Bioxytran, Inc. · OTC:BIXT

Bioxytran — Investor Presentation (August 2023)

43 slides from Bioxytran's investor presentation, Aug 25, 2023

  1. Slide 1: Science Behind Galectin Antagonists

    $BIXT Science Behind Galectin Antagonists First line of defense against Coronaviruses Copyright © Bioxytran 2022. All rights. Version 2.01.01

  2. Slide 2: Inspiration For Glycovirology

    Inspiration For Glycovirology Adhesion Drug Entry Inhibitor • Most common means of viral adhesion are • Galectin Fold discovered on spike protein in surface lectins combining with carbohydrates a conserved region • Carbohydrates block surface lectins. • Interfere with spike protein activation • Gale

  3. Slide 3: 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 together. The major focus of research is on extracellular interaction

  4. Slide 4: Galectins Linked to Chronic Disease

    Galectins Linked to Chronic Disease 30 years of Over 4000 Journal Galectins are a key No approved research articles on Galectins biomarker of chronic Galectin inhibitor - disease YET Disease Indication Journals Areas of Focus Cancer 1500 Cervical, Breast, Endometrial, Pancreatic, Thyroid, CRC, Bioma

  5. Slide 5: 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/PMC575217

  6. Slide 6: Galectin Linkage to COVID-19

    Galectin Linkage to COVID-19 “People With Underlying Medical Conditions” aka tendency for high galectin serum levels • Cancer • Mental Health • Kidney Disease Conditions • Liver Disease • Obesity • Lung Disease (COPD, • Sickle Cell Anemia Asthma, Cystic • Smoker Fibrosis) • Organ Transplant • Dement

  7. Slide 7: Underlying Conditions Increase Galectin Serum Markers

    “Underlying Conditions” Increase Galectin Serum Markers Galectin-3 & Galectin-9 Serum Levels Rise with the Number of Underlying Conditions https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html Copyright © Bioxytran 2022. All rights. Version 2.01.01 7

  8. Slide 8: Galectins Predict Mortality

    Galectins Predict Mortality Highlights • Assess the utility of Galectin-3 for prognosis prediction This was one of many journal articles that served as a rationale for a Galectin-3 Prognostic Test. • Increased Galectin-3 serum levels are associated with higher risk of death, ICU, and Severe ARDS dev

  9. Slide 9: Galectin Serum Test Data Summary

    Galectin Serum Test Data Summary Results Galectin-3 correlated with many other prognostic predictors tested in our analysis. Moreover, patients with serum levels of Galectin-3 above 35.3 ng/ml had increased risk for mortality, Intensive Care Unit admission and severe Acute Respiratory Distress Syndr

  10. Slide 10: ROC Curve – Galectin-3

    ROC Curve – Galectin -3 High Gal-3 Serum predicting 30 Day Mortality Receiver Operating Characteristic Analysis n=39 Gal-3 Serum >= 35.3 ng/ml 80% sensitivity and 92.1% specificity for mortality prediction. AUC = .906 (95% CI .85-.96, p,.0001) Copyright © Bioxytran 2022. All rights. Version 2.01.01

  11. Slide 11: ROC Curve – WHO Comparison

    ROC Curve – WHO Comparison 5 predictive factors vs 20 factors 5 Clinical Features • Age • Min O2 saturation • Type of Patient • Hydroxycloroquine use • Max Body Temp NYC – Mount Sinai Health Development Cohort N=3,841 Retrospective Analysis N=961 AUC = .91 WHO Recommended Clinical Predictor of COVID

  12. Slide 12: ROC Curve – Other Biomarkers

    ROC Curve – Other Biomarkers IL-6 and CD8 counts Combined ROC curves derived from the model of combined elevated IL-6 (A) ROC curves of each category of T lymphocyte subgroup. (B) ROC curves for each and reduced CD8+ T cell counts and CURB-65 scores in our category of serum cytokines. AUC, area unde

  13. Slide 13: Kaplan Meir Curve – COVID-19

    Kaplan Meir Curve – COVID-19 Gal-3 Serum Levels 100% SURVIVAL Galectin-3 has shown good diagnostic power for severe ARDS (AUC 0.75, Low to moderate levels of Gal-3 serum were not good p =0.001). In this case, using the fixed cut-off of 35.3 ng/ml, we found a prognosticators of ARDS. sensitivity of 7

