Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — World Vaccine Congress-Europe 2024
23 slides from Tonix Pharmaceuticals's conference presentation, Nov 1, 2024
Slide 1: TNX-801 MPOX: A Live, Attenuated, Minimally Replicative, Mpox Vaccine Candidate
Slide 2: Cautionary Note on Forward-Looking Statements
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 Litigation Reform Act of 1995. These statements may be i
Slide 3: In 1796, Jenner Successfully Used Vaccination to Protect Against Smallpox
In 1796, Jenner Successfully Used Vaccination to Protect Against Smallpox Jenner believed “vaccinia” was spread from horses to cows by farriers Next Gen sequencing shows horsepox was used as a vaccine in 19" century Solid Coated Dissolving Hollow MN MN: MN: MN ¢ Skin reaction called “take” also desc
Slide 4: Illustrative Safety Spectrum of Pox-Based Vaccine Vectors
ILLUSTRATIVE SAFETY SPECTRUM OF POX-BASED VACCINE VECTORS OPTIMIZING LIVE VIRUS VACCINES Non-replicating Minimally replicating Robustly replicating vaccines vaccines vaccines i 1 { 1 20 Century smallpox MVA ' vaccines a ay I Dryvax Copenhagen P H Lister Tashkent y > ! TianTan cy P*) ! 9 —_ ' fe) = '
Slide 5: Epidemic Curve of Weekly Reported Confirmed Mpox Cases in Africa
EPIDEMIC CURVE OF WEEKLY REPORTED CONFIRMED MPOX CASES IN AFRICA JANUARY 1- OCTOBER 6, 2024 Number of cases Ce 400 - --- 300 200 - --- 100 0 29 Dec 14 Feb 01 Apr 18 May 04 Jut 20 Aug 06 Oct 2023 2024 2024 2024 2024 2024 2024 [Bh Democratic Republic of the Congo BB oburunai Other Africa Date of notif
Slide 6: Mpox Vaccine Landscape
MPOX VACCINE LANDSCAPE TNX-801* Tonix Pre-IND written Single dose: Minimally replicating live virus response fro Microneedle patch May block forward transmission FDA in Aug 2023 Expected thermostability Expected long durability (decades) Increased accessibility (patch) MVA-BN Bavarian FDAApproved Tw
Slide 7: Ring Vaccination (Surveillance-Containment)
RING VACCINATION ( SURVEILLANCE-CONTAINMENT) * Aggressive case-finding followed by vaccination of all known and possible contacts to seal off outbreak from rest of population. ¢ Used during smallpox eradication campaign first in Nigeria, led to the disappearance of smallpox in Nigeria although popul
Slide 8: U.S. National Academies of Science Recommend Single Dose Orthopox Virus Vaccines Be Developed
U.S. NATIONAL ACADEMIES OF SCIENCE RECOMMEND SINGLE DOSE ORTHOPOX VIRUS VACCINES BE DEVELOPED (2-2) Smallpox vaccines that have improved safety across different population subgroups _ and are available as a single dose would support faster and more effective response to contain smallpox and other or
Slide 9: WHO SAGE Target Product Profile (TPP) Mpox Vaccine
WHO SAGE TARGET PRODUCT PROFILE (TPP)MPOX VACCINE Vaccine characteristic Preferred Gitical or Minima” Indication for use People at risk of exposure to monkeypox virus in| People at risk of exposure to monkeypox virus in an an outbreak: Prevention of mpox disease outbreak: Prevention of mpox disease
Slide 10: Single Dose of TNX-801 Protects Macaques from Lethal Monkeypox Challenge
viruses (mbP1) Article Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge Ryan S. Noyce 1, Landon W. Westfall >**, Siobhan Fogarty *, Karen Gilbert 7, Onesmo Mpanju ¢, Helen Stillwell 34, José Esparza 5, Bruce Daugherty 3, Fusat
Slide 11: Immunogenicity and Efficacy in NHP - Study Design
IMMUNOGENICITY AND EFFICACY IN NHP - STUDY DESIGN Vaccination Challenge Dose Dose Group | Vaccine N Route Virus (LOG 49 Route (Logi9 PFU) PFU) al Tie 4 6.6 Percutaneous 2 tg 4 BF Percutaneous MPXV a fe: Clade I 7 3 rVACV* 4 5.0) Percutaneous 4 Mock 4 - Percutaneous *FLVACY = Synthetic vaccinia virus
Slide 12: Immunogenicity: Neutralizing Antibody (PRNT50 Assay)
IMMUNOGENICITY: NEUTRALIZING ANTIBODY (PRNT;, ASSAY) OO TNx-801 (HD) OO TNX-801 (LD) OD rvacv O Mock 640- i —_ g 160 - e = 401 i = 10-| e-em e-em -----|0)-(@--@|-em-----) | fel iob am ---- ele [a4 ao 3 28 60 Days Post Vaccination 100% Seroconversion and 88% of TNX-801 vaccinated NHPs had neutralizin
