TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Exhibit 99.2
TNX - 801, A SINGLE - DOSE LIVE VACCINE PLATFORM FOR MPOX AND OTHER EMERGING VIRAL DISEASES: SAFETY, IMMUNOGENICITY, AND EFFICACY Sina Bavari, Ph.D. World Congress on Vaccines July 10 th , 2025 © 2025 Tonix Pharmaceuticals Holding Corp.
2 © 2025 Tonix Pharmaceuticals Holding Corp. DISCLAIMER "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 Litigation Reform Act of 1995 . These statements may be identified by the use of forward - looking words such as “anticipate,” “believe,” “forecast,” “estimate” and “intend,” among others . These forward - looking statements are based on Tonix’s current expectations and actual results could differ materially . There are a number of factors that could cause actual events to differ materially from those indicated by such forward - looking statements . These factors include, but are not limited to, the risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations ; risks related to the failure to successfully market any of our products ; risks related to the timing and progress of clinical development of our product candidates ; our need for additional financing ; uncertainties of patent protection and litigation ; uncertainties of government or third party payor reimbursement ; limited research and development efforts and dependence upon third parties ; and substantial competition . As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products . The forward - looking statements in this presentation are made as of the date of this presentation, even if subsequently made available by Tonix on its website or otherwise . Tonix does not undertake an obligation to update or revise any forward - looking statement, except as required by law . Investors should read the risk factors set forth in the Annual Report on Form 10 - K for the year ended December 31 , 2024 , as filed with the Securities and Exchange Commission (the “SEC”) on March 18 , 2025 , and periodic reports and current reports filed with the SEC on or after the date thereof . All of Tonix's forward - looking statements are expressly qualified by all such risk factors and other cautionary statements . "
TALK OVERVIEW © 2025 Tonix Pharmaceuticals Holding Corp. 1) Background 2) TNX - 801 attenuation in vitro and in vivo 3) TNX - 801 immunogenicity and efficacy in animal models *TNX - 801 is in the pre - IND stage of development and has not been approved for any indication.
POXVIRUSES » Double stranded DNA, ~128 - 456 kb size » Virions: enveloped, brick - shaped » Size: 220 to 450 nm long î 140 to 260 nm wide î 140 to 260 nm thick » Infect vertebrate or invertebrate hosts » Genus Orthopoxvirus : ▪ Human Pathogens: • VARV: Case fatality rate 30 to 50% • MPXV: Case fatality rate 0.1 to 11% ▪ Vaccines: • Vaccinia, Cowpox, Horsepox • Horsepox virus: TNX - 801 © 2025 Tonix Pharmaceuticals Holding Corp.
POXVIRUSES: UBIQUITOUS IN THE ENVIRONMENT © 2025 Tonix Pharmaceuticals Holding Corp.
MONKEYPOX VIRUS (MPOX) © 2025 Tonix Pharmaceuticals Holding Corp. » Endemic in Central and West Africa » Two Clades: 1) Clade I (DRC) 2) Clade IIa (West Africa) and IIb (Nigeria) » Human Case Fatality Rate: ▪ Clade I – 11% ▪ Clade IIa – 3% ▪ Clade IIb – <0.1% » Clade IIb – 2022 Outbreak ▪ 122 Countries ▪ 100,000 Confirmed Cases
VARIOLA VIRUS (SMALLPOX) © 2025 Tonix Pharmaceuticals Holding Corp. » Oldest written record – 3,500 years » Oldest sequences – 1,400 years » Human Case Fatality Rate: 30% » 20 th century – 250 to 500 million deaths » Eradication: 1980
EDWARD JENNER - SMALLPOX VACCINE (1796) » Jenner observed milkmaids were protected from smallpox, reasoned that infection with an illness similar to smallpox but less deadly could protect one against smallpox ▪ “Cowpox” was the name of a disease in cows that could transfer to humans and cause sores ▪ Jenner “vaccinated” (from vacca , Latin for “cow”) a patient with pustule matter from “cowpox” sores on a milkmaid’s hands; that patient remained healthy when challenged with smallpox virus » Jenner suspected that the agent causing cowpox, which he called vaccinia originated in horses and had been transferred from horses to cows’ udders by dirty hands The College of Physicians of Philadelphia. Accessed July 15, 2021. https:/ /w w w.historyofvaccines.org © 2025 Tonix Pharmaceuticals Holding Corp.
SMALLPOX VACCINES © 2025 Tonix Pharmaceuticals Holding Corp. » Vaccine: Cowpox origin » Serial passaging: Humans, cows, and horses (143 years) » Vaccine: Vaccinia Virus (1939) closely related to cowpox but serologically distinct 1 » Multiple Vaccinia virus - based vaccines developed » Smallpox eradication 1 Downie AW. 1939. Br J Exp Pathol 20:158 – 176.