  14. Slide 14: Kaplan Meir Curve – Chronic Heart Failure

    Kaplan Meir Curve – Chronic Heart Failure Gal-3 Serum Levels Heart Failure Kaplan–Meier curves according to quartiles of baseline galectin-3 values. Log-rank P = 0.048. Q1 galectin-3 values FDA Approved test shows patient stratification Heart Disease <13.63 ng/mL, Q2 13.63–17.63 ng/mL, Q3 17.64– usi

  15. Slide 15: Mortality Risk – Galectin-3 Serum Levels

    Mortality Risk – Galectin -3 Serum Levels Gal-3 Serum Levels COVID-19 Day 12 there is a 60% mortality with high Gal-3 levels upon admission. Similar stratification in Heart Disease based on serum levels. Copyright © Bioxytran 2022. All rights. Version 2.01.01 15

  16. Slide 16: Galectin-9 Prognosticates Severe COVID-19

    Galectin-9 Prognosticates Severe COVID-19 Patients with high levels of Galectin-9 serum are extremely likely to die https://pubmed.ncbi.nlm.nih.gov/33947753/ Copyright © Bioxytran 2022. All rights. Version 2.01.01 16

  17. Slide 17: 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 pr

  18. Slide 18: 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/file

  19. Slide 19: Functions of Galectin-3 in Viral Infections

    Functions of Galectin-3 in Viral Infections Drivers of the Cytokine Storm • Innate Immune System – helping the trafficking of cells • Dampening of adaptive immune system (the CD8+ response) • Feeds the inflammatory cycle of fibrosis. Copyright © Bioxytran 2022. All rights. Version 2.01.01 19

  20. Slide 20: Galectin Linkage to Cancer

    Galectin Linkage to Cancer Binding to the spike protein and acting as entry inhibitor Open Label Clinical Trial demonstrated viral elimination in 2-5 days Zero safety signals. Increased IgG levels on par with vaccinated Makes Keytruda 100% effective if excluded for high Galectin-3 Copyright © Bioxyt

  21. Slide 21: Galectins Modulate Viral Infection

    Galectins Modulate Viral Infection Galectin-1,3, and 9 are modulators of viral infection Gal-1 has been reported to participate in the regulation of COVID-19 influenza A virus infection. An in vitro study showed that Gal-1 expression inhibited the Influenza A (H1N1) virus infection on BEAS-2B (human

  22. Slide 22: High Galectin Expression Leads to Bad Outcomes

    High Galectin Expression Leads to Bad Outcomes What if Galectins Were Galectins are the Smoking Gun of COVID- Blocked? 19 • Extremely accurate predictors of mortality • Galectin serum levels are more accurate than composite scores • Entire disease pathogenesis explained by their MOA • Responsible fo

  23. Slide 23: Patients Treated With Galectin Antagonist Experienced Reductions In Viral Load

    Patients Treated With Galectin Antagonist Experienced Reductions In Viral Load Viral Load Vs. Time N1+N2 Copies/mL Treated Patients Day 1 3 5 7 PL-CIM-002 137080 6970 13180 16340 7.00 PL-CIM-004 4468590 101170 9660 510 PL-CIM-005 159730 15630 410 600 (Log10(average(N1+N2) Copies/mL)) 6.00 PL-CIM-008

  24. Slide 24: Viral Curve Comparison

    Viral Curve Comparison Viral Load Vs. Time Galectin Antagonist Vs. SARS-CoV-2 Historical Control Historical control is taken from a mathematical Symptom Onset Randomization model using longitudinal data across four different 6 studies of symptomatic, untreated cases1 (Log10(average(N1+N2) Copies/mL)

  25. Slide 25: 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

  26. Slide 26: Clinical Trial Result Summary

    Clinical Trial Result Summary Compete elimination of the viral load 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

  27. Slide 27: 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 27

  28. Slide 28: Galectin-3 Ideal Target

    Galectin-3 Ideal Target Coronavirus Receptor Recognition Pattern • Spikes use one or more S1 domains as receptor binding domains (RBD) • Galectin receptors appear to have no effect on viral entry In the viral evolutionary path it appears that the CoV stole a host galectin gene and inserted it at the

  29. Slide 29: Universal Target – Galectin Fold

    Universal Target – Galectin Fold Attaching to the Virus • S1 NTD Region across all Coronaviruses is the ideal Binding site for a Galectin-3 Inhibitor • Monoclonal Antibodies(Mab) cannot take advantage of this spot because the Mab’s are too large. • This includes INFLUENZA Copyright © Bioxytran 2022.

