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Anxiety Disorder PTSD Awareness Day October 26, 2016 Welcome & Introduction Seth Lederman, MD Version P0035 10-24-16 © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 2 Safe Harbor Statement 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 identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain U.S. Food and Drug Administration clearances or approvals and noncompliance with its regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. The forward-looking statements in this presentation are made as of the date of this presentation, even if subsequently made available by the Company on its website or otherwise. Tonix does not undertake an obligation to update or revise any forward-looking statement, except as required by law. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2016, and future periodic reports filed with the SEC on or after the date hereof. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 3 Presenters Introductions and Disclosures • Seth Lederman, MD – Tonix Pharmaceuticals President & CEO • Jonathan Davidson, MD – Emeritus Professor, Duke University • Thomas Mellman, MD – Professor, Howard University • Gregory Sullivan, MD – Tonix Pharmaceuticals Chief Medical Officer © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 4 Tonix Pharmaceuticals at a glance Posttraumatic Stress Disorder (PTSD) – TNX-102 SL* Phase 2 trial reported data in May 2016 • Primary focus- PTSD Phase 3 clinical program – Planning to start Phase 3 in Q1 2017 – Targeting interim analysis topline 2H2017 • Discontinued fibromyalgia development – Narrowly missed primary endpoint in first Phase 3 study (September 2016) – Strong effects on sleep quality measures – Redirected resources to PTSD *TNX-102 SL is an Investigational New Drug and has not been approved for any indication. © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 5 Management Team Seth Lederman, MD President & CEO Bruce Daugherty, PhD, MBA Chief Scientific Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer Jessica Morris EVP, Operations © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 6 Board of Directors Seth Lederman, MD Ernest Mario, PhD Chairman ALZA, Glaxo, Reliant Pharma Stuart Davidson Charles Mather Labrador Ventures, Alkermes, Combion BTIG, Janney, Jefferies, Cowen, Smith Barney Patrick Grace John Rhodes Apollo Philanthropy, WR Grace, Chemed NYSERDA, NRDC, Booz Allen Hamilton Donald Landry, MD, PhD Samuel Saks, MD Chair of Medicine, Columbia University Jazz Pharma, ALZA, Johnson & Johnson © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 7 PTSD milestones – recent and upcoming TNX-102 SL – PTSD Dec. 2015 Entered into Collaborative Research and Development Agreement (CRADA) with the United States Army Medical Materiel Development Activity (USAMMDA) May 2016 Report results from AtEase study Aug. 2016 End-of-Phase 2 meeting with FDA - Proposed Phase 3 clinical and NDA plan accepted - Breakthrough Therapy Designation Request can be submitted for review Q1 2017 Target commencement of Phase 3 study in military-related PTSD 2H 2017 Topline data from interim analysis of Phase 3 study in ~180 military-related PTSD patients © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute st 8 History of PTSD in the 21 century I V PTSD in the Cyclobenzaprine and 21st century the potential efficacy of TNX-102 SL II IV The neurobiology The current of PTSD treatment landscape III Sleep and PTSD © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 9 References to PTSD have appeared in literature for more than 1,000 years1 The Iliad Henry IV, Part I The Red Badge of Courage Homer William Shakespeare Stephen Crane ca 8th Century BC ca AD 1598 Published AD 1895 Terms referring to PTSD as: “…soldier’s heart…” “…traumatic neurosis…” “…shell shock…” “…combat fatigue…” 1Stein D, Friedman M, Blanco C, eds. Post-traumatic Stress Disorder. 1st ed. John Wiley & Sons, Ltd.; 2011 © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute The classification of PTSD 10 has evolved over time1 Recognition of PTSD in the Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-I DSM-II DSM-III DSM-IV DSM-5 1952 1968 1980 1994 2013 1950 1960 1970 1980 1990 2000 2010 Gross Stress Omitted PTSD classified PTSD classified as Reaction as an Anxiety a Trauma- and “Stress response to an Disorder Stressor-Related 2 exceptional Disorder physical or mental stress” 1Andreasen, N.C. Annals of the New York Academy of Sciences. 2010; 2American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute The DSM-5 (2013) introduced significant 11 changes to the diagnostic criteria for PTSD Diagnostic Criteria for PTSD (DSM-5) The “A” stressor A. Exposure to actual or threatened death, serious injury or criteria refined and sexual violence now excludes 1. Directly experienced criterion for 2. Witness in person individual’s response 3. Indirectly (close family member or friend) 4. Repeated or extreme exposure (e.g. first responders) to the event B. Presence of one (or more) intrusion symptoms Avoidance separated C. Persistent avoidance of stimuli associated with traumatic event from negative cognitions and mood D. Negative alterations in cognitions and mood E. Marked alterations in arousal and reactivity F. Duration of disturbance (Criteria B-E) is more than 1 month Reckless and self- destructive behavior G. Disturbance causes clinically significant distress or impairment added H. Disturbance not attributable to physiological effects of a substance or medication American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013. © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute Evolving cultural and professional 12 perceptions Abnormal response Normal response to to normal trauma abnormal trauma © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute High prevalence of PTSD 13 among combat veterans Prevalence of PTSD 2-8% 19-31% 10-21% General population1 Vietnam veterans2 Operation Enduring Freedom (OEF; Afghanistan) / Operation Iraqi Freedom 8.6 million American adults affected5 (OIF) veterans3,4 Women more likely to develop than men5 Susceptibility may run in families5 1Kessler, Arch Gen Psych 2005; 2Norris, PTSD Res Quar. 2013; 3Tanielan, Invisible wounds of war. 2005; 4CBO Report 2012; 5http://www.nimh.nih.gov/health/topics/post-traumatic-stress-disorder-ptsd/index.shtml © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute 14 PTSD Prevalence and Market Characteristics Prevalent Population (U.S.) ~8.6 million1 Rx 510,000 6% Veterans Treated in VA3,4 Undiagnosed No Rx 6,788,000 79% 128,000 Diagnosed population 2% Large population (~1.8 million) Majority receive drug treatment Rx Civilians: ~75%2 872,000 Veterans: ~80%4 10% Civilians No Rx Population2 288,000 3% 1Kessler, et al., 2005; ; Prevalence rate of 3.5% applied to U.S. Census estimate of 247 million U.S. adult (>18) population in 2015 (www.census.gov/quickfacts/table/PST045215/00) 2IMS Consulting, Market Sizing & Treatment Dynamics: Posttraumatic Stress Disorder (PTSD) Patients", 2016 3Bowe and Rosenheck, 2015 ((638,451 veterans diagnosed with PTSD in the VA in fiscal year 2012 across all medical centers) 4Bernardy et al., 2012 (80% of veterans diagnosed with PTSD had at least one medication from the Clinical Practice Guidelines) © Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute Growing economic and social burden 15 to care for veterans with PTSD Health care costs associated with PTSD for OEF/OIF veterans: Direct costs Indirect costs $6,000-10,000 $2-3 billion per patient per year for estimated yearly cost OEF/OIF Veterans1 to society2 > 2 million Families, social care soldiers deployed since agencies,
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