Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (July 2012)
29 slides from Tonix Pharmaceuticals's investor presentation, Jul 30, 2012
Slide 1: Corporate Presentation July 2012
Corporate Presentation July 2012 OTC/QB: TNXP
Slide 2: Disclosures
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS 2 Disclosures 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
Slide 3: Company Overview
TONIX PHARMACEUTICALS • Specialty pharmaceutical company developing innovative non - addictive products for chronic pain syndromes - Fibromyalgia syndrome (FM ) - Post - traumatic stress disorder (PTSD) • Unmet medical needs and large commercial opportunities - Targets sleep pathology - Central pain
Slide 4: Experienced Leadership
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS 4 Experienced Leadership Selected Previous Corporate Affiliations Selected Previous Product Affiliations Seth Lederman, MD CEO & Chairman • Vela • Targent • Validus • Fontus Benjamin Selzer COO • Reliant • Aton • Investment Banking (Lehman, Bo
Slide 5: Accomplished Independent Board
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS 5 Accomplished Independent Board Selected Current & Previous Affiliations Selected Previous Product Affiliations Seth Lederman, MD Chairman • Vela • Targent • Validus/Fontus Stuart Davidson • Alkermes • Combion Patrick Grace • WR Grace • Cheme
Slide 6: Product Pipeline
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Product Pipeline 6 Product Indication Status TNX - 102 FM • Very low dose cyclobenzaprine (VLDC) in novel formulation • Phase 2a successfully completed • Pivotal t rial expected to begin Q1 2013 TNX - 105 PTSD • VLDC in novel formulation • Will leverage da
Slide 7: FM Market Opportunity
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS FM Market Opportunity • ~5 million U.S. patients* • U.S. prescription drug market estimated at $1.4 billion** - 2007 - 2010 CAGR of 18.4%*** • First approved drug for FM in 2007 - Lyrica® (Pfizer) approved 2007: $450 million in FM sales in 2011** - Cymbalt
Slide 8: FM Market Dynamics
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS FM Market Dynamics • No FDA approved drugs until 2007 • Market growth driven by on - label drugs replacing off - label generics* - Lyrica replacing off - label generic analgesics - Cymbalta and Savella replacing off - label generic anti - depressants • Dru
Slide 9: Fibromyalgia: A Vicious Cycle
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Fibromyalgia: A Vicious Cycle 9 • 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 Sleep No
Slide 10: Novel Mechanism in FM Treatment
TONIX PHARMACEUTICALS 10 Off - Label Abandoned In Development Approved Sleep • cyclobenzaprine • muscle relaxants • sodium oxybate (Xyrem®) • sodium oxybate (Rekinla®) • TNX - 102 (Phase 3 ready) Pain • gabapentin • opioids • Effirma TM (Phase 2) Mood • venlafaxine • bupropion Novel Mechanism in FM
Slide 11: TNX-102: Optimizing Cyclobenzaprine for Fibromyalgia
TONIX PHARMACEUTICALS TNX - 102: Optimizing Cyclobenzaprine for Fibromyalgia 11 • Cyclobenzaprine widely used off - label in FM • Current doses and formulations poorly suited for FM - Long half - life contributes to somnolence and accumulation - Lowest approved daily dose is 15 mg • Phase 2a trial o
Slide 12: Cyclobenzaprine: Impressive Safety, Widely Used
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Cyclobenzaprine: Impressive Safety, Widely Used • Off - label cyclobenzaprine is the third most widely prescribed medication for FM* • 1977: FDA approved Flexeril® (Merck) • 1990s: Extensive safety and efficacy studies (Merck) • 2007: FDA appr
Slide 13: Relationship between Sleep and FM
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Relationship between Sleep and FM • FM patients complain of poor sleep - Non - restorative sleep exacerbates FM symptoms • Cyclic alternating pattern (CAP) is an objective physiological measure of the quality of sleep - A2, A3 patterns = indic
Slide 14: Sodium Oxybate Data in FM & Sleep
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Sodium Oxybate Data in FM & Sleep • Jazz Pharmaceuticals was developing sodium oxybate for FM • Phase 3 trials demonstrated highly significant improvements in fibromyalgia symptoms Study Treatment n Responders* n (%) p - value (chi - square) P
Slide 15: VLDC FM Phase 2a – Overview
