Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (January 2013)
26 slides from Tonix Pharmaceuticals's investor presentation, Jan 28, 2013
Slide 1: Corporate Presentation
Corporate Presentation 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: TONIX Profile
TONIX PHARMACEUTICALS 3 CONFIDENTIAL TONIX PHARMACEUTICALS 3 Full Name: Tonix Pharmaceuticals Holding Corp. Ticker: TNXP (OTC/QB) Common Shares Outstanding: 43.2 million (as of January 1, 2013) 52 - week Trading Range*: $0.25 - $2.06 Auditor: EisnerAmper LLP Corporate Counsel: Sichenzia Ross Friedma
Slide 4: Company Overview
TONIX PHARMACEUTICALS 4 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 early 2014 - Phase 2 data demonstrated efficacy - Unique, non - addictive treatm
Slide 5: Experienced Leadership
TONIX PHARMACEUTICALS 5 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 6: Accomplished Independent Board
TONIX PHARMACEUTICALS 6 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 7: Product Pipeline
TONIX PHARMACEUTICALS 7 CONFIDENTIAL TONIX PHARMACEUTICALS Product Pipeline 7 Indication Product Status Fibromyalgia TNX - 102 SL • C yclobenzaprine (CBP) in sublingual formulation • First pivotal t rial to begin in 1H 2013 • Topline results expected in 1Q 2014 PTSD (Post - Traumatic Stress Disorder
Slide 8: Fibromyalgia SL Program
TONIX PHARMACEUTICALS 8 TONIX PHARMACEUTICALS 8 Fibromyalgia TNX - 102 SL Program:
Slide 9: Fibromyalgia
TONIX PHARMACEUTICALS 9 • Complex syndrome - Despite three FDA - approved medications, patients are dissatisfied - FDA primary endpoint is pain • Complaint: “Hurt all over, can’t sleep” - Central pain – originates in the CNS - Restorative sleep can improve pain and other symptoms - No benefit from o
Slide 10: Fibromyalgia Market Opportunity
TONIX PHARMACEUTICALS 10 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 replac
Slide 11: Managed Care Perspective on FM
TONIX PHARMACEUTICALS 11 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
Slide 12: Evolution of Fibromyalgia Market
TONIX PHARMACEUTICALS 12 Legacy Off - Label Abandoned In Development FDA Approved Sleep • cyclobenzaprine • muscle relaxants • sodium oxybate * • sodium oxybate ** (Phase 3) • TNX - 102 SL (Phase 3 ready) Pain • gabapentin • opioids • pregabalin CR (Phase 3) • flupirtine (Phase 2) Mood • venlafaxine
Slide 13: Sleep Quality: Validated Target in FM
TONIX PHARMACEUTICALS 13 CONFIDENTIAL TONIX PHARMACEUTICALS Sleep Quality: Validated Target in FM • TNX - 102 SL expected to be first - in - class FDA - approved product targeting sleep quality for the “management of FM ” • Cyclobenzaprine is FDA approved as a muscle relaxant but has off - label use
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 • FDA approved as Flexeril ® since 1977 for muscle spasm • Used off - label as slow - acting sleep aid in fibromyalgia • Not ap
Slide 15: Bedtime Cyclobenzaprine: FM Phase 2 Overview
TONIX PHARMACEUTICALS 15 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 16: Bedtime Cyclobenzaprine: FM Phase 2 Efficacy
TONIX PHARMACEUTICALS 16 -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 16
Slide 17: Current CBP Products Not Optimal for Chronic Fibromyalgia Treatment
TONIX PHARMACEUTICALS 17 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 18: SL: First-in-Class Fibromyalgia Medicine
TONIX PHARMACEUTICALS 18 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 19: SL: Sublingual CBP Tablet
TONIX PHARMACEUTICALS 19 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 20: SL: Pivotal Development in FM
TONIX PHARMACEUTICALS 20 CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102 SL: Pivotal Development in FM • First pivotal efficacy trial to begin in 1H 2013 - Randomized, double blind, placebo controlled - To enroll 100 - 200 patients; 8 - 10 U.S. centers - 12 - week treatment period, nightly bedtime dosi
Slide 21: Post-Traumatic Stress Disorder SL Program
TONIX PHARMACEUTICALS 21 TONIX PHARMACEUTICALS 21 Post - Traumatic Stress Disorder TNX - 102 SL Program:
Slide 22: SL: Sublingual CBP for PTSD
TONIX PHARMACEUTICALS 22 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 23: Upcoming Milestones
TONIX PHARMACEUTICALS 23 CONFIDENTIAL TONIX PHARMACEUTICALS Timing Milestones - Fibromyalgia 1H 2013 • Commence first pivotal trial 1Q 2014 • Topline results from first pivotal trial • Evaluate partnership opportunities Timing Milestones - PTSD 2H 2013 • Conduct proof of concept study in PTSD patien
Slide 24: SL: Intellectual Property
TONIX PHARMACEUTICALS 24 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 25: Investment Highlights
TONIX PHARMACEUTICALS 25 Investment Highlights • Developing novel medications for challenging disorders of the central nervous system - Large and underserved indications • Pivotal trial in fibromyalgia to report in early 2014 - Phase 2 data demonstrated efficacy - Unique, non - addictive treatment a
Slide 26: Tonix Pharmaceuticals
PHARMACEUTICALS OTC/QB: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (January 2013) on 6ix