Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Technical Presentation (November 2022)

20 slides from Tonix Pharmaceuticals's technical presentation, Nov 30, 2022

  1. Slide 1: Platform for Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal Antibodies

    © 2022 Tonix Pharmaceuticals Holding Corp. Platform for Generating Fully Human anti - SARS - CoV - 2 Spike Therapeutic Monoclonal Antibodies Collaboration with Columbia University Version 1121 November 30 , 2022 (Doc 0391)

  2. Slide 2: Cautionary Note on Forward-Looking Statements

    2 © 2022 Tonix Pharmaceuticals Holding Corp. Cautionary Note on Forward - Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are “forward - looking statements” as defined by the Private Securities Litigat

  3. Slide 3: Immuno-compromised People are at Increased Risk of Severe COVID-19 and Poor Outcomes

    3 © 2022 Tonix Pharmaceuticals Holding Corp. 3 Immuno - compromised People are at Increased Risk of Severe COVID - 19 and Poor Outcomes 1 78% Required hospitalization 34% Required intensive care 27% Required mechanical ventilation In a multicenter study of solid organ transplant recipients with COVI

  4. Slide 4: Timeline of COVID-19 and the Availability of Monoclonal Antibody Therapeutics

    4 © 2022 Tonix Pharmaceuticals Holding Corp. 4 Timeline of COVID - 19 and the Availability of Monoclonal Antibody ( mAb ) Therapeutics and Prophylactics 1 https://www.fda.gov/emergency - preparedness - and - response/mcm - legal - regulatory - and - policy - framework/emergency - use - authorization

  5. Slide 5: Available Monoclonal Antibodies are Losing Their Activity as SARS-CoV-2 Mutates

    5 © 2022 Tonix Pharmaceuticals Holding Corp. 5 However, the Available anti - SARS - CoV - 2 Monoclonal Antibodies are Losing Their Activity as SARS - CoV - 2 Mutates and Evasive Variants Arise The efficacy of any mAb treatment varies as the dominant circulating variant changes 1,2 1 https://www.covi

  6. Slide 6: Need for a Strategy to Frequently Update Monoclonal Antibodies

    6 © 2022 Tonix Pharmaceuticals Holding Corp. 6 Need for a Strategy to Frequently Update Monoclonal Antibodies Current and prior mAb therapeutics were developed in collaborations A platform to quickly develop and test novel SARS - CoV - 2 neutralizing mAbs may represent a significant advancement in t

  7. Slide 7: Comparing Development Platforms for Novel Monoclonal Antibodies

    7 © 2022 Tonix Pharmaceuticals Holding Corp. 7 Comparing Development Platforms for Novel anti - SARS - CoV - 2 Monoclonal Antibodies 1 Vir isolated sotrovimab from the blood of a SARS - CoV - 1 patent 2 Regeneron used both convalescent patient cells and a humanized mouse platform: Hansen J et al. Sc

  8. Slide 8: Fully Human Monoclonal Antibody Platform TNX-3600: COVID-19 Therapeutic and Preventive Agents

    © 2022 Tonix Pharmaceuticals Holding Corp. 8 Fully Human anti - SARS - CoV - 2 Monoclonal Antibody Platform TNX - 3600 1 : COVID - 1 9 Therapeutic and Preventive Agents 8 Collaboration with Columbia University Fully human mAbs generated from SARS - CoV - 2 + asymptomatic individuals or COVID - 19 co

  9. Slide 9: Generation of Fully Human Monoclonal Antibodies (1 of 3)

    © 2021 Tonix Pharmaceuticals Holding Corp. 9 Generation of Fully Human Monoclonal Antibodies (1 of 3) Peripheral Blood Collection Mononuclear Cell Isolation ELISA/ cELISA T - Cell Depletion Fusion with Partner Cell Line IgG/IgA IgM/ IgD MFP - 2S Patients Recover from COVID - 19 Infection

  10. Slide 10: Generation of Fully Human Monoclonal Antibodies (2 of 3)

    10 © 2022 Tonix Pharmaceuticals Holding Corp. 10 Generation of Fully Human Monoclonal Antibodies (2 of 3) ELISA Expression of recombinant Human mAbs in CHO Cells Cloning and Expansion Hybridoma Clones cDNA Cloning of Heavy and Light Chains Recombinant Monoclonal Antibody - Containing Culture Media S

