Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Investor Presentation (October 2022)

44 slides from Tonix Pharmaceuticals's investor presentation, Oct 21, 2022

1. Slide 1: Investor Presentation

   © 2022 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0382 October 3, 2022 (Doc 1107)

2. Slide 2: Cautionary Note on Forward-Looking Statements

   2 © 2022 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 © 2022 Tonix Pharmaceuticals Holding Corp. Who We Are Tonix Pharmaceuticals is committed to improving patient care by advancing science and developing innovative therapies which have the potential to address important unmet needs across multiple therapeutic areas OUR MISSION Tonix strives to be a

4. Slide 4: Milestones: Recently Completed and Upcoming

   4 © 2022 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming* Expected Clinical Trial Initiations □ 4 th Quarter 2022 Phase 2 study start of TNX - 102 SL for the treatment of PTSD in Kenya □ 4 th Quarter 2022 Phase 2 study start of TNX - 1900 for the treatment of migraine

5. Slide 5: Central Nervous System (CNS) Portfolio Pipeline

   5 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO ADHD = attention - deficit hyperactivity disorder; FM = fibromyalgia; IND = investigational new drug; PASC = post - acute sequelae o f COVID - 19; PTSD = posttraumatic stress disorder. Pipeline Central Nervous System (CNS) Port

6. Slide 6: Rare Disease & Immunology Portfolios Pipeline

   6 © 2022 Tonix Pharmaceuticals Holding Corp. RARE DISEASE & IMMUNOLOGY PORTFOLIOS Pipeline Rare Disease Portfolio TNX - 2900 1 Prader - Willi Syndrome FDA Orphan Drug Designation Preclinical CANDIDATE S * INDICATION STATUS / NEXT MILESTONE *All of Tonix’s product candidates are investigational new d

7. Slide 7: Infectious Disease Portfolio Pipeline

   7 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. 1 Live attenuated vaccine based on horsepox virus 2 Live attenuated vaccine based on horsepox virus v

8. Slide 8: CNS: Key Candidates

   © 2022 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES

9. Slide 9: TNX-102 SL: Fibromyalgia

   9 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia Cyclobenzaprine Protectic ® Sublingual tablets CNS PORTFOLIO A unique formulation of cyclobenzaprine designed to optimize delivery and absorption Innovative and proprieta

10. Slide 10: TNX-102 SL: Long COVID (PASC)

    10 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Long COVID (PASC) Cyclobenzaprine Protectic ® Sublingual Tablets Long COVID or Post - acute Sequelae of COVID - 19 (PASC 1 ) • Symptoms can include fatigue, sleep disorders, pain, fe

11. Slide 11: Role of Infections in Triggering Fibromyalgia or Chronic Fatigue-Like Illnesses

    11 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Role of Infections in Triggering Fibromyalgia or Chronic fatigue (CFS) - Like Illnesses Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 2 - 7 • Infections can trigger any o

12. Slide 12: Long COVID a.k.a. Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

    12 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Long COVID a.k.a Post - Acute Sequelae of SARS - CoV - 2 Infection (PASC) • Long COVID is a heterogeneous condition that displays elements of nociplastic pain in many individuals, who experience otherwise unexplained 1 - 2 : •

13. Slide 13: Prevalence of Long COVID

    13 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Prevalence of Long COVID ~30% of Recovered SARS - CoV - 2 Patients after 6 Months Long COVID (PASC) is more prevalent among patients 1,2 : • Requiring hospitalization (93% vs 23% for those not requiring hospitalization) • With severe sympto

14. Slide 14: Rate of Opioid Use in Long COVID Patients

    14 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 18.8% 34.0% 39.0% 50.1% 51.1% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Percent of Patients taking Opioids Rate of Opioid Use in Long COVID Patients Potential Health Concern • In only a few days some people can develop a physical dependen

15. Slide 15: TNX-102 SL: Posttraumatic Stress Disorder (PTSD)

    15 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX 102 SL*: Posttraumatic Stress disorder (PTSD) Cyclobenzaprine Protectic ® Sublingual Tablets PTSD is a serious chronic psychiatric illness • Defined as maladaptive prolonged stress response whi

16. Slide 16: TNX-1300: Cocaine Intoxication

    16 © 2022 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 Cocaine use can cause irreversible structural damage to the heart and accelerate

17. Slide 17: TNX-601 ER: Depression

    17 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 E R*: Depression Tianeptine Hemioxalate Extended - Release Tablets CNS PORTFOLIO A novel, oral, extended - release once - daily tablet Mechanistically different from traditional monoamine

18. Slide 18: TNX-1900: Migraine

    18 © 2022 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 • Intranasal OT reaches the trigeminal ganglion •

19. Slide 19: Magnesium is at the Core of Oxytocin Binding

    19 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900 for Migraine Magnesium (Mg 2+ ) is at the Core of Oxytocin Binding 1 1 Adapted from Meyerowitz, J.G., Robertson, M.J., Barros - Álvarez, X. et al. The oxytocin signaling complex reveals a molecular switch for cation dependence. N

20. Slide 20: Addition of Mg2+ Augments Oxytocin-Induced Analgesia in Animal Model

    20 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Bharadwaj VN, et al. Pharmaceutics . 2022;14(5):1105. in vivo effect of Mg 2+ ion addition with intranasal oxytocin - induced craniofacial analgesia on the withdrawal response time to noxious heat stimulation of the cheek of pre - inflamed

