Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (September 2012)
23 slides from Tonix Pharmaceuticals's investor presentation, Sep 19, 2012
Slide 1: Corporate Presentation September 2012
Corporate Presentation September 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 Company Overview 3 • Developing novel drugs for chronic pain syndromes - Large and underserved indications - Unique, non - addictive treatment approach – targets sleep quality • Pivotal trial in fibromyalgia (FM) to report in 2013 - Phase 2 data demonstrated efficacy • Capital
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 SL Fibromyalgia • C yclobenzaprine (CBP) in sublingual formulation • First pivotal t rial to begin 1Q 2013 • Topline results in 4Q 2013 PTSD • C yclobenzaprine in sublingual formulation • Proof of conc
Slide 7: Fibromyalgia
TONIX PHARMACEUTICALS • Chronic pain syndrome - Central pain – originates in brain - Despite three FDA - approved medications, patients are dissatisfied • Complaint: “Hurt all over, can’t sleep” - No benefit from opiates or prescription sleep drugs • FDA primary endpoint is pain • Problem with sleep
Slide 8: Fibromyalgia Market Opportunity
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Fibromyalgia Market Opportunity • ~5 million U.S. patients* • U.S. prescription drug market in 2011 ~$1.4 billion** - 2007 - 2010 CAGR of 18.4%*** • First approved drug for fibromyalgia in 2007 • Market growth driven by on - label drugs replacing legacy of
Slide 9: Managed Care Perspective on FM
TONIX PHARMACEUTICALS Managed Care Perspective on FM 9 • Fibromyalgia presents a significant economic burden - Studies show high cost in overall care, lost productivity, and disability • Physicians and payors are aware of high unmet need in pharmacological treatment of fibromyalgia - Patients take m
Slide 10: Evolution of Fibromyalgia Market
TONIX PHARMACEUTICALS 10 Legacy Off - Label Abandoned In Development FDA Approved Sleep • cyclobenzaprine • muscle relaxants • sodium oxybate (Xyrem®)* • sodium oxybate (Rekinla®)** • TNX - 102 SL (Phase 3 ready) Pain • gabapentin • opioids • Effirma TM (Phase 2) Mood • venlafaxine • bupropion Evolu
Slide 11: Sleep Quality: Validated Target in FM
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Sleep Quality: Validated Target in FM 11 • TNX - 102 SL will be a first - in - class FDA - approved medication targeting sleep quality for the “management of FM” • By targeting sleep quality, Rekinla demonstrated powerful efficacy in both Phase 3 studies (
Slide 12: Bedtime Cyclobenzaprine: FM Phase 2a – Overview
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Bedtime Cyclobenzaprine: FM Phase 2a – Overview • Double blind, randomized, placebo controlled • 36 fibromyalgia patients; 18 per arm - Cyclobenzaprine or placebo taken between dinner and bedtime daily • Eight - week, dose escalating study, fr
Slide 13: Bedtime Cyclobenzaprine: 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% 13 Bedtime Cyclobenzaprine: FM Phase 2a – Efficacy • Change from baseline at week eight
Slide 14: Cyclobenzaprine: Impressive Safety, Widely Used
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Cyclobenzaprine: Impressive Safety, Widely Used • Not a controlled substance • N o recognized addictive potential 14 * Carette et al., Arthritis & Rheumatism January 1994 Timeframe Cyclobenzaprine History 1977 • Flexeril® (Merck) FDA approved
Slide 15: Current Cyclobenzaprine Products Not Optimal for Fibromyalgia
TONIX PHARMACEUTICALS Current Cyclobenzaprine Products Not Optimal for Fibromyalgia 15 • Loss of efficacy in fibromyalgia with chronic use - Benefit at month 1 lost by month 6* • Current formulations poorly - suited for bedtime dosing - Slow uptake via oral route - ~2 hours before cyclobenzaprine is
Slide 16: TNX-102 SL: First-in-Class Fibromyalgia Medicine
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102 SL : First - in - Class Fibromyalgia Medicine • Optimized for chronic bedtime dosing - Sublingual transmucosal delivery - Designed for rapid onset and decreased next - morning hangover - Drug exposure better matched to sleeping period • Avoids ‘f
Slide 17: TNX-102 SL: Sublingual CBP Tablet
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102 SL: Sublingual CBP Tablet • Faster absorption • Bypasses liver “first - pass” metabolism Cyclobenzaprine p450 Metabolism To feces Liver Dose Absorption Norcyclobenzaprine Sublingual Oral Dose Swallowed Oral Dose Cyclobenzaprine p450 Metabolism Br
Slide 18: TNX-102 SL: Pivotal Development in FM
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102 SL: Pivotal Development in FM • First Phase 3 efficacy trial to begin in 1Q 2013 - Randomized, double blind, placebo controlled, 76 patients; 8 - 10 U.S. centers - 12 - week treatment period, daily bedtime dosing - Pre - defined efficacy endpoint
Slide 19: TNX-102 SL: Sublingual CBP for PTSD
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102 SL: Sublingual CBP for PTSD • Patients experience disturbed sleep and widespread pain - Painkiller abuse and addiction is common • 3.5% of U.S. adult population has suffered from PTSD in past 12 months* - Experiencing any trauma can lead to PTSD
Slide 20: Upcoming Milestones
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS 20 Timing Milestones Related to Fibromyalgia Q4 2012 • Manufacture commercial tablets Q1 2013 • Commence first pivotal trial Q4 2013 • Topline results from first pivotal trial • Evaluate partnership opportunities Timing Milestones Related to P
Slide 21: Intellectual Property
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Intellectual Property • Pharmacokinetics (PK) - Patent filed around unique PK profile with sublingual (June 2012) • Surprising and unexpected observations • Protection expected through 2033 - Difficult patent class to circumvent • Method of Us
Slide 22: Investment Highlights
TONIX PHARMACEUTICALS • Developing novel drugs for chronic pain syndromes - Large and underserved indications - Unique, non - addictive treatment approach – targets sleep quality • Pivotal trial in fibromyalgia to report in 2013 - Phase 2 data demonstrated efficacy • Capital - efficient strategy mit
Slide 23: = Wes
= Wes IONIA | PHARMACEUTICALS OTC/QB: TNXP
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