Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — IPO Roadshow (July 2019)

31 slides from Tonix Pharmaceuticals's IPO roadshow presentation, Jul 3, 2019

  1. Slide 1: Investor Presentation, July 2019

    © 2019 Tonix Pharmaceuticals Holding Corp. 1 July 2019 Investor Presentation Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333-232195

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

    © 2019 Tonix Pharmaceuticals Holding Corp. 2 Cautionary Note on Forward-Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operationsorresultsare“forward-lookingstatements”asdefinedbythePrivateSecuritiesLitigationReform Actof1

  3. Slide 3: Free Writing Prospectus Statement

    © 2019 Tonix Pharmaceuticals Holding Corp. 3 Free Writing Prospectus Statement This presentation highlights basic information about us and the offering to which this communication relates. Because it is a summary, it does not contain all of the information that you should consider before investing i

  4. Slide 4: Offering Summary

    © 2019 Tonix Pharmaceuticals Holding Corp. 4 Offering Summary Issuer: Tonix Pharmaceuticals Holding Corp. Ticker / Exchange: TNXP / Nasdaq Global Market Offering Size: Approximately $10,400,000 (excluding 15% Over-Allotment) Securities Issued: Common Stock Use of Proceeds: • Fund Phase 3 development

  5. Slide 5: Tonix Pharmaceuticals: Who we are

    © 2019 Tonix Pharmaceuticals Holding Corp. 5 TonixPharmaceuticals Who we are: • A clinical stage biopharmaceutical company dedicated to developing innovative treatments for patients and making meaningful contributions to society • Focusing on small molecules and biologics to treat psychiatric, pain

  6. Slide 6: CNS Candidates in Development

    © 2019 Tonix Pharmaceuticals Holding Corp. 6 CNS Candidates in Development Psychiatry, Pain and Addiction Preclinical Phase 2 NDA 1 /BLA 2 Market Pipeline Product Indication Phase 3 TNX-102 SL 3 Bedtime Treatment for PTSD –Tonmya ®4 Daytime Treatment for PTSD TNX-601 TNX-1300 5 Cocaine intoxication

  7. Slide 7: Biodefense Candidates in Development

    © 2019 Tonix Pharmaceuticals Holding Corp. 7 Biodefense Candidates in Development 1 NDA-New Drug Application; 2 BLA –Biologic Licensing Application Biodefense programs owned outright with no royalties due Preclinical Phase 2 NDA 1 /BLA 2 Market Pipeline Product Indication Phase 3 TNX-801 Smallpox- p

  8. Slide 8: Management Team

    © 2019 Tonix Pharmaceuticals Holding Corp. 8 Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

  9. Slide 9: TNX-102 SL Intellectual Property

    © 2019 Tonix Pharmaceuticals Holding Corp. 9 TNX-102 SL Intellectual Property – U.S. Protection expected until 2034 •United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9636408in May 2017, U.S. Patent No. 9956188 in May 2018, and U.S. Patent No. 10117936in Nov 2018 •China Nation

  10. Slide 10: Prevalence of PTSD Among Civilians and Veterans

    © 2019 Tonix Pharmaceuticals Holding Corp. 10 Prevalence of PTSD Among Civilians and Veterans 1 Goldstein et al., 2016 (adjusted for 2019); 2 Norris, PTSD Res Quar. 2013; 3 Analysis of VA Health Care Utilization among Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn Vetera

  11. Slide 11: Unmet Need for Effective and Safe Therapies for Treatment of PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 11 Unmet Need for Effective and Safe Therapies for Treatment of PTSD No FDA-approved products for PTSD since Pfizer’s Zoloft ® (sertraline) and GSK’s Paxil ® (paroxetine) circa 2000 • Neither has shown efficacy in military-related PTSD • Male PTSD patients

  12. Slide 12: Tonmya: a Potential Bedtime Treatment for PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 12 Tonmya: a Potential Bedtime Treatment for PTSD First investigational new drug to show treatment effect in military-related PTSD in two potential pivotal efficacy studies • Phase 2 study (P201/AtEase) showed Tonmya5.6 mg had a signal of treatment effect a