  11. Slide 11: Generation of Fully Human Monoclonal Antibodies (3 of 3)

    11 © 2022 Tonix Pharmaceuticals Holding Corp. 11 Generation of Fully Human Monoclonal Antibodies (3 of 3) Pseudovirus Neutralization Assay Recombinant Purified humAb Live Virus Neutralization Assay In vivo Testing Confirmation of Target Binding and Characterization Analysis of C omplementarity Deter

  12. Slide 12: Live virus in vitro Neutralization Assay: TNX-3607

    12 © 2022 Tonix Pharmaceuticals Holding Corp. 12 Live virus in vitro Neutralization Assay: TNX - 3607* *TNX - 3607 is in the pre - IND stage of development and has not been approved for any indication. -1.0 -0.5 0.0 0.5 1.0 1.5 0 50 100 IC 50 : 5.8 m g/ml -1.0 -0.5 0.0 0.5 1.0 1.5 0 50 100 IC 50 : 0

  13. Slide 13: Therapeutic Monoclonal Antibody Development for COVID-19 Focused on a 'Whack-a-Mole'

    13 © 2022 Tonix Pharmaceuticals Holding Corp. 13 Therapeutic Monoclonal Antibody Development for COVID - 19 has been Focused on a “Whack - a - Mole” 1x1 Monoclonal Antibody v. Variant Battle Delta Omicron 1 Waltz, E. Nature. “Does the World Need an Omicron Vaccine?” 28 Jan 2022 https://www.nature.co

  14. Slide 14: Assemble a Diverse Inventory of Monoclonal Antibodies to Match Circulating Variants

    14 © 2022 Tonix Pharmaceuticals Holding Corp. 14 As the Circulating Mix of SARS - CoV - 2 Variants Changes, it Seems Prudent to Assemble a Diverse Inventory of Monoclonal Antibodies to Match It 1 Callaway, E. Oct 28 2022. Nature (News). COVID ‘variant soup’ is making winter surges hard to predict: D

  15. Slide 15: Platform Designed to Develop and Maintain a Diverse Inventory of Monoclonal Antibodies

    15 © 2022 Tonix Pharmaceuticals Holding Corp. 15 The Platform is Designed to Develop and Maintain a Diverse Inventory of Monoclonal Antibodies to Keep Up with SARS - CoV - 2 “Variant Soup” 1 Currently circulating “Variant Soup” New variants Biotech industry Inventory of available anti - SARS - CoV -

  16. Slide 16: Desired Inventory vs Current Situation

    16 © 2022 Tonix Pharmaceuticals Holding Corp. 16 Desired Inventory Current Situation As the Circulating Mix of SARS - CoV - 2 Variants Changes, it Seems Prudent to Assemble a Diverse Inventory of Monoclonal Antibodies to Match It 1 Callaway, E. Oct 28 2022. Nature (News). COVID ‘variant soup’ is mak

  17. Slide 17: Key Takeaways on Immune-Evading Variants and Need for Extensive mAb Palate

    © 2022 Tonix Pharmaceuticals Holding Corp. 17 • Immune - evading SARS - CoV - 2 variants are arising by divergent and convergent evolutionary processes 1 ‒ Potentially speeded by recombination between variants • To protect immuno - compromised individuals from a changing “soup” of SARS - CoV - 2 var

  18. Slide 18: Investigators and Collaborators

    © 2022 Tonix Pharmaceuticals Holding Corp. 18 • Tonix ‒ Seth Lederman ‒ Bruce Daugherty ‒ Herb Harris ‒ Candace Flint • Columbia ‒ Ilya Trakht ‒ Gavreel Kalantarov ‒ Sergei Rudchenko ‒ Milan Stojanovic Investigators and Collaborators 18 • Texas BioMed ‒ Viraj Kulkarni ‒ Marco Argonza • Chicago BioSo

  19. Slide 19: Infectious Disease Portfolio: Internal Development & Manufacturing Capabilities

    19 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities Infectious Disease R&D Center (RDC) – Frederick, MD • Function: Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other infectious d

  20. Slide 20: Thank You

    © 2022 Tonix Pharmaceuticals Holding Corp. THANK YOU

Tonix Pharmaceuticals Holding — Technical Presentation (November 2022) on 6ix