Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (June 2012)
20 slides from Tonix Pharmaceuticals's investor presentation, Jun 12, 2012
Slide 1: Corporate Presentation June 12, 2012
Corporate Presentation June 12, 2012 OTC/QB: TNXP
Slide 2: Forward-looking Statements
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Forward - looking Statements The statements and discussions contained in this presentation that are not historical facts constitute forward - looking statement s. These can be identified by the use of forward - looking words, such as “believes
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 - Targeting sleep pathology - Central pa
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 Leland Gers
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 • Completing formulation to take into first pivotal trial • T rial expected to begin Q1 2013 TNX - 105 P
Slide 7: FM Market Opportunity
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS FM Market Opportunity • ~5 million U.S. patients* • U.S. prescription drug market estimated at $1.2 billion** - 2007 - 2010 CAGR of 18.4 %** • No FDA approved drugs until 2007 - Lyrica (Pfizer) approved 2007: replacing off - label generic analgesics - Cymb
Slide 8: Novel Mechanism in FM Treatment
TONIX PHARMACEUTICALS 8 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 T
Slide 9: Impressive Safety, Widely Used
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS 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 approved controlled -
Slide 10: VLDC FM Phase 2a Results
TONIX PHARMACEUTICALS Change from Baseline (week 8): tenderness measured by dolorimetry; HAD is the Hospital Anxiety and Depression Scale; HAD Depression is the HAD depression subscale -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
Slide 11: Addressing the Limitations of Cyclobenzaprine for Fibromyalgia
TONIX PHARMACEUTICALS TNX - 102: Addressing the Limitations of Cyclobenzaprine for Fibromyalgia 11 • Cyclobenzaprine currently widely used off label in the management of FM • Current dose and formulation not optimal for FM - Long half life contributes to somnolence and accumulation - Lowest approved
Slide 12: 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 FM therapies - First - in - class sleep quality treatment indicated for bedtime dosing - Restorative sleep sho
Slide 13: Development Plan
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: Development Plan • Formulation and PK trials - 30 - subject, 3 - week PK study on first version completed - Completion of PK study on second version expected in September 2012 - Pharmacodynamic study contemplated by year - end • Piv
Slide 14: 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 15: 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 16: Intellectual Property
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Intellectual Property • Active patenting strategy to extend exclusivity - Plan to file patents around unique PK profiles, which are a difficult patent class to circumvent • TNX - 102 - Methods of Use patents for use of VLDC in treatment of FM
Slide 17: Financial Information
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS 17 OTC/QB ticker TNXP Shares outstanding (in millions)* 34.3 Cash balance as of 3/31/12 (in millions) $2.5 52 - week trading range (as of 5/31/12)** $0.98 - $2.06 * As of 5/31/12 ** Stock first traded in February 2012 Financial Information
Slide 18: Upcoming Milestones
TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS 18 Timing Milestones Related to TNX - 102 Q2 2012 • PK study on second formulation Q3 2012 • PK/PD on “commercial” formulation and dose Q1 2013 • Commencement of initial pivotal trial Q3 2013 • Interim look at initial pivotal trial data H1 2014 • Final stu
Slide 19: 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 20: NIA
TONIX NIA | PHARMACEUTICALS OTC/QB: TNXP
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