  30. Slide 30: Finding the Virus

    Finding the Virus The Immune System Journal Articles on Target Receptors Virus in the blood Virus in tissue Spreads through blood - Innate Immune System Removing Infected Tissue – Adaptive Immune Copyright © Bioxytran 2022. All rights. Version 2.01.01 30

  31. Slide 31: Clearing the Virus

    Clearing the Virus The Immune System Virus in the blood Virus in diseased Innate Defense tissue • Dendritic Cell Adaptive Defense • Mast Cell • T-Cell (CD4+ CD8+) • Macrophage • B Cell • Natural Killer Cells • Antibodies • Neutrophil • Eosinophil • Basophil • Compliment Protein Copyright © Bioxytran

  32. Slide 32: Targeting the Blood

    Targeting the Blood Galectin Inhibitors eliminates the virus in the blood & build long term immunity • Eliminating the viral load in the blood prevents activation of innate immune response (it does the heavy lifting) • Halting the spread of the disease to other organs and thereby reduces clinical sy

  33. Slide 33: Neutralizing the Spike Protein

    Neutralizing the Spike Protein How it Works No Sugar Shield Shielded in antibody Sugar Conserved Galectin Fold Ideal Binding Site binding site Binding to the spike protein prevents viral entry Common to all variants Immensely tighter bond to galectin fold vs tip (Prolectin-RX 99% binding affinity) G

  34. Slide 34: Key and Lock Mechanism

    Key and Lock Mechanism Galectin Inhibitor Acts as Key and the Galectin Fold is the Lock The tight binding affinity allows the virion stick to the galectin inhibitor like a fly to fly-paper Galectin Inhibitor Key Copyright © Bioxytran 2022. All rights. Version 2.01.01 34

  35. Slide 35: 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 Copyright © Bioxytran 2022. All rights. Version 2.01.01 35

  36. Slide 36: Clinical Research

    Clinical Research https://www.longdom.org/abstract/galectin-antagonist-use-in-mild-cases-of-sarscov2-pilot-feasibility-randomised-open-label- controlled-trial-61087.html Copyright © Bioxytran 2022. All rights. Version 2.01.01 36

  37. Slide 37: Benefits

    Product Benefits Eliminates virus and Promotes stops the spread immunity Easy to transport and No adverse administer effects Conserved binding Universally region resistant to compatible with mutations other therapies Copyright © Bioxytran 2022. All rights. Version 2.01.01 37

  38. Slide 38: Science Behind Galectin Antagonists

    Science Behind Galectin 4000+ Journal Articles Antagonists Clinical Research on Target Receptors Proven Safety Profile in Drug Class Peer-reviewed clinical trial in COVID-19 30+ years Galectin Inhibitors in phase 2 & 3 of research in Galectins, trials for IPF, NASH, Cancer, carbohydrate-binding Atop

  39. Slide 39: End-to-End Solution

    End-to-End Solution ProLectin-M ProLectin-I ProLectin-A ProLectin-F Treatment Oral Intravenous Intravenous Intravenous Combination MDX-Viewer Stage IV (long hauler) oad alL r Vi Viral response r ity ARDS Fibrosis ev e S Elevated Galectin-3 ~20 days Copyright © Bioxytran 2022. All rights. Version 2.0

  40. Slide 40: Technology Comparison

    Technology Comparison Stops the Easy to Resistant to Storage Promotes Safety spread administer mutations Condition Immunity Galectin Antagonists + + + + + + Vaccines - - + - - + Anti-replication drugs + + - - + - Immunomodulatory drugs - - + + + - Regenerative medicine - - - + - - Copyright © Bioxyt

  41. Slide 41: Galectin Antagonist Scalability

    Business Model Galectin Direct cost: Antagonist Scalability 10-12 cents per tablet Chewable tablet formulation Treatment: United States and Worldwide Pharmacopeia Supply of API Learn more 45 tablets (Active Pharmaceutical Ingredients) per bottle, 9 tablets a day Copyright © Bioxytran 2022. All right

  42. Slide 42: 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 42

  43. Slide 43: $BIXT

    $BIXT 233 Needham St., Suite 300 Newton MA, 02464 (617)-454-1199 www.bioxytraninc.com info@bioxytraninc.com Copyright © Bioxytran 2022. All rights. Version 2.01.01

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