Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — NobleCon18 Investor Conference (April 2022)

37 slides from Tonix Pharmaceuticals's conference presentation, Apr 20, 2022

  1. Slide 1: Investor Presentation - NobleCon18 Investor Conference

    © 2022 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION N oble C on 18 Investor Conference NASDAQ: TNXP Version P0348 April 12, 2022 (Doc 0993)

  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: CNS Portfolio

    3 © 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

  4. Slide 4: Immunology Portfolio

    4 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. 1 anti - CD40L humanized monoclonal antibody 2 Recombinant trefoil factor 2 (rTFF2) based protein; licensed f

  5. Slide 5: Infectious Disease Portfolio

    5 © 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

  6. Slide 6: Rare Disease Portfolio

    6 © 2022 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO 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 drugs or biolog

  7. Slide 7: CNS: Key Candidates

    © 2022 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES

  8. Slide 8: TNX-102 SL: Fibromyalgia

    8 © 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

  9. Slide 9: TNX-102 SL: Fibromyalgia Program Update

    9 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: FIBROMYALGIA PROGRAM UPDATE CNS PORTFOLIO Phase 3 Study, RESILIENT (F307), will compare TNX - 102 SL 5.6 mg and placebo • First patient enrolled in April 2022 • Interim Analysis results expected 1Q 2023 • Parallel design, doubl

  10. Slide 10: TNX-102 SL: RALLY Study Increased Adverse Event-Related Discontinuations

    10 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY STUDY INCREASED ADVERSE EVENT - RELATED DISCONTINUATIONS CNS PORTFOLIO TEAE = treatment - emergent adverse event Increases in AE - Related discontinuations in RALLY study compared with RELIEF study in both placebo and TN

  11. Slide 11: TNX-102 SL: RALLY Study Impact of Missing Data on P-Values

    11 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY STUDY IMPACT OF MISSING DATA ON P - VALUES IN RALLY MI missing data treatment attenuated p - values in RALLY • At the current time, we expect MI will be part of the statistical analysis for the RESILIENT trial CNS PORTFO

  12. Slide 12: Chronic Overlapping Pain Conditions Believed to Result from Shared Brain Processes

    12 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CHRONIC OVERLAPPING PAIN CONDITIONS (COPC) BELIEVED TO RESULT FROM SHARED BRAIN PROCESSES • COPC is a set of disorders that coaggregate ; these disorders can include but are not limited to 1,2 : • Temporomandibular disorder • Fibromyalgia •

  13. Slide 13: Infections May Trigger or Exacerbate CNS Conditions

    13 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO INFECTIONS MAY TRIGGER OR EXACERBATE CNS CONDITIONS FIBROMYALGIA OR CFS/ME 1 SHARE THIS CHARACTERISTIC Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 2 - 7 • Infections ca

  14. Slide 14: Potential Increase in Myalgia Following the COVID Pandemic

    14 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO POTENTIAL INCREASE IN MYALGIA FOLLOWING THE COVID - 19 PANDEMIC The specific causes may be due to: Chronic pain increase due to COVID - 19 could be nociplastic , neuropathic, or nociceptive Chronic pain newly triggered in individuals withou

  15. Slide 15: New Classification of Pain Types: Nociplastic Pain

    15 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO NEW CLASSIFICATION OF PAIN TYPES NOCIPLASTIC PAIN ( f.k.a . “CENTRAL NEUROPATHIC PAIN”) Nociceptive pain Nociplastic pain Neuropathic pain Pain due to the activation of nociceptors that arises from actual or threatened damage to non - neura

  16. Slide 16: Central Sensitization: A Feature of Many Nociplastic Pain Syndromes

    16 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CENTRAL SENSITIZATION (CS) A FEATURE OF MANY NOCIPLASTIC PAIN SYNDROMES • CS is caused by amplified neural signaling in CNS pain circuits 1 - 3 • Patients with CS perceive higher pain to a slightly noxious stimuli than in non - CS individua

  17. Slide 17: Central Sensitization Can Occur in a Range of Diseases and Conditions

    17 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CENTRAL SENSITIZATION (CS) CAN OCCUR IN A RANGE OF DISEASES AND CONDITIONS Degree of central sensitization Nijs J, et al. Lancet . 2021;3(5):e383 - e392.