  13. Slide 13: Potential Therapeutic Advantages of Tonmya

    © 2019 Tonix Pharmaceuticals Holding Corp. 13 Potential Therapeutic Advantages of Tonmya Tonmyais believed to treat PTSD by improving sleepquality • The brain naturally processes memories during sleep • PTSD sufferers’ emotionally charged memories disturb sleep and disrupt the natural processing of

  14. Slide 14: Tonmya Phase 2 Dose-Effect in Military-Related PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 14 TonmyaPhase 2 Dose-Effect in Military-Related PTSD 1 1 CompletedPhase 2 P201/AtEase study: Retrospective analysis of Tonmya 5.6 mg on CAPS-5 =33 (high-moderate) subgroup. Primary analysis of P201/AtEase, based on Tonmya 2.8 mg in participants with entry

  15. Slide 15: Primary Outcome (CAPS-5) in Phase 3 mITT and Time Since Trauma Subgroups

    © 2019 Tonix Pharmaceuticals Holding Corp. 15 Primary Outcome (CAPS-5) in Phase 3 (mITT) and =9 Years Time Since Trauma Subgroups Modified intent to treat (mITT) population Phase 3 P301/HONOR Study 1 **p=0.004, *p=0.039, # p=0.069, TNX-102 SL 5.6 mg group v. placebo, using MMRM with MI ~50% mITTPopu

  16. Slide 16: Sustained Remission in Phase 2 and Phase 3 Studies

    © 2019 Tonix Pharmaceuticals Holding Corp. 16 Sustained Remission in Phase 2 and Phase 3 Studies: Retrospective Analyses of P201 Entry CAPS-5 =33 and P301 =9 Years Since Trauma Subgroups Remission is a clinical state that is essentially asymptomatic In order to confirm remission: • Determined rates

  17. Slide 17: Adverse Events in P201/AtEase and P301/HONOR Studies

    © 2019 Tonix Pharmaceuticals Holding Corp. 17 Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious or unexpected AEs in P201 or P301 related to Tonmya • Systemic AEs comparable between studies and also consistent with those described in approved oral cyclobenzaprine product labeling

  18. Slide 18: New Phase 3 P302/RECOVERY Study

    © 2019 Tonix Pharmaceuticals Holding Corp. 18 New Phase 3 P302/RECOVERY Study – Initiated 1Q 2019 Primary endpoint: • CAPS-5 1 mean change from baseline at Week 4 (Tonmya5.6 mg vs. placebo) Key Secondary endpoints include: • CAPS-5 mean change from baseline at Week 12(Tonmya5.6 mg vs. placebo) • Cha

  19. Slide 19: Fibromyalgia as a Pain Alarm Malfunction

    © 2019 Tonix Pharmaceuticals Holding Corp. 19 Volkswagen Check Engine [Photograph]. (2011, October 14). Wikipedia • Pain is a sensor system in the brain similar to a check engine light on a car’s dashboard • When the check engine light malfunctions, the light is on even though the car is not malfunc

  20. Slide 20: Large Need for New Fibromyalgia Therapies

    © 2019 Tonix Pharmaceuticals Holding Corp. 20 Large Need for New Fibromyalgia Therapies that Provide Broad Symptom Improvement with Better Tolerability • Currently-approved medications may have side effects that limit long-term use 1 • Many patients skip doses or discontinue altogether within months

  21. Slide 21: TNX-1300 for the Treatment of Cocaine Intoxication

    © 2019 Tonix Pharmaceuticals Holding Corp. 21 TNX-1300* for the Treatment of Cocaine Intoxication Recombinant protein that degrades cocaine in the bloodstream 1 • Double-mutant cocaine esterase Phase 2 study completed by Rickett Benckiser (TNX-1300 was formerly RBP-8000) 2 • Volunteer cocaine abuser