BALANCE OF TOLERABILITY AND REACTOGENICITY FOR POX - BASED VACCINES Well tolerated, Requires high dose, 2 vaccinations ~1 death per million ~10 deaths per million Non - propagating © 2025 Tonix Pharmaceuticals Holding Corp. Robustly Propagating Dryvax Lister TianTan Copenhagen Tashkent MVA NYVAC Canarypox Fowlpox Focus Generation of Replication Deficient
BALANCE OF TOLERABILITY AND REACTOGENICITY FOR POX - BASED VACCINES Well tolerated, Requires high dose, 2 vaccinations ~1 death per million ~10 deaths per million Non - propagating © 2025 Tonix Pharmaceuticals Holding Corp. Robustly Propagating Dryvax Lister TianTan Copenhagen Tashkent MVA NYVAC Canarypox Fowlpox Minimally Replicating Horsepox (TNX - 801)
4 PRONG APPROACH TO MPOX/SMALLPOX VACCINE (TNX - 801) © 2025 Tonix Pharmaceuticals Holding Corp. 1) Well - tolerated 2) Single dose 3) Durable 4) Protection against mpox disease (lesions)
TNX - 801 ATTENUATION IN VITRO AND IN VIVO © 2025 Tonix Pharmaceuticals Holding Corp.
IN VITRO ATTENUATION OF TNX - 801 © 2025 Tonix Pharmaceuticals Holding Corp. » Investigate attenuation of TNX - 801 in vitro relative to VACV strains ▪ Positive Control: VACV - Western Reserve (WR) , VACV - International Health Department (IHD) ▪ Older vaccines used in smallpox eradication: 1) VACV - Lister (Lis) 2) VACV - New York City Board of Health (NYCBH) ▪ New Vaccine: TNX - 801 ▪ Non - replicating control: MVA » In vitro Assays: 1) Plaque phenotype – BSC - 40 and Vero - E6 2) Replication Kinetics ▪ Immortalized non - human primate cell lines ▪ Human primary cells from two main route of poxvirus transmission • Dermal and respiratory tracts
TNX - 801 DISPLAYS SMALL PLAQUE PHENOTYPE VACCINA VIRUSES VACV - Western Reserve (WR) VACV - International Health Department (IHD) VACV - Lister (Lis) VACV - New York City Board of Health (NYCBH) TNX - 801 MVA © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801: REPLICATION IN PRIMARY HUMAN CELLS (DERMAL TRACT) Plaque Assay qPCR TNX - 801: 27 - to 119 - fold more attenuated than VACV based vaccines VACV - Western Reserve (WR) VACV - International Health Department (IHD) VACV - Lister (Lis) VACV - New York City Board of Health (NYCBH) TNX - 801 MVA Similar results were obtained with human primary cells from the respiratory tract © 2025 Tonix Pharmaceuticals Holding Corp.
IN VIVO ATTENUATION OF TNX - 801 » Investigate attenuation of TNX - 801 in vivo relative to VACV based vaccines ▪ Immunocompromised Mice (C57BL/6 ifnar - / - , C57BL/6 ifngr - / - , C57BL/6 ifnar - / - /ifngr - / - ) • Interferon receptor knockout model • Sensitive to virus infection ▪ Positive Control: VACV - WR , VACV - IHD ▪ Older vaccines: VACV - Lis, VACV - NYCBH ▪ TNX - 801 ▪ Route: Intranasal » Parameters measured: 1) Disease Score 2) Temperature 3) Weight loss 4) Survival © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 LACKS LETHALITY ASSOCIATED WITH OLDER SMALLPOX VACCINE STRAINS (LIS, NYCBH) TNX - 801*, Mock ~3 x 10 8 PFU VACV - Lis, NYCBH ~10 4 and 10 3 PFU VACV - WR, IHD ~10 3 PFU TNX - 801 is up to 100,000 - fold more attenuated © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 INFECTION DISPLAYS LIMITED REPLICATION VACV - IHD ~10 6 PFU ( ) VACV - NYCBH ~10 6 PFU ( ) TNX - 801 ~10 8 PFU ( ) © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 IS HIGHLY ATTENUATED WITH IMPROVED SAFETY PROFILES COMPARED TO OTHER VACCINA - BASED VACCINES © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 IMMUNOGENICITY AND EFFICACY IN ANIMAL MODELS (SINGLE DOSE) 1) 2) 3) © 2025 Tonix Pharmaceuticals Holding Corp.
NHP IMMUNOGENICITY AND EFFICACY STUDY DESIGN rVACV = Plaque pick from ACAM2000 (Approved Vaccine) © 2025 Tonix Pharmaceuticals Holding Corp.
