Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (November 2011)
20 slides from Tonix Pharmaceuticals's investor presentation, Nov 16, 2011
Slide 1: Corporate Presentation
Corporate Presentation November 2011
Slide 2: Disclosures
Disclosures o Forward-looking Statements The statements and discussions contained in this presentation that are not historical facts constitute forward-looking forward looking statements. statements These can be identified by the use of forward-looking words, such as “believes”, “expects”, “may”, “i
Slide 3: TONIX Pharmaceuticals Summary
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 cyclobenzaprine - Capital-efficient, C it l ffi i t llow-risk i k
Slide 4: Experienced Leadership
Experienced pe e ced Leadership eade s p Management Team Seth Lederman, MD Founder, F d CEO, CEO Chairman Ch i Co--founder, Vela, Targent, Validus, Fontus Co B j i Selzer Benjamin S l Chief Operating Officer Aton, Reliant, investment banking (Lehman Brothers & Banc of America Securities) Rhonda Rose
Slide 5: Accomplished Independent Board
Accomplished cco p s ed Independent depe de Board oa d 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 Ernest Mario,, PhD Former CEO of Gl
Slide 6: Fibromyalgia Market Opportunity
Fibromyalgia b o y g Market Oppo Opportunityy • 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 U til 2007, 2007 there th were no FDA approved d FM drugs d - Lyrica® (Pfizer) was approved for FM in 2007 an
Slide 7: Fibromyalgia: Vicious Cycle
Fibromyalgia: Vicious Cycle • Medications that target pain or depressed mood are approved pp for the maintenance of FM • TNX-102 will be a first-in-class medication targeting disturbed or non-restorative sleep (NRS) in FM Pain L i Lyrica Sleep Depressed Disturbance Mood TNX-102 No approved Cymbalta
Slide 8: Comparison of Fibromyalgia Drugs
Comparison Co p o oof Fibromyalgia b o y g Drugs g • Physicians often switch drugs when patients are dissatisfied • TNX-102 TNX 102 is i a first-in-class fi t i l bedtime b dti treatment t t t and d is i nott expected to compete with approved treatments Pipeline Treatments Approved Treatments • Anal
Slide 9: Cyclobenzaprine Has an Impressive Safety Record and is Widely Used
Cyclobenzaprine Has an Impressive Safety Record and is Widely Used • Merck developed and launched Flexeril® in 1977 • Over one billion tablets prescribed in 2010 • Extensive safety & efficacy studies conducted by Merck in 1990s • FDA approved controlled release products in 2007 (15 mg and 30 mg) • N
Slide 10: VLDC FM Pilot Study Results: Symptom Measures
VLDC FM Pilot Study Results: Symptom Measures* • Study published in Journal of Rheumatology Dec. 2011 • Lead investigator Harvey Moldofsky thought leader in FM 15% 10% 5% ecrent Changge from 0% Pain 0% Fatigue Tenderness HAD HAD Depression Baseline e -5% 5% VLDC -10% Placebo -15% p=0.039 -20% Pe -25
Slide 11: TNX-102: VLDC New Formulation
TNX-102: 0 VLDC C New Formulation o o • 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 during the night and lower levels the next day to redu
Slide 12: TNX-102: Development Plan
TNX-102: 0 Development op Plan • PK trial to begin 4Q 2011 and clinical phase will be completed l t d by b year-end d - 30 subjects; three week study - To be conducted by PharmaNet Canada Canada, a division of inVentive Health - TNX-102 vs. generic 5 mg tablet - TNX-102 fed/fasted - Expect different
Slide 13: TNX-102: Compelling Risk / Reward Profile
TNX-102: Compelling Ri k / Reward Risk R d Profile P fil • Low risk – safety, efficacy and demand established Risk Factor Commentary FDA Risk • Cyclobenzaprine is one of the more widely prescribed pharmaceuticals; 1 billion tablets - Safety per year in the U.S. • FDA approved d and d prescribed ib d
Slide 14: TNX-102: Compelling Risk / Reward Profile
TNX-102: Compelling Ri k / Reward Risk R d Profile P fil • Short-term Monetization Focus - The first of two pivotal clinical trials to commence Q3 2012 - Initial,l ““interim”, ”d data should h ld bbe available l bl b by Q1 2013, with h ffinall study d report available Q2-Q3 2013 - Somewhere between
Slide 15: TNX-105: VLDC for PTSD
TNX-105: 05 VLDC C for o PTSD S • 3 3.5% 5% of o U.S. U S adult adu t population popu at o will have a e suffered su e ed from o PTSD S in past 12 months* - Any trauma can lead to PTSD • Unsatisfied market - Only Zoloft® and Paxil® have FDA approval • Widespread painkiller abuse and addiction • Leve
Slide 16: FM & PTSD - Related Conditions
FM & PTSD S - Related d Co Conditions d o • PTSD, S , like e FM iss characterized c a acte ed by groups g oups of o symptoms sy pto s - Some patients with FM meet PTSD criteria - Some patients with PTSD meet FM criteria - Some are believed to suffer from both conditions simultaneously • Overlap of P
Slide 17: TONIX Pharmaceuticals Pipeline
TONIX O Pharmaceuticals Pipeline p • TONIX has a comprehensive pipeline of CNS products Product Indication Status TNX-102 Fibromyalgia • Very low dose cyclobenzaprine in novel formulation • Phase 2a successfully f completed • PK trial in new formulation expected completion YE 2011 • First of two piv
Slide 18: Exclusivity & Patents
Exclusivityy & Patents • TNX-102 - Issued Methods of Use patents for use of VLDC in treatment of fibromyalgia with expiration mid-2020 - Two issued formulation p patents with expiration p in mid-2021 - Further patents on pharmacokinetics expected to be filed in near term • TNX-105 - Filed Fil d M Me
Slide 19: Upcoming Milestones
Upcoming Milestones •S Short o t and a d intermediate te ed ate term te value a ue inflection ect o milestones esto es Timingg Milestones es o es Related e a ed to o TNX-102 0 December 2011 • Pharmacokinetic (PK) trial Jan-Feb 2012 • PK data analysis and new patent filings Q1 2012 • Announcement of
Slide 20: Why Invest in TONIX?
Why Invest in TONIX? • Capital p efficient drugg development p strategy gy 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-class treatment for FM and differentiated from generic cyclobenza
Tonix Pharmaceuticals Holding — Investor Presentation (November 2011) on 6ix