  18. Slide 18: TNX-102 SL: Long COVID (PASC)

    18 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: LONG COVID a.k.a POST - ACUTE SEQUELAE OF SARS - COV - 2 INFECTION (PASC 1 ) • Long COVID is a heterogeneous condition that displays elements of nociplastic pain in many individuals, who experience otherwise unexplained 2 - 3

  19. Slide 19: Timeline of Long COVID After Acute COVID

    19 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TIMELINE OF L ONG COVID AFTER ACUTE COVID - 19 POST - INFECTIOUS SYNDROME Week - 2 Week - 1 Week 1 Week 2 Week 3 Week 4 6 months Detection unlikely PCR positive PCR negative Acute COVID - 19 PASC Viral load Nasopharyngeal Respiratory tract

  20. Slide 20: Prevalence of Long COVID

    20 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PREVALENCE OF L ONG COVID ~30% OF RECOVERED SARS - C o V - 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 sym

  21. Slide 21: Rate of Central Sensitization in Long COVID Survey

    21 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RATE OF CENTRAL SENSITIZATION (CS) IN L ONG COVID SURVEY CS SYMPTOMS REPORTED IN 70% 70% 30% Long COVID with CSI ≥40/100 Long COVID with CSI <40/100 491 total participants Goudman , L, et al. J of Clin Med . 2021;10(23):5594. 70% of Long CO

  22. Slide 22: Long COVID Patients in TriNetX Study

    22 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO L ONG COVID PATIENTS IN T ri N et X STUDY 1 RETROSPECTIVE OBSERVATIONAL DATABASE STUDY 1 Harris, H, et al. Tonix data on file. 2022. 2 TriNetX Analytics 3 Topaloglu, U, and Palchuk , MB. JCO clinical cancer informatics . 2018;2:1 - 10. TriN

  23. Slide 23: Long COVID Patients in TriNetX Study: FM-Like Symptoms

    23 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO L ONG COVID PATIENTS IN T ri N et X STUDY 1 FM - LIKE SYMPTOMS (MULTI - SITE PAIN) IN OVER 40% PATIENTS 1,2 79% 13% 6% 2% 52,322 total Long COVID patients 21,694 total FM - like Long COVID patients 1 Harris, H, et al. Tonix data on file. 20

  24. Slide 24: Long COVID Patients in TriNetX Study: Recorded Medication Use

    24 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO L ONG COVID PATIENTS IN T ri N et X STUDY 1 RECORDED MEDICATION USE, DAYS 91 - 180 15.0% 18.8% 39.8% 28.8% 34.0% 29.9% 25.9% 39.0% 35.8% 35.8% 50.1% 59.2% 43.1% 51.1% 62.8% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Patients with compoundi

  25. Slide 25: The Rate of Opioid Use in Long COVID Patients

    25 © 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 THE RATE OF OPIOID USE IN L ONG COVID PATIENTS POTENTIAL HEALTH CONCERN • In only a few days some people can develop a physical dep

  26. Slide 26: Significant Financial Impact of Long COVID

    26 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO SIGNIFICANT FINANCIAL IMPACT OF L ONG COVID FOR HOUSEHOLDS AND ECONOMIES 25% of Long COVID patients are unable to return to work 1 Over 250,000 Quality Adjusted Life - Years (QUALYS) will be lost due to Long COVID in the UK 2 $23.3 billion

  27. Slide 27: Long COVID Presidential Memorandum

    27 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO L ONG COVID PRESIDENTIAL MEMORANDUM PRESIDENT BIDEN – APRIL 5, 2022 1 Policy • Commits to redoubling efforts to address the long - term effects of COVID - 19 Organizing Government Wide Response • Harnesses the full potential of the Federal

  28. Slide 28: TNX-102 SL: Long COVID (PASC)

    28 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: L ONG COVID ( PASC ) CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS Long COVID or Post - acute Sequelae of COVID - 19 (PASC 1 ) • Symptoms can include fatigue, sleep disorders, pain,

  29. Slide 29: TNX-1300: Cocaine Intoxication

    29 © 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

  30. Slide 30: TNX-1900: Migraine

    30 © 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 •

  31. Slide 31: TNX-1900 for Migraine: Magnesium at the Core of Oxytocin Binding

    31 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 1900* FOR MIGRAINE MAGNESIUM (M g 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.

  32. Slide 32: TNX-601 CR: Depression

    32 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 CR*: DEPRESSION TIANEPTINE OXALATE AND NALOXONE CNS PORTFOLIO A novel, oral, controlled release once - daily tablet Mechanistically different from traditional monoaminergic treatments for

  33. Slide 33: Future Outlook

    © 2022 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

  34. Slide 34: Key Development Partners

    34 © 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

  35. Slide 35: Milestones: Recently Completed and Upcoming

    35 © 2022 Tonix Pharmaceuticals Holding Corp. Expected Clinical Trial Initiations □ 2 nd Quarter 2022 Phase 2 OL safety study start of TNX - 1300 in ED setting for cocaine intoxication □ 2 nd Quarter 2022 Phase 2 study start of TNX - 102 SL for the treatment of PTSD in Kenya □ 2 nd Quarter 2022 Phas

  36. Slide 36: Management Team

    36 © 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

  37. Slide 37: Thank You

    © 2022 Tonix Pharmaceuticals Holding Corp. THANK YOU

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