Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (March 2023)

36 slides from Tonix Pharmaceuticals's investor presentation, Mar 13, 2023

  1. Slide 1: Investor Presentation

    © 2023 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0419 March 13 , 2023 (Doc 1177 )

  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: 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

  4. 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

  5. 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) Long COVID (PASC 2 ) Mid - Phase 3 - >50% enrolled Phase 2 - enrolling TNX - 1300 3 Cocaine Intoxication - FDA Breakthrough Designation Mid - Phase 2, Tar

  6. Slide 6: CNS: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES

  7. Slide 7: CNS Portfolio: Five Late-Stage CNS Programs in the Clinic by 1H 2023

    7 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Five Late - Stage CNS Programs to be in the Clinic by 1H 2023 Three Studies Enrolling Now ENROLLING • In Phase 3: ‒ TNX - 102 SL for fibromyalgia (>50% enrolled) Potential Pivotal Study • In Phase 2: ‒ TNX - 102 SL for fibromyalgia - type Lo

  8. Slide 8: TNX-102 SL Cyclobenzaprine: Pipeline in a Product

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL* Cyclobenzaprine ( Protectic ® ) Pipeline in a Product Fibromyalgia Status: Mid - Phase 3 • One positive Phase 3 study (RELIEF) completed • Second Phase 3 study (RALLY) missed primary endpoint • Confirmatory Phase 3 study (RESILIENT) is current

  9. Slide 9: TNX-102 SL: Fibromyalgia

    9 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia Cyclobenzaprine Protectic ® Sublingual Tablets CNS PORTFOLIO Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the C

  10. Slide 10: Phase 3 RESILIENT Study Design

    10 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 3 R ESILIENT Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in fibromyalgia • U.S. sites only, expected to enroll approximately 470 patients • One unblinded interim analysis bas

  11. Slide 11: Fibromyalgia-Type Long COVID

    11 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia - Type Long COVID • Long COVID is a heterogeneous condition that displays elements of nociplastic pain in many individuals, who experience otherwise unexplained symptoms 1 - 2 Symptoms (multi - site pain, fatigue, sleep disorde

  12. Slide 12: TNX-102 SL: Fibromyalgia-Type Long COVID (PASC)

    12 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia - Type Long COVID (PASC) Cyclobenzaprine Protectic ® Sublingual Tablets • Occurs in approximately 13% of recovered COVID - 19 patients 1 • As many as 40% of Long COVID p

  13. Slide 13: Phase 2 PREVAIL Study Design

    13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 2 Fibromyalgia - Type Long COVID Study Design (PREVAIL) Study c haracteristics: • Randomized, double - blind, placebo - controlle d study of TNX - 102 SL in fibromyalgia - type Long COVID • U.S. sites only, expected to enroll approxim

  14. Slide 14: TNX-601 ER: Depression

    14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 E R*: Depression Tianeptine Hemioxalate Extended - Release Tablets (39.4 mg) CNS PORTFOLIO • A novel, oral, extended - release once - daily tablet • Treatment effect of tianeptine sodium

  15. Slide 15: TNX-601 ER: Phase 2 UPLIFT Study Design

    15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 601 ER: Phase 2 UPLIFT Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in Major Depressive Disorder • Parallel design (two arms – treatment (tianeptine hemioxalate 39.4 mg) and p

  16. Slide 16: TNX-1900: Migraine

    16 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1900*: Migraine Intranasal Potentiated Oxytocin (OT) with Magnesium CNS PORTFOLIO • Intranasal OT has potential utility in treating migraine 1 • Magnesium is known to potentiate the binding o

  17. Slide 17: Phase 2 PREVENTION Study Design

    17 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 2 PREVENTION Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study (three arms – two treatment regimens and one placebo) in chronic migraine • U.S. sites only, expected to enroll appro

  18. Slide 18: TNX-1300: Cocaine Intoxication

    18 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1300*: Cocaine Intoxication Cocaine Esterase ( CocE ) Cocaine is the main cause for drug - related ED visits 1 CocE is a recombinant protein that degrades cocaine in the bloodstream • Rapidly

