Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (May 2012)
20 slides from Tonix Pharmaceuticals's investor presentation, May 2, 2012
Slide 1: Corporate Presentation May 2012
Corporate Presentation May 2012 Ticker: TNXP.OB
Slide 2: Disclosures: Forward-looking Statements
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Disclosures Forward - looking Statements The statements and discussions contained in this presentation that are not historical facts constitute forward - looking statement s. These can be identified by the use of forward - looking words, such
Slide 3: Tonix Summary
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TONIX Summary • Specialty pharmaceutical company - Non - addictive treatments for chronic pain syndromes - Capital - efficient development strategy • Innovative products for high - value central nervous system (CNS) indications: - Fibromyalgia
Slide 4: Experienced Leadership Management Team
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Experienced Leadership Management Team Seth Lederman, MD Founder, CEO, Chairman Vela, Targent, Validus, Fontus Benjamin Selzer Chief Operating Officer Aton, Reliant, investment banking (Lehman Brothers & Banc of America Securities) Leland Gers
Slide 5: Accomplished Independent Board
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Accomplished Independent Board Board of Directors Seth Lederman, MD Founder, CEO, Chairman Stuart Davidson Former CEO of Alkermes & Combion Patrick Grace WR Grace, Chemed, Grace Institute Donald W. Landry, MD, PhD Columbia Chair of Medicine Er
Slide 6: Fibromyalgia Market Opportunity
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Fibromyalgia Market Opportunity • Approximately 5 million U.S. patients* • U.S. drug market estimated at $1.2 billion** - 2007 - 2010 CAGR of 18.4 %** • Until 2007, there were no FDA approved drugs - Lyrica (Pfizer) approved 2007: replacing off - label gen
Slide 7: Fibromyalgia: Vicious Cycle
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia: Vicious Cycle 7 • Medications that target pain or depressed mood are approved for the management of FM • TNX - 102 will be a first - in - class medication targeting disturbed or non - restorative sleep in FM TNX - 102 Pain Lyrica
Slide 8: Comparison of Fibromyalgia Drugs
TONIX PHARMACEUTICALS Comparison of Fibromyalgia Drugs Approved Treatments Pipeline Treatments • Antidepressant category • Suicidality warning • Taken 1 - 2 times a day • Interferes with sleep • Analgesic category • DEA scheduled • Taken 2 times a day • Antidepressant category • Suicidality warning
Slide 9: Drugs Used to Treat Fibromyalgia
TONIX PHARMACEUTICALS Drugs Used to Treat Fibromyalgia 9 • Off - label drugs dominate the sleep quality market - Approved as “muscle relaxants” • TNX - 102 to be first - in - class sleep quality treatment Non - restorative Sleep Analgesic / P ain Killers Anti - depressant Muscle Relaxants FDA Approv
Slide 10: Cyclobenzaprine Has an Impressive Safety Record and is Widely Used
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Cyclobenzaprine Has an Impressive Safety Record and is Widely Used • Off - label Cyclobenzaprine: third most widely prescribed medication for FM* • 1977: FDA approved Flexeril® (Merck) • 1990’s: Extensive safety & efficacy studies (Merck) • 20
Slide 11: VLDC FM Pilot Study Results: Symptom Measures
TONIX PHARMACEUTICALS VLDC FM Pilot Study Results: Symptom Measures * Change from Baseline (week 8): tenderness measured by dolorimetry; HAD is the Hospital Anxiety and Depression Scale; HAD Depression is the HAD depression subscale -35% -30% -25% -20% -15% -10% -5% 0% 5% 10% 15% Pecrent Change from
Slide 12: VLDC New Formulation
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: VLDC New Formulation • Specifically designed for the treatment of FM - Fast absorption - Elevated blood levels during the night to improve sleep quality - Low next - day blood levels to minimize morning somnolence • Differentiated f
Slide 13: Development Plan
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: Development Plan • Formulation and PK trials - PK Study on first version completed: 30 subjects; three week study - PK Study on second version: completion expected in September 2012 - Pharmacodynamic study contemplated by year - end
Slide 14: TNX-105: VLDC for PTSD
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 105: VLDC for PTSD • 3.5% of U.S. adult population will have suffered from PTSD in past 12 months* - Any trauma can lead to PTSD • Unsatisfied market - Only Zoloft® and Paxil® have FDA approval • Widespread painkiller abuse and addiction • Leverage f
Slide 15: FM and PTSD - Related Conditions
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS FM and PTSD - Related Conditions • Overlap of PTSD and FM symptoms - PTSD is thought to be exacerbated by non - restorative sleep - Some are believed to suffer from both conditions simultaneously - Some patients with FM meet PTSD criteria, and
Slide 16: Tonix Pharmaceuticals Pipeline
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TONIX Pharmaceuticals Pipeline • TONIX has a comprehensive pipeline of CNS products 16 Product Indication Status TNX - 102 Fibromyalgia • Very low dose cyclobenzaprine in novel formulation • Phase 2a successfully completed • Completing formulation to take
Slide 17: Intellectual Property
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Intellectual Property • Active patenting strategy to extend exclusivity - Plan to file patents around TONIX products’ unique PK profiles, which are a difficult patent class to circumvent • TNX - 102 - Methods of Use patents for use of VLDC in
Slide 18: Upcoming Milestones
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Upcoming Milestones 18 • Short and intermediate term value inflection milestones Timing Milestones Related to TNX - 102 Q2 2012 • PK study on second formulation Q3 2012 • PK/PD on “commercial” formulation and dose Q1 2013 • Commencement of initial pivotal
Slide 19: Why Invest in Tonix?
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Why Invest in TONIX? • Capital efficient drug development strategy focused on high - value, first - in - class products • FM and PTSD are significant unmet needs with large market opportunities • TNX - 102 is expected to be a first - in - clas
Slide 20: Financial Information
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Financial Information 20 Ticker TNXP:OTCQB Shares Outstanding (in millions) 34.3 Cash Balance at 12/31/11 (in millions)* $4.0 52 Week Trading Range (as of 4/30/12)** $0.99 - $2.06 * Pro - forma for the closing of a PIPE financing with net proc
Tonix Pharmaceuticals Holding — Investor Presentation (May 2012) on 6ix