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS VLDC FM Phase 2a – Overview • Published in Journal of Rheumatology * December 2011 • Harvey Moldofsky, MD – lead investigator (University of Toronto) • Patients with documented FM • Double blind, randomized, placebo controlled • 36 patients; 1
Slide 16: VLDC FM Phase 2a – Endpoints
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS VLDC FM Phase 2a – Endpoints • Endpoints consistent with ACR* and OMERACT** guidelines • Pain (Visual Analog Scale) and fatigue assessed ̴ 24 hours following each dose • Tenderness assessed via dolorimetry • Mood assessed via Hospital Anxiety
Slide 17: VLDC FM Phase 2a – Demographics
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Characteristic VLD C (n = 18) Placebo (n = 18) Sex, n (%) Male 0 (0) 1 (6) Female 18 (100) 17 (94) Age, yrs , mean (SD) range 45.9 (11.4) 26 - 62 39.3 (9.3) 23 - 56 Race (white, non - Hispanic) (%) 18 (100) 18 (100) Weight, kg, mean (SD) range
Slide 18: VLDC FM Phase 2a – Efficacy
TONIX PHARMACEUTICALS -35% -30% -25% -20% -15% -10% -5% 0% 5% 10% 15% Percent Change from Baseline VLDC Placebo p=0.010 p=0.039 p=0.006 p=0.012 p=0.017 Fatigue HAD HAD Depression Pain Tenderness 0% 18 VLDC FM Phase 2a – Efficacy • Change from baseline at week eight
Slide 19: VLDC Phase 2a FM – Sleep Data
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS VLDC Phase 2a FM – Sleep Data VLDC CAP A2+A3(Norm) Correlation Variable r p Fatigue 0.617 0.006 HAD score 0.505 0.033 HAD depression subscore 0.556 0.017 Patient - rated change in fatigue 0.614 0.007 Clinician - rated change in fatigue 0.582 0
Slide 20: TNX-102: Sublingual Cyclobenzaprine
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102: Sublingual Cyclobenzaprine • Specifically designed for the treatment of FM - Human PK study of sublingual solution version of proprietary tablet showed rapid transmucosal absorption • Faster and more efficient absorption - First - in - class sle
Slide 21: TNX-102: Sublingual Cyclobenzaprine
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102: Sublingual Cyclobenzaprine • Faster absorption • Bypasses GI tract “first pass” metabolism Cyclobenzaprine To feces Liver Dose Swallowed Oral Dose Cyclobenzaprine Portal Vein Gut Wall Hepatic Vein/Inf. Vena Cava Sublingual Oral Dose Brain
Slide 22: TNX-102: Pivotal Development
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: Pivotal Development • First pivotal efficacy trial in fibromyalgia to begin in Q1 2013 - 12 - week study, 150 patients per arm - Study design and endpoints to mirror those used by Lyrica and Cymbalta • Pain and a composite endpoint
Slide 23: TNX-102: Unique Market Position
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: Unique Market Position • Specifically designed for the treatment of FM • Differentiated from / not competitive with other therapies - First - in - class sleep quality treatment indicated for bedtime dosing - Restorative sleep shown
Slide 24: TNX-105: VLDC for PTSD
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 105: VLDC for PTSD • 3.5% of U.S. adult population has 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 formula
Slide 25: FM & PTSD are Related Conditions
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS FM & PTSD are Related Conditions • Symptom overlap - 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 vice versa • PT
Slide 26: Intellectual Property
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Intellectual Property • Active patenting strategy to extend VLDC exclusivity • Pharmacokinetics - Patent filed around unique PK profile with sublingual (June 2012) • Surprising and unexpected observations - Difficult patent class to circumvent
Slide 27: Upcoming Milestones
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS 27 Timing Milestones Related to TNX - 102 in Fibromyalgia Q3 2012 • Completion of human PK study on proprietary formulation Q4 2012 • Completion of human PK/PD on commercial formulation, dose Q1 2013 • Commencement of first pivotal trial H1 2014 • Final st
Slide 28: Investment Summary
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Investment Summary • Significant unmet needs and large market opportunities • First - in - class products; not competitive with existing therapies • Capital efficient, low risk drug development strategy • Near - term value inflection points •
Slide 29: OTC/QB: TNXP
TONIX PHARMACEUTICALS OTC/QB: INXP
Tonix Pharmaceuticals Holding — Investor Presentation (July 2012) on 6ix