Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — World Vaccine Congress - Europe 2023

22 slides from Tonix Pharmaceuticals's conference presentation, Oct 19, 2023

  1. Slide 1: TNX-801: A Novel Mpox Vaccine (Horsepox Platform) to Enhance Preparedness and Global Vaccine Equity

    TNX - 801: A Novel Mpox Vaccine (Horsepox Platform) to Enhance Preparedness and Global Vaccine Equity Zeil Rosenberg MD, MPH Executive Vice President, Medical World Vaccine Congress - Europe October 18, 2023 © 2023 Tonix Pharmaceuticals Holding Corp.

  2. 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

  3. Slide 3: Tonix Pharmaceuticals

    3 Tonix Pharmaceuticals • NASDAQ traded, commercial stage biopharmaceutical company • Focus: CNS (incl. 2 commercial), Long Covid, and Infectious Disease • Poxvirus – based Vaccine program: • Mpox/Smallpox (TNX - 801) • COVID (TNX - 1800) Infectious Disease R&D Center (RDC) – Frederick, MD Accelerat

  4. Slide 4: In 1796 Edward Jenner Successfully Used Vaccination to Protect Against Smallpox

    4 In 1796 Edward Jenner Successfully Used Vaccination to Protect Against Smallpox • Jenner reasoned infection with illness similar to smallpox, but less deadly, could protect against smallpox ‒ “Jenner “vaccinated” ( vacca , Latin for “cow”) a patient with pustule matter from “cowpox” sores on a mil

  5. Slide 5: Vaccinia Induces a Skin Reaction Called "Take" Described by Dr. Edward Jenner

    5 Vaccinia Induces a Skin Reaction Called “Take” Described by Dr. Edward Jenner * Example of major cutaneous reaction, or “take,” resulting from a replication - competent live - virus vaccine with intradermal delivery, indicating successful vaccination 1,2 5 mm Vaccine Intradermal (intra - epidermal

  6. Slide 6: Development

    6 TNX - 801 Development • U.S. smallpox vaccine manufactured in 1902 (H.K. Mulford) ‒ 99.7% similar to horsepox in core viral sequence 1,2 • Tonix - 801 is based on a sequence of an isolated horsepox (HPXV) clone 3 − Synthesized 4 in 2018 (isolate was unavailable outside of CDC) − No new gene elemen

  7. Slide 7: Illustrative Safety Spectrum of Pox-based Vaccine Vectors

    7 Illustrative Safety Spectrum Of Pox - based Vaccine Vectors Optimizing Live Virus Vaccines Very safe but high, multiple dose ~1 death per million ~10 deaths per million Nonreplicating Poor Transgene immunogenicity Waning immunity Robust Replication Risk for Adverse Events Parental smallpox vaccine

  8. Slide 8: Characterization of Platform: Naturally Attenuated Relative to VACV Based Vaccines

    8 Characterization of TNX - 801 Platform: Naturally Attenuated Relative to VACV Based Vaccines (Smallpox) Plaque Size - V A C V ( ∼ 3 - 4 mm) TNX - 801 ( ∼ 1 - 2 mm) Smallpox Vaccines © 2022 Tonix Pharmaceuticals Holding Corp.

  9. Slide 9: Characterization of Platform: Naturally Attenuated Relative to VACV Based Vaccines

    9 Characterization of TNX - 801 Platform: Naturally Attenuated Relative to VACV Based Vaccines (Smallpox) » TNX - 801 is attenuated in vitro relative to all VACV (WR, IHD, Lis, NYC) ▪ Immortalized NHP cell lines: • Up to 119 - fold ▪ Primary Human cells 1) Dermal Track 2) Respiratory Track • Up to 2

  10. Slide 10: Characterization of Platform: Murine Model Mpox Clade 1 Challenge

    10 Characterization of TNX - 801 Platform: Naturally Attenuated Relative to VACV Based Smallpox Vaccines Murine Model : Mpox Clade 1 Challenge Immunocompromised mice with deficiencies in the IFN - α and/or IFN - γ receptors. 1000x more attenuated than older VACV - based vaccines © 2022 Tonix Pharmac

  11. Slide 11: 11 © 2023 Tonix Pharmaceuticals Holding Corp.

    11 © 2023 Tonix Pharmaceuticals Holding Corp.