Slide 13: Clinical Signs (Lesions) After MPXV Challenge
CLINICAL SIGNS (LESIONS) AFTER MPXV CHALLENGE 25 20 151 101 lesion counts lesion counts ‘Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234. T re xX TNX-801 High Dose @ 16544 am 16545 te 16572 * 16573 7 14 21 28 Days post MPXV challenge rVACV @
Slide 14: Clinical Disease: Lethality
CLINICAL DISEASE: LETHALITY g 100 _ A 53 7 : 7p) if = 50- ® =@= TNX-801 (High) ° 25-4 == TNX-801 (Low) o =e rVACV Qa == Mock 0 T T T T T T T 1 T T 0 3 6 9 12 15 18 21 24 27 30 Time (dpi) 100% survival in TNX-807 vaccinated animals Noyce et al 2023 Viruses Jan 26;15(2):356 © 2024 Tonix Pharmaceutical
Slide 15: TNX-801 Is Attenuated Relative to Vaccinia Virus Strains
ec. MICROBIOLOGY @| Biotechnology | Research Article Recombinant chimeric Horsepox virus (TNX-801) is attenuated relative to Vaccinia virus strains in both in vitro and in vivo models ‘Stephanie V. Trefry,’ Mayanka Awasthi,' Christy N. Raney,’ Amy L. Cregger,’ Chase A. Gonzales,’ Brittney L. Layton,
Slide 16: TNX-801 Is 10-to-1,000-Fold Less Virulent Than "Modern" Vaccinia
TNX-801 IS 10-TO-1,000-FOLD LESS VIRULENT THAN “MODERN” VACCINIA Plaque Phenotype ——> TNX-801: Small plaque phenotype In Vitro Characterization — Attenuation of TNX-801 relative to VACV strains ——> TNX-801: >10- to 100-fold attenuated Susceptibility Studies (e576 nar C57BLI6 ifngr* C57BLI6 ifnar“lit
Slide 17: TNX-801 Plaque Phenotype in BSC-40 Cells
TNX-801 PLAQUE PHENOTYPE IN BSC-40 CELLS VACV-WR pt IHD VACV-Lis = NYCBH TNX-801 MVA on Ys YY ~& oo BG Ee wwe & ww ” Bo a3 p+ +4 Trefry S et al mSphere 2024 {in press) © 2024 Tonix Pharmaceutical is Holding Corp. - Confidential TONIX -—
Slide 18: TNX-801 Minimally Replicative: Kinetics in Primary Human Cells
TNX-801 MINIMALLY REPLICATIVE: KINETICS IN PRIMARY HUMAN CELLS (DERMAL TRACT) Melanocytes Titer (logyg PFU/mL) 0 12 24 36 48 60 72 84 96 Time (hpi) Dermal Titer (log49 PFU/mL) 0 12 24 36 48 60 72 84 96 Time (hp a Trefry S et al mSphere 2024 (in press) ae) > \ NX-801: ~30- to 120-fold more attenuated
Slide 19: TNX-801 Characterization in Immunocompromised Mouse Model
TNX-801 CHARACTERIZATION IN IMMUNOCOMPROMISED MOUSE MODEL C57BL/6 Ifnar “/lfngr * Disease Score VACV-WR. VAGVAHD, -Lis, NYC 1/Mock 3 3 3 g 2 2 8 2 8 2 82 B B a re ° re d 3 3 3 8 8 8 3B 1 a * 3B 1 a a a 0- 0 T ? 2.6 > 0.2 4 6 8 1012 14 024 6 8 11244 0.24 6 8 10 12 14 Time (dpi) Time (dpi) Time (dpi)
Slide 20: TNX-801 Characterization in Immunocompromised Mouse Model
TNX-801 CHARACTERIZATION IN IMMUNOCOMPROMISED MOUSE MODEL C57BL/6 Ifnar “/lfngr * Weight Loss » 5 = 2 40-4 g 404 a 304 Z 304 = 204 z 204 2 ea Poe Cen Ee = 0 Re 40 12 14 24 6 8 10 f 4 8204 “FY 8 204 2 2 mal *ps0.03 é al { pso0s Time (dpi) Time (dpi) Time (dpi) Survival 100 100--—____—e < s < 2 754 2
Slide 21: TNX-801 at 100-Fold Higher Dose Is Unable to Cause Disseminated Infection
TNX-801 AT 100-FOLD HIGHER DOSE IS UNABLE TO CAUSE DISSEMINATED INFECTION = VACV-IHD (5.9 log,, PFU) ‘A VACV-NYCBH (5.8 log, PFU) @ TNX-801 (7.9 log,, PFU) Route: IN Collect: Lung, Serum, Spleen, Brain f E A > 0 1 2 4 n= n=5 n= Lung Serum Spleen Brain <0.02 S fan 5 3 *p<ago009 ° 8 = ¥ 8 pale ze at 8
Slide 22: Meeting Summary: Vaccine Gaps Panel Discussion
Meeting summary: Vaccine Gaps Panel Discussion effectiveness studies, modifiers: HIV, malnutrition, other infections; Data on post-exposure efficacy. Fractional dosing, single dose efficacy. Clade-specific data Collection of real world safety data via active surveillance, using standardized definiti
Slide 23: Agreement with KEMRI to Jointly Develop Early-Stage Clinical Trials for TNX-801 in Kenya
Agreement with KEMRI in Process to Jointly Develop Early-Stage Clinical Trials for TNX-801 in Kenya _ TONIX PHARMACEUTICALS © 2024 Tonix Pharmaceuticals Holding Corp. - Confidential
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