21. Slide 21: Rare Disease: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. RARE DISEASE: KEY CANDIDATES

22. Slide 22: TNX-2900: Hyperphagia in Prader-Willi Syndrome

    22 © 2022 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

23. Slide 23: Immunology: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

24. Slide 24: TNX-1500: Prevention of Allograft Rejection

    24 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1500*: Prevention of Allograft Rejection 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 1 Cam

25. Slide 25: Third-Generation α-CD40L Engineered to Decrease Risk of Thrombosis

    25 © 2022 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

26. Slide 26: Development and Regulatory Strategy

    26 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Development and Regulatory Strategy • 1 st Indication – Kidney allotransplantation (human to human) ‒ Replacement for nephrotoxic CNI’s (calcineurin inhibitors, e.g. Prograf ® (tacrolimus) 1 , Neoral ® (cyclosporin) 2 ‒ Similar devel

27. Slide 27: TNX-1700: Gastric and Colorectal Cancers

    27 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700*: Gastric and Colorectal Cancers Recombinant Trefoil Factor 2 (rTFF2) Fusion Protein POTENTIAL NEW CANCER TREATMENT • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment • Mecha

28. Slide 28: Infectious Disease: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES

29. Slide 29: TNX-801: Monkeypox and Smallpox Vaccine

    29 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 801: Monkeypox and Smallpox Vaccine Live Virus Platform Development Program APPLICATION OF LIVE VIRUS PLATFORM • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture

30. Slide 30: Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology

    30 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Monkeypox and Smallpox Future Pandemics & New Infectious Diseases COVID - 19 Biodefense Using Proven Scienc

31. Slide 31: Spectrum of Pox-Virus Replicative Capacity

    31 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Spectrum of Pox - Virus Replicative Capacity Horsepox Has Lower Replicative Capacity in Human Cells Tolerability Replicative Capacity Lister 5 MVA 2 , ALVAC/Canarypox 3 Dryvax 4 ~1 death per million ~10 deaths per million Hor

32. Slide 32: Vaccinia and Horsepox Induce a Skin Reaction Called a "Take"

    32 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Vaccinia and Horsepox Induce a Skin Reaction Called a “Take” Described by Dr. Edward Jenner *Example of major cutaneous reaction, or “take,” resulting from a replication - competent live - virus vaccine with intradermal deli

33. Slide 33: TNX-1850: COVID-19 Vaccine

    33 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 1850*: COVID - 19 Vaccine Live Virus Platform Development Program APPLICATION OF LIVE VIRUS PLATFORM • First version TNX - 1800 encodes spike protein from SARS - CoV - 2, Wuhan strain • Planned new version

34. Slide 34: What Makes TNX-1850 Different from mRNA Vaccines

    34 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus Platform: What Makes TNX - 1850 Different from mRNA Vaccines CRITERIA mRNA VACCINES TNX - 1850 Number of shots Two One Duration 6 months Years / decades Boosters Recommended Likely not required Protection from vari

35. Slide 35: TNX-2300: COVID-19 Vaccine

    35 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 2300*: COVID - 19 Vaccine Live Virus Vaccine Based on Bovine Parainfluenza (BPI) Virus LIVE VIRUS VACCINE 1 - 5 • Previously has been shown to be an effective antigen delivery vector in humans, notably wel

36. Slide 36: TNX-3600: COVID-19 Therapeutics

    36 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO PROFILE DEVELOPMENT PROGRAM TNX - 3600*: COVID - 1 9 Therapeutics Fully Human Monoclonal Antibody Platform Collaboration with Columbia University Human monoclonal antibodies ( mAbs ) generated from COVID - 19 convalescent pat

37. Slide 37: TNX-3700: COVID-19 Vaccine

    37 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3700*: COVID - 19 Vaccine Zinc Nanoparticle (ZNP) Formulation for mRNA Vaccines Collaboration with Kansas State University ZNP technology is a potential replacement for the Lipi

38. Slide 38: Internal Development & Manufacturing Capabilities

    38 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus RPV P latform Internal Development & Manufacturing Capabilities Infectious Disease R&D Center (RDC) – Frederick, MD • Function : Accelerated development of vaccines and antiviral drugs against COVID - 19, its varia

39. Slide 39: American Pandemic Preparedness Plan (AP3)

    39 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO American Pandemic Preparedness Plan (AP3) • “Platforms” – Foundation of Pandemic Response ‒ Key element of AP3 from White House Office of Science and Technology Policy or OSTP 1,2 ▪ 100 days to human trials ▪ Technologies tha

40. Slide 40: Future Outlook

    © 2022 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

41. Slide 41: Key Development Partners

    41 © 2022 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION TNX - 1700: GASTRIC AND COLORECTAL CANCERS TNX - 3600: MONOCLONAL ANTIBODIES FOR COVID - 19 TREATMENT Key Development Partners TNX - 1500: ALLOGRAFT REJECTION TNX - 1900: MIGRAINE & OTHER INDICATIONS TNX - 801: SMALLPOX A

42. Slide 42: Milestones: Recently Completed and Upcoming

    42 © 2022 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming* Expected Clinical Trial Initiations □ 4 th Quarter 2022 Phase 2 study start of TNX - 102 SL for the treatment of PTSD in Kenya □ 4 th Quarter 2022 Phase 2 study start of TNX - 1900 for the treatment of migrain

43. Slide 43: Management Team

    43 © 2022 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

44. Slide 44: Thank You

    © 2022 Tonix Pharmaceuticals Holding Corp. THANK YOU

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