieting the cytokine storm Robust antibody response (Post Infection Immunization Copyright © Bioxytran 2021. 2022. All rights. Version 2.01.01 26
Slide 27: Glycovirology Pipeline
Glycovirology Pipeline Drug & Process Development Cleared Completed Planned IND Product Indication Preclinical Phase I Phase II Phase III Phase IV Submission Virology – Mild to Moderate ProLectin-M • Covid-19 Oral Virology – Severe cases ProLectin-I • Covid-19 Intravenous • Long Covid Fibrosis: ProL
Slide 28: BioXyTran, Inc. Contact
BioXyTran, Inc. 233 Needham St., Suite 300 Newton MA, 02464 (617)-454-1199 www.bioxytraninc.com info@bioxytraninc.com 28 Copyright © Bioxytran 2022. All rights. Version 2.01.01 28
Slide 29: Hypoxia Science Research Won the Nobel Prize in 2019
Hypoxia Science Research Won the Nobel Prize in 2019 BIOXYTRAN World Leaders in the Field of Hypoxia • Bioxytran has the only FDA approved device to measure tissue oxygenation. • Its MDX Viewer quantify hypoxia (measuring the efficacy of treatments). • Bioxytran has a molecule (BXT-25) to deliver ox
Slide 30: Theory of the Cellular Universe
Theory of the Cellular Universe This is the E=mc2 for cells Delivering Oxygen to Tissues Reduces Hypoxia: Reduced Hypoxia Improves the Condition of Tissues Theory Predicts Cellular Interaction within the Tissue Micro-Environment https://www.nobelprize.org/prizes/medicine/2019/press-release/Nobel Pri
Slide 31: Defeating the Outbreak – A Simple Plan
Defeating the Outbreak – A Simple Plan Time a luxury we don’t have. Use of Virus Drugs • Containing the disease takes time Only Viable Option to Treat Symptoms • Developing a vaccine take time • Learning how it transmitted takes time Distribution of drugs a real challenge in • Use of antiretrovirals
Slide 32: 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 oxygenat
Slide 33: Solution: BXT-25 an Oxygen Bridge
Erythrocyte Hemoglobin Heme Solution: BXT-25 an Oxygen Bridge BXT-25 polymer • 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
Slide 34: Continuous Real-time In-vivo Tissue Spectroscopy
34 Continuous Real-time In-vivo Tissue Spectroscopy Copyright © Bioxytran 2022. All rights. Version 2.01.01 34
Slide 35: FDA Approved Proprietary Companion Diagnostics
FDA Approved Proprietary Companion Diagnostics MDX Viewer - A clinical end-point for measuring oxygen delivery to the brain in real-time Tissue/brain monitored parameters Mitochondrial NADH Brain metabolic score (ATP) 90 Hb Saturation (O2) Cerebral Blood Flow Tissue Reflectance Tissue metabolic scor
Slide 36: Science Behind Galectin Antagonists
Science Behind Galectin Antagonists 4000+ Clinical Research Journal Articles on Target Receptors Proven Safety Profile in Drug Class Peer-reviewed clinical trial in COVID-19 Galectin Inhibitors in phase 2 & 3 30+ years trials for IPF, NASH, Cancer, Atopic of research in Galectins, Dermatitis, Psoria
Slide 37: Galectin Antagonist Treatment Results in Spike Protein Specific Antibody Immunity
Galectin Antagonist Treatment Results in SARS-CoV-2 Spike Protein Specific Antibody Immunity Introducing Post Infection Immunization Galectin antagonists clear the blood of viral load thereby reducing the strain on the Innate immune system so the Adaptive immune system can build a robust response to
Slide 38: Galectin-3 Upregulated
Galectin-3 Upregulated Virally infected cells upregulate Gal-3 which is used in the budding process of virion. When cells burst after the nuclear material is used up it goes into the inflammatory environment. Effect of Elevated - Galectin-3 Galectin-3 plaque creates CD8+ T-Cell Anergy. Gal- 3 also p
Slide 39: Galectin Effect (T-Cell Anergy)
Galectin Effect (T-Cell Anergy) Galectins are responsible for T-Cell anergy and prevent the LFA-1 lectins (depicted in blue) from coalescing at the target cell and developing good adhesion in order to destroy it with cytotoxins. SAME MOA IN VIRUSES https://www.deduveinstitute.be/sites/default/files/
Slide 40: Proposed Clinical Trial Design
Proposed Clinical Trial Design Clinical Trial • 408 participants • Double Blind Randomized Controlled Trial (DBRCT) • Change in seropositivity at day 14 • Broad inclusion criteria (Vaccination status irrelevant) Copyright © Bioxytran 2022. All rights. Version 2.01.01 40
Slide 41: Galectins Linked to Chronic Disease
Galectins Linked to Chronic Disease 30 years of Over 4000 Journal Galectins are a key No approved Galectin research articles on Galectins biomarker of chronic inhibitor - YET disease Disease Indication Journals Areas of Focus Cancer 1500 Cervical, Breast, Endometrial, Pancreatic, Thyroid, CRC, Bioma
Slide 42: MDX Monitoring for Acute Respiratory Distress Syndrome (ARDS)
42 MDX Monitoring for Acute Respiratory Distress Syndrome (ARDS) Systemic vital parameters (probe 3) Power Electronics Supply Light Source Unit & Embedded Photoplethysmography Computer analysis Detection Unit System Systemic vital parameters (probe 2) Panel Computer Parameters: Core Temperature Copy