  19. Slide 19: Rare Disease: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE: KEY CANDIDATES

  20. Slide 20: TNX-2900: Hyperphagia in Prader-Willi Syndrome

    20 © 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Patents Issued PROFILE DEVELOPMENT PROGRAM TNX - 2900*: Hyperphagia in Prader - Willi Syndrome Intranasal Potentiated Oxytocin (OT) with Magnesium Prader - Willi Syndrome is the most common genetic cause of life - threatening child

  21. Slide 21: Immunology: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

  22. Slide 22: TNX-1500 Next Generation α-CD40L 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

  23. Slide 23: Third-Generation α-CD40L Engineered to Decrease Risk of Thrombosis

    23 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO THIRD - GENERATION α - CD40L ENGINEERED TO DECREASE RISK OF THROMBOSIS First - generation anti - CD40L mAbs Constant fragment (Fc) domain interacted with FcγRIIA (CD32A), which suggested a mechanism for the increased risk of thrombos

  24. Slide 24: Other Anti-CD40L Monoclonal Antibodies in Development

    24 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Other anti - CD40L Monoclonal Antibodies in Development UCB (Co - developed with Biogen) – Systemic Lupus Erythematosus (SLE) • Phase 3 Trial Currently Enrolling (NCT04294667) − Topline results expected 1H 2024 1 • Dapirolizumab pego

  25. Slide 25: TNX-1700: Gastric and Colorectal Cancers

    25 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700*: Gastric and Colorectal Cancers Recombinant Trefoil Factor 2 (rTFF2 - HSA) Fusion Protein Potential New Cancer Treatment • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment •

  26. Slide 26: Infectious Disease: Key Candidates

    © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES

  27. Slide 27: TNX-801 & TNX-1850 Recombinant Pox Vaccine Platform

    © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801 & TNX - 1850* Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology Mpox and Smallpox Vaccine Status: Preclinical • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture Next Steps: Developing GMP

  28. Slide 28: TNX-3600: COVID-19 Fully Human Monoclonal Antibody

    28 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3600*: COVID - 19 Therapeutic/Preventative Fully Human Monoclonal Antibody • Fully human monoclonal antibodies • Generated from SARS - CoV - 2+ asymptomatic individuals or COVID

  29. Slide 29: TNX-3800: COVID-19 Humanized Mouse Monoclonal Antibodies

    29 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3800*: COVID - 19 Therapeutic/Preventative Humanized Mouse Monoclonal Antibodies Market Entry: COVID - 19 treatment and prophylaxis in immuno - compromised individuals Status: P

  30. Slide 30: Additional Infectious Disease Therapeutics in Development

    30 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Additional Infectious Disease Therapeutics in Development TNX - 2300*: Live Virus Vaccine Based on Bovine Parainfluenza (BPI) Virus Market Entry: COVID - 19 Vaccine Status: Preclinical Next Steps: Animal studies with Kansas S

  31. Slide 31: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology

    31 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Mpox and Smallpox Future Pandemics & New Infectious Diseases COVID - 19 Biodefense Using Proven Science To

  32. Slide 32: Internal Development & Manufacturing Capabilities

    32 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities R&D Center (RDC) – Frederick, MD • Functions: ‒ Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other infectious diseases ‒ Resear

  33. Slide 33: Future Outlook

    © 2023 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

  34. Slide 34: Management Team

    34 © 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

  35. Slide 35: Milestones: Recently Completed and Upcoming

    35 © 2023 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming Expected Clinical Trial Initiations □ 1 st Quarter 2023 Phase 2 UPLIFT study start of TNX - 601 ER for major depressive disorder □ 2 nd Quarter 2023 Phase 1 study start of TNX - 1500 for prevention of allograft

  36. Slide 36: Thank You

    © 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU

Tonix Pharmaceuticals Holding — Investor Presentation (March 2023) on 6ix