Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (November 2012)
23 slides from Tonix Pharmaceuticals's investor presentation, Nov 5, 2012
Slide 1: Corporate Presentation November 2012
Corporate Presentation November 2012 OTC/QB: TNXP
Slide 2: Disclosures
TONIX PHARMACEUTICALS 2 CONFIDENTIAL TONIX PHARMACEUTICALS 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 3 Company Overview • Developing novel medications for challenging disorders of the central nervous system (CNS) - Large and underserved indications • Pivotal trial in fibromyalgia (FM) to report in 2013 - Phase 2 data demonstrated efficacy - Unique, non - addictive treatment ap
Slide 4: Experienced Leadership
TONIX PHARMACEUTICALS 4 CONFIDENTIAL TONIX PHARMACEUTICALS Experienced Leadership Selected Previous Corporate Affiliations Selected Previous Product Affiliations Seth Lederman, MD CEO & Chairman • Vela • Targent • Validus • Fontus Leland Gershell, MD, PhD CFO • Cowen • Apothecary Capital • Favus Res
Slide 5: Accomplished Independent Board
TONIX PHARMACEUTICALS 5 CONFIDENTIAL TONIX PHARMACEUTICALS 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 6 CONFIDENTIAL 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 (Post - Traumatic Stress Disorder) • C yclobe
Slide 7: Fibromyalgia
TONIX PHARMACEUTICALS 7 • Chronic pain syndrome - Central pain – originates in the CNS - 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 s
Slide 8: Fibromyalgia Market Opportunity
TONIX PHARMACEUTICALS 8 CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia Market Opportunity • ~5 million U.S. patients* • U.S. prescription drug market in 2011 ~$1.4 billion** - 2007 – 2011 CAGR of 17%** • First approved drug for fibromyalgia in 2007 • Market growth driven by on - label drugs replaci
Slide 9: Managed Care Perspective on FM
TONIX PHARMACEUTICALS 9 Managed Care Perspective on FM • 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 11 CONFIDENTIAL TONIX PHARMACEUTICALS Sleep Quality: Validated Target in FM • 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 Phas
Slide 12: Bedtime Cyclobenzaprine: FM Phase 2 Overview
TONIX PHARMACEUTICALS 12 CONFIDENTIAL TONIX PHARMACEUTICALS Bedtime Cyclobenzaprine: FM Phase 2 – Overview • Double blind, randomized, placebo controlled • 36 fibromyalgia patients; 18 per arm - Very low dose cyclobenzaprine (VLDC) or placebo taken between dinner and bedtime daily • Eight - week, do
Slide 13: Bedtime Cyclobenzaprine: FM Phase 2 Efficacy
TONIX PHARMACEUTICALS 13 -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% Bedtime Cyclobenzaprine: FM Phase 2 – Efficacy • Change from baseline at week eight 13
Slide 14: Cyclobenzaprine: Impressive Safety, Widely Used
TONIX PHARMACEUTICALS 14 CONFIDENTIAL TONIX PHARMACEUTICALS Cyclobenzaprine: Impressive Safety, Widely Used • Not a controlled substance • No recognized addictive potential * Carette et al., Arthritis & Rheumatism January 1994 Timeframe Cyclobenzaprine History 1977 • Flexeril® (Merck) FDA approved f
Slide 15: Current CBP Products Not Optimal for Chronic Fibromyalgia Treatment
TONIX PHARMACEUTICALS 15 Current CBP Products Not Optimal for Chronic Fibromyalgia Treatment • Current daytime regimens poorly suited for FM - Chronic daytime cyclobenzaprine may confound long - term efficacy • Current doses poorly suited for bedtime use - Off - label use of available doses of cyclo
Slide 16: TNX-102 SL: First-in-Class Fibromyalgia Medicine
TONIX PHARMACEUTICALS 16 CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102 SL : First - in - Class Fibromyalgia Medicine • Chronic bedtime dosing - Drug exposure during the night to target non - restorative sleep • Lower dose than available CBP tablets - Tailored to reduce next - morning grogginess • Pro
Slide 17: TNX-102 SL: Sublingual CBP Tablet
TONIX PHARMACEUTICALS 17 CONFIDENTIAL 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 p4
Slide 18: TNX-102 SL: Pivotal Development in FM
TONIX PHARMACEUTICALS 18 CONFIDENTIAL 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 e
Slide 19: TNX-102 SL: Sublingual CBP for PTSD
TONIX PHARMACEUTICALS 19 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 PT
Slide 20: Upcoming Milestones
TONIX PHARMACEUTICALS 20 CONFIDENTIAL TONIX PHARMACEUTICALS Timing Milestones Related to Fibromyalgia 4Q 2012 • Manufacture commercial tablets 1Q 2013 • Commence first pivotal trial 4Q 2013 • Topline results from first pivotal trial • Evaluate partnership opportunities Timing Milestones Related to P
Slide 21: TNX-102 SL: Intellectual Property
TONIX PHARMACEUTICALS 21 CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102 SL: Intellectual Property • Pharmacokinetics (PK) - Patent filed around unique PK profile • Surprising and unexpected observations • Protection expected through 2033 - Difficult patent class to circumvent • Method of Use - FM: iss
Slide 22: Investment Highlights
TONIX PHARMACEUTICALS 22 Investment Highlights • Developing novel medications for challenging disorders of the central nervous system - Large and underserved indications • Pivotal trial in fibromyalgia to report in 2013 - Phase 2 data demonstrated efficacy - Unique, non - addictive treatment approac
Slide 23: Ta NTY
Ta NTY ! N LA PHARMACEUTICALS OTC/QB: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (November 2012) on 6ix