NHP IMMUNOGENICITY: TNX - 801 INDUCES NEUTRALIZING ANTIBODY RESPONSE © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES PROTECTION AGAINST MPOX DISEASE NO LESIONS in TNX - 801 vaccinated groups © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES PROTECTION AGAINST LETHAL MONKEYPOX CLADE I CHALLENGE NO LETHALITY in TNX - 801 vaccinated groups © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 VACCINATION VIA ALTERNATIVE ROUTES (ID, SC, IM): STUDY DESIGN Number of Animal per Group Dose (PFU) Route Treatment 6 (3M/3F) 10 6 ID TNX - 801 6 (3M/3F) 10 5 ID TNX - 801 6 (3M/3F) 10 6 SC TNX - 801 6 (3M/3F) 10 5 SC TNX - 801 6 (3M/3F) 10 6 IM TNX - 801 6 (3M/3F) 10 5 IM TNX - 801 6 (4M/2F) - - Mock © 2025 Tonix Pharmaceuticals Holding Corp.
IMMUNOGENICITY: DAY 28 ANTI - VACV (MVA) TITERS © 2025 Tonix Pharmaceuticals Holding Corp. LOD Comparable IgG titers regardless of Route or Dose
TNX - 801 PROTECTS AGAINST CLINICAL DISEASE (LESIONS) NO LESIONS in TNX - 801 vaccinated groups © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROTECTS AGAINST CLINICAL DISEASE (LESIONS) NO LESIONS in TNX - 801 vaccinated groups © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROTECTS AGAINST LETHAL RPXV CHALLENGE NO LETHALITY in TNX - 801 vaccinated groups © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES PROTECTION AGAINST LETHAL MONKEYPOX CLADE IIA CHALLENGE: ALTERNATIVE ROUTES © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES PROTECTION AGAINST LETHAL MONKEYPOX CLADE IIA CHALLENGE: ALTERNATIVE ROUTES TNX - 801 (PERCUT) TNX - 801 (SC) TNX - 801 (IM) Mock Weight Loss Survival *p <0.0001 *p <0.003 * * * * © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES DURABLE PROTECTION AGAINST LETHAL RABBITPOX CHALLENGE: 6 MONTHS © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES DURABLE PROTECTION AGAINST LETHAL RABBITPOX CHALLENGE: 6 MONTHS © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES DURABLE PROTECTION AGAINST LETHAL RABBITPOX CHALLENGE: 6 MONTHS © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 PROVIDES DURABLE PROTECTION AGAINST LETHAL RABBITPOX CHALLENGE: 14 MONTHS © 2025 Tonix Pharmaceuticals Holding Corp.
TNX - 801 SAFETY © 2025 Tonix Pharmaceuticals Holding Corp. » In vitro : ▪ Small plaque phenotype ▪ Up to 100 - fold lower replication than VACV strains ▪ Primary cells from dermal and respiratory tracts » In vivo : ▪ Well tolerated in mice, rabbits, hamsters, and NHPs ▪ Minimal or no disease in immunocompromised murine models ▪ up to 100,000 - fold more attenuated than VACV - based vaccines ▪ Minimally replicates at site of delivery
TNX - 801 IMMUNOGENICITY AND EFFICACY (SINGLE DOSE) © 2025 Tonix Pharmaceuticals Holding Corp. » Evaluated in multiple animal models ▪ Mouse, Rabbit, and NHP (Cynomolgus) » Elicits IgG and/or neutralizing responses ▪ Various route percutaneous, subcutaneous, intramuscular ▪ Microneedle delivery » Provides 100% protection against lesions ▪ Rabbit and NHP models ▪ Rabbit model: 6 - and 14 - months » Provides 100% protection against lethal challenge ▪ Models: Mouse, Rabbit, and NHP ▪ Viruses: VACV, RPXV, MPXV clade Ia and IIa
ACKNOWLEDGEMENTS © 2025 Tonix Pharmaceuticals Holding Corp. » University of Alberta ▪ Ryan Noyce ▪ David Evans » Southern Research » TNX - 801 Team ▪ Scott Goebel ▪ Tinoush Moulaei ▪ Natasza Ziółkowska ▪ Siobhan Fogarty ▪ Helen Stillwell ▪ Bruce Daugherty ▪ Farooq Nasar ▪ Seth Lederman » TNX - 801 Team ▪ Mayanka Awasthi ▪ Christy Raney ▪ Amy Cregger ▪ Robert Enamorado ▪ Stephanie Trefry ▪ Nelson Martinez ▪ Deborah Gohegan ▪ Zeil Rosenberg