  22. Slide 22: Cocaine Intoxication Is a Growing Problem in the U.S.

    Cocaine Intoxication Is a Growing Problem in the U.S. N a t i o n a l D r u g O v e r d o s e D e a t h s I n v o l v i n g C o c a i n e 0 5000 10000 15000 Cocaine is involved in more emergency department (ED) visits than any other illicit substance 1 Drug overdose deaths involving cocaine have inc

  23. Slide 23: Cocaine Intoxication Results from Activity at Multiple Targets

    Cocaine Intoxication Is the Result of Cocaine’s Activity at Multiple Targets 1. Brim et al. Mol Pharmacol. 2011. Psychosis Seizures Arrythmia Hypertension Hyperthermia The effects of cocaine intoxication include 1 : In addition to dopamine transporters, cocaine also blocks other targets 1 Dopamine t

  24. Slide 24: Pharmacotherapies for Cocaine Intoxication Have Not Been Effective

    © 2019 Tonix Pharmaceuticals Holding Corp. 24 Pharmacotherapies for Cocaine Intoxication Have Not Been Effective 1. Brim et al. Mol Pharmacol. 2011. 2. Melicharet al. Eur J Phamacol. 2003. 3. Narasimhan et al. Future Medicinal Chemistry.2012. Opiates Simple; mediated by opioid receptors 2 Agonists 2

  25. Slide 25: TNX-1300 Is a Fast-acting Cocaine Antidote

    © 2019 Tonix Pharmaceuticals Holding Corp. 25 TNX-1300 (Cocaine Esterase or CocE) Is a Fast- acting Cocaine Antidote CocE Rhodococcus bacteria living in the roots of the coca plant use CocE to metabolize cocaine 1 CocE cleaves chemical bonds in cocaine and disintegrates it 800 times faster than the

  26. Slide 26: TNX-1300 Accelerates Recovery From Cocaine Intoxication in Humans

    © 2019 Tonix Pharmaceuticals Holding Corp. 26 TNX-1300 cleaves cocaine in humans and removes it from the blood circulation 1 (N=29) T i m e R e q u i r e d t o R e t u r n t o B a s e l i n e ( m i n u t e s ) 120 0 240 Pulse Rate Diastolic Blood Pressure Systolic Blood Pressure 60 180 Time (minutes

  27. Slide 27: TNX-601 (Tianeptine Oxalate): A Potential Clinical Candidate for PTSD

    © 2019 Tonix Pharmaceuticals Holding Corp. 27 TNX-601 (TianeptineOxalate): A Potential Clinical Candidate for PTSD Pre-IND Candidate Targeted as a 1 st line monotherapy for PTSD: oral formulation for daytime dosing xLeverages expertise in PTSD (clinical and regulatory experience, market analysis, et

  28. Slide 28: TNX-801: A Smallpox-Preventing Vaccine Candidate

    © 2019 Tonix Pharmaceuticals Holding Corp. 28 TNX-801 (Synthesized Live Horsepox Virus): A Smallpox-Preventing Vaccine Candidate Pre-IND Stage Potential improvement over current biodefense tools against smallpox ? Leverages Tonix’sgovernment affairs effort ? Collaboration with Professor David Evans

  29. Slide 29: Milestones – Recently Completed and Upcoming

    © 2019 Tonix Pharmaceuticals Holding Corp. 29 Milestones –Recently Completed and Upcoming □ November2018 Received FDA minutes confirming agreement on the design of P302/RECOVERY study □ March 2019 Met with FDA to discuss new FM Phase 3 study design using TNX-102 SL 5.6 mg □ March 2019 P302/RECOVERY

  30. Slide 30: Summary

    © 2019 Tonix Pharmaceuticals Holding Corp. 30 Summary Two Phase 3 Programs in indications affecting millions of Americans • Tonmyafor PTSD: affects 12 million adults in U.S.; currently conducting Phase 3 trial with data expected next year; bedtime treatment • TNX-102 SL for Fibromyalgia: affects bet

  31. Slide 31: Thank you!

    © 2019 Tonix Pharmaceuticals Holding Corp. 31 Thank you! NASDAQ: TNXP

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