  12. Slide 12: Vaccination and Lethal Challenge in Macaques

    12 TNX - 801 Vaccination and Lethal Challenge in Macaques “Take” observed in all TNX - 801 vaccinated NHPs except one. • If no take by day 7 NHPs were revaccinated on day 14. Post - vaccination, no NHP showed lesions during first 60 days TNX - 801 (High Dose) TNX - 801 (Low Dose ) © 2023 Tonix Pharm

  13. Slide 13: Immunogenicity: Neutralizing Antibody (PRNT Assay)

    13 Immunogenicity: Neutralizing Antibody (PRNT 50 Assay) 88% of TNX - 801 vaccinated NHPs had neutralizing antibody responses 8 - to 50 - fold from baseline © 2023 Tonix Pharmaceuticals Holding Corp.

  14. Slide 14: Measured Virus Shedding: Oral Swabs

    14 Measured Virus Shedding: Oral Swabs TNX - 801 (High Dose) © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801 (Low Dose) rVACV Mock Minimal or no virus shedding in Tonix - 801 vaccinated groups

  15. Slide 15: Clinical Signs After MPXV Challenge

    15 Clinical Signs After MPXV Challenge NHPs vaccinated with Tonix - 801: No lesions observed after MPXV challenge in any of the eight animals 1 Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of

  16. Slide 16: Clinical Disease: Lethality

    16 Clinical Disease: Lethality No deaths in Tonix - 801 vaccinated groups © 2023 Tonix Pharmaceuticals Holding Corp.

  17. Slide 17: Study Conclusions for Non-Human Primate Challenge

    17 © 2023 Tonix Pharmaceuticals Holding Corp. Study Conclusions for TNX - 801 Non - Human Primate Challenge • A single dose vaccination was well tolerated ‒ No severe adverse events • Vaccination was immunogenic • Mpox disease (lesions) was not observed following MPXV (Zaire) challenge • All vaccina

  18. Slide 18: Efficacy of Current Vaccines - RWE Mpox

    18 Efficacy of Current Vaccines - RWE Mpox • Jynneos - Most recent data • Earliest study had VE 86% but CI was 59% - 95 %1. • More recent data towards bottom of CI. • CDC US National Study 2 • Epic Database : 173 million persons capturing 2193 mpox cases • 2 dose adjusted VE 66.0% (CI 47.4 - 78.1) •

  19. Slide 19: Do we need an additional approved Mpox vaccine?

    19 © 2023 Tonix Pharmaceuticals Holding Corp. Do we need an additional approved Mpox vaccine? • Durable Immunity • Attenuated for safety • One dose microneedle • Improve compliance • Reduce administrative burden in epidemic setting • Ring vaccination strategy • Proven effective for disease eradicati

  20. Slide 20: Global Vaccine Equity

    20 © 2023 Tonix Pharmaceuticals Holding Corp. Global Vaccine Equity : TNX - 801 • Epidemic continues in Africa 1 • Distribution and Finance are significant barriers 2 • Developed countries ordered nearly all available and future doses of mpox vaccine 3 • Africa access to vaccines is patchy or non -

  21. Slide 21: Investigators and Collaborators

    21 © 2022 Tonix Pharmaceuticals Holding Corp. Investigators and Collaborators Tonix • Seth Lederman • Siobhan Fogarty • Sina Bavari • Scott Goebel • Bruce Daugherty • Farooq Nasar • Helen Stillwell 1 Univ. of Alberta • Ryan Noyce • David Evans Current Addresses 1 University of Pennsylvania 2 IITRI U

  22. Slide 22: Thank You

    THANK YOU © 2023 Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Holding — World Vaccine Congress - Europe 2023 on 6ix