Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (April 2012)
21 slides from Tonix Pharmaceuticals's investor presentation, Apr 5, 2012
Slide 1: Corporate Presentation April 2012
Corporate Presentation April 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 Pharmaceuticals Summary
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TONIX Pharmaceuticals Summary • Specialty pharmaceutical company developing innovative products for high - value CNS indications • Lead programs target fibromyalgia syndrome (FM) and post traumatic stress disorder (PTSD) - Reformulated cyclobe
Slide 4: Experienced Leadership Management Team
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Experienced Leadership Management Team Seth Lederman, MD Founder, CEO, Chairman Co - founder, Vela, Targent, Validus, Fontus Benjamin Selzer Chief Operating Officer Aton, Reliant, investment banking (Lehman Brothers & Banc of America Securitie
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. fibromyalgia (FM) patients* • U.S. FM drug market estimated at $1.2 billion** - 2007 - 2010 CAGR of 18.4 %** • Until 2007, there were no FDA approved FM drugs - Lyrica ® (Pfizer) was approved f
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 maintenance of FM • TNX - 102 will be a first - in - class medication targeting disturbed or non - restorative sleep (NRS) in FM TNX - 102 Pain
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 • Interferes with sleep • Antidepressant categor
Slide 9: Drugs Used to Treat Fibromyalgia
TONIX PHARMACEUTICALS Drugs Used to Treat Fibromyalgia 9 • Off - label drugs dominate the sleep quality market but are approved as “muscle relaxants” • TNX - 102 is proposed as first - in - class sleep quality treatment Sleep Disturbance Pain Depressed Mood “Muscle Spasm” FDA Approved • Lyrica ( pre
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 • Merck developed and launched Flexeril ® in 1977 • O ver one billion tablets prescribed in 2010 • Extensive safety & efficacy studies conducted by Merck in 1990s • FDA approve
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: TNX-102: VLDC New Formulation
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: VLDC New Formulation • Designed for the treatment of fibromyalgia - Muscle relaxant products aim for stable high blood levels over 24 hours - Aiming for faster and more reliable absorption for FM - Designed for high blood levels dur
Slide 13: TNX-102: 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 - Follow - on PK Study expected to be completed in September 2012 • Following PK work, plan is to begin first pivotal
Slide 14: TNX-102: Compelling Risk / Reward Profile
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102: Compelling Risk / Reward Profile 14 Risk Factor Commentary FDA Risk - Safety • Cyclobenzaprine is one of the more widely prescribed pharmaceuticals; 1 billion tablets per year in the U.S. • FDA approved and prescribed since the 1970’s • Widely s
Slide 15: TNX-102: Compelling Risk / Reward Profile
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102: Compelling Risk / Reward Profile 15 • Short - term Monetization Focus - The first of two pivotal clinical trials to commence Q1 2013 - Initial “interim” data should be available by Q3 2013, with final study report available Q1 - Q2 2014 - Somewh
Slide 16: 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 • Leveraging
Slide 17: FM and PTSD - Related Conditions
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS FM and PTSD - Related Conditions • PTSD, like FM is characterized by groups of symptoms - Some patients with FM meet PTSD criteria - Some patients with PTSD meet FM criteria - Some are believed to suffer from both conditions simultaneously • O
Slide 18: TONIX Pharmaceuticals Pipeline
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TONIX Pharmaceuticals Pipeline • TONIX has a comprehensive pipeline of CNS products 18 Product Indication Status TNX - 102 Fibromyalgia • Very low dose cyclobenzaprine in novel formulation • Phase 2a successfully completed • PK trial in new formulation com
Slide 19: Exclusivity & Patents
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Exclusivity & Patents • TNX - 102 - Issued Methods of Use patents for use of VLDC in treatment of fibromyalgia with expiration mid - 2020 - Two issued formulation patents with expiration in mid - 2021 - Further patents on pharmacokinetics expe
Slide 20: Upcoming Milestones
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Upcoming Milestones 20 • Short and intermediate term value inflection milestones Timing Milestones Related to TNX - 102 April 2012 • Pharmacokinetic (PK) trial topline results Q2 2012 • PK study on second formulation Q3 2012 • PK/PD on “commercial” formula
Slide 21: 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
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