Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Biotech Showcase 2023
30 slides from Tonix Pharmaceuticals's conference presentation, Jan 10, 2023
Slide 1: COVID antiviral agents: anti-SARS-CoV-2 Spike Protein Monoclonal Antibodies
© 2023 Tonix Pharmaceuticals Holding Corp. Biotech Showcase COVID antiviral agents: anti - SARS - CoV - 2 Spike Protein Monoclonal Antibodies for Treatment and Prevention of COVID - 19 Version 1145 January 7, 2023 (Doc 0402)
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2023 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
Slide 3: Who We Are
3 © 2023 Tonix Pharmaceuticals Holding Corp. Who We Are Tonix Pharmaceuticals is committed to improving population health by inventing and developing innovative therapies and vaccines, through broad in - house capabilities and creative collaborations , to help address important unmet needs. OUR MISS
Slide 4: Investment Highlights
4 © 2023 Tonix Pharmaceuticals Holding Corp. Investment Highlights DIVERSE PIPELINE Tonix’s c ore focus is on central nervous system disorders , but we also target unmet needs across multiple therapeutic areas including immunology, infectious disease and rare disease. STRATEGIC PARTNERSHIPS Partneri
Slide 5: Pipeline: Key Programs
5 © 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Programs Candidates* Indication Status/Next Milestone TNX - 102 SL 1 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (PASC 2 ) Mid - Phase 3 Phase 2, Targeted 2Q 2023 Start Phase 2 TNX - 1300 3 Cocaine Intoxication - FDA Br
Slide 6: TNX-1500 Next Generation anti-CD40 Ligand Antibody
© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1500* Next Generation ߙ - CD40 Ligand (CD40L) Antibody The CD40 - CD40L pathway is a pivotal immune system modulator and a well - established and promising treatment target First Generation: Development halted due to thromboembolic (TE) complications
Slide 7: Infectious Disease Portfolio: Internal Development & Manufacturing Capabilities
7 © 2023 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 di
Slide 8: Infectious Disease: Anti-SARS-CoV-2 Monoclonal Antibodies
© 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: Anti - SARS - C o V - 2 MONOCLONAL ANTIBODIES
Slide 9: Immunocompromised People at Increased Risk of Severe COVID-19
9 © 2023 Tonix Pharmaceuticals Holding Corp. 9 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
Slide 10: Timeline of COVID-19 and Availability of mAb Therapeutics
10 © 2023 Tonix Pharmaceuticals Holding Corp. 10 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 - authorizati
Slide 11: Timeline of COVID-19 and Availability of mAb Therapeutics
11 © 2023 Tonix Pharmaceuticals Holding Corp. 11 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 - authorizati
Slide 12: Available Monoclonal Antibodies Are Losing Activity as Variants Arise
12 © 2023 Tonix Pharmaceuticals Holding Corp. 12 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 varied as the dominant circulating variant changed 1,2 1 https://www.covid19trea
Slide 13: Need for a Strategy to Frequently Update Monoclonal Antibodies
13 © 2023 Tonix Pharmaceuticals Holding Corp. 13 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
Slide 14: Fully Human anti-SARS-CoV-2 Monoclonal Antibody Platform TNX-3600
© 2023 Tonix Pharmaceuticals Holding Corp. 14 Fully Human anti - SARS - CoV - 2 Monoclonal Antibody Platform TNX - 3600 1 : COVID - 1 9 Therapeutic and Preventive Agents 14 Collaboration with Columbia University Fully human mAbs generated from SARS - CoV - 2 + asymptomatic individuals or COVID - 19
Slide 15: Live Virus In Vitro Neutralization Assay: TNX-3607
15 © 2023 Tonix Pharmaceuticals Holding Corp. 15 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
Slide 16: Comparing Development Platforms for Novel anti-SARS-CoV-2 Monoclonal Antibodies
16 © 2023 Tonix Pharmaceuticals Holding Corp. 16 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.
Slide 17: Humanized Murine anti-SARS-CoV-2 Monoclonal Antibodies TNX-3800
© 2023 Tonix Pharmaceuticals Holding Corp. 17 Humanized Murine anti - SARS - CoV - 2 Monoclonal Antibodies TNX - 3800 1 : COVID - 1 9 Therapeutic and Preventive Agents 17 Licensed from Curia Global Humanized mAbs generated from SARS - CoV - 2 + mice immunized with SARS - CoV - 2 spike protein 3 Pote
Slide 18: Human and Mouse Genomes Encode Different Repertoires for Antibody Production
18 © 2023 Tonix Pharmaceuticals Holding Corp. 18 Human and Mouse Genomes Encode Different Repertoires of Component Regions for Antibody Production V/D/J heavy chain gene segments and V/J light chain gene segments undergo recombination during B - cell development, and are then mixed and matched to pr
Slide 19: Mouse-derived Antibodies May Retain Broad Neutralizing Activity Against Variants
19 © 2023 Tonix Pharmaceuticals Holding Corp. 19 Mouse - derived Antibodies May Offer an Advantage in Retaining Broad Neutralizing Activity Against Novel Viral Variants SARS - CoV - 2 circulating in the human population is under constant selective pressure to evade antibodies produced by billions of
Slide 20: Potential for Longer Period of Time for Mouse-Derived anti-Spike Antibodies
© 2023 Tonix Pharmaceuticals Holding Corp. 20 • Mice have a different repertoire of antibodies 1 ‒ Bind to different epitopes than human - derived antibodies • Widespread, global COVID and SARS - CoV - 2 infection are putting selective pressure on SARS - CoV - 2 to evade human antibody repertoire ‒
Slide 21: COVID-19 mAb Development Has Been a Whack-a-Mole
21 © 2023 Tonix Pharmaceuticals Holding Corp. 21 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
Slide 22: Assemble a Diverse Inventory of Monoclonal Antibodies to Match Variants
22 © 2023 Tonix Pharmaceuticals Holding Corp. 22 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
Slide 23: Platform Designed to Maintain a Diverse Inventory of Monoclonal Antibodies
23 © 2023 Tonix Pharmaceuticals Holding Corp. 23 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 -
Slide 24: Desired Inventory vs Current Situation
24 © 2023 Tonix Pharmaceuticals Holding Corp. 24 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
Slide 25: Murine-Derived Antibodies Provide Diversity in the Therapeutic Arsenal
25 © 2023 Tonix Pharmaceuticals Holding Corp. 25 Murine - Derived Antibodies Provide Diversity in the Monoclonal Antibody Therapeutic Arsenal Human Antibodies • Faster to develop/deploy in response to new variants or pathogens • May lose efficacy as new variants arise Mouse Antibodies • Slower devel
Slide 26: Future of COVID-19 mAb Therapeutics and Prophylactics
© 2023 Tonix Pharmaceuticals Holding Corp. 26 • 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
Slide 27: Future Outlook
© 2023 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK
Slide 28: Milestones: Recently Completed and Upcoming
28 © 2023 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming* Expected Clinical Trial Initiations □ 1 st Quarter 2023 Phase 2 study start of TNX - 1900 for the treatment of migraine □ 1 st Quarter 2023 Phase 2 study start of TNX - 1300 for the treatment of cocaine intoxi
Slide 29: Management Team
29 © 2023 Tonix Pharmaceuticals Holding Corp. Management Team Seth Lederman, MD Co - Founder, CEO & Chairman Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer
Slide 30: Thank You
© 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU
Tonix Pharmaceuticals Holding — Biotech Showcase 